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GLIVEC Tablets


1. Name Of The Medicinal Product

Glivec® 100 mg film-coated tablets

Glivec® 400 mg film-coated tablets

2. Qualitative And Quantitative Composition

Glivec 100 mg film-coated tablets: Each film-coated tablet contains 100 mg imatinib (as mesilate).

Glivec 400 mg film-coated tablets: Each film-coated tablet contains 400 mg imatinib (as mesilate).

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Glivec 100 mg film-coated tablets: Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side.

Glivec 400 mg film-coated tablets: Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “NVR” on one side and “SL” on the other side.

4. Clinical Particulars 4.1 Therapeutic Indications

Glivec is indicated for the treatment of

• adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.

• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

• adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

• adult patients with relapsed or refractory Ph+ ALL as monotherapy.

• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR? rearrangement.

The effect of Glivec on the outcome of bone marrow transplantation has not been determined.

Glivec is indicated for

• the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.

• The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

4.2 Posology And Method Of Administration

Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.

For doses of 400 mg and above (see dosage recommendation below) a 400 mg tablet (not divisible) is available.

For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.

The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations. Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.

For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of mineral water or apple juice. The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).

Posology for CML in adult patients

The recommended dosage of Glivec is 400 mg/day for adult patients in chronic phase CML. Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 109/l.

The recommended dosage of Glivec is 600 mg/day for adult patients in accelerated phase. Accelerated phase is defined by the presence of any of the following: blasts 9/l unrelated to therapy.

The recommended dose of Glivec is 600 mg/day for adult patients in blast crisis. Blast crisis is defined as blasts

Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression. The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.

Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.

Posology for CML in children

Dosing for children should be on the basis of body surface area (mg/m2). The doses of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg). Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening. The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2). There is no experience with the treatment of children below 2 years of age.

Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response. Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.

Posology for Ph+ ALL

The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL. Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.

Treatment schedule: On the basis of the existing data, Glivec has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL. The duration of Glivec therapy can vary with the treatment programme selected, but generally longer exposures to Glivec have yielded better results.

For adult patients with relapsed or refractory Ph+ALL Glivec monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.

Posology for MDS/MPD

The recommended dose of Glivec is 400 mg/day for adult patients with MDS/MPD.

Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1). At the time of analysis, the treatment duration was a median of 47 months (24 days - 60 months).

Posology for HES/CEL

The recommended dose of Glivec is 100 mg/day for adult patients with HES/CEL.

Dose increase from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

Treatment should be continued as long as the patient continues to benefit.

Posology for GIST

The recommended dose of Glivec is 400 mg/day for adult patients with unresectable and/or metastatic malignant GIST.

Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose (see section 5.1).

Treatment duration: In clinical trials in GIST patients, treatment with Glivec was continued until disease progression. At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months). The effect of stopping treatment after achieving a response has not been investigated.

The recommended dose of Glivec is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST. Optimal treatment duration is not yet established. Length of treatment in the clinical trial supporting this indication was 12 months.

Posology for DFSP

The recommended dose of Glivec is 800 mg/day for adult patients with DFSP.

Dose adjustment for adverse reactions

Non-haematological adverse reactions

If a severe non-haematological adverse reaction develops with Glivec use, treatment must be withheld until the event has resolved. Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.

If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN. Treatment with Glivec may then be continued at a reduced daily dose. In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.

Haematological adverse reactions

Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.

Dose adjustments for neutropenia and thrombocytopenia:

HES/CEL (starting dose 100 mg)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).

Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).

3. In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Glivec at reduced dose of 300 mg.

Paediatric chronic phase CML

(at dose 340 mg/m2)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

 

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).

3. In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x109/l, repeat step 1 and resume Glivec at reduced dose of 260 mg/m2.

Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)

aANC < 0.5 x 109/l

and/or

platelets < 10 x 109/l

1. Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).

2. If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg.

3. If cytopenia persists for 2 weeks, reduce further to 300 mg.

4. If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC 9/l and platelets 9/l, then resume treatment at 300 mg.

Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)

aANC < 0.5 x 109/l

and/or

platelets < 10 x 109/l

1. Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).

2. If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m2.

3. If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.

4. If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC 9/l and platelets 9/l, then resume treatment at 200 mg/m2.

DFSP

(at dose 800 mg)

ANC < 1.0 x 109/l

and/or

platelets < 50 x 109/l

1. Stop Glivec until ANC 9/l and platelets 9/l.

2. Resume treatment with Glivec at 600 mg.

3. In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Glivec at reduced dose of 400 mg.

ANC = absolute neutrophil count

   

a occurring after at least 1 month of treatment

   

Special populations

Paediatric use: There is no experience in children with CML below 2 years of age (see section 5.1). There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/MPD and DFSP. There is no experience in children or adolescents with GIST and HES/CEL.

Hepatic insufficiency: Imatinib is mainly metabolised through the liver. Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily. The dose can be reduced if not tolerated (see sections 4.4, 4.8 and 5.2).

Liver dysfunction classification:

Liver dysfunction

Liver function tests

Mild

Total bilirubin: = 1.5 ULN

AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)

Moderate

Total bilirubin: >1.5-3.0 ULN

AST: any

Severe

Total bilirubin: >3-10 ULN

AST: any

ULN = upper limit of normal for the institution

AST = aspartate aminotransferase

Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose. However, in these patients caution is recommended. The dose can be reduced if not tolerated. If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).

Elderly patients: Imatinib pharmacokinetics have not been specifically studied in the elderly. No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older. No specific dose recommendation is necessary in the elderly.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special Warnings And Precautions For Use

When Glivec is co-administered with other medicinal products, there is a potential for drug interactions. Caution should be used when taking Glivec with ketoconazole or other strong CYP3A4 inhibitors, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin or pimozide) or CYP2C9 substrates with a narrow therapeutic window (e.g. warfarin and other coumarin derivatives) (see section 4.5).

Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure. Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).

Hypothyroidism

Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Glivec (see section 4.5). Thyroid-stimulating hormone (TSH) levels should be closely monitored in such patients.

Hepatotoxicity

Metabolism of Glivec is mainly hepatic, and only 13% of excretion is through the kidneys. In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2). It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.

Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib. When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected. Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).

Fluid retention

Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec. Therefore, it is highly recommended that patients be weighed regularly. An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken. In clinical trials, there was an increased incidence of these events in elderly patients and those with a prior history of cardiac disease. Therefore, caution should be exercised in patients with cardiac dysfunction.

Patients with cardiac disease

Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.

In patients with hypereosinophilic syndrome (HES) and cardiac involvement, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with the initiation of imatinib therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib. As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation. Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels. Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered. If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.

Gastrointestinal haemorrhage

In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8). Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage. Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.

Tumor lysis syndrome

Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Glivec (see section 4.8).

Laboratory tests

Complete blood counts must be performed regularly during therapy with Glivec. Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia. However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML. Treatment with Glivec may be interrupted or the dose may be reduced, as recommended in section 4.2.

Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.

In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients. Patients with renal impairment should be given the minimum starting dose. Patients with severe renal impairment should be treated with caution. The dose can be reduced if not tolerated (see section 4.2 and 5.2).

Paediatric population

There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib. The long-term effects of prolonged treatment with imatinib on growth in children are unknown. Therefore, close monitoring of growth in children under imatinib treatment is recommended (see section 4.8).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Active substances that may increase imatinib plasma concentrations:

Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin) could decrease metabolism and increase imatinib concentrations. There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor). Caution should be taken when administering Glivec with inhibitors of the CYP3A4 family.

Active substances that may decrease imatinib plasma concentrations:

Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure. Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of Glivec resulted in decrease in Cmax and AUC(0- by at least 54% and 74%, of the respective values without rifampicin treatment. Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbazepine, oxcarbazepine and phenytoin. The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs. Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.

Active substances that may have their plasma concentration altered by Glivec

Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib. Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin or pimozide). Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).

Because warfarin is metabolised by CYP2C9, patients who require anticoagulation should receive low-molecular-weight or standard heparin.

In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity. Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]). Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol. In patients treated with metoprolol clinical monitoring should be considered.

In vitro, Glivec inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l. This inhibition has not been observed in vivo after the administration of Glivec 400 mg and paracetamol 1000 mg. Higher doses of Glivec and paracetamol have not been studied.

Caution should therefore be exercised when using high doses of Glivec and paracetamol concomitantly.

In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4). Caution is therefore recommended. However, the mechanism of the observed interaction is presently unknown.

In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised. Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8). Therefore, the use of Glivec in combination requires special precaution.

4.6 Pregnancy And Lactation

Pregnancy

There are limited data on the use of imatinib in pregnant women. Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown. Glivec should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.

Women of childbearing potential must be advised to use effective contraception during treatment.

Breast-feeding

There is limited information on imatinib distribution on human milk. Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk. The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk. Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose). However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breast-feed.

Fertility

In non-clinical studies, the fertility of male and female rats was not affected (see section 5.3). Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Glivec treatment should consult with their physician.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib. Therefore, caution should be recommended when driving a car or operating machinery.

4.8 Undesirable Effects

Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.

In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy. In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.

The adverse reactions were similar in all indications, with two exceptions. There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease. In the study in patients with unresectable and/or metastatic GIST, 7 (5%) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient). GI tumour sites may have been the source of the GI bleeds (see section 4.4). GI and tumoural bleeding may be serious and sometimes fatal. The most commonly reported (

When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.

Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”. These reactions can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures. However, some of these reactions may be serious or life-threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure. There were no special safety findings in paediatric clinical trials.

Adverse reactions

Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequency categories are defined using the following convention: very common (

Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.

Adverse reactions and their frequencies reported in Table 1 are based on the main registration studies.

Table 1 Adverse reactions in clinical studies

Infections and infestations

 

Uncommon:

Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis

Rare:

Fungal infection

Neoplasm benign, malignant and unspecified (including cysts and polyps)

 

Rare:

Tumour lysis syndrome

Blood and lymphatic system disorders

 

Very common:

Neutropenia, thrombocytopenia, anaemia

Common:

Pancytopenia, febrile neutropenia

Uncommon:

Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy

Rare:

Haemolytic anaemia

Metabolism and nutrition disorders

 

Common:

Anorexia

Uncommon:

Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia

Rare:

Hyperkalaemia, hypomagnesaemia

Psychiatric disorders

 

Common:

Insomnia

Uncommon:

Depression, libido decreased, anxiety

Rare:

Confusional state

Nervous system disorders

 

Very common:

Headache2

Common:

Dizziness, paraesthesia, taste disturbance, hypoaesthesia

Uncommon:

Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage

Rare:

Increased intracranial pressure, convulsions, optic neuritis

Eye disorders

 

Common:

Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision

Uncommon:

Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema

Rare:

Cataract, glaucoma, papilloedema

Ear and labyrinth disorders

 

Uncommon:

Vertigo, tinnitus, hearing loss

Cardiac disorders

 

Uncommon:

Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema

Rare:

Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion

Vascular disorders4

 

Common:

Flushing, haemorrhage

Uncommon:

Hypertension, haematoma, peripheral coldness, hypotension, Raynaud's phenomenon

Respiratory, thoracic and mediastinal disorders

 

Common:

Dyspnoea, epistaxis, cough

Uncommon:

Pleural effusion5, pharyngolaryngeal pain, pharyngitis

Rare:

Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage

Gastrointestinal disorders

 

Very common:

Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6

Common:

Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis

Uncommon:

Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis

Rare:

Colitis, ileus, inflammatory bowel disease

Hepatobiliary disorders

 

Common:

Increased hepatic enzymes


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Limbitrol DS


Generic Name: amitriptyline and chlordiazepoxide (a mi TRIP ti leen and klor dye az e POX ide)
Brand Names: Limbitrol, Limbitrol DS

What is Limbitrol DS (amitriptyline and chlordiazepoxide)?

Amitriptyline is a tricyclic (try-SYE-klik) antidepressants. Amitriptyline affects chemicals in the brain that may become unbalanced.

Chlordiazepoxide is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Chlordiazepoxide affects chemicals in the brain that may become unbalanced and cause anxiety.

The combination of amitriptyline and chlordiazepoxide is used to treat depression and anxiety.

Amitriptyline and chlordiazepoxide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Limbitrol DS (amitriptyline and chlordiazepoxide)? You should not use this medication if you have recently had a heart attack, or if you are allergic to amitriptyline (Elavil), chlordiazepoxide (Librium), or to Valium, Xanax, or any other benzodiazepine. Do not use this medication if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Amitriptyline and chlordiazepoxide can harm an unborn baby or cause birth defects. Do not use amitriptyline and chlordiazepoxide if you are pregnant.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Do not drink alcohol while taking this medication. What should I discuss with my healthcare provider before taking Limbitrol DS (amitriptyline and chlordiazepoxide)? You should not use this medication if you have recently had a heart attack, or if you are allergic to amitriptyline (Elavil), chlordiazepoxide (Librium), or to any benzodiazepine such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax). Do not use this medication if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days.

To make sure you can safely take amitriptyline and chlordiazepoxide, tell your doctor if you have any of these other conditions:

epilepsy or seizure disorder;

a thyroid disorder;

kidney or liver disease;

heart disease;

bipolar disorder (manic-depression);

a history of suicidal thoughts or behavior;

history of drug or alcohol addiction;

narrow-angle glaucoma; or

problems with urination.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

This medication can harm an unborn baby or cause birth defects. Do not use amitriptyline and chlordiazepoxide if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking amitriptyline and chlordiazepoxide.

The sedative effects of this medication may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking amitriptyline and chlordiazepoxide.

How should I take Limbitrol DS (amitriptyline and chlordiazepoxide)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment. If you need surgery, tell the surgeon ahead of time that you are using amitriptyline and chlordiazepoxide. You may need to stop using the medicine for a short time.

If you use this medication long-term, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Do not stop using amitriptyline and chlordiazepoxide suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine. Amitriptyline and chlordiazepoxide may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Benzodiazepines are drugs of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline and chlordiazepoxide can be fatal, especially if taken with alcohol.

Overdose symptoms may include irregular heartbeats, extreme drowsiness, overactive reflexes, stiff muscles, dilated pupils, vomiting, feeling hot or cold, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking Limbitrol DS (amitriptyline and chlordiazepoxide)? Do not drink alcohol. Amitriptyline and chlordiazepoxide can increase the effects of alcohol, which could be dangerous. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Limbitrol DS (amitriptyline and chlordiazepoxide) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have a serious side effect such as:

confusion, hallucinations, unusual thoughts or behavior;

feeling light-headed, fainting;

seizure (convulsions);

weak or shallow breathing;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

sudden numbness or weakness (especially on one side of the body), headache, confusion, problems with vision, speech, or balance.

Less serious side effects may include:

dry mouth, stuffy nose, blurred vision;

dizziness, drowsiness;

feeling restless or tired;

constipation, bloating, loss of appetite;

strange dreams or nightmares; or

decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Limbitrol DS (amitriptyline and chlordiazepoxide)?

Before taking this medicine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by amitriptyline and chlordiazepoxide. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.

Many drugs can interact with amitriptyline and chlordiazepoxide. Below is just a partial list. Tell your doctor if you are using:

celecoxib (Celebrex);

cimetidine (Tagamet);

darifenacin (Enablex);

ropinirole (Requip);

terbinafine (Lamisil);

ADHD medications (Adderall, Ritalin, Strattera);

anti-malaria medication such as chloroquine (Arelan), hydroxychloroquine (Plaquenil, Quinaprox), or quinine (Qualaquin);

cancer medications such as gefitinib (Iressa), imatinib (Gleevec), or nilotinib (Tasigna);

a heart rhythm medication such as amiodarone (Cordarone, Pacerone), flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quin-G);

HIV medication such as delavirdine (Rescriptor) or ritonavir (Norvir);

medicine to treat or prevent nausea and vomiting, such as metoclopramide (Reglan) or promethazine (Pentazine, Phenergan);

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), fluphenazine (Permitil), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril);

a narcotic such as methadone (Methadose, Dolophine) or propoxyphene (Darvon, Darvocet).

This list is not complete and there are many other drugs that can interact with amitriptyline and chlordiazepoxide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More Limbitrol DS resources Limbitrol DS Side Effects (in more detail) Limbitrol DS Use in Pregnancy & Breastfeeding Drug Images Limbitrol DS Drug Interactions Limbitrol DS Support Group 3 Reviews for Limbitrol DS - Add your own review/rating Limbitrol DS MedFacts Consumer Leaflet (Wolters Kluwer) Limbitrol DS Advanced Consumer (Micromedex) - Includes Dosage Information Limbitrol Prescribing Information (FDA) Compare Limbitrol DS with other medications Anxiety Depression Where can I get more information? Your pharmacist can provide more information about amitriptyline and chlordiazepoxide.

See also: Limbitrol DS side effects (in more detail)


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Mysoline Oral, Parenteral, Rectal


Generic Name: barbiturate (Oral route, Parenteral route, Rectal route)

Commonly used brand name(s)

In the U.S.

Butisol Sodium Mebaral Mysoline Seconal

In Canada

Nova Rectal

Available Dosage Forms:

Elixir Tablet Suppository Capsule Enema Suspension Solution Uses For Mysoline

Barbiturates belong to the group of medicines called central nervous system (CNS) depressants (medicines that cause drowsiness). They act on the brain and CNS to produce effects that may be helpful or harmful. This depends on the individual patient's condition and response and the amount of medicine taken.

Some of the barbiturates may be used before surgery to relieve anxiety or tension. In addition, some of the barbiturates are used as anticonvulsants to help control seizures in certain disorders or diseases, such as epilepsy. Barbiturates may also be used for other conditions as determined by your doctor.

The barbiturates have been used to treat insomnia (trouble in sleeping); but if they are used regularly (for example, every day) for insomnia, they are usually not effective for longer than 2 weeks. The barbiturates have also been used to relieve nervousness or restlessness during the daytime. However, the barbiturates have generally been replaced by safer medicines for the treatment of insomnia and daytime nervousness or tension.

If too much of a barbiturate is used, it may become habit-forming.

Barbiturates should not be used for anxiety or tension caused by the stress of everyday life.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, phenobarbital is used in certain patients with the following medical condition:

Hyperbilirubinemia (high amount of bile pigments in the blood that may lead to jaundice) Before Using Mysoline Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Unusual excitement may be more likely to occur in children, who are usually more sensitive than adults to the effects of barbiturates.

Geriatric

Confusion, mental depression, and unusual excitement may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of barbiturates.

Pregnancy

Barbiturates have been shown to increase the chance of birth defects in humans. However, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this and the following information with your doctor:

Taking barbiturates regularly during pregnancy may cause bleeding problems in the newborn infant. In addition, taking barbiturates regularly during the last 3 months of pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects in the baby after birth. One study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby. Barbiturates taken for anesthesia during labor and delivery may reduce the force and frequency of contractions of the uterus; this may prolong labor and delay delivery. Use of barbiturates during labor may cause breathing problems in the newborn infant. Breast Feeding

Barbiturates pass into the breast milk and may cause drowsiness, slow heartbeat, shortness of breath, or troubled breathing in babies of nursing mothers taking this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Nifedipine Praziquantel Ranolazine Rilpivirine Voriconazole

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acenocoumarol Adinazolam Alfentanil Alprazolam Amobarbital Anileridine Anisindione Aprobarbital Bortezomib Bromazepam Brotizolam Butabarbital Butalbital Cabazitaxel Carisoprodol Chloral Hydrate Chlordiazepoxide Chlorzoxazone Clobazam Clonazepam Clorazepate Codeine Crizotinib Dantrolene Dasatinib Delavirdine Diazepam Dicumarol Dronedarone Erlotinib Estazolam Ethchlorvynol Etravirine Everolimus Fentanyl Flunitrazepam Flurazepam Fospropofol Halazepam Hydrocodone Hydromorphone Imatinib Irinotecan Ixabepilone Ketazolam Ketorolac Lapatinib Levorphanol Linagliptin Lopinavir Lorazepam Lormetazepam Maraviroc Medazepam Meperidine Mephenesin Mephobarbital Meprobamate Metaxalone Methocarbamol Methohexital Methoxyflurane Midazolam Morphine Morphine Sulfate Liposome Naproxen Nilotinib Nitrazepam Nordazepam Oxazepam Oxycodone Oxymorphone Pentobarbital Phenindione Phenobarbital Phenprocoumon Prazepam Primidone Propoxyphene Quazepam Quetiapine Remifentanil Rivaroxaban Roflumilast Romidepsin Secobarbital Sirolimus Sodium Oxybate Succinylcholine Sufentanil Sunitinib Tacrolimus Tapentadol Temazepam Temsirolimus Teniposide Thiopental Ticagrelor Tolvaptan Triazolam Valproic Acid Vandetanib Vemurafenib Zolpidem Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse (or history of) or Drug abuse or dependence (or history of)—Dependence on barbiturates may develop. Anemia (severe) or Asthma (history of), emphysema, or other chronic lung disease or Type 2 diabetes mellitus or Hyperactivity (in children) or Mental depression or Overactive thyroid or Porphyria (or history of)—Barbiturates may make the condition worse. Kidney disease or Liver disease—Higher blood levels of barbiturates may result, increasing the chance of side effects. Pain—Barbiturates may cause unexpected excitement or mask important symptoms of more serious problems. Underactive adrenal gland—Barbiturates may interfere with the effects of other medicines needed for this condition. Proper Use of barbiturate

This section provides information on the proper use of a number of products that contain barbiturate. It may not be specific to Mysoline. Please read with care.

For patients taking the extended-release capsule or tablet form of this medicine:

These capsules or tablets are to be swallowed whole. Do not break, crush, or chew before swallowing.

For patients using the rectal suppository form of this medicine:

To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. Wash your hands with soap and water.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much is used, it may become habit-forming (causing mental or physical dependence).

If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. To do so may increase the chance of your becoming dependent on the medicine. Instead, check with your doctor.

If you are taking this medicine for epilepsy, it must be taken every day in regularly spaced doses as ordered by your doctor in order for it to control your seizures. This is necessary to keep a constant amount of medicine in the blood. To help keep the amount constant, do not miss any doses.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For amobarbital For oral dosage form (tablets or capsules): For trouble in sleeping: Adults—65 to 200 milligrams (mg) at bedtime. Children—Dose must be determined by your doctor. For daytime sedation: Adults—50 to 300 mg, taken in smaller doses during the day. Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight taken three times a day. For sedation before surgery: Adults—200 mg taken one to two hours before surgery. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, taken before surgery. However, the dose is usually not more than 100 mg. For sedation during labor: Adults—200 to 400 mg every one to three hours if needed. However, the total dose is usually not more than 1000 mg. For injection dosage form: For trouble in sleeping: Adults—65 to 200 mg, injected into a muscle or vein. Children up to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mg per kg (0.9 to 1.4 mg per pound) of body weight, injected into a muscle. Children 6 years of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mg per kg (0.9 to 1.4 mg per pound) of body weight, injected into a muscle, or 65 to 500 mg injected into a vein. For daytime sedation: Adults—30 to 50 mg two or three times a day, injected into a muscle or vein For sedation before surgery: Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight or 65 to 500 mg per dose, injected into a vein. For control of seizures: Adults and children 6 years of age and over—65 to 500 mg per dose, injected into a vein. Children up to 6 years of age—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle or vein. For aprobarbital For oral dosage form (elixir): For trouble in sleeping: Adults—40 to 160 milligrams (mg) at bedtime. Children—Dose must be determined by your doctor. For daytime sedation: Adults—40 mg three times a day. Children—Dose must be determined by your doctor. For butabarbital For oral dosage forms (elixir or tablets): For trouble in sleeping: Adults—50 to 100 milligrams (mg) at bedtime. Children—Dose must be determined by your doctor. For daytime sedation: Adults—15 to 30 mg three or four times a day. Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day. For sedation before surgery: Adults—50 to 100 mg sixty to ninety minutes before surgery. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight. However, the dose is usually not more than 100 mg. For mephobarbital For oral dosage form (tablets): For daytime sedation: Adults—32 to 100 milligrams (mg) three or four times a day. Children—16 to 32 mg three or four times a day. For control of seizures: Adults—200 to 600 mg a day, taken in smaller doses during the day. Children 5 years of age and over—32 to 64 mg three or four times a day. Children up to 5 years of age—16 to 32 mg three or four times a day. For metharbital For oral dosage form (tablets): For control of seizures: Adults—At first, 100 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 800 mg a day. Children—50 mg one to three times a day. For pentobarbital For oral dosage forms (elixir or capsules): For trouble in sleeping: Adults—100 milligrams (mg) at bedtime. Children—Dose must be determined by your doctor. For daytime sedation: Adults—20 mg three or four times a day. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kilogram (kg) (0.9 to 2.7 mg per pound) of body weight per day. For sedation before surgery: Adults—100 mg before surgery. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kilogram (0.9 to 2.7 mg per pound) of body weight, taken before surgery. However, the dose is usually not more than 100 mg. For injection dosage form: For trouble in sleeping: Adults—150 to 200 mg, injected into a muscle. Or, 100 mg injected into a vein, with additional small doses given if needed. However, the dose is usually not more than 500 mg. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, injected into a muscle. Or, 50 mg injected into a vein, with additional small doses given if needed. For sedation before surgery: Adults—150 to 200 mg, injected into a muscle. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight, injected into a muscle. However, the dose is usually not more than 100 mg. For control of seizures: Adults—At first, 100 mg injected into a vein. Additional small doses may be given if needed. However, the dose is usually not more than 500 mg. Children—At first, 50 mg injected into a muscle or vein. Additional small doses may be given if needed. For rectal dosage form (suppositories): For trouble in sleeping: Adults—120 to 200 mg inserted into the rectum at bedtime. Children 12 to 14 years of age—60 or 120 mg inserted into the rectum at bedtime. Children 5 to 12 years of age—60 mg inserted into the rectum at bedtime. Children 1 to 4 years of age—30 or 60 mg inserted into the rectum at bedtime. Children 2 months to 1 year of age—30 mg inserted into the rectum at bedtime. Children up to 2 months of age—Dose must be determined by your doctor. For daytime sedation: Adults—30 mg inserted into the rectum two to four times a day. Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kg (0.9 mg per pound) of body weight, inserted into the rectum three times a day. For sedation before surgery: Children 12 to 14 years of age—60 or 120 mg inserted into the rectum. Children 5 to 12 years of age—60 mg inserted into the rectum. Children 1 to 4 years of age—30 or 60 mg inserted into the rectum. Children 2 months to 1 year of age—30 mg inserted into the rectum. Children up to 2 months of age—Dose must be determined by your doctor. For phenobarbital For oral dosage forms (elixir, capsules, or tablets): For trouble in sleeping: Adults—100 to 320 milligrams (mg) at bedtime. Children—Dose must be determined by your doctor. For daytime sedation: Adults—30 to 120 mg a day, taken in smaller doses two or three times during the day. Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day. For sedation before surgery: Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.4 mg per pound) of body weight. For control of seizures: Adults—60 to 250 mg a day. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 6 mg per kg (0.45 to 2.7 mg per pound) of body weight a day. For injection dosage form: For trouble in sleeping: Adults—100 to 325 mg, injected into a muscle or vein, or under the skin. Children—Dose must be determined by your doctor. For daytime sedation: Adults—30 to 120 mg a day, injected into a muscle or a vein, or under the skin, in smaller doses two or three times during the day. Children—Dose must be determined by your doctor. For sedation before surgery: Adults—130 to 200 mg, injected into a muscle sixty to ninety minutes before surgery. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mg per kg (0.45 to 1.4 mg per pound) of body weight, injected into a muscle or vein sixty to ninety minutes before surgery. For control of seizures: Adults—100 to 320 mg injected into a vein. The dose may be repeated if needed, but is usually not more than 600 mg a day. However, higher doses may be needed for certain types of continuing seizures. Children—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 20 mg per kg (4.5 to 9 mg per pound) of body weight, injected into a vein. Later, 1 to 6 mg per kg (0.45 to 2.7 mg per pound) of body weight a day, injected into a vein. Higher doses may be needed for certain types of continuing seizures. For secobarbital For oral dosage form (capsules): For trouble in sleeping: Adults—100 milligrams (mg) at bedtime. Children—Dose must be determined by your doctor. For daytime sedation: Adults—30 to 50 mg three or four times a day. Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 2 mg per kilogram (kg) (0.9 mg per pound) of body weight three times a day. For sedation before surgery: Adults—200 to 300 mg one or two hours before surgery. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight one or two hours before surgery. However, the dose is usually not more than 100 mg. For injection dosage form: For trouble in sleeping: Adults—100 to 200 mg injected into a muscle, or 50 to 250 mg injected into a vein. Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle. However, the dose is usually not more than 100 mg. For sedation before dental procedures: Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 1.1 to 2.2 mg per kg (0.5 to 1 mg per pound) of body weight, injected into a muscle ten to fifteen minutes before the procedure. Children—Dose must be determined by your dentist. For sedation before a nerve block: Adults—100 to 150 mg, injected into a vein. For sedation before surgery: Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 4 to 5 mg per kg (1.8 to 2.3 mg per pound) of body weight, injected into a muscle. For seizures from tetanus: Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 5.5 mg per kg (2.5 mg per pound) of body weight, injected into a muscle or vein. Dose may be repeated every three to four hours if needed. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 3 to 5 mg per kg (1.4 to 2.3 mg per pound) of body weight, injected into a muscle or vein. For secobarbital and amobarbital combination For oral dosage form (capsules): For trouble in sleeping: Adults—1 capsule at bedtime. Children—Dose must be determined by your doctor. For sedation before surgery: Adults—1 capsule taken one hour before surgery. Children—Dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Store the suppository form of this medicine in the refrigerator.

Precautions While Using Mysoline

If you will be using this medicine regularly for a long time:

Your doctor should check your progress at regular visits. Do not stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by this medicine.

If you have been using this medicine for a long time and you think that you may have become mentally or physically dependent on it, check with your doctor. Some signs of mental or physical dependence on barbiturates are:

a strong desire or need to continue taking the medicine. a need to increase the dose to receive the effects of the medicine. withdrawal side effects (for example, anxiety or restlessness, convulsions [seizures], feeling faint, nausea or vomiting, trembling of hands, trouble in sleeping) occurring after the medicine is stopped.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of a barbiturate or taking alcohol or other CNS depressants with the barbiturate may lead to unconsciousness and possibly death. Some signs of an overdose are severe drowsiness, severe confusion, severe weakness, shortness of breath or slow or troubled breathing, slurred speech, staggering, and slow heartbeat.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking barbiturates. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking barbiturates. If you have any questions about this, check with your health care professional.

Mysoline Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Bleeding sores on lips chest pain fever muscle or joint pain red, thickened, or scaly skin skin rash or hives sores, ulcers, or white spots in mouth (painful) sore throat and/or fever swelling of eyelids, face, or lips wheezing or tightness in chest

Check with your doctor as soon as possible if any of the following side effects occur:

Less common Confusion mental depression unusual excitement Rare Hallucinations (seeing, hearing, or feeling things that are not there) unusual bleeding or bruising unusual tiredness or weakness With long-term or chronic use Bone pain, tenderness, or aching loss of appetite muscle weakness weight loss (unusual) yellow eyes or skin Symptoms of overdose Confusion (severe) decrease in or loss of reflexes drowsiness (severe) fever irritability (continuing) low body temperature poor judgment shortness of breath or slow or troubled breathing slow heartbeat slurred speech staggering trouble in sleeping unusual movements of the eyes weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Clumsiness or unsteadiness dizziness or lightheadedness drowsiness "hangover" effect Less common Anxiety or nervousness constipation feeling faint headache irritability nausea or vomiting nightmares or trouble in sleeping

Confusion, mental depression, and unusual excitement may be more likely to occur in very ill patients.

After you stop using this medicine, your body may need time to adjust. If you took this medicine in high doses or for a long time, this may take up to about 15 days. During this period of time check with your doctor if any of the following side effects occur (usually occur within 8 to 16 hours after medicine is stopped):

Anxiety or restlessness convulsions (seizures) dizziness or lightheadedness feeling faint hallucinations (seeing, hearing, or feeling things that are not there) muscle twitching nausea or vomiting trembling of hands trouble in sleeping, increased dreaming, or nightmares vision problems weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Erythromycin Ointment


Pronunciation: eh-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: Akne-Mycin
Erythromycin Ointment is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Erythromycin Ointment is a topical macrolide antibiotic that is thought to improve acne by slowing the growth of bacteria on the skin, which causes acne.

Do NOT use Erythromycin Ointment if: you are allergic to any ingredient in Erythromycin Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Erythromycin Ointment:

Some medical conditions may interact with Erythromycin Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, food, or other substances if you have liver disease or you have a blood disorder called porphyria

Some MEDICINES MAY INTERACT with Erythromycin Ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:

Efavirenz or rifampin because they may decrease Erythromycin Ointment's effectiveness Arsenic, cimetidine,diltiazem,dofetilide,HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole), pimozide, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin/dalfopristin), or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur Anticoagulants (eg, warfarin), aldosterone blockers (eg, spironolactone), alfentanil, arsenic, astemizole, benzodiazepines (eg, alprazolam), bromocriptine, buspirone, carbamazepine, cilostazol, cisapride, clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, digitoxin, digoxin, disopyramide, ergot alkaloids (eg, ergotamine , felodipine, H1 antagonists (eg, diphenhydramine), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), meglitinide antidiabetics (eg, repaglinide), midazolam, phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin, rifampin, serotonin reuptake inhibitors (eg, fluoxetine), sumatriptan theophyllines, tricyclic antidepressants (eg, amitriptyline), valproic acid, or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Erythromycin Ointment

This may not be a complete list of all interactions that may occur. Ask your health care provider if Erythromycin Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Erythromycin Ointment:

Use Erythromycin Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Wash affected areas with soap and water. Rinse well and pat dry before applying the medicine. Moisten a pad or use your fingertips to apply the medicine. Cover the affected and surrounding areas with a thin film of medicine. Wash your hands after you finish using Erythromycin Ointment. Erythromycin Ointment works best if it is used at the same time each day. To clear up your infection completely, take Erythromycin Ointment for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Erythromycin Ointment, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Erythromycin Ointment.

Important safety information: Erythromycin Ointment is for external use only. Avoid contact with the eyes, nose, mouth, and other mucous membranes. If you get Erythromycin Ointment in your eyes, immediately rinse them out with cool tap water. If severe diarrhea or stomach pain or cramping develops during treatment or within several months after treatment with Erythromycin Ointment, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor. Be sure to use Erythromycin Ointment for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Erythromycin Ointment may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erythromycin Ointment while you are pregnant. Erythromycin Ointment is found in breast milk. If you are or will be breast-feeding while you use Erythromycin Ointment, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Erythromycin Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Peeling; redness; skin irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; diarrhea; stomach cramps/pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Erythromycin Ointment may be harmful if swallowed.

Proper storage of Erythromycin Ointment:

Store Erythromycin Ointment at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container. Store away from heat and light. Keep Erythromycin Ointment out of the reach of children and away from pets.

General information: If you have any questions about Erythromycin Ointment, please talk with your doctor, pharmacist, or other health care provider. Erythromycin Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Erythromycin Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Erythromycin resources Erythromycin Use in Pregnancy & Breastfeeding Erythromycin Support Group 1 Review for Erythromycin - Add your own review/rating Compare Erythromycin with other medications Acne Perioral Dermatitis
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Erythromycin Solution


Pronunciation: eh-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: Eryderm
Erythromycin Solution is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Erythromycin Solution is a topical macrolide antibiotic that is thought to improve acne by slowing the growth of bacteria on the skin, which causes acne.

Do NOT use Erythromycin Solution if: you are allergic to any ingredient in Erythromycin Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Erythromycin Solution:

Some medical conditions may interact with Erythromycin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have liver disease or you have a blood disorder called porphyria

Some MEDICINES MAY INTERACT with Erythromycin Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Arsenic, cisapride, diltiazem, disopyramide, dofetilide, HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole), pimozide, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin/dalfopristin), or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur Anticoagulants (eg, warfarin), aldosterone blockers (eg, spironolactone), benzodiazepines (eg, alprazolam), buspirone, carbamazepine, cilostazol, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, ergot alkaloids (eg, ergotamine), felodipine, H1 antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), midazolam, phosphodiesterase type 5 inhibitors (eg, sildenafil), rifampin, sumatriptan, theophyllines, or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Erythromycin Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Erythromycin Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Erythromycin Solution:

Use Erythromycin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Wash affected areas with soap and warm water. Rinse well and pat dry before applying the medicine. To use the applicator, hold the bottle upside down and moisten applicator by pressing once on the applicator surface with a clean fingertip. Then apply Erythromycin Solution to the affected area using a dabbing motion. Use enough medicine to cover the entire affected area. Wash your hands immediately after applying Erythromycin Solution. Erythromycin Solution works best if it is used at the same time each day. To clear up your infection completely, take Erythromycin Solution for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Erythromycin Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Erythromycin Solution.

Important safety information: Erythromycin Solution is for external use only. Avoid contact with the eyes, nose, mouth, and other mucous membranes. If you get Erythromycin Solution in your eyes, immediately wash them out with cool tap water. Talk with your doctor before you use any other medicines or cleansers on your skin. Once you begin using Erythromycin Solution, it may take 3 to 8 weeks before you begin to see improvement. If severe diarrhea or stomach pain or cramping develops during treatment or within several months after treatment with Erythromycin Solution, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor. Be sure to use Erythromycin Solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Erythromycin Solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Erythromycin Solution is flammable. Do not store or use near an open flame or while smoking. Erythromycin Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erythromycin Solution while you are pregnant. Erythromycin Solution is found in breast milk. If you are or will be breast-feeding while you use Erythromycin Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Erythromycin Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; dryness; mild stinging; peeling.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; itching, burning, tenderness, or redness of skin; severe diarrhea; stomach cramps/pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Erythromycin Solution may be harmful if swallowed.

Proper storage of Erythromycin Solution:

Store Erythromycin Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat and light. Keep Erythromycin Solution out of the reach of children and away from pets.

General information: If you have any questions about Erythromycin Solution, please talk with your doctor, pharmacist, or other health care provider. Erythromycin Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Erythromycin Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Erythromycin resources Erythromycin Use in Pregnancy & Breastfeeding Erythromycin Support Group 1 Review for Erythromycin - Add your own review/rating Compare Erythromycin with other medications Acne Perioral Dermatitis
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Eryderm Solution


Pronunciation: eh-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: Eryderm
Eryderm Solution is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Eryderm Solution is a topical macrolide antibiotic that is thought to improve acne by slowing the growth of bacteria on the skin, which causes acne.

Do NOT use Eryderm Solution if: you are allergic to any ingredient in Eryderm Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Eryderm Solution:

Some medical conditions may interact with Eryderm Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have liver disease or you have a blood disorder called porphyria

Some MEDICINES MAY INTERACT with Eryderm Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Arsenic, cisapride, diltiazem, disopyramide, dofetilide, HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole), pimozide, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin/dalfopristin), or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur Anticoagulants (eg, warfarin), aldosterone blockers (eg, spironolactone), benzodiazepines (eg, alprazolam), buspirone, carbamazepine, cilostazol, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, ergot alkaloids (eg, ergotamine), felodipine, H1 antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), midazolam, phosphodiesterase type 5 inhibitors (eg, sildenafil), rifampin, sumatriptan, theophyllines, or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Eryderm Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eryderm Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Eryderm Solution:

Use Eryderm Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Wash affected areas with soap and warm water. Rinse well and pat dry before applying the medicine. To use the applicator, hold the bottle upside down and moisten applicator by pressing once on the applicator surface with a clean fingertip. Then apply Eryderm Solution to the affected area using a dabbing motion. Use enough medicine to cover the entire affected area. Wash your hands immediately after applying Eryderm Solution. Eryderm Solution works best if it is used at the same time each day. To clear up your infection completely, take Eryderm Solution for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Eryderm Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Eryderm Solution.

Important safety information: Eryderm Solution is for external use only. Avoid contact with the eyes, nose, mouth, and other mucous membranes. If you get Eryderm Solution in your eyes, immediately wash them out with cool tap water. Talk with your doctor before you use any other medicines or cleansers on your skin. Once you begin using Eryderm Solution, it may take 3 to 8 weeks before you begin to see improvement. If severe diarrhea or stomach pain or cramping develops during treatment or within several months after treatment with Eryderm Solution, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor. Be sure to use Eryderm Solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Eryderm Solution may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Eryderm Solution is flammable. Do not store or use near an open flame or while smoking. Eryderm Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Eryderm Solution while you are pregnant. Eryderm Solution is found in breast milk. If you are or will be breast-feeding while you use Eryderm Solution, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Eryderm Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; dryness; mild stinging; peeling.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; itching, burning, tenderness, or redness of skin; severe diarrhea; stomach cramps/pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Eryderm side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Eryderm Solution may be harmful if swallowed.

Proper storage of Eryderm Solution:

Store Eryderm Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat and light. Keep Eryderm Solution out of the reach of children and away from pets.

General information: If you have any questions about Eryderm Solution, please talk with your doctor, pharmacist, or other health care provider. Eryderm Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Eryderm Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Eryderm resources Eryderm Side Effects (in more detail) Eryderm Use in Pregnancy & Breastfeeding Eryderm Support Group 0 Reviews for Eryderm - Add your own review/rating Compare Eryderm with other medications Acne Perioral Dermatitis
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Erythromycin Gel


Pronunciation: eh-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: Emgel
Erythromycin Gel is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Erythromycin Gel is a topical macrolide antibiotic that is thought to improve acne by slowing the growth of bacteria on the skin, which causes acne.

Do NOT use Erythromycin Gel if: you are allergic to any ingredient in Erythromycin Gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Erythromycin Gel:

Some medical conditions may interact with Erythromycin Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have liver disease or you have a blood disorder called porphyria

Some MEDICINES MAY INTERACT with Erythromycin Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

Efavirenz or rifampin because they may decrease Erythromycin Gel's effectiveness Arsenic, cimetidine,diltiazem,dofetilide,HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole) ,pimozide, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin/dalfopristin), orverapamil because side effects, such as heart toxicity or irregular heartbeat, may occur Anticoagulants (eg, warfarin), aldosterone blockers (eg, spironolactone), alfentanil, arsenic, astemizole, benzodiazepines (eg, alprazolam), bromocriptine, buspirone, carbamazepine, cilostazol, cisapride, clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, digitoxin, digoxin, disopyramide, ergot alkaloids (eg, ergotamine ), felodipine, H1 antagonists (eg, diphenhydramine), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), meglitinide antidiabetics (eg, repaglinide), midazolam, phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide,QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), rifampin, serotonin reuptake inhibitors (eg, fluoxetine),sumatriptan, theophyllines, tricyclic antidepressants (eg, amitriptyline), valproic acid, or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Erythromycin Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Erythromycin Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Erythromycin Gel:

Use Erythromycin Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Wash affected areas with soap and water. Rinse well and pat dry before applying the medicine. Cover the affected and surrounding area with a thin film of medicine. Spread the medicine lightly over the affected areas rather than rubbing it in. Allow the medicine to dry. Wash your hands immediately after applying Erythromycin Gel. Erythromycin Gel works best if it is used at the same time each day. To clear up your infection completely, take Erythromycin Gel for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Erythromycin Gel, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Erythromycin Gel.

Important safety information: Erythromycin Gel is for external use only. Avoid contact with the eyes, nose, mouth, and other mucous membranes. If you get Erythromycin Gel in your eyes, immediately wash them out with cool tap water. If severe diarrhea or stomach pain or cramping develops during treatment or within several months after treatment with Erythromycin Gel, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor. Be sure to use Erythromycin Gel for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Erythromycin Gel may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Talk with your doctor before you use any other medicines or cleansers on your skin. Once you begin using Erythromycin Gel, it may take 3 to 8 weeks before you begin to see improvement. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erythromycin Gel while you are pregnant. Erythromycin Gel is found in breast milk. If you are or will be breast-feeding while you use Erythromycin Gel, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Erythromycin Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; dryness; mild stinging; peeling.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; irritation of the eyes; itching, burning, tenderness, or redness of skin; severe diarrhea; stomach cramps/pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Erythromycin Gel may be harmful if swallowed.

Proper storage of Erythromycin Gel:

Store Erythromycin Gel at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly-closed container. Store away from heat and light. Keep Erythromycin Gel out of the reach of children and away from pets.

General information: If you have any questions about Erythromycin Gel, please talk with your doctor, pharmacist, or other health care provider. Erythromycin Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Erythromycin Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Erythromycin resources Erythromycin Use in Pregnancy & Breastfeeding Erythromycin Support Group 1 Review for Erythromycin - Add your own review/rating Compare Erythromycin with other medications Acne Perioral Dermatitis
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Stilnoct 10mg


Stilnoct 10 mg Tablets

zolpidem tartrate

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Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Stilnoct is and what it is used for 2. Before you take Stilnoct 3. How to take Stilnoct 4. Possible side effects 5. How to store Stilnoct 6. Further information What Stilnoct is and what it is used for

The name of your medicine is Stilnoct 10mg Tablets (called Stilnoct in this leaflet). Stilnoct contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.

Stilnoct is used for temporary sleep problems that are causing you severe distress or that are affecting your every day life. This includes sleep problems such as:

Difficulty falling asleep Waking in the middle of the night Waking too early

Stilnoct is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.

Before you take Stilnoct Do not take this medicine and tell your doctor if: You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Stilnoct (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Your lungs do not work properly (respiratory failure) You have severe liver problems You have a problem where you stop breathing for short periods at night (sleep apnoea) You have a problem that causes severe muscle weakness (myasthenia gravis) You have been told by a doctor that you have a mental illness (psychosis) You are under the age of 18

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Stilnoct.

Take special care with Stilnoct

Check with your doctor or pharmacist before taking your medicine if:

You have a history of alcohol or drug abuse You have liver problems You have depression or have had another mental illnesses in the past You have recently taken Stilnoct or other similar medicines for more than four weeks You are elderly

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Stilnoct.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because Stilnoct can affect the way some other medicines work. Also some medicines can affect the way Stilnoct works.

Tell your doctor if you are taking any of the following medicines:

Stilnoct may increase the effect of the following medicines:

Medicines for some mental health problems (antipsychotics) Medicines for depression such as sertraline Medicines for epilepsy (anticonvulsants) Medicines used in surgery (anaesthetics) Medicines to calm or reduce anxiety or for sleep problems Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol

The following medicines can increase the chance of you getting side effects when taken with Stilnoct. To make this less likely, your doctor may decide to lower your dose of Stilnoct:

Some antibiotics such as clarithromycin or erythromycin Some medicines for fungal infections such as ketaconazole and itraconazole Ritonavir (a protease inhibitor) - for HIV infections

The following medicines can make Stilnoct work less well:

Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin Rifampicin (an antibiotic) - for infections St John’s Wort (a herbal medicine) - for mood swings and depression Taking Stilnoct with food and drink Do not drink alcohol while you are taking Stilnoct.
Alcohol can increase the effects of Stilnoct and make you sleep very deeply so that you do not breathe properly or have difficulty waking Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Taking Stilnoct during pregnancy may harm your baby.

You should not breast-feed if you are taking Stilnoct. This is because small amounts may pass into mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

On the day after taking Stilnoct, do not drive or use machinery or tools if you feel sleepy, dizzy or confused. For more information about possible side effects which could affect your driving see section 4 of this leaflet.

Important information about some of the ingredients of Stilnoct

Stilnoct contains:

Lactose. This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine How to take Stilnoct

Always take Stilnoct exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine Take this medicine by mouth Swallow the tablet whole with a drink of water Take just before bedtime. Make sure you have at least 7-8 hours for sleep after taking this medicine The usual length of treatment is 2 days to 4 weeks Adults

The usual dose is one Stilnoct tablet (10 mg) just before bedtime.

Elderly

The usual dose is half a tablet (5mg) just before bedtime.

Patients with liver problems

The usual starting dose is half a tablet (5mg) just before bedtime. Your doctor may decide to increase this to one tablet (10mg) if it is safe to do so.

Children and Adolescents

Stilnoct should not be used in people under 18 years old.

If you take more Stilnoct than you should

If you take more Stilnoct than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

Taking too much Stilnoct can be very dangerous.

The following effects may happen:

Feeling drowsy, confused, sleeping deeply and possibly falling into a fatal coma. If you forget to take Stilnoct

Stilnoct must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Stilnoct

Keep taking Stilnoct until your doctor tells you to stop.

Do not stop taking Stilnoct suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.

If you stop taking Stilnoct suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below.

See a doctor straight away if you get any of the following effects:

Feeling anxious, restless, irritable or confused Headache Faster heartbeat or uneven heartbeat (palpitations) Nightmares, seeing or hearing things that are not real (hallucinations) Being more sensitive to light, noise and touch than normal Relaxed grip on reality Feeling distant from your body or feeling ‘puppet-like’ Numbness and tingling in your hands and feet Aching muscles Stomach problems Sleep problems come back worse than before

In rare cases fits (seizures) may also occur.

Stilnoct 10mg Side Effects

Like all medicines, Stilnoct can cause side effects, although not everybody gets them.

Stop taking Stilnoct and see a doctor or go to a hospital straight away if: You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Tell your doctor as soon as possible if you have any of the following side effects:

Common (affects less than 1 in 10 people)

Poor memory while taking Stilnoct (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 7-8 hours sleep after taking Stilnoct, this is less likely to cause you a problem. Sleeping problems that get worse after taking this medicine Seeing or hearing things that are not real (hallucinations)

Uncommon (affects less than 1 in 100 people)

Blurred eyesight or ‘seeing double’

Frequency unknown

Being less aware of your environment Falling, especially in the elderly

Sleep-Driving and other strange behaviour

There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine.

This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Common (affects less than 1 in 10 people)

Diarrhoea Headache Feeling tired or agitated Nightmares

Uncommon (affects less than 1 in 100 people)

Feeling confused or irratable

Frequency unknown

Itching skin or skin rash Weak muscles Feeling restless, aggressive, angry or showing unusual behaviour Thinking things that are not true (delusions) Changes in sex drive (libido) Change in the amount of liver enzymes – shown up in the results of blood tests Changes in the way you walk Stilnoct having less effect than normal

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

How to store Stilnoct

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Stilnoct after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Stilnoct contains Each tablet of Stilnoct contains 10 mg of the active substance zolpidem tartrate Other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, titanium dioxide (E171), sodium starch glycollate, magnesium stearate and macrogol 400. What Stilnoct looks like and contents of the pack

Stilnoct is a white to off-white film-coated oblong (rectangle) shaped tablet with a scored and engraved ‘SN 10’ on one side contained within clear PVC/ foil blisters in cartons containing 4 or 28 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS Tel:01483 505515 Fax:01483 535432 email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie 6, Blvd. De L’Europe 21 800 Qu?tigny France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2008

© sanofi-aventis, 1993 - 2008

209512


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cabazitaxel


Generic Name: cabazitaxel (ka BAZ i TAX el)
Brand Names: Jevtana

What is cabazitaxel?

Cabazitaxel is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic).

Cabazitaxel is usually given after other cancer medicines have been tried without successful treatment.

Cabazitaxel may also be used for purposes not listed in this medication guide.

What is the most important information I should know about cabazitaxel? Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. You should not use this medication if you are allergic to cabazitaxel, or if you have liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80. You should not breast-feed while you are receiving cabazitaxel.

Before you receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.

Cabazitaxel is used together with prednisone, and you may also be given other medications to help prevent certain side effects. Use all medications as directed by your doctor.

To make sure cabazitaxel is helping your condition and not causing harmful effects, your blood will need to be tested often. What should I discuss with my health care provider before receiving cabazitaxel? You should not use this medication if you are allergic to cabazitaxel, or if you have:

liver disease;

low white blood cell counts; or

an allergy to any medicine that contains polysorbate 80.

To make sure you can safely receive cabazitaxel, tell your doctor if you have ever had a severe allergic reaction to any medication.

FDA pregnancy category D. Do not use cabazitaxel if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cabazitaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving cabazitaxel. Serious side effects may be more likely in older adults receiving cabazitaxel. How is cabazitaxel given?

Cabazitaxel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cabazitaxel must be given slowly, and the IV infusion can take about 1 hour to complete.

Cabazitaxel is usually given once every 3 weeks. You will most likely take prednisone by mouth every day throughout your cabazitaxel treatment. Follow your doctor's dosing instructions very carefully.

Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by cabazitaxel. Tell your doctor if you have missed any doses or have stopped taking prednisone for any reason.

About 30 minutes before you receive cabazitaxel, you may be given other medications to help prevent certain side effects.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Your doctor may tell you to check your temperature at home throughout your treatment with cabazitaxel.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving cabazitaxel, which can lead to a serious electrolyte imbalance.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your cabazitaxel injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while receiving cabazitaxel? Avoid taking an herbal supplement containing St. John's wort while you are being treated with cabazitaxel. Cabazitaxel side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives, red skin rash; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, cough, chills, muscle aches, flu symptoms, sores in your mouth and throat, rapid and shallow breathing, fainting;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

severe or ongoing diarrhea;

trouble breathing;

feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

swelling or rapid weight gain; or

blood in your urine, pain or burning when you urinate.

Less serious side effects may include:

nausea, vomiting, stomach pain;

constipation, mild diarrhea;

weakness, tired feeling;

joint pain, back pain;

numbness, burning pain, or tingly feeling en your hands or feet;

changes in your sense of taste; or

hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cabazitaxel Dosing Information

Usual Adult Dose for Prostate Cancer:

Initial dose: 25 mg/m2 IV every 3 weeks in combination with prednisone 10 mg orally once daily.

What other drugs will affect cabazitaxel?

Many drugs can interact with cabazitaxel. Below is just a partial list. Tell your doctor if you are using:

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

aprepitant (Emend);

cimetidine (Tagamet);

cyclosporine (Gengraf, Neoral, Sandimmune);

haloperidol (Haldol);

lidocaine (Xylocaine);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl), norfloxacin (Noroxin), telithromycin (Ketek), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

antifungal medication such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

an antidepressant such as nefazodone, desipramine (Norpramin), or sertraline (Zoloft);

heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there are many other drugs that can interact with cabazitaxel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More cabazitaxel resources Cabazitaxel Side Effects (in more detail) Cabazitaxel Dosage Cabazitaxel Use in Pregnancy & Breastfeeding Cabazitaxel Drug Interactions Cabazitaxel Support Group 0 Reviews for Cabazitaxel - Add your own review/rating cabazitaxel Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Cabazitaxel Professional Patient Advice (Wolters Kluwer) Cabazitaxel MedFacts Consumer Leaflet (Wolters Kluwer) Cabazitaxel Monograph (AHFS DI) Jevtana Prescribing Information (FDA) Jevtana Consumer Overview Compare cabazitaxel with other medications Prostate Cancer Where can I get more information? Your doctor or pharmacist can provide more information about cabazitaxel.

See also: cabazitaxel side effects (in more detail)


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Mephobarbital


Pronunciation: me-foe-BAR-bih-tal
Generic Name: Mephobarbital
Brand Name: Mebaral
Mephobarbital is used for:

Treating anxiety, tension, and apprehension, and preventing seizures. It may also be used for other conditions as determined by your doctor.

Mephobarbital is a barbiturate. It works by depressing the central nervous system or brain. In low doses, it causes mild sedation. As the dose increases, it can cause sleep and even coma. As it causes the brain to relax, it also decreases seizure activity.

Do NOT use Mephobarbital if: you are allergic to any ingredient in Mephobarbital you have the blood disorder porphyria you are taking sodium oxybate (GHB) or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mephobarbital:

Some medical conditions may interact with Mephobarbital. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have depression, pain, lung or breathing problems, heart problems, or myasthenia gravis if you have a history of kidney or liver problems, substance abuse or dependence, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Mephobarbital. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin), monoamine oxidase (MAO) inhibitors (eg, phenelzine), quinine, sodium oxybate (GHB), stiripentol, or valproic acid because side effects, such as increased sedation and difficulty breathing, may occur Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, estrogens (eg, estradiol), griseofulvin, imatinib, metronidazole, oral contraceptives (eg, birth control pills), quinidine, theophylline, or voriconazolebecause the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mephobarbital may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mephobarbital:

Use Mephobarbital as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Mephobarbital may be taken with or without food. Take Mephobarbital regularly to receive the most benefit from it. Taking Mephobarbital at the same time each day will help you remember to take it. If you miss a dose of Mephobarbital, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mephobarbital.

Important safety information: Mephobarbital may cause dizziness, drowsiness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mephobarbital. Using Mephobarbital alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Mephobarbital. Mephobarbital will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. Mephobarbital may decrease the effectiveness of your birth control pills. To prevent pregnancy, use an additional form of birth control while you are using Mephobarbital and for a month after stopping Mephobarbital. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Mephobarbital. LAB TESTS, including blood cell counts and kidney and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Use Mephobarbital with caution in the ELDERLY because they may be more sensitive to its effects. Caution is advised when using Mephobarbital in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: Mephobarbital has been shown to cause harm to the human fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Mephobarbital during pregnancy. Mephobarbital is excreted in breast milk. If you are or will be breast-feeding while you are using Mephobarbital, check with your doctor to discuss the risks to your baby.

Mephobarbital may be habit-forming and lead to DEPENDENCE if used in high doses or for a long period of time. If you are on long-term or high dosage therapy, you may have WITHDRAWAL symptoms (eg, anxiety, nausea, sleeplessness, body aches) if you suddenly stop taking Mephobarbital. Do not stop taking Mephobarbital suddenly or change the dose without asking your pharmacist or doctor. Also, when Mephobarbital is used in high doses or for a long period of time, it may not work as well and may require higher doses to have the same effect. This is known as TOLERANCE. Talk with your doctor if Mephobarbital stops working as well. Do not take more than prescribed. Discuss overuse with your doctor or pharmacist.

Possible side effects of Mephobarbital:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Clumsiness; dizziness; drowsiness; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; tired feeling; vomiting; weak bones.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty sleeping; fainting; very slow breathing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mephobarbital side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in size of pupil; cold, clammy skin; deep sleep; loss of consciousness; slowed or fast breathing.

Proper storage of Mephobarbital:

Store Mephobarbital at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mephobarbital out of the reach of children and away from pets.

General information: If you have any questions about Mephobarbital, please talk with your doctor, pharmacist, or other health care provider. Mephobarbital is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mephobarbital. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Mephobarbital resources Mephobarbital Side Effects (in more detail) Mephobarbital Use in Pregnancy & Breastfeeding Drug Images Mephobarbital Drug Interactions Mephobarbital Support Group 2 Reviews for Mephobarbital - Add your own review/rating Mephobarbital Prescribing Information (FDA) Mephobarbital Professional Patient Advice (Wolters Kluwer) mephobarbital Concise Consumer Information (Cerner Multum) Mebaral Prescribing Information (FDA) Mebaral Advanced Consumer (Micromedex) - Includes Dosage Information Compare Mephobarbital with other medications Epilepsy Sedation
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paclitaxel protein-bound


Generic Name: paclitaxel protein-bound (PAK li TAX el PRO teen-bound)
Brand Names: Abraxane

What is paclitaxel protein-bound?

Paclitaxel protein-bound is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Paclitaxel protein-bound is used in the treatment of breast cancer.

Paclitaxel protein-bound is usually given after other cancer medicines have been tried without successful treatment.

Paclitaxel protein-bound may also be used for purposes not listed in this medication guide.

What is the most important information I should know about paclitaxel protein-bound? Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving paclitaxel protein-bound, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. You should not use paclitaxel protein-bound if you are allergic to it, or if you have a low white blood cell count.

Before you receive this medication, tell your doctor if you have kidney disease, liver disease, heart disease, or bone marrow suppression.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, mouth sores, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, swelling or rapid weight gain, chest pain, sudden cough, rapid heart rate, or trouble breathing. What should I discuss with my healthcare provider before receiving paclitaxel protein-bound? You should not use paclitaxel protein-bound if you are allergic to it, or if you have a low white blood cell count.

To make sure you can safely receive paclitaxel protein-bound, tell your doctor if you have any of these other conditions:

kidney disease;

liver disease;

heart disease; or

bone marrow suppression.

FDA pregnancy category D. Do not use paclitaxel protein-bound if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Use birth control to prevent pregnancy while you are receiving paclitaxel protein-bound, whether you are a man or a woman. Paclitaxel protein-bound use by either parent may cause birth defects. It is not known whether paclitaxel protein-bound passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving paclitaxel protein-bound. How is paclitaxel protein-bound given?

Paclitaxel protein-bound is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Paclitaxel protein-bound must be given slowly, and the IV infusion can take at least 30 minutes to complete.

Paclitaxel protein-bound is usually given once every 3 weeks. Follow your doctor's dosing instructions very carefully.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when paclitaxel protein-bound is injected.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your paclitaxel protein-bound injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while using paclitaxel protein-bound? Paclitaxel protein-bound can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. Paclitaxel protein-bound side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

feeling like you might pass out;

swelling, rapid weight gain; or

chest pain, sudden cough, wheezing, trouble breathing, fast heart rate.

Less serious side effects may include:

numbness or tingly feeling;

muscle or joint pain;

nausea, vomiting;

diarrhea; or

hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Paclitaxel protein-bound Dosing Information

Usual Adult Dose for Breast Cancer:

260 mg/m2 administered intravenously over 30 minutes every 3 weeks

What other drugs will affect paclitaxel protein-bound?

Tell your doctor about all other medicines you use, especially:

bosentan (Tracleer);

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

montelukast (Singulair) or zafirlukast (Accolate);

rifampin (Rifater, Rifadin, Rifamate);

selegiline (Eldepryl, Emsam, Zelapar);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

an antidepressant such as nefazodone or fluoxetine (Prozac);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

a blood thinner such as warfarin (Coumadin);

cancer medication such as paclitaxel (Taxol) or tamoxifen (Soltamox);

heart or blood pressure medications such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cartia, Cardizem), felodipine (Plendil), losartan (Hyzaar, Cozaar), nifedipine (Nifedical, Procardia), torsemide (Demadex), verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);

seizure medications such as fosphenytoin (Cerebyx), or phenytoin (Dilantin);

oral diabetes medication such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase); or

sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

This list is not complete and other drugs may interact with paclitaxel protein-bound. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More paclitaxel protein-bound resources Paclitaxel protein-bound Side Effects (in more detail) Paclitaxel protein-bound Dosage Paclitaxel protein-bound Use in Pregnancy & Breastfeeding Paclitaxel protein-bound Drug Interactions Paclitaxel protein-bound Support Group 1 Review for Paclitaxel protein-bound - Add your own review/rating paclitaxel protein-bound Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Abraxane Prescribing Information (FDA) Abraxane MedFacts Consumer Leaflet (Wolters Kluwer) Abraxane Consumer Overview Compare paclitaxel protein-bound with other medications Breast Cancer Breast Cancer, Metastatic Where can I get more information? Your doctor or pharmacist can provide more information about paclitaxel protein-bound.

See also: paclitaxel protein-bound side effects (in more detail)


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Boots Pharmacy Cold & Flu Night Liquid


Boots Pharmacy Cold & Flu Night Liquid

Specifically to: Give full strength dose of paracetamol Relieve congestion and reduce coughing Relieve fever, aches and pains Aid restful sleep

240 ml e

Read all of this carton for full instructions.

This medicine is made specially for night-time and contains a combination of ingredients to give you relief from the major symptoms of colds and flu. It relieves fever, aches and pains, nasal congestion, dry, tickly coughs and helps you sleep.

Before you take this medicine

Contains Paracetamol
Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Do not take: If you are allergic to any of the ingredients If you have heart disease or have high blood pressure (including that due to a tumour near your kidneys) If you suffer from diabetes, an overactive thyroid, glaucoma If you suffer from severe kidney disease, liver failure, long term lung problems e.g. bronchitis or bronchiectasis If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid) If you are a man with prostate problems If you are pregnant or breastfeeding Talk to your pharmacist or doctor: If you have asthma If you have other kidney or liver problems (including a disease caused by drinking alcohol) If you are on a controlled sodium diet (each 30 ml contains 33 mg of sodium) If you take other medicines Medicines for heart problems (e.g. digoxin) Medicines for high blood pressure Barbiturates (for epilepsy) Sleeping tablets Strong pain killers, sedatives, tranquillisers, tricyclic antidepressants Atropine Metoclopramide or domperidone (for feeling sick) Colestyramine (to reduce blood fat levels) Warfarin or other blood thinners If you suffer from alcoholism, epilepsy, brain injury or disease (this medicine contains alcohol which may be harmful to you)

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine (propylene glycol may enhance the effects of alcohol).

Information about some of the ingredients:

Each 30 ml contains 1169 mg of alcohol (ethanol) equivalent to 29 ml of beer or 12 ml of wine.

Glycerol may cause headache, stomach upset and diarrhoea.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Take at bedtime only. Use the measuring cup provided.

Adults and children of 12 years and over

Take 30 ml

At bedtime only

This medicine should be swallowed

Do not give to children under 12 years.

Warning:

Do not exceed stated dose.

Do not take this medicine for more than 7 days unless your doctor tells you to.

If symptoms persist consult your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the medicine.

See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious.

If they bother you talk to a pharmacist:

Drowsiness, tiredness, dizziness, muscular weakness Feeling sick, being sick, diarrhoea, constipation, stomach upset, stomach pains Headache, blurred vision, ringing in the ears, loss of appetite Irritability, nightmares, hallucinations (particularly in children) Fast heart rate, shaking, difficulty in passing urine, dry mouth, phlegm on the chest, sweating Skin rash Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 30 ml of oral solution contains Diphenhydramine Hydrochloride 25 mg, Paracetamol 1000 mg, Pholcodine 10 mg, Pseudoephedrine Hydrochloride 60 mg.

Also contains: glycerol (E422), propylene glycol, maltitol liquid (E965), purified water, ethanol (4.8 vol %), citric acid, sodium citrate, sodium benzoate (E211), acesulfame potassium, quinoline yellow (E104), patent blue V (E131), flavours (peppermint, aniseed (containing benzyl alcohol, propylene glycol)).

PL 00014/0571

P

Text prepared 3/08

Manufactured for the Marketing Authorisation holder Boots Pharmacy Nottingham NG2 3AA

by

The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC19179 vF 28/08/08


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vinorelbine


Generic Name: vinorelbine (vin OR el been)
Brand Names: Navelbine

What is vinorelbine?

Vinorelbine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vinorelbine is used to treat non-small cell lung cancer.

Vinorelbine is sometimes used in combination with other cancer medications.

Vinorelbine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vinorelbine? You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts. Do not use vinorelbine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vinorelbine, tell your doctor if you have liver disease, bone marrow suppression, a nerve disorder, or if you have received radiation therapy or other cancer treatments.

Vinorelbine is sometimes used in combination with other cancer medications.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vinorelbine is injected.

Vinorelbine can lower blood cells that help your body fight infections. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with vinorelbine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. What should I discuss with my healthcare provider before receiving vinorelbine? You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

liver disease;

bone marrow suppression;

a nerve disorder; or

if you have received radiation therapy or other cancer treatments.

FDA pregnancy category D. Vinorelbine can cause harm to an unborn baby or cause birth defects. Before you receive vinorelbine, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether vinorelbine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are being treated with vinorelbine. How is vinorelbine given?

Vinorelbine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion.

Vinorelbine is usually given once every 7 days. You may also receive the medication once every 6 weeks. Follow your doctor's instructions.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Vinorelbine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your vinorelbine injection.

What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include white patches or sores in your mouth or throat, painful swallowing, heartburn, severe constipation, and stomach pain.

What should I avoid while receiving vinorelbine?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with vinorelbine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine.

Talk to your doctor about ways to avoid constipation while being treated with vinorelbine.

Vinorelbine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;

cough, bronchospasm (wheezing, chest tightness, trouble breathing);

severe constipation, stomach pain, bloody or black stools;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

numbness, burning, pain, or tingly feeling;

problems with vision, hearing, speech, balance, or daily activities;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

pain, burning, redness, swelling, or skin changes where the IV needle was placed.

Less serious side effects may include:

temporary hair loss;

jaw pain, joint or muscle pain;

tumor pain;

weight loss;

nausea, vomiting, diarrhea, loss of appetite; or

feeling dizzy, weak, or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vinorelbine Dosing Information

Usual Adult Dose for Non-Small Cell Lung Cancer:

vinorelbine 30 mg/m2 administered weekly as a single agent. The recommended method of administration is an intravenous injection over 6 to 10 minutes. In controlled trials, single-agent vinorelbine was given weekly until progression or dose-limiting toxicity.
or
vinorelbine 25 mg/m2 weekly in combination with cisplatin. Blood counts should be checked weekly to determine whether dose reductions of vinorelbine and/or cisplatin are necessary. (In the SWOG study, most patients required a 50% dose reduction of vinorelbine at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3.)
or
vinorelbine 30 mg/m2 weekly in combination with cisplatin.

What other drugs will affect vinorelbine?

Tell your doctor about all other medications you use, especially:

conivaptan (Vaprisol);

diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

an antidepressant such as nefazodone;

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

cancer medicines such as cisplatin (Platinol), carboplatin (Paraplatin), mitomycin (Mutamycin), or oxaliplatin (Elixatin);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with vinorelbine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More vinorelbine resources Vinorelbine Side Effects (in more detail) Vinorelbine Dosage Vinorelbine Use in Pregnancy & Breastfeeding Vinorelbine Drug Interactions Vinorelbine Support Group 0 Reviews for Vinorelbine - Add your own review/rating vinorelbine Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Vinorelbine MedFacts Consumer Leaflet (Wolters Kluwer) Vinorelbine Prescribing Information (FDA) Navelbine Monograph (AHFS DI) Compare vinorelbine with other medications Non-Small Cell Lung Cancer Where can I get more information? Your doctor or pharmacist can provide more information about vinorelbine.

See also: vinorelbine side effects (in more detail)


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thiethylperazine Oral, Intramuscular, Rectal


thye-eth-il-PER-a-zeen

Commonly used brand name(s)

In the U.S.

Torecan

Available Dosage Forms:

Suppository Tablet Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Phenothiazine

Chemical Class: Piperazine (class)

Uses For thiethylperazine

Thiethylperazine is a phenothiazine medicine. It is used to treat nausea and vomiting.

thiethylperazine is available only with your doctor's prescription.

Before Using thiethylperazine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For thiethylperazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to thiethylperazine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children are usually more sensitive than adults to the effects of phenothiazine medicines such as thiethylperazine. Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration.

Geriatric

Elderly patients are usually more sensitive to the effects of phenothiazine medicines such as thiethylperazine. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, uncontrolled movements may be more likely to occur in elderly patients taking thiethylperazine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking thiethylperazine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using thiethylperazine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride Grepafloxacin Sparfloxacin

Using thiethylperazine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Fentanyl Gatifloxacin Ibutilide Isradipine Levorphanol Methadone Metrizamide Morphine Morphine Sulfate Liposome Moxifloxacin Octreotide Oxycodone Pentamidine Procarbazine Tramadol

Using thiethylperazine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Belladonna Belladonna Alkaloids Betel Nut Evening Primrose Meperidine Phenylalanine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using thiethylperazine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use thiethylperazine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Other Medical Problems

The presence of other medical problems may affect the use of thiethylperazine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse—thiethylperazine, if taken together with alcohol, may lower the blood pressure and cause CNS depressant effects, such as severe drowsiness Asthma attack or Other lung diseases—Thiethylperazine may cause secretions to become thick so that it might be difficult to cough them up, for example, during an asthma attack Blood disease or Heart or blood vessel disease—thiethylperazine may cause more serious conditions to develop Difficult urination or Enlarged prostate—thiethylperazine may cause urinary problems to get worse Glaucoma—thiethylperazine may cause an increase in inner eye pressure Liver disease—Thiethylperazine may accumulate in the body, increasing the chance of side effects, such as muscle spasms Parkinson's disease or Seizure disorders—The chance of thiethylperazine causing seizures or uncontrolled movements is greater when these conditions are present Proper Use of thiethylperazine

Thiethylperazine is used only to relieve or prevent nausea and vomiting. Use it only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

For patients taking thiethylperazine by mouth:

thiethylperazine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients using the suppository form of thiethylperazine :

To insert suppository: First, remove foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper. Wash your hands with soap and water. Dosing

The dose of thiethylperazine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of thiethylperazine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nausea and vomiting: For oral dosage form (tablets): Adults—10 milligrams (mg) one to three times a day. Children—Use and dose must be determined by your doctor. For injection dosage form: Adults—10 mg one to three times a day, injected into a muscle. Children—Use and dose must be determined by your doctor. For rectal dosage form (suppositories): Adults—10 mg one to three times a day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of thiethylperazine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using thiethylperazine

If you are going to be taking thiethylperazine for a long time, your doctor should check your progress at regular visits, especially during the first few months of treatment with thiethylperazine. This will allow your dosage to be changed if necessary to meet your needs.

Thiethylperazine will add to the effects of alcohol and other CNS depressants (medicines that cause you to feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using thiethylperazine .

thiethylperazine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to thiethylperazine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

When using thiethylperazine on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin or other salicylates at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by thiethylperazine.

Thiethylperazine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

thiethylperazine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare Abdominal or stomach pains aching muscles and joints blurred vision, change in color vision, or difficulty in seeing at night confusion (especially in the elderly) convulsions (seizures) difficulty in speaking or swallowing fast heartbeat fever and chills inability to move eyes lip smacking or puckering loss of balance control mask-like face muscle spasms (especially of face, neck, and back) nausea, vomiting, or diarrhea nightmares (continuing) nosebleeds puffing of cheeks rapid or fine, worm-like movements of tongue shuffling walk skin itching (severe) sore throat and fever stiffness of arms or legs swelling of arms, hands, and face tic-like or twitching movements trembling and shaking of hands and fingers twisting movements of body uncontrolled chewing movements uncontrolled movements of arms or legs unusual bleeding or bruising unusual excitement, nervousness, restlessness, or irritability unusual tiredness or weakness weakness of arms and legs yellow eyes or skin Symptoms of overdose Confusion (severe) convulsions (seizures) dizziness (severe) drowsiness (severe) dry mouth (severe) hyperextension of neck and trunk inability to move eyes loss of consciousness spasms of face and neck stuffy nose troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Dizziness drowsiness Less common or rare Constipation dizziness or lightheadedness, especially when getting up from a lying or sitting position dryness of mouth, nose and throat fainting fever headache ringing or buzzing in ears skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: thiethylperazine Oral, Intramuscular, Rectal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More thiethylperazine Oral, Intramuscular, Rectal resources Thiethylperazine Oral, Intramuscular, Rectal Side Effects (in more detail) Thiethylperazine Oral, Intramuscular, Rectal Use in Pregnancy & Breastfeeding Thiethylperazine Oral, Intramuscular, Rectal Drug Interactions Thiethylperazine Oral, Intramuscular, Rectal Support Group 0 Reviews for Thiethylperazine Oral, Intramuscular, Rectal - Add your own review/rating Compare thiethylperazine Oral, Intramuscular, Rectal with other medications Nausea/Vomiting
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Torecan


Generic Name: thiethylperazine (Oral route, Intramuscular route, Rectal route)

thye-eth-il-PER-a-zeen

Commonly used brand name(s)

In the U.S.

Torecan

Available Dosage Forms:

Suppository Tablet Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Phenothiazine

Chemical Class: Piperazine (class)

Uses For Torecan

Thiethylperazine is a phenothiazine medicine. It is used to treat nausea and vomiting.

This medicine is available only with your doctor's prescription.

Before Using Torecan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children are usually more sensitive than adults to the effects of phenothiazine medicines such as thiethylperazine. Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration.

Geriatric

Elderly patients are usually more sensitive to the effects of phenothiazine medicines such as thiethylperazine. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, uncontrolled movements may be more likely to occur in elderly patients taking thiethylperazine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride Grepafloxacin Sparfloxacin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Fentanyl Gatifloxacin Ibutilide Isradipine Levorphanol Methadone Metrizamide Morphine Morphine Sulfate Liposome Moxifloxacin Octreotide Oxycodone Pentamidine Procarbazine Tramadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Belladonna Belladonna Alkaloids Betel Nut Evening Primrose Meperidine Phenylalanine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse—This medicine, if taken together with alcohol, may lower the blood pressure and cause CNS depressant effects, such as severe drowsiness Asthma attack or Other lung diseases—Thiethylperazine may cause secretions to become thick so that it might be difficult to cough them up, for example, during an asthma attack Blood disease or Heart or blood vessel disease—This medicine may cause more serious conditions to develop Difficult urination or Enlarged prostate—This medicine may cause urinary problems to get worse Glaucoma—This medicine may cause an increase in inner eye pressure Liver disease—Thiethylperazine may accumulate in the body, increasing the chance of side effects, such as muscle spasms Parkinson's disease or Seizure disorders—The chance of thiethylperazine causing seizures or uncontrolled movements is greater when these conditions are present Proper Use of Torecan

Thiethylperazine is used only to relieve or prevent nausea and vomiting. Use it only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

For patients taking this medicine by mouth:

This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients using the suppository form of this medicine :

To insert suppository: First, remove foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper. Wash your hands with soap and water. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nausea and vomiting: For oral dosage form (tablets): Adults—10 milligrams (mg) one to three times a day. Children—Use and dose must be determined by your doctor. For injection dosage form: Adults—10 mg one to three times a day, injected into a muscle. Children—Use and dose must be determined by your doctor. For rectal dosage form (suppositories): Adults—10 mg one to three times a day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Torecan

If you are going to be taking this medicine for a long time, your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs.

Thiethylperazine will add to the effects of alcohol and other CNS depressants (medicines that cause you to feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

When using thiethylperazine on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin or other salicylates at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by this medicine.

Thiethylperazine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Torecan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare Abdominal or stomach pains aching muscles and joints blurred vision, change in color vision, or difficulty in seeing at night confusion (especially in the elderly) convulsions (seizures) difficulty in speaking or swallowing fast heartbeat fever and chills inability to move eyes lip smacking or puckering loss of balance control mask-like face muscle spasms (especially of face, neck, and back) nausea, vomiting, or diarrhea nightmares (continuing) nosebleeds puffing of cheeks rapid or fine, worm-like movements of tongue shuffling walk skin itching (severe) sore throat and fever stiffness of arms or legs swelling of arms, hands, and face tic-like or twitching movements trembling and shaking of hands and fingers twisting movements of body uncontrolled chewing movements uncontrolled movements of arms or legs unusual bleeding or bruising unusual excitement, nervousness, restlessness, or irritability unusual tiredness or weakness weakness of arms and legs yellow eyes or skin Symptoms of overdose Confusion (severe) convulsions (seizures) dizziness (severe) drowsiness (severe) dry mouth (severe) hyperextension of neck and trunk inability to move eyes loss of consciousness spasms of face and neck stuffy nose troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Dizziness drowsiness Less common or rare Constipation dizziness or lightheadedness, especially when getting up from a lying or sitting position dryness of mouth, nose and throat fainting fever headache ringing or buzzing in ears skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Torecan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Torecan resources Torecan Side Effects (in more detail) Torecan Use in Pregnancy & Breastfeeding Torecan Drug Interactions Torecan Support Group 0 Reviews for Torecan - Add your own review/rating Torecan Prescribing Information (FDA) Torecan Concise Consumer Information (Cerner Multum) Compare Torecan with other medications Nausea/Vomiting
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tamsulosin


Generic Name: tamsulosin (tam soo LOE sin)
Brand Names: Flomax

What is tamsulosin?

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Tamsulosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. What should I discuss with my healthcare provider before taking tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take this tamsulosin.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Tamsulosin is not for use in children. How should I take tamsulosin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Tamsulosin is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a tamsulosin capsule. Swallow it whole. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

See also: Tamsulosin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking tamsulosin? Tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of tamsulosin. Tamsulosin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tamsulosin and call your doctor at once if you have any of these serious side effects:

feeling like you might pass out;

chest pain;

fever, chills, body aches, or flu symptoms; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

weakness, drowsiness;

headache;

nausea, diarrhea;

back pain;

blurred vision;

dental problems;

sleep problems (insomnia);

abnormal ejaculation, decreased sex drive; or

runny nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tamsulosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.4 mg orally once daily one-half hour following the same meal each day

What other drugs will affect tamsulosin?

Tell your doctor about all other medications you use, especially:

cimetidine (Tagamet);

conivaptan (Vaprisol);

cyclosporine (Gengraf, Neoral, Sandimmune);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

methimazole (Tapazole);

pioglitazone (Actos);

ropinirole (Requip);

ticlopidine (Ticlid);

warfarin (Coumadin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl, Protostat), telithromycin (Ketek), or terbinafine (Lamisil);

an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and there are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More tamsulosin resources Tamsulosin Side Effects (in more detail)Tamsulosin DosageTamsulosin Use in Pregnancy & BreastfeedingDrug ImagesTamsulosin Drug InteractionsTamsulosin Support Group65 Reviews for Tamsulosin - Add your own review/rating tamsulosin Advanced Consumer (Micromedex) - Includes Dosage Information Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer) Tamsulosin Prescribing Information (FDA) Flomax Prescribing Information (FDA) Flomax Monograph (AHFS DI) Flomax Consumer Overview Compare tamsulosin with other medications Benign Prostatic HyperplasiaOveractive BladderUrinary Tract Stones Where can I get more information? Your pharmacist can provide more information about tamsulosin.

See also: tamsulosin side effects (in more detail)


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insulin glargine, recombinant Subcutaneous


IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Lantus Lantus SoloStar

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For insulin glargine, recombinant

Insulin glargine is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

insulin glargine, recombinant is available only with your doctor's prescription.

Before Using insulin glargine, recombinant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For insulin glargine, recombinant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to insulin glargine, recombinant or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

insulin glargine, recombinant has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Geriatric

insulin glargine, recombinant has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of insulin glargine, recombinant. Make sure you tell your doctor if you have any other medical problems, especially:

Emotional disturbances or Infection or Stress—These conditions increase blood sugar and may increase the amount of insulin or insulin glargine you need Kidney disease or Liver disease—Effects of insulin glargine may be increased; this may change the amount of insulin glargine you need Proper Use of insulin glargine, recombinant Dosing

The dose of insulin glargine, recombinant will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of insulin glargine, recombinant. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine. How to inject the medicine. How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For injection dosage form: For type 2 diabetes mellitus: Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor. Children up to 6 years of age—Use and dose must be determined by your doctor. Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using insulin glargine, recombinant

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take insulin glargine, recombinant.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team. Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems. Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy. Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines. Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs. Keep some kind of quick-acting sugar handy to treat low blood sugar. Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

insulin glargine, recombinant Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Convulsions (seizures) unconsciousness

Check with your doctor as soon as possible if any of the following side effects occur:

More common Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue Less common or rare Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Bloating or swelling of face, hands, lower legs, and/or feet depression of skin at injection site injection site pain local allergy, including itching, redness, or swelling at injection site thickening of skin at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: insulin glargine, recombinant Subcutaneous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More insulin glargine, recombinant Subcutaneous resources Insulin glargine, recombinant Subcutaneous Side Effects (in more detail)Insulin glargine, recombinant Subcutaneous Use in Pregnancy & BreastfeedingInsulin glargine, recombinant Subcutaneous Drug InteractionsInsulin glargine, recombinant Subcutaneous Support Group15 Reviews for Insulin glargine, recombinant Subcutaneous - Add your own review/rating Compare insulin glargine, recombinant Subcutaneous with other medications Diabetes, Type 1Diabetes, Type 2
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Lantus SoloStar


Generic Name: insulin glargine, recombinant (Subcutaneous route)

IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Lantus Lantus SoloStar

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For Lantus SoloStar

Insulin glargine is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

This medicine is available only with your doctor's prescription.

Before Using Lantus SoloStar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Emotional disturbances or Infection or Stress—These conditions increase blood sugar and may increase the amount of insulin or insulin glargine you need Kidney disease or Liver disease—Effects of insulin glargine may be increased; this may change the amount of insulin glargine you need Proper Use of insulin glargine, recombinant

This section provides information on the proper use of a number of products that contain insulin glargine, recombinant. It may not be specific to Lantus SoloStar. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine. How to inject the medicine. How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For injection dosage form: For type 2 diabetes mellitus: Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor. Children up to 6 years of age—Use and dose must be determined by your doctor. Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using Lantus SoloStar

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team. Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems. Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy. Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines. Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs. Keep some kind of quick-acting sugar handy to treat low blood sugar. Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Lantus SoloStar Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Convulsions (seizures) unconsciousness

Check with your doctor as soon as possible if any of the following side effects occur:

More common Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue Less common or rare Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Bloating or swelling of face, hands, lower legs, and/or feet depression of skin at injection site injection site pain local allergy, including itching, redness, or swelling at injection site thickening of skin at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lantus SoloStar side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Lantus SoloStar resources Lantus SoloStar Side Effects (in more detail) Lantus SoloStar Use in Pregnancy & Breastfeeding Lantus SoloStar Drug Interactions Lantus SoloStar Support Group 5 Reviews for Lantus SoloStar - Add your own review/rating Compare Lantus SoloStar with other medications Diabetes, Type 1 Diabetes, Type 2
read more / Download


sunitinib malate


soo-NI-ti-nib MAL-ate

Oral route(Capsule)

Hepatotoxicity has been observed in clinical trials and postmarketing experience. This hepatotoxicity may be severe, and deaths have been reported .

Commonly used brand name(s)

In the U.S.

Sutent

Available Dosage Forms:

Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Sunitinib

Uses For sunitinib malate

Sunitinib belongs to the group of medicines known as antineoplastics. It is used to treat a gastrointestinal stromal tumor (GIST) after a medicine called imatinib did not work very well. It may also be used when patients are not able to take imatinib. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Sunitinib is also used to treat advanced (late-stage) kidney cancer.

Sunitinib is also used to treat a type of pancreatic cancer called pancreatic neuroendocrine tumor (pNET), that cannot be surgically removed and is locally advanced or metastatic (cancer that has spread).

Sunitinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with sunitinib, you and your doctor should talk about the benefits sunitinib malate will do as well as the risks of using it.

sunitinib malate is available only with your doctor's prescription.

Before Using sunitinib malate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sunitinib malate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sunitinib malate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sunitinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sunitinib in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sunitinib malate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sunitinib malate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dronedarone Fluconazole Mesoridazine Pimozide Posaconazole Sparfloxacin Thioridazine

Using sunitinib malate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfuzosin Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Atazanavir Azithromycin Boceprevir Bretylium Carbamazepine Chloroquine Chlorpromazine Ciprofloxacin Cisapride Citalopram Clarithromycin Clomipramine Clozapine Conivaptan Crizotinib Dasatinib Desipramine Dexamethasone Disopyramide Dofetilide Dolasetron Droperidol Erythromycin Flecainide Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Ibutilide Iloperidone Imipramine Indinavir Itraconazole Ketoconazole Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Methadone Mitotane Moxifloxacin Nefazodone Nelfinavir Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Perflutren Lipid Microsphere Phenobarbital Phenytoin Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Rifabutin Rifampin Rifapentine Ritonavir Salmeterol Saquinavir Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol St John's Wort Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of sunitinib malate. Make sure you tell your doctor if you have any other medical problems, especially:

Bleeding problems or Bradycardia (very slow heart beat), history of or Congestive heart failure, history of or Heart disease (e.g., cardiomyopathy), history of or Heart rhythm problems (e.g., QT prolongation), history of or Hypertension (high blood pressure) or Hyperthyroidism (overactive thyroid) or Hypothyroidism (underactive thyroid) or Kidney problems (other than cancer) or Liver problems or Seizures or Stomach ulcers—Use with caution. May make these conditions worse. Hypokalemia (low potassium in the blood) or Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse. Infection, severe or Surgery or Trauma—These conditions may cause adrenal gland problems. Proper Use of sunitinib malate

Your doctor will tell you how much of sunitinib malate to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

You may take sunitinib malate with or without food. Do not open the capsules.

sunitinib malate comes with a Medication Guide and a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of sunitinib malate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sunitinib malate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules): For the treatment of GIST and kidney cancer: Adults—50 milligrams (mg) once a day for 4 weeks. This is followed by 2 weeks without medicine. Your doctor may tell you to repeat this cycle. Children—Use and dose must be determined by your doctor. For advanced pancreatic cancer or pancreatic neuroendocrine tumor (pNET): Adults—37.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose

sunitinib malate needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using sunitinib malate

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib treatment.

Using sunitinib malate while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are using sunitinib malate. The results of some tests may be affected by sunitinib malate.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

Sunitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you are rapidly gaining weight or have shortness of breath; chest pain or discomfort; extreme tiredness or weakness; irregular breathing; uneven heartbeats; or excessive swelling of the hands, wrist, ankles, or feet. These may be symptoms of a heart problem.

sunitinib malate can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or dizziness. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

sunitinib malate may also increase your risk of bleeding and cause delay in wound healing. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

Make sure any doctor or dentist who treats you knows that you are using sunitinib malate. You may need to stop using sunitinib malate several days before having surgery or medical tests.

Grapefruit and grapefruit juice may cause you to have too much of sunitinib malate in the blood. You should not eat grapefruit or drink grapefruit juice while you are taking sunitinib malate.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's Wort) or vitamin supplements.

sunitinib malate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Bleeding gums bloating or swelling of the face, arms, hands, fingers, lower legs, or feet blurred vision chest pain chills confusion coughing up blood cracked lips decreased urination decreased urine output diarrhea difficulty with breathing or swallowing dilated neck veins dizziness dry mouth extreme fatigue fainting fast, slow, or irregular heartbeat fever headache increase in heart rate increased menstrual flow or vaginal bleeding irregular breathing labored breathing lightheadedness nervousness nosebleeds paralysis pounding in the ears prolonged bleeding from cuts rapid breathing rapid weight gain red or black, tarry stools red or dark brown urine shortness of breath sores, ulcers, or white spots on the lips, tongue, or inside the mouth sunken eyes swelling or inflammation of the mouth thirst tightness in the chest tingling of the hands or feet troubled breathing unusual tiredness or weakness unusual weight gain or loss wheezing wrinkled skin yellow eyes or skin Less common Constipation depressed mood dry skin and hair feeling cold hair loss hoarseness or husky voice indigestion loss of appetite muscle cramps and stiffness nausea pain in the chest, groin, or legs, especially the calves pain in the stomach, side, or abdomen, possibly radiating to the back severe, sudden headache slurred speech sudden loss of coordination sudden, severe weakness or numbness in the arm or leg sudden, unexplained shortness of breath vision changes vomiting Rare Back pain chest discomfort cloudy or bloody urine convulsions darkening of the skin drowsiness general feeling of tiredness or weakness irregular or slow heart rate light-colored stools mental depression skin rash stomach pain, continuing swelling of the face, feet, or lower legs Incidence not known Cough dark-colored urine decreased frequency or amount of urine increased thirst lower back or side pain muscle cramps or spasms muscular pain, tenderness, wasting, or weakness painful or difficult urination pale skin sore throat sudden, severe chest pain unusual bleeding or bruising weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal or stomach pain acid or sour stomach belching blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet change in color of the treated skin change in taste difficulty with moving discouragement excess air or gas in the stomach or intestines feeling sad or empty full feeling hair color changes hair loss or thinning of the hair heartburn irritability joint pain lack of appetite lack or loss of strength loss of interest or pleasure muscle aches or pains numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet pain or burning in the throat passing gas sleeplessness stomach discomfort, upset, or pain swollen joints trouble concentrating trouble sleeping unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: sunitinib malate side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More sunitinib malate resources Sunitinib malate Side Effects (in more detail) Sunitinib malate Dosage Sunitinib malate Use in Pregnancy & Breastfeeding Sunitinib malate Drug Interactions Sunitinib malate Support Group 7 Reviews for Sunitinib malate - Add your own review/rating Compare sunitinib malate with other medications Gastrointestinal Stromal Tumor Pancreatic Cancer Renal Cell Carcinoma
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Lantus


Generic Name: insulin glargine, recombinant (Subcutaneous route)

IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Lantus Lantus SoloStar

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For Lantus

Insulin glargine is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

This medicine is available only with your doctor's prescription.

Before Using Lantus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Emotional disturbances or Infection or Stress—These conditions increase blood sugar and may increase the amount of insulin or insulin glargine you need Kidney disease or Liver disease—Effects of insulin glargine may be increased; this may change the amount of insulin glargine you need Proper Use of insulin glargine, recombinant

This section provides information on the proper use of a number of products that contain insulin glargine, recombinant. It may not be specific to Lantus. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine. How to inject the medicine. How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For injection dosage form: For type 2 diabetes mellitus: Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor. Children up to 6 years of age—Use and dose must be determined by your doctor. Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using Lantus

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team. Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems. Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy. Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines. Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs. Keep some kind of quick-acting sugar handy to treat low blood sugar. Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Lantus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Convulsions (seizures) unconsciousness

Check with your doctor as soon as possible if any of the following side effects occur:

More common Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue Less common or rare Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Bloating or swelling of face, hands, lower legs, and/or feet depression of skin at injection site injection site pain local allergy, including itching, redness, or swelling at injection site thickening of skin at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lantus side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Lantus resources Lantus Side Effects (in more detail) Lantus Use in Pregnancy & Breastfeeding Lantus Drug Interactions Lantus Support Group 7 Reviews for Lantus - Add your own review/rating Lantus Prescribing Information (FDA) Lantus Monograph (AHFS DI) Lantus Cartridge Systems MedFacts Consumer Leaflet (Wolters Kluwer) Lantus Consumer Overview Compare Lantus with other medications Diabetes, Type 1 Diabetes, Type 2
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