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Familial Mediterranean Fever Medications


Definition of Familial Mediterranean Fever: Familial Mediterranean fever is an inherited disorder characterized by recurrent fever and inflammation, often involving the abdomen or the lung.

Drugs associated with Familial Mediterranean Fever

The following drugs and medications are in some way related to, or used in the treatment of Familial Mediterranean Fever. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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Medical Encyclopedia:

Familial Mediterranean fever
Drug List: Colcrys
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Colcrys


Generic Name: colchicine
Dosage Form: tablet, film coated
FULL PRESCRIBING INFORMATION Indications and Usage for Colcrys Gout Flares

Colcrys® (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.

  Prophylaxis of Gout Flares:
Colcrys is indicated for prophylaxis of gout flares.   Treatment of Gout Flares:
Colcrys tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. Familial Mediterranean fever (FMF)

Colcrys® (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).

Colcrys Dosage and Administration

The long term use of colchicine is established for FMF and the prophylaxis of gout flares but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for Colcrys are different for each indication and must be individualized.

The recommended dosage of Colcrys depends on the patient's age, renal function, hepatic function, and use of co-administered drugs [see Dose Modification for Co-administration of Interacting Drugs (2.4)].

Colcrys tablets are administered orally, without regard to meals.

Colcrys is not an analgesic medication and should not be used to treat pain from other causes.

Gout Flares

Prophylaxis of Gout Flares:

The recommended dosage of Colcrys for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day.

Treatment of Gout Flares:

The recommended dose of Colcrys for treatment of a gout flare is 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1 hour period. Colcrys may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (2 tablets) at the first sign of the flare followed by 0.6 mg (1 tablet) one hour later. Wait 12 hours and then resume the prophylactic dose.

FMF

The recommended dosage of Colcrys for FMF in adults is 1.2 mg to 2.4 mg daily.

Colcrys should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily Colcrys dose may be administered in one to two divided doses.

Recommended Pediatric Dosage

Prophylaxis and Treatment of Gout Flares:

Colcrys is not recommended for pediatric use in prophylaxis or treatment of gout flares.

FMF:

The recommended dosage of Colcrys for FMF in pediatric patients 4 years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily:

Children 4 – 6 years: 0.3 mg to 1.8 mg daily Children 6 – 12 years: 0.9 mg to 1.8 mg daily Adolescents older than 12 years: 1.2 mg to 2.4 mg daily Dose Modification for Co-administration of Interacting Drugs

Concomitant Therapy:

Co-administration of Colcrys with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown on the table below [see DRUG INTERACTIONS (7)].

Table 1 Colcrys Dose Adjustment for Co-administration with Interacting Drugs if no Alternative Available* Strong CYP3A4 Inhibitors† * For magnitude of effect on colchicine plasma concentrations [see Pharmacokinetics (12.3)] † Patients with renal or hepatic impairment should not be given Colcrys in conjunction with strong CYP3A4 or P-gp inhibitors [see CONTRAINDICATIONS (4)]. ‡ When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [see CONTRAINDICATIONS (4)]. Drug Noted or Anticipated Outcome Gout Flares FMF Prophylaxis of Gout Flares Treatment of Gout Flares Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Atazanavir
Clarithromycin
Darunavir/
Ritonavir‡
Indinavir
Itraconazole Ketoconazole
Lopinavir/
Ritonavir‡
Nefazodone
Nelfinavir
Ritonavir
Saquinavir Telithromycin
Tipranavir/
Ritonavir‡ Significant increase in colchicine plasma levels*; fatal colchicine toxicity has been reported with clarithromycin, a strong CYP3A4 inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other strong CYP3A4 inhibitors. 0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day 1.2 mg
(2 tablets) followed by 0.6 mg
(1 tablet)
1 hour later. Dose to be repeated no earlier than
3 days. 0.6 mg
(1 tablet) ?
1 dose, followed by 0.3 mg
(1/2 tablet)
1 hour later. Dose to be repeated no earlier than
3 days. Maximum daily dose of 1.2 – 2.4 mg Maximum daily dose of 0.6 mg (may be given as
0.3 mg twice a day) Moderate CYP3A4 Inhibitors Drug Noted or Anticipated Outcome Gout Flares FMF Prophylaxis of Gout Flares Treatment of Gout Flares Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Amprenavir‡ Aprepitant
Diltiazem Erythromycin Fluconazole Fosamprenavir‡
(pro-drug of
Amprenavir)
Grapefruit Juice Verapamil Significant increase in colchicine plasma concentration is anticipated. Neuromuscular toxicity has been reported with diltiazem and verapamil interactions. 0.6 mg twice a day
0.6 mg once a day
0.3 mg twice a day or 0.6 mg once a day
0.3 mg once a day
1.2 mg
(2 tablets) followed by 0.6 mg
(1 tablet)
1 hour later. Dose to be repeated no earlier than
3 days. 1.2 mg
(2 tablets) ?
1 dose. Dose to be repeated no earlier than
3 days.
Maximum daily dose of 1.2 – 2.4 mg. Maximum daily dose of 1.2 mg (may be given as
0.6 mg twice a day) P-gp Inhibitors† Drug Noted or Anticipated Outcome Gout Flares FMF Prophylaxis of Gout Flares Treatment of Gout Flares Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Original Intended Dosage Adjusted Dose Cyclosporine Ranolazine Significant increase in colchicine plasma levels*; fatal colchicine toxicity has been reported with cyclosporine, a
P-gp inhibitor. Similarly, significant increase in colchicine plasma levels is anticipated with other P-gp inhibitors. 0.6 mg twice a day
0.6 mg once a day
0.3 mg once a day
0.3 mg once every other day 1.2 mg
(2 tablets) followed by 0.6 mg
(1 tablet)
1 hour later. Dose to be repeated no earlier than
3 days. 0.6 mg
(1 tablet) ?
1 dose. Dose to be repeated no earlier than
3 days. Maximum daily dose of 1.2 – 2.4 mg Maximum daily dose of 0.6 mg (may be given as
0.3 mg twice a day) Table 2 Colcrys Dose Adjustment for Co-administration with Protease Inhibitors Protease Inhibitor Clinical Comment w/Colchicine – Prophylaxis of Gout Flares w/Colchicine –
Treatment of Gout Flares w/Colchicine – Treatment of FMF Atazanavir sulfate
(Reyataz) Patients with renal or hepatic impairment should not be given colchicine with Reyataz. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Darunavir (Prezista) Patients with renal or hepatic impairment should not be given colchicine with Prezista/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Fosamprenavir (Lexiva) with Ritonavir Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Fosamprenavir (Lexiva) Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir. Original dose Adjusted dose 1.2 mg (2 tablets) ? 1 dose. Dose to be repeated no earlier than 3 days. Maximum daily dose of 1.2 mg (may be given as 0.6 mg twice a day) 0.6 mg twice a day 0.3 mg twice a day or 0.6 mg once a day         0.6 mg once a day 0.3 mg once a day         Indinavir (Crixivan) Patients with renal or hepatic impairment should not be given colchicine with Crixivan. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Lopinavir/Ritonavir (Kaletra) Patients with renal or hepatic impairment should not be given colchicine with Kaletra. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Nelfinavir mesylate (Viracept) Patients with renal or hepatic impairment should not be given colchicine with Viracept. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Ritonavir (Norvir) Patients with renal or hepatic impairment should not be given colchicine with Norvir. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Saquinavir mesylate (Invirase) Patients with renal or hepatic impairment should not be given colchicine with Invirase/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day         Tipranavir (Aptivus)
Patients with renal or hepatic impairment should not be given colchicine with Aptivus/ritonavir. Original dose Adjusted dose 0.6 mg (1 tablet) ? 1 dose, followed by 0.3 mg (1/2 tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day
0.6 mg once a day 0.3 mg once a day
0.3 mg once every other day        

Treatment of gout flares with Colcrys is not recommended in patients receiving prophylactic dose of Colcrys and CYP3A4 inhibitors.

Dose Modification in Renal Impairment

Colchicine dosing must be individualized according to the patient's renal function [see Renal Impairment (8.6)].

Clcr in mL/minute may be estimated from serum creatinine (mg/dL) determination using the following formula:

Clcr = [140-age (years) ? weight (kg)]   ? 0.85 for female patients 72 ? serum creatinine (mg/dL)    

Gout Flares:

Prophylaxis of Gout Flares:

For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].

Treatment of Gout Flares:

For treatment of gout flares in patients with mild (Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every 2 weeks. For patients with gout flares requiring repeated courses consideration should be given to alternate therapy. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (1 tablet). For these patients, the treatment course should not be repeated more than once every 2 weeks [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].

Treatment of gout flares with Colcrys is not recommended in patients with renal impairment who are receiving Colcrys for prophylaxis.

FMF:

Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing dialysis. For these patients, the dosage should be reduced [see Clinical Pharmacology (12.3)]. Patients with mild (Clcr 50 – 80 mL/min) and moderate (Clcr 30 – 50 mL/min) renal impairment should be monitored closely for adverse effects of Colcrys. Dose reduction may be necessary. For patients with severe renal failure (Clcr less than 30 mL/minute), start with 0.3 mg/day; any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Renal Impairment (8.6)]. For patients undergoing dialysis, the total recommended starting dose should be 0.3 mg (half tablet) per day. Dosing can be increased with close monitoring. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine [see Clinical Pharmacology (12.3) and Renal Impairment (8.6)].

Dose Modification in Hepatic Impairment

Gout Flares

Prophylaxis of Gout Flares:

For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Hepatic Impairment (8.7)].

Treatment of Gout Flares:

For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, for the treatment of gout flares in patients with severe impairment while the dose does not need to be adjusted, but a treatment course should be repeated no more than once every 2 weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Hepatic Impairment (8.7)].

Treatment of gout flares with Colcrys is not recommended in patients with hepatic impairment who are receiving Colcrys for prophylaxis.

FMF:

Patients with mild to moderate hepatic impairment should be monitored closely for adverse effects of colchicine. Dose reduction should be considered in patients with severe hepatic impairment [see Hepatic Impairment (8.7)].

Dosage Forms and Strengths

0.6 mg tablets — purple capsule-shaped, film-coated with AR 374 debossed on one side and scored on the other side.

Contraindications

Patients with renal or hepatic impairment should not be given Colcrys in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors, except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses.

Warnings and Precautions Fatal Overdose

Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [see OVERDOSAGE (10)]. Colcrys should be kept out of the reach of children.

Blood Dyscrasias

Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.

Drug Interactions

Colchicine is a P-gp and CYP3A4 substrate. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine given with P-gp and strong CYP3A4 inhibitors. If treatment with a P-gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, the patient's dose of colchicine may need to be reduced or interrupted [see DRUG INTERACTIONS (7)]. Use of Colcrys in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors, except fosamprenavir) is contraindicated in patients with renal or hepatic impairment [see CONTRAINDICATIONS (4)].

Neuromuscular Toxicity

Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk. Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, gemfibrozil, fenofibrate, fenofibric acid, or benzafibrate (themselves associated with myotoxicity) or cyclosporine with Colcrys may potentiate the development of myopathy [see DRUG INTERACTIONS (7)]. Once colchicine is stopped, the symptoms generally resolve within 1 week to several months.

Adverse Reactions

Prophylaxis of Gout Flares:

The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea.

Treatment of Gout Flares:

The most common adverse reactions reported in the clinical trial with Colcrys for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%).

FMF:

Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating Colcrys, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, nausea, diarrhea, abdominal pain, and vomiting. These events should be viewed as dose-limiting if severe as they can herald the onset of more significant toxicity.

Clinical Trials Experience in Gout

Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice.

In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over 1 hour) of Colcrys compared to 77% of patients taking a non-recommended high-dose (4.8 mg over 6 hours) of colchicine and 20% of patients taking placebo. Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with Colcrys treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose regimen. Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the non-recommended high-dose colchicine regimen but did not occur in the recommended low-dose Colcrys regimen.

Table 3 Number (%) of Patients with at Least One Drug-Related Treatment Emergent Adverse Events with an Incidence of ? 2% of Patients in Any Treatment Group MedDRA System Organ Class Colcrys Dose Placebo MedDRA Preferred Term High (N=52)
n (%) Low (N=74)
n (%) (N=59)
n (%) Number of Patients with at Least One Drug-Related TEAE 40 (77) 27 (37) 16 (27) Gastrointestinal Disorders 40 (77) 19 (26) 12 (20)   Diarrhea 40 (77) 17 (23) 8 (14)   Nausea 9 (17) 3 (4) 3 (5)   Vomiting 9 (17) 0 0   Abdominal Discomfort 0 0 2 (3) General Disorders and Administration Site Conditions 4 (8) 1 (1) 1 (2)   Fatigue 2 (4) 1 (1) 1 (2) Metabolic and Nutrition Disorders 0 3 (4) 2 (3)   Gout 0 3 (4) 1 (2) Nervous System Disorders 1 (2) 1 (1.4) 2 (3)   Headache 1 (2) 1 (1) 2 (3) Respiratory Thoracic Mediastinal Disorders 1 (2) 2 (3) 0   Pharyngolaryngeal Pain 1 (2) 2 (3) 0 Postmarketing Experience

Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous systems.

These most often occur with excessive accumulation or overdosage [see OVERDOSAGE (10)].

The following adverse reactions have been reported with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine.

  Neurological: sensory motor neuropathy       Dermatological: alopecia, maculopapular rash, purpura, rash       Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting       Hematological: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia       Hepatobiliary: elevated AST, elevated ALT       Musculoskeletal: myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis       Reproductive: azoospermia, oligospermia Drug Interactions

Colcrys (colchicine) is a substrate of the efflux transporter P-glycoprotein (P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicine. If Colcrys is administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicine are likely. Fatal drug interactions have been reported.

Physicians should ensure that patients are suitable candidates for treatment with Colcrys and remain alert for signs and symptoms of toxicities related to increased colchicine exposure as a result of a drug interaction. Signs and symptoms of Colcrys toxicity should be evaluated promptly and, if toxicity is suspected, Colcrys should be discontinued immediately.

Table 4 provides recommendations as a result of other potentially significant drug interactions. Table 1 provides recommendations for strong and moderate CYP3A4 inhibitors and P-gp inhibitors.

Table 4 Other Potentially Significant Drug Interactions Concomitant Drug Class or Food Noted or anticipated Outcome Clinical Comment HMG-Co A Reductase Inhibitors:
atorvastatin, fluvastatin, pravastatin, simvastatin Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a stable long-term regimen of the other has resulted in myopathy and rhabdomyolysis (including a fatality) Weigh the potential benefits and risks and carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during initial therapy; monitoring CPK (creatine phosphokinase) will not necessarily prevent the occurrence of severe myopathy. Other Lipid Lowering Drugs:
fibrates, gemfibrozil     Digitalis Glycosides:
digoxin P-gp substrate; rhabdomyolysis has been reported   USE IN SPECIFIC POPULATIONS Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies with colchicine in pregnant women. Colchicine crosses the human placenta. While not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth, or teratogenic effects among pregnant women using colchicine to treat familial Mediterranean fever (FMF). Although animal reproductive and developmental studies were not conducted with Colcrys, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range. Colcrys should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

The effect of colchicine on labor and delivery is unknown.

Nursing Mothers

Colchicine is excreted into human milk. Limited information suggests that exclusively breast-fed infants receive less than 10 percent of the maternal weight-adjusted dose. While there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine, colchicine can affect gastrointestinal cell renewal and permeability. Caution should be exercised and breast-feeding infants should be observed for adverse effects when Colcrys is administered to a nursing woman.

Pediatric Use

The safety and efficacy of colchicine in children of all ages with FMF has been evaluated in uncontrolled studies. There does not appear to be an adverse effect on growth in children with FMF treated long-term with colchicine. Gout is rare in pediatric patients, safety and effectiveness of colchicine in pediatric patients has not been established.

Geriatric Use

Clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of FMF did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy [see Dose Modification for Co-administration of Interacting Drugs (2.4)].

Renal Impairment

Colchicine is significantly excreted in urine in healthy subjects. Clearance of colchicine is decreased in patients with impaired renal function. Total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis.

Prophylaxis of Gout Flares:

For prophylaxis of gout flares in patients with mild (estimated creatinine clearance Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. However, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Dose Modification in Renal Impairment (2.5)].

Treatment of Gout Flares:

For treatment of gout flares in patients with mild (Clcr 50 – 80 mL/min) to moderate (Clcr 30 – 50 mL/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of Colcrys. However, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every 2 weeks. For patients with gout flares requiring repeated courses consideration should be given to alternate therapy. For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (1 tablet). For these patients, the treatment course should not be repeated more than once every 2 weeks [see Dose Modification in Renal Impairment (2.5)].

FMF

Although, pharmacokinetics of colchicine in patients with mild (Clcr 50 – 80 mL/min) and moderate (Clcr 30 – 50 mL/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. Dose reduction may be necessary. In patients with severe renal failure (Clcr less than 30 mL/minute) and end-stage renal disease requiring dialysis, Colcrys may be started at the dose of 0.3 mg/day. Any increase in dose should be done with adequate monitoring of the patient for adverse effects of Colcrys [see Pharmacokinetics (12.3) and Dose Modification in Renal Impairment (2.5)].

Hepatic Impairment

The clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment, compared to healthy subjects [see Pharmacokinetics (12.3)].

Prophylaxis of Gout Flares:

For prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. Dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see Dose Modification in Hepatic Impairment (2.6)].

Treatment of Gout Flares:

For treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended Colcrys dose is not required, but patients should be monitored closely for adverse effects of Colcrys. However, for the treatment of gout flares in patients with severe impairment while the dose does not need to be adjusted, the treatment course should be repeated no more than once every 2 weeks. For these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see Dose Modification in Hepatic Impairment (2.6)].

FMF

In patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see Pharmacokinetics (12.3) and Dose Modification in Hepatic Impairment (2.6)].

Drug Abuse and Dependence

Tolerance, abuse, or dependence with colchicine has not been reported.

Overdosage

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a 4-day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities, such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions, such as myelosuppression. There was 100% mortality in those who ingested more than 0.8 mg/kg.

The first stage of acute colchicine toxicity typically begins within 24 hours of ingestion and includes gastrointestinal symptoms, such as abdominal pain, nausea, vomiting, diarrhea, and significant fluid loss, leading to volume depletion. Peripheral leukocytosis may also be seen. Life-threatening complications occur during the second stage, which occurs 24 to 72 hours after drug administration, attributed to multi-organ failure and its consequences. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery of multi-organ injury may be accompanied by rebound leukocytosis and alopecia starting about 1 week after the initial ingestion.

Treatment of colchicine poisoning should begin with gastric lavage and measures to prevent shock. Otherwise, treatment is symptomatic and supportive. No specific antidote is known. Colchicine is not effectively removed by dialysis [see Pharmacokinetics (12.3)].

Colcrys Description

Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below.

Colchicine occurs as a pale yellow powder that is soluble in water.

Colcrys® (colchicine, USP) tablets are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575" ? 0.3030"), debossed with 'AR 374' on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

Colcrys - Clinical Pharmacology Mechanism of Action

The mechanism by which Colcrys exerts its beneficial effect in patients wi


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Maxzide


Generic Name: hydrochlorothiazide and triamterene (HYE dro klor oh THY a zide and trye AM ter een)
Brand Names: Dyazide, Maxzide, Maxzide-25

What is Maxzide (hydrochlorothiazide and triamterene)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Triamterene is a potassium-sparing diuretic that also prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

The combination of hydrochlorothiazide and triamterene is used to treat fluid retention (edema) and high blood pressure (hypertension).

Hydrochlorothiazide and triamterene may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Maxzide (hydrochlorothiazide and triamterene)? You should not use this medication if you are allergic to hydrochlorothiazide or triamterene, or if you have kidney disease, urination problems, high levels of potassium in your blood, or if you are taking other diuretics similar to triamterene. Do not use potassium supplements unless your doctor has told you to.

Before using this medication, tell your doctor if you have heart or liver disease, glaucoma, diabetes, a breathing disorder, gout, lupus, kidney stones, a pancreas disorder, or an allergy to sulfa drugs or penicillin.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and triamterene.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use potassium supplements, salt substitutes, or low-sodium milk while you are taking hydrochlorothiazide and triamterene, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

What should I discuss with my doctor before taking Maxzide (hydrochlorothiazide and triamterene)? You should not use this medication if you are allergic to hydrochlorothiazide (HCTZ, HydroDiuril, Lotensin HCT, Prinzide, Zestoretic, Ziac, and others) or triamterene (Dyrenium), or if you have: kidney disease or are unable to urinate;

high potassium levels (hyperkalemia);

if you are taking diuretics similar to triamterene, such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide); or

if you are taking potassium supplements (unless your doctor tells you to).

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

diabetes;

heart disease;

cirrhosis or other liver disease;

glaucoma;

a breathing disorder;

gout;

lupus;

a history of kidney stones;

a pancreas disorder; or

an allergy to sulfa drugs or penicillin.

FDA pregnancy category C. It is not known whether hydrochlorothiazide and triamterene will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hydrochlorothiazide and triamterene can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking hydrochlorothiazide and triamterene. How should I take Maxzide (hydrochlorothiazide and triamterene)?

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.

You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using hydrochlorothiazide and triamterene.

If you need surgery or a blood transfusion, tell the doctor ahead of time that you are using hydrochlorothiazide and triamterene.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light. 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.

Overdose symptoms may include increased urination, nausea, vomiting, weakness, fever, warmth or flushing in your face, or muscle spasms.

What should I avoid while taking Maxzide (hydrochlorothiazide and triamterene)? Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and triamterene.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use potassium supplements, salt substitutes, or low-sodium milk while you are taking hydrochlorothiazide and triamterene, unless your doctor has told you to. Hydrochlorothiazide and triamterene may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Maxzide (hydrochlorothiazide and triamterene) 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 hydrochlorothiazide and triamterene and call your doctor at once if you have a serious side effect such as:

eye pain, vision problems;

slow, fast, or uneven heartbeat;

feeling like you might pass out;

swelling or rapid weight gain;

urinating less than usual or not at all;

headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, hallucinations, fainting, seizure, shallow breathing or breathing that stops;

low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

high potassium (irregular heart rate, weak pulse, muscle weakness, tingly feeling);

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

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

patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild nausea, diarrhea, constipation;

dizziness, headache;

blurred vision;

dry mouth;

skin rash.

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 can affect Maxzide (hydrochlorothiazide and triamterene)? Before using hydrochlorothiazide and triamterene, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by hydrochlorothiazide and triamterene.

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

lithium (Eskalith, LithoBid);

amphotericin B (Amphotec, AmBisome, Abelcet);

methenamine (Hipprex, Mandelamine, Urex);

gout medication such as allopurinol (Zyloprim), colchicine (Colcrys), or probenecid (Benemid);

steroid medication (prednisone and others);

a blood thinner such as warfarin (Coumadin, Jantoven);

insulin or oral diabetes medication;

laxatives;

an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others; or

indomethacin (Indocin) or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with hydrochlorothiazide and triamterene. 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 Maxzide resources Maxzide Side Effects (in more detail)Maxzide Use in Pregnancy & BreastfeedingDrug ImagesMaxzide Drug InteractionsMaxzide Support Group2 Reviews for Maxzide - Add your own review/rating Maxzide Prescribing Information (FDA) Maxzide Advanced Consumer (Micromedex) - Includes Dosage Information Maxzide MedFacts Consumer Leaflet (Wolters Kluwer) Dyazide Prescribing Information (FDA) Dyazide Consumer Overview Compare Maxzide with other medications EdemaHigh Blood Pressure Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and triamterene.

See also: Maxzide side effects (in more detail)


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Metenix 5 Tablets


1. Name Of The Medicinal Product

Metenix 5mg Tablets

2. Qualitative And Quantitative Composition

Metolazone 5 mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Metenix 5mg Tablets is a diuretic for use in the treatment of mild and moderate hypertension. Metenix 5mg Tablets may be used in conjunction with non-diuretic antihypertensive agents and, in these circumstances, it is usually possible to achieve satisfactory control of blood pressure with a reduced dose of the non-diuretic agent. Patients who have become resistant to therapy with these agents may respond to the addition of Metenix 5mg Tablets to their antihypertensive regimen.

Metenix 5mg Tablets may also be used for the treatment of cardiac, renal and hepatic oedema, ascites or toxaemia of pregnancy.

4.2 Posology And Method Of Administration

Route of administration: Oral

Hypertension: The recommended initial dose in mild and moderate hypertension is 5 mg daily. After three to four weeks, the dose may be reduced if necessary to 5 mg on alternate days as maintenance therapy.

Oedema: In oedematous conditions, the normal recommended dose is 5-10 mg daily, given as a single dose. In resistant conditions, this may be increased to 20 mg daily or above. However, no more than 80 mg should be given in any 24-hour period.

Children: There is insufficient knowledge of the effects of Metenix 5mg Tablets in children for any dosage recommendations to be made.

Elderly: Metolazone may be excreted more slowly in the elderly.

4.3 Contraindications

Metenix 5mg Tablets is contra-indicated in electrolyte deficiency states, anuria, coma or pre-comatose states associated with liver cirrhosis; also in patients with known allergy or hypersensitivity to metolazone.

4.4 Special Warnings And Precautions For Use

Because of the antihypertensive effects of metolazone the dosage of concurrently administered non-diuretic antihypertensive agents may need to be reduced.

Caution should be exercised during Metenix 5mg Tablets therapy in patients liable to electrolyte deficiency.

Chloride deficit, hyponatraemia and a low salt syndrome may also occur, particularly when the patient is also on a diet with restricted salt intake. Hypomagnesaemia has been reported as a consequence of prolonged diuretic therapy.

Prolonged therapy with Metenix 5mg Tablets may result in hypokalaemia. Serum potassium levels should be determined at regular intervals and, if necessary, potassium supplementation should be instituted.

Fluid and electrolyte balance should be carefully monitored during therapy especially if Metenix 5mg Tablets is used concurrently with other diuretics. In particular, Metenix 5mg Tablets may potentiate the diuresis produced by furosemide and, if the two agents are used concurrently, patients should be carefully monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The dosage of concurrently administered cardiac glycosides may require adjustment. Metenix 5mg Tablets may aggravate the increased potassium excretion associated with steroid therapy or diseases such as cirrhosis or severe ischaemic heart disease. Latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.

Non steroidal anti-inflammatory drugs (e.g. Indometacin, Sulindac) may attenuate the action of Metolazone.

Prolongation of bleeding time has been reported during concomitant administration of Metenix and warfarin.

4.6 Pregnancy And Lactation

There is little evidence of safety of the drug in human pregnancy, but it has been in wide, general use for many years without apparent ill consequence, animal studies having shown no hazard.

If Metenix 5mg Tablets is given to nursing mothers, metolazone may be present in the breast milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Metenix 5mg Tablets is generally well tolerated. There have been occasional reports of headache, anorexia, vomiting, abdominal discomfort, muscle cramps and dizziness. There have been isolated reports of urticaria, leucopenia, tachycardia, chills and chest pain.

Hyperuricaemia or azotaemia may occur during treatment with Metenix 5mg Tablets, particularly in patients with impaired renal function. On rare occasions, clinical gout has been reported.

4.9 Overdose

In cases of overdose there is a danger of dehydration and electrolyte depletion. Treatment should therefore be aimed at fluid replacement and correction of the electrolyte imbalance.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Metolazone is a substituted quinazolinone diuretic.

5.2 Pharmacokinetic Properties

Diuresis and saluresis begin within one hour of administration of Metenix 5mg Tablets tablets, reaching a maximum in two hours and continuing for 12-24 hours according to dosage.

5.3 Preclinical Safety Data

None applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose, magnesium stearate, F D and C blue no 2 lake (E132)

6.2 Incompatibilities

None.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Metenix 5mg Tablets tablets should be stored protected from light, in the original container or in containers similar to those of the manufacturer.

6.5 Nature And Contents Of Container

Blister pack of 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0212

9. Date Of First Authorisation/Renewal Of The Authorisation

5 November 2001

10. Date Of Revision Of The Text

21 September 2010

LEGAL STATUS

POM


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Tarka


Generic Name: trandolapril and verapamil (tran DOL a pril and ver AP a mil)
Brand Names: Tarka

What is Tarka (trandolapril and verapamil)?

Trandolapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Verapamil is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

The combination of trandolapril and verapamil is used to treat high blood pressure (hypertension).

Trandolapril and verapamil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tarka (trandolapril and verapamil)? Do not use trandolapril and verapamil if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not use this medicine if you have certain serious heart problems, or if you are allergic to trandolapril (Mavik) or similar medicines such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

There are many other drugs that can interact with trandolapril and verapamil. Tell your doctor about all medications you use.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. What should I discuss with my healthcare provider before taking Tarka (trandolapril and verapamil)? You should not use this medicine if you are allergic to trandolapril (Mavik) or verapamil (Calan, Covera, Isoptin, Verelan), or if you have:

certain serious heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

a heart rhythm disorder;

low blood pressure; or

if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

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

kidney disease (or if you are on dialysis);

liver disease;

congestive heart failure;

diabetes;

a nerve-muscle disease such as muscular dystrophy; or

a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.

FDA pregnancy category D. Do not use trandolapril and verapamil if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Trandolapril and verapamil can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking trandolapril and verapamil. Trandolapril and verapamil can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using trandolapril and verapamil. How should I take Tarka (trandolapril and verapamil)?

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.

Trandolapril and verapamil works best if you take it with food.

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

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking trandolapril and verapamil. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. If you need surgery, tell the surgeon ahead of time that you are using trandolapril and verapamil.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat. 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.

Overdose symptoms may include slow heart rate, weak pulse, muscle weakness, tingly feeling, seizure (convulsions), feeling light-headed, or fainting.

What should I avoid while taking Tarka (trandolapril and verapamil)?

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.

Do not use salt substitutes or potassium supplements while taking trandolapril and verapamil, unless your doctor has told you to. Tarka (trandolapril and verapamil) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

swelling, weight gain, feeling short of breath;

feeling like you might pass out;

anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;

chest pain, fast, slow, or uneven heart rate; or

fever, upper stomach pain, and jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

cough;

headache;

runny or stuffy nose, sore throat;

constipation, diarrhea;

dizziness;

back pain;

joint pain; or

nausea.

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 Tarka (trandolapril and verapamil)?

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

buspirone (BuSpar);

colchicine (Colcrys);

cyclosporine (Neoral, Sandimmune, Gengraf);

dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

digoxin (digitalis, Lanoxin);

gold injections (to treat arthritis);

lithium (Lithobid, Eskalith);

phenobarbital (Solfoton) or other barbiturates;

insulin or oral diabetes medication;

sirolimus (Rapamune) or tacrolimus (Prograf);

St. John's wort;

theophylline (Elixophyllin, Respbid, Theo-Dur, and others);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate) and others;

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;

a diuretic (water pill);

drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);

cholesterol-lowering drugs such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync);

heart rhythm or blood pressure medication such as disopyramide (Norpace), flecainide (Tambocor), nicardipine (Cardene) or quinidine (Quin-G);

HIV or AIDS medication; or

seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and there are many other drugs that can interact with trandolapril and verapamil. 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 Tarka resources Tarka Side Effects (in more detail) Tarka Use in Pregnancy & Breastfeeding Drug Images Tarka Drug Interactions Tarka Support Group 4 Reviews for Tarka - Add your own review/rating Tarka Prescribing Information (FDA) Tarka Advanced Consumer (Micromedex) - Includes Dosage Information Tarka MedFacts Consumer Leaflet (Wolters Kluwer) Compare Tarka with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about trandolapril and verapamil.

See also: Tarka side effects (in more detail)


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Diurexan Tablets


1. Name Of The Medicinal Product

Diurexan Tablets

2. Qualitative And Quantitative Composition

Xipamide 20 mg

3. Pharmaceutical Form

The tablets are white, round and biplanar with bisecting score on one side and debossed A on the other. They have a diameter of approximately 6 mm.

For oral use.

4. Clinical Particulars 4.1 Therapeutic Indications

For treatment of hypertension, either alone or as an adjunct to treatment with anti-hypertensive drugs.

For use as a diuretic.

4.2 Posology And Method Of Administration

1. Treatment of hypertension

Dosage:

Adults: 1 tablet (20 mg) daily, as a single early morning dose. When using Diurexan in combination with other antihypertensive therapy, the same dose of 20 mg as a single early morning dose should be maintained.

Children: No dose recommended.

Elderly: See 'Precautions'.

2. Use as a diuretic

Dosage:

Adults: In the initial phase of treatment the usual dose is 2 tablets (40 mg) daily in a single early morning dose. Depending on the patient's response, the dose may be lowered to 1 tablet daily when sufficient control of oedema has been achieved. Higher doses, up to 4 tablets daily (80 mg), may be employed in resistant cases.

Children: No dose recommended.

Elderly: See 'Precautions'.

4.3 Contraindications

Diurexan is contra-indicated in severe electrolyte deficiency, precomatose states associated with liver cirrhosis, severe renal insufficiency, hypersensitivity to xipamide and untreated Addisons disease.

4.4 Special Warnings And Precautions For Use

Like other diuretics, Diurexan may induce hypokalaemia in long-term therapy. Potassium supplements may be necessary, particularly in the elderly where dietary potassium intake may be inadequate, in digitalised patients and in conditions where additional potassium loss occurs such as vomiting, diarrhoea, malnutrition, nephrosis, hepatic cirrhosis and hyperaldosteronism.

Diurexan may exacerbate gout or induce hyperuricaemia or impaired glucose metabolism in patients predisposed to these conditions. In such patients serum urate or glucose levels should be monitored. Hyperuricaemia may require concomitant use of a uricosuric agent while diabetic patients will probably require an adjustment of insulin dosage, or other hypoglycaemic agent therapy.

As with all antihypertensive agents, care should be taken in patients with severe coronary or cerebral arteriosclerosis.

An increased risk of developing urinary retention may arise in patients with prostatic hypertrophy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The dosage of other hypotensive drugs and cardiac glycosides may require adjustment when used in conjunction with Diurexan. Diabetic patients may require an increase in their dose of insulin or oral hypoglycaemic drug. Corticosteroids, ACTH, carbenoxolone, amphotericin and laxatives may provoke hypokalaemia.

Increased serum lithium levels may occur due to diminished urinary excretion.

4.6 Pregnancy And Lactation

Use in pregnancy: Animal experiments have indicated that Diurexan is devoid of teratogenic properties or effects on fertility and reproduction. However, care should be taken when treating hypertension or oedema in pregnancy as excessive use may result in hypovolaemia and reduced placental perfusion. As with all drugs, treatment should be avoided in the first trimester of pregnancy.

No information is available on the excretion of xipamide in breast milk. Treatment should be avoided in breast feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Diurexan is generally well-tolerated. Slight gastro-intestinal disturbances have been reported in a few cases as have episodes of mild dizziness. Hypokalaemia and, more rarely, other electrolyte disturbances such as hyponatraemia have been reported.

4.9 Overdose

Little information is available on the effects of acute overdosage with xipamide, however hypotension with metabolic disturbances and electrolyte imbalances are likely. Chronic overdose may lead to a temporary increase in blood viscosity due to haemoconcentration although thromboembolic complications have not been reported.

There is no specific antidote to xipamide. Gastric lavage or induced emesis may prevent further absorption. General measures should be aimed at the maintenance of blood pressure, restoration of blood volume and correction of electrolyte imbalance with appropriate intravenous infusion as required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Xipamide is an anti-hypertensive diuretic which can be characterised pharmacologically neither as a thiazide nor as a specific loop diuretic. Although structurally similar to chlorthalidone, it has a markedly different pharmacological profile with its main diuretic effect exerted at the distal section of the nephron.

As a diuretic, xipamide has been shown to be as effective as frusemide in terms of daily urine output, but has a more gradual and prolonged action.

5.2 Pharmacokinetic Properties

Following single oral administration of 20 mg xipamide, peak plasma concentrations of up to 3 g/ml occur within 1 hour. Absolute bioavailability after oral administration is about 73%.

Xipamide is highly bound to plasma protein and has a volume of distributions of about 10 litres. After oral or i.v. administration, the apparent elimination t? is of the order of 5-8 h. About 90% of an oral or i.v. dose is excreted in the urine with 50% of the dose eliminated in urine unchanged and a further 30% as the 0-0 glucuronide.

5.3 Preclinical Safety Data

Not relevant.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Maize starch EP, Mannitol BP, Cellulose powder EP, Colloidol silicon dioxide EP, Magnesium stearate EP, Purified Water EP.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium - PVC Blister strip holds 14 tablets

Ten blister strips in folded cardboard box.

6.6 Special Precautions For Disposal And Other Handling

Not relevant.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

8. Marketing Authorisation Number(S)

PL 15142/0132

9. Date Of First Authorisation/Renewal Of The Authorisation

30 June 02

10. Date Of Revision Of The Text

December 2009


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methyclothiazide


Generic Name: methyclothiazide (METH i kloe THYE a zide)
Brand names: Aquatensen, Enduron

What is methyclothiazide?

Methyclothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Methyclothiazide treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or kidney disorders, or edema caused by taking steroids or estrogen. This medication is also used to treat high blood pressure (hypertension).

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

What is the most important information I should know about methyclothiazide? Do not use this medication if you are allergic to methyclothiazide or if you are unable to urinate.

Before using this medication, tell your doctor if you have liver disease, kidney disease, asthma or allergies, gout, diabetes, or if you are allergic to sulfa drugs.

Avoid drinking alcohol, which can increase some of the side effects of methyclothiazide.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

There are many other medicines that can interact with methyclothiazide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

What should I discuss with my doctor before taking methyclothiazide? Do not use this medication if you are allergic to methyclothiazide, or if you are unable to urinate.

Before using methyclothiazide, tell your doctor if you have:

kidney disease; liver disease;

asthma or allergies;

gout;

diabetes; or

an allergy to sulfa drugs.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take methyclothiazide.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Methyclothiazide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take methyclothiazide?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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

To be sure this medication is not causing harmful effects, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Your blood and urine may both be tested if you have been vomiting or are dehydrated.

Methyclothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store the tablets at room temperature away from heat, light, and moisture.

See also: Methyclothiazide dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, dizziness, dry mouth, thirst, confusion, leg discomfort, and muscle pain, weakness, or limp feeling. What should I avoid while taking methyclothiazide? Avoid drinking alcohol, which can increase some of the side effects of methyclothiazide.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Methyclothiazide 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 this medication and call your doctor at once if you have a serious side effect such as:

dry mouth, thirst, nausea, vomiting;

feeling weak, drowsy, restless, or light-headed;

fast or uneven heartbeat;

muscle pain or weakness;

urinating less than usual;

numbness or tingly feeling;

a red, blistering, peeling skin rash;

jaundice (yellowing of the skin or eyes); or

pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate).

Less serious side effects may include:

mild nausea, vomiting, loss of appetite;;

diarrhea;

constipation; or

blurred vision.

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.

Methyclothiazide Dosing Information

Usual Adult Dose for Hypertension:

2.5 to 5 mg orally once a day.

Usual Adult Dose for Edema:

2.5 to 10 mg once a day.

What other drugs will affect methyclothiazide?

Before taking this medication, tell your doctor if you are using any of the following drugs:

lithium;

digoxin (Lanoxin);

steroids (prednisone and others);

other blood pressure medications; or

insulin or diabetes medicine taken by mouth.

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

More methyclothiazide resources Methyclothiazide Side Effects (in more detail) Methyclothiazide Dosage Methyclothiazide Use in Pregnancy & Breastfeeding Drug Images Methyclothiazide Drug Interactions Methyclothiazide Support Group 0 Reviews for Methyclothiazide - Add your own review/rating methyclothiazide Advanced Consumer (Micromedex) - Includes Dosage Information Methyclothiazide Prescribing Information (FDA) Methyclothiazide MedFacts Consumer Leaflet (Wolters Kluwer) Compare methyclothiazide with other medications Edema High Blood Pressure Where can I get more information? Your pharmacist can provide more information about methyclothiazide.

See also: methyclothiazide side effects (in more detail)


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Loniten Tablets 5 mg


1. Name Of The Medicinal Product

Loniten® Tablets 5 mg

2. Qualitative And Quantitative Composition

Each Loniten Tablet contains 5 mg minoxidil USP.

3. Pharmaceutical Form

Tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Loniten is indicated for the treatment of severe hypertension.

It should not be used as the sole agent to initiate therapy. It is a peripheral vasodilator and should be given in conjunction with a diuretic, to control salt and water retention, and a beta-adrenergic blocking agent, or appropriate substitute, to control reflex tachycardia.

4.2 Posology And Method Of Administration

Oral Administration

Adults and Patients over 12 years of age: An initial daily dose of 5 mg, which may be given as a single or divided dosage, is recommended. This dose may first be increased to 10 mg daily and subsequent increases should be by increments of 10 mg in the daily dose. Dosage adjustments should be made at intervals of not less than three days, until optimum control of blood pressure is achieved. It is seldom necessary to exceed 50 mg per day although, in exceptional circumstances, doses up to 100 mg per day have been used. Twice-daily dosage is satisfactory. Where diastolic pressure reduction of less than 30 mm Hg is required, once daily dosing has been reported as effective.

Dosage requirements may be lower in dialysis patients. Minoxidil is removed from the blood by dialysis, but its pharmacological action, once established is not reversed. Therefore haemodialysis patients should take Loniten either after or at least two hours before dialysis.

Children: For patients of 12 years of age or under, the initial dose should be 200 micrograms per kilogram (0.2 mg/kg) given as a single or divided daily dosage. Incremental increases of 100-200 micrograms per kilogram (0.1-0.2 mg/kg) in the daily dose are recommended at intervals of not less than three days until optimum blood pressure control has been achieved, or the maximum daily dose of 1.0 mg/kg has been reached.

Rapid reduction of blood pressure: Under hospital monitoring conditions, rapid reduction of blood pressure can be achieved using continuous blood pressure monitoring and incremental doses of 5 mg every six hours.

Concomitant antihypertensive therapy: It is recommended that, where possible, antihypertensive therapy, other than a beta

Loniten causes sodium retention and if used alone can result in several hundred milli-equivalents of salt being retained together with a corresponding volume of water.

Therefore, in all patients who are not on dialysis, Loniten must be given in conjunction with a diuretic in sufficient dosage to maintain salt and water balance. Examples of the daily dosages of diuretics commonly used when starting therapy with Loniten include:

1. Hydrochlorothiazide (100 mg)

2. Chlorthalidone (100 mg).

3. Frusemide (80 mg).

If excessive water retention results in a weight gain of more than 3 pounds when a thiazide or chlorthalidone is being used, diuretic therapy should be changed to frusemide, the dose of which may be increased in accordance with the patient's requirements. Diuretic dosage in children should be proportionally less in relation to weight.

Patients will require a sympathetic nervous system suppressant to limit a Loniten-induced rise in heart rate. The preferred agent is a beta-blocker equivalent to an adult propranolol dosage of 80-160 mg/day. Higher doses may be required when pre-treated patients have an increase in heart rate exceeding 20 beats per minute or when simultaneous introduction causes an increase exceeding 10 beats per minute. When beta-blockers are contra-indicated, alternatives such as methyldopa may be used instead and should be started 24 hours prior to Loniten.

Elderly patients: At present there are no extensive clinical studies with minoxidil in patients over age 65. There is data indicating that elevated systolic and diastolic pressures are important risk factors for cardiovascular disease in individuals over age 65. However, elderly patients may be sensitive to the blood pressure lowering effect of minoxidil and thus caution is urged in initiating therapy as orthostatic hypotension may occur. It is suggested that 2.5 mg per day be used as the initial starting dose in patients over 65 years of age.

4.3 Contraindications

Loniten is contra-indicated in patients with a phaeochromocytoma.

4.4 Special Warnings And Precautions For Use

If used alone, Loniten can cause a significant retention of salt and water leading to positive physical signs such as oedema, and to clinical deterioration of some patients with heart failure. Diuretic treatment alone, or in combination with restricted salt intake is, therefore, necessary for all patients taking Loniten.

Patients who have had myocardial infarction should only be treated with Loniten after a stable post-infarction state has been established.

The physician should bear in mind that if not controlled by sympathetic suppressants, the rise in cardiac rate and output that follows the use of potent vasodilators may induce anginal symptoms in patients with undiagnosed coronary artery disease, or may aggravate pre-existing angina pectoris.

The effect of Loniten may be additive to concurrent antihypertensive agents. The interaction of Loniten with sympathetic-blocking agents such as guanethidine or bethanidine may produce excessive blood pressure reduction and/or orthostasis.

Hypertrichosis occurs in most patients treated with Loniten and all patients should be warned of this possibility before starting therapy. Spontaneous reversal to the pre-treatment state can be expected one to three months after cessation of therapy.

Soon after starting Loniten therapy approximately 60% of patients exhibit ECG alterations in the direction and magnitude of their T waves. Large changes may encroach on the ST segment, unaccompanied by evidence of ischaemia. These asymptomatic changes usually disappear with continuing Loniten treatment. The ECG reverts to the pre-treatment state if Loniten is discontinued.

Pericardial effusion has been detected in patients treated with a Loniten-containing regime. A cause and effect relationship has not been established. Most effusions have either been present before Loniten was given, or occurred among uraemic patients. However, it is suggested that Loniten

Salt and water retention in excess of 2 to 3 pounds may diminish the effectiveness of Loniten. Patients should, therefore, be carefully instructed about compliance with diuretic therapy and a detailed record of body weight should be maintained.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The effect of Loniten may be additive to concurrent antihypertensive agents. The interaction of Loniten with sympathetic-blocking agents such as guanethidine or bethanidine may produce excessive blood pressure reduction and/or orthostasis.

4.6 Pregnancy And Lactation

The safety of Loniten in pregnancy remains to be established. Minoxidil has been shown to reduce the conception rate in rats and to show evidence of increased fetal absorption in rabbits. There was no evidence of teratogenic effects in rats and rabbits. Minoxidil has been reported to be secreted in breast milk. Therefore, breast-feeding should not be undertaken while a patient is on Loniten Tablets.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects reported

4.8 Undesirable Effects

Most patients receiving Loniten experience a diminution of pre-existing side effects attributable to their disease or previous therapy. New events or side effects likely to increase include peripheral oedema, associated with or independent of weight gain; increases in heart rate; hypertrichosis; and a temporary rise in creatinine and blood urea nitrogen. Gastro-intestinal intolerance, rash and breast tenderness are infrequently reported side effects of Loniten therapy.

4.9 Overdose

If exaggerated hypotension is encountered, it is most likely to occur in association with residual sympathetic nervous system blockade (guanethidine-like effects or alpha-adrenergic blockade). Recommended treatment is intravenous administration of normal saline. Sympathomimetic drugs, such as noradrenaline or adrenaline, should be avoided because of their excessive cardiac-stimulating action. Phenylephrine, angiotensin II and vasopressin, which reverse the effect of Loniten, should be used only if inadequate perfusion of a vital organ is evident.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Minoxidil is an antihypertensive agent which acts predominantly by causing direct peripheral vasodilation of the arterioles.

5.2 Pharmacokinetic Properties

About 90% of an oral dose of minoxidil has been reported to associated from the GI tract.

Following oral administration the maximum hypotensive effect usually occurs after 2-3 hours. The action may persist for up to 75 hours. The plasma half-life is about 4.2 hours.

Minoxidil is not bound to plasma proteins. It is extensively metabolised in the liver primarily by conjugation with glucuronic acid and is excreted in the urine mainly in the form of metabolites.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose hydrous, microcrystalline cellulose, starch, colloidal silicon dioxide and magnesium stearate.

6.2 Incompatibilities

None

6.3 Shelf Life

Shelf life of the medicinal product as packaged for sale: 36 months.

6.4 Special Precautions For Storage

Store below 25oC.

6.5 Nature And Contents Of Container

High density polyethylene (HDPE) bottles with LDPE caps. Each bottle contains 100 tablets.

20-25 micron aluminium foil/250 micron opaque PVC blister. Pack contains 60 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Pharmacia Limited

Davy Avenue

Milton Keynes

MK5 8PH

UK

8. Marketing Authorisation Number(S)

PL 0032/0065

9. Date Of First Authorisation/Renewal Of The Authorisation

14 November 1979/17 September 2005

10. Date Of Revision Of The Text

April 2001

Legal Category

POM


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Mytelase Chloride


Generic Name: ambenonium (am ben OH nee um)
Brand Names: Mytelase Chloride

What is Mytelase Chloride (ambenonium)?

Ambenonium affects chemicals in the body that are involved in the communication between nerve impulses and muscle movement.

Ambenonium is used to treat the symptoms of myasthenia gravis.

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

What is the most important information I should know about Mytelase Chloride (ambenonium)? You should not use this medication if you are allergic to ambenonium, or if you are using certain medications.

Be sure your doctor knows if you use: mecamylamine, (Inversine), atropine (Atreza, Donnatal, Sal-Tropine, Lomotil, Lomocot, and others), blood pressure medications, or a diuretic (water pill).

Before using ambenonium, tell your doctor if you have asthma, Parkinson's disease, or a bladder or bowel obstruction.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

What should I discuss with my health care provider before taking Mytelase Chloride (ambenonium)? You should not use this medication if you are allergic to ambenonium, or if you are using certain medications. Be sure your doctor knows if you use:

mecamylamine, (Inversine);

atropine (Atreza, Donnatal, Sal-Tropine, Lomotil, Lomocot, and others);

blood pressure medications; or

a diuretic (water pill).

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

asthma;

Parkinson's disease; or

a bladder or bowel obstruction.

It is not known whether ambenonium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ambenonium passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ambenonium. How should I take Mytelase Chloride (ambenonium)?

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.

Ambenonium is usually taken every 3 to 4 hours during the day. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

Store at room temperature away from moisture and heat. 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.

Overdose symptoms may include severe diarrhea, muscle twitching, anxiety, sweating, and cough or breathing problems.

What should I avoid while taking Mytelase Chloride (ambenonium)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Mytelase Chloride (ambenonium) 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:

severe diarrhea;

muscle twitching; or

cough with sputum (mucus).

Less serious side effects may include:

sweating or urinating more than usual;

drooling, watery eyes;

warmth or tingly feeling;

nausea, vomiting, stomach pain;

blurred vision;

anxiety;

dizziness, spinning feeling; or

muscle cramps.

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 Mytelase Chloride (ambenonium)?

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

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

bladder or urinary medicines such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

irritable bowel medicines such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with ambenonium. 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 Mytelase Chloride resources Mytelase Chloride Use in Pregnancy & Breastfeeding Mytelase Chloride Drug Interactions Mytelase Chloride Support Group 0 Reviews for Mytelase Chloride - Add your own review/rating Ambenonium MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mytelase Chloride with other medications Myasthenia Gravis Where can I get more information? Your pharmacist can provide more information about ambenonium.
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Amiloride Tablets BP 5mg


1. Name Of The Medicinal Product

AMILORIDE TABLETS BP 5mg

2. Qualitative And Quantitative Composition

Each tablet contains Amiloride Hydrochloride BP equivalent to 5mg anhydrous amiloride hydrochloride.

3. Pharmaceutical Form

Yellow uncoated tablets.

4. Clinical Particulars 4.1 Therapeutic Indications

Potassium-conserving agent; diuretic. Although amiloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy. It is indicated for use in:

1) Congestive heart failure.

2) Hypertension.

3) Hepatic cirrhosis with ascites.

4.2 Posology And Method Of Administration

Monotherapy: Initially 10mg which may be given as a single or divided dose. This may be increased if necessary to a maximum of 20mg daily. When diuresis has been achieved, the dosage may be reduced by 5mg increments to the least amount required.

In conjunction with other diuretic therapy: When amiloride is used with a diuretic which is given on an intermittent basis, it should be given at the same time as the diuretic.

Congestive heart failure: Initially 5-10mg daily, together with the usual dosage of the diuretic concurrently employed. Where diuresis is not achieved dosage of both agents may be increased if necessary, however, the maximum dose for amiloride is 20mg a day. Once diuresis is achieved, reduction in dosage of both agents may be attempted for maintenance therapy. The dosage of both drugs is determined by diuresis and the level of plasma potassium.

Hypertension: 5-10mg daily, together with the usual antihypertensive dosage of the thiazide concurrently employed. It is not usually necessary to exceed 10mg of amiloride daily; in any event, not more than 20mg a day should be given.

Hepatic cirrhosis with ascites: When used in conjunction with another diuretic, treatment should be commenced with a small amiloride dose of 5mg, plus a low dosage of the other diuretic agent. If necessary, dosage of both agents may gradually be increased until there is effective diuresis. The maximum dose for amiloride is 20mg daily. Maintenance doses may be lower than those required to initiate diuresis; reduction in the daily dosage should therefore be attempted when the patient's weight is stabilised.

Elderly: Dosage in the elderly should be carefully adjusted according to renal function, blood electrolytes and diuretic response. The elderly are more susceptible to electrolyte imbalance and more likely to experience hyperkalaemia since renal reserve may be reduced.

Children: The use of amiloride in children is contraindicated.

For oral administration.

4.3 Contraindications

Hyperkalaemia (plasma potassium over 5.5mmol/l); other potassium-conserving agents or potassium supplements; anuria, acute renal failure, severe progressive renal disease, diabetic nephropathy; known sensitivity to amiloride; use in children as safety has not been established.

4.4 Special Warnings And Precautions For Use

Diabetes mellitus: To minimise the risk of hyperkalaemia in known or suspected diabetic patients, the status of renal function should be determined before initiating therapy. Amiloride should be discontinued for at least three days before a glucose-tolerance test.

Metabolic or respiratory acidosis: Potassium-conserving therapy should be initiated only with caution in severely ill patients in whom metabolic or respiratory acidosis may occur, eg patients with cardiopulmonary disease of decompensated diabetes. Shifts in acid-base balance alter the balance of extracellular-intracellular potassium, and the development of acidosis may be associated with rapid increase in plasma potassium.

Hyperkalaemia: This has been observed in some patients receiving amiloride, alone or with other diuretics. These patients should be observed carefully for clinical, laboratory, and ECG evidence of hyperkalaemia. Some deaths have been reported in this group of patients. Hyperkalaemia has been noted particularly in the elderly and in hospital patients with hepatic cirrhosis or cardiac oedema who have known renal involvement, who were seriously ill, or were undergoing vigorous diuretic therapy.

Neither potassium-conserving agents nor a diet rich in potassium should be used with amiloride except in severe and/or refractory cases of hypokalaemia. If the combination is used, plasma potassium levels must be continuously monitored.

Treatment of hyperkalaemia: If hyperkalaemia occurs, amiloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.

Impaired renal function: Patients with blood urea over 10mmol/l, serum creatinine over 130µmol/l, or with diabetes mellitus require careful monitoring of serum electrolytes and blood urea levels. In renal impairment, use of a potassium-conserving agent may result in rapid development of hyperkalaemia.

Electrolyte imbalance and blood urea increases: Hyponatraemia and hypochloraemia may occur when amiloride is used with other diuretics. Reversible increases in blood urea levels have been reported accompanying vigorous diuresis, especially when diuretics were used in seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant oedema. Careful monitoring of serum electrolytes and blood urea levels should therefore be carried out when amiloride is given with oral diuretics to such patients.

Cirrhotic patients: Oral diuretic therapy is more frequently accompanied by side-effects in patients with hepatic cirrhosis with or without ascites, because these patients are intolerant of acute shifts in electrolyte balance, and because they often already have hypokalaemia as a result of associated aldosteronism.

Reports suggest that patients with pre-existing severe liver disease treated with diuretics, including amiloride hydrochloride, may experience hepatic encephalopathy, manifested by tremors, confusion and coma, and increased jaundice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium should not generally be given with diuretics because they reduce it renal clearance and add a high risk of lithium toxicity.

When combined with thiazide diuretics, amiloride can act synergistically with chlorpropamide to increase the risk of hyponatraemia.

When amiloride is administered concurrently with an angiotensin-converting enzyme inhibitor, NSAIDs or ciclosporin the risk of hyperkalaemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.In patients receiving amiloride with NSAIDs or ciclosporin the risk of nephrotoxcity may also be increased.

4.6 Pregnancy And Lactation

Amiloride is not recommended for use during pregnancy due to limited clinical experience. The potential benefits must be weighed against the possible hazard to the foetus if administered to a woman of childbearing age.

The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema is not indicated because they may be associated with hypovolaemia, increased blood viscosity and decreased placental perfusion. Foetal and neonatal jaundice, foetal bone depression and thrombocytopenia have also been described.

It is not known whether amiloride is excreted in human milk. Therefore, due to the risk that it may take this route of excretion, and possibly cause serious adverse reactions to the nursing infant, the mother should either stop breast-feeding or cease taking the drug.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Amiloride is usually well tolerated, although minor side-effects are reported relatively frequently. Apart from hyperkalaemia, significant adverse reactions have been infrequently reported. Nausea/anorexia, abdominal pain, flatulence and mild skin rash are probably due to amiloride; but other side-effects are generally associated with diuresis or with the underlying disease being treated.

Body as a whole: Headache, weakness, fatigue, back pain, chest pain, neck/shoulder ache, pain in the extremities.

Cardiovascular: Angina pectoris, orthostatic hypotension, arrhythmias, palpitation, one patient with partial heart block developed complete heart block.

Digestive: Anorexia, nausea, vomiting, diarrhoea, constipation, abdominal pain, GI bleeding, jaundice, thirst, dyspepsia, flatulence.

Metabolic: Elevated plasma potassium levels above 5.5mmol/l, hyponatraemia.

Musculoskeletal: Muscle cramps, joint pain.Serum uric acid levels may rise during treatment with amiloride and acute attacks of gout may be precipitated.

Nervous: Dizziness, vertigo, paraesthesia, tremors, encephalopathy.

Psychiatric: nervousness, mental confusion, insomnia, decreased libido, depression, somnolence.

Respiratory: Cough, dyspnoea.

Special senses: Nasal congestion, visual disturbances, increased intra-ocular pressure, tinnitus.

Urogenital: Impotence, polyuria, dysuria, bladder spasms, frequency of micturition.

Reactions in which no causal relationship could be established were activation of probable pre-existing peptic ulcer, aplastic anaemia, neutropenia and abnormal liver function tests. In a few cirrhotic patients, jaundice associated with the underlying disease has deepened, but the drug relationship is unknown.

4.9 Overdose

No data are available; it is not known whether the drug is dialysable. No specific antidote is available.

The most likely signs and symptoms are dehydration and electrolyte imbalance which should be treated by established methods. Therapy should be discontinued and the patient closely observed. Emesis should be induced or gastric lavage performed if ingestion is recent. Treatment is symptomatic and supportive. If hyperkalaemia occurs, active measures should be taken to reduce plasma potassium levels.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Amiloride hydrochloride is a diuretic.

5.2 Pharmacokinetic Properties

Amiloride is incompletely absorbed from the gastrointestinal tract. Peak serum concentrations are achieved about 3-4 hours after administration by mouth. It is excreted unchanged in the urine. Amiloride has been estimated to have a serum half-life of about 6 hours.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Also contains: lactose, magnesium stearate, maize starch, E172, E460.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

Protect from light.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M? PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 50,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data 7. Marketing Authorisation Holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/0210

9. Date Of First Authorisation/Renewal Of The Authorisation

August 1986; August 1991

10. Date Of Revision Of The Text

May 2007


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simvastatin and sitagliptin


Generic Name: simvastatin and sitagliptin (SIM va stat in and SIT a GLIP tin)
Brand Names: Juvisync

What is simvastatin and sitagliptin?

Simvastatin is an HMG CoA reductase inhibitor, or "statin." Simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Sitagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

The combination of simvastatin and sitagliptin is for people with type 2 diabetes diabetes who also have high cholesterol or triglycerides (types of fat) in the blood. This medication is not for treating type 1 diabetes.

Simvastatin and sitagliptin is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.

Simvastatin and sitagliptin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about simvastatin and sitagliptin? Simvastatin and sitagliptin can harm an unborn baby or cause birth defects. Do not use if you are pregnant. You should not use this medicine if you are allergic to simvastatin (Zocor) or sitagliptin (Januvia), if you have liver disease or severe kidney disease, or if you are pregnant or breast-feeding. Do not use this medication if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Before taking simvastatin and sitagliptin, tell your doctor if you have underactive thyroid, a history of pancreatitis, liver disease, or kidney disease, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily

There are many other drugs that should not be used together with simvastatin and sitagliptin. Tell your doctor about all other medicines you use. Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not drink more than 1 quart of grapefruit juice daily.

What should I discuss with my healthcare provider before taking simvastatin and sitagliptin? You should not use this medicine if you are allergic to simvastatin (Zocor) or sitagliptin (Januvia), if you have liver disease or severe kidney disease, or if you are pregnant or breast-feeding. Do not use this medication if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with simvastatin and sitagliptin. The following drugs should not be used while you are taking simvastatin and sitagliptin:

cyclosporine (Gengraf, Neoral, Sandimmune);

danazol (Danocrine);

gemfibrozil (Lopid);

nefazodone (an antidepressant);

the antibiotics clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), and telithromycin (Ketek);

the antifungal medications itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); or

the HIV/AIDS medications atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and tipranavir (Aptivus).

Before you start taking simvastatin and sitagliptin, tell your doctor if you are already using any of these other medicines:

amiodarone (Cordarone, Pacerone);

amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide);

diltiazem (Cartia, Cardizem);

ranolazine (Ranexa); or

verapamil (Calan, Covera, Isoptin, Verelan).

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

a history of liver or kidney disease;

a history of pancreatitis;

underactive thyroid; or

if you drink more than 2 alcoholic beverages daily.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take simvastatin and sitagliptin if you are pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking simvastatin and sitagliptin 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 you are using simvastatin and sitagliptin. How should I take simvastatin and sitagliptin?

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.

Simvastatin and sitagliptin is usually taken once daily in the evening.

Do not crush, chew, or break the tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change. Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Simvastatin and sitagliptin is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Simvastatin and sitagliptin 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.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking simvastatin and sitagliptin?

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not drink more than 1 quart of grapefruit juice daily.

Avoid eating foods that are high in fat or cholesterol. Simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of liver damage while taking this medicine. Simvastatin and sitagliptin 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 taking the medication and call your doctor at once if you have a serious side effect such as:

unexplained muscle pain, tenderness, or weakness;

fever, unusual tiredness, and dark colored urine;

swelling, weight gain, urinating less than usual or not at all;

severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate;

itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

mild stomach pain, mild nausea;

constipation, diarrhea; or

headache.

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.

Simvastatin and sitagliptin Dosing Information

Usual Adult Dose for Diabetes Mellitus Type II:

Recommended usual starting dose is 100 mg/40 mg orally once a day in the evening. Patients already taking simvastatin (10, 20, or 40 mg) can initiate simvastatin-sitagliptin at a dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

Usual Adult Dose for Hyperlipidemia:

Recommended usual starting dose is 100 mg/40 mg orally once a day in the evening. Patients already taking simvastatin (10, 20, or 40 mg) can initiate simvastatin-sitagliptin at a dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Recommended usual starting dose is 100 mg/40 mg orally once a day in the evening. Patients already taking simvastatin (10, 20, or 40 mg) can initiate simvastatin-sitagliptin at a dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia:

Recommended usual starting dose is 100 mg/40 mg orally once a day in the evening. Patients already taking simvastatin (10, 20, or 40 mg) can initiate simvastatin-sitagliptin at a dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

Usual Adult Dose for Cardiovascular Risk Reduction:

Recommended usual starting dose is 100 mg/40 mg orally once a day in the evening. Patients already taking simvastatin (10, 20, or 40 mg) can initiate simvastatin-sitagliptin at a dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

What other drugs will affect simvastatin and sitagliptin?

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

colchicine (Colcrys);

digoxin (Lanoxin);

a blood thinner such as warfarin (Coumadin, Jantoven);

fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);

antifungal medication such as voriconazole (Vfend);

medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or

any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or other medication that contains simvastatin (Simcor, Vytorin).

Although sitagliptin is not as likely to cause hypoglycemia (low blood sugar) as some other oral diabetes medications, tell your doctor if you are taking any other drugs that can potentially lower blood sugar, such as:

probenecid (Benemid);

some nonsteroidal anti-inflammatory drugs (NSAIDs);

aspirin or other salicylates (including Pepto-Bismol);

sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);

a monoamine oxidase inhibitor (MAOI);

beta-blockers (Tenormin and others); or

an oral diabetes medication such as glipizide (Glucotrol, Metaglip), glimepiride (Amaryl, Avandaryl, Duetact), glyburide (DiaBeta, Micronase, Glucovance), and others.

This list is not complete and other drugs may interact with simvastatin and sitagliptin. 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 simvastatin and sitagliptin resources Simvastatin and sitagliptin Dosage Simvastatin and sitagliptin Use in Pregnancy & Breastfeeding Simvastatin and sitagliptin Drug Interactions Simvastatin and sitagliptin Support Group 0 Reviews for Simvastatin and sitagliptin - Add your own review/rating Compare simvastatin and sitagliptin with other medications Cardiovascular Risk Reduction Diabetes, Type 2 High Cholesterol High Cholesterol, Familial Heterozygous High Cholesterol, Familial Homozygous Where can I get more information? Your pharmacist can provide more information about simvastatin and sitagliptin.
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Aquazide H


Generic Name: hydrochlorothiazide (hye dro klor o THY a zide)
Brand Names: Aquazide H, HydroDIURIL, Microzide

What is Aquazide H (hydrochlorothiazide)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Hydrochlorothiazide treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or kidney disorders, or edema caused by taking steroids or estrogen. This medication is also used to treat high blood pressure (hypertension).

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

What is the most important information I should know about Aquazide H (hydrochlorothiazide)? You should not use this medication if you are allergic to hydrochlorothiazide or if you are unable to urinate.

Before using this medication, tell your doctor if you have liver disease, kidney disease, glaucoma, asthma or allergies, gout, diabetes, or if you are allergic to sulfa drugs or penicillin.

Avoid drinking alcohol, which can increase some of the side effects of hydrochlorothiazide.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

There are many other drugs that can interact with hydrochlorothiazide. 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.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

What should I discuss with my doctor before taking Aquazide H (hydrochlorothiazide)? You should not use this medication if you are allergic to hydrochlorothiazide, or if you are unable to urinate.

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

kidney disease; liver disease;

glaucoma;

asthma or allergies;

gout;

diabetes; or

an allergy to sulfa drugs or penicillin.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrochlorothiazide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Aquazide H (hydrochlorothiazide)?

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.

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

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood and urine may both be tested if you have been vomiting or are dehydrated.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light. 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.

Overdose symptoms may include nausea, weakness, dizziness, dry mouth, thirst, and muscle pain or weakness.

What should I avoid while taking Aquazide H (hydrochlorothiazide)? Drinking alcohol can increase certain side effects of hydrochlorothiazide.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Aquazide H (hydrochlorothiazide) 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 this medication and call your doctor at once if you have a serious side effect such as:

eye pain, vision problems;

dry mouth, thirst, nausea, vomiting;

feeling weak, drowsy, restless, or light-headed;

fast or uneven heartbeat;

muscle pain or weakness;

numbness or tingly feeling;

a red, blistering, peeling skin rash; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

diarrhea;

mild stomach pain;

constipation; or

blurred vision.

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.

What other drugs will affect Aquazide H (hydrochlorothiazide)? Tell your doctor if you regularly use other medicines that make you light-headed (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to the side effects of hydrochlorothiazide.

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

lithium (Eskalith, Lithobid);

digoxin (Lanoxin);

cholestyramine (Prevalite, Questran) or colestipol (Colestid);

steroids (prednisone and others);

other blood pressure medications;

NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

insulin or oral diabetes medication.

This list is not complete and other drugs may interact with hydrochlorothiazide. 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 Aquazide H resources Aquazide H Side Effects (in more detail) Aquazide H Use in Pregnancy & Breastfeeding Aquazide H Drug Interactions Aquazide H Support Group 0 Reviews for Aquazide H - Add your own review/rating Aquazide H Advanced Consumer (Micromedex) - Includes Dosage Information Hydrochlorothiazide Prescribing Information (FDA) Hydrochlorothiazide Professional Patient Advice (Wolters Kluwer) Hydrochlorothiazide Monograph (AHFS DI) Hydrochlorothiazide MedFacts Consumer Leaflet (Wolters Kluwer) Esidrix Prescribing Information (FDA) Microzide Prescribing Information (FDA) Microzide MedFacts Consumer Leaflet (Wolters Kluwer) Compare Aquazide H with other medications Diabetes Insipidus Edema High Blood Pressure Nephrocalcinosis Osteoporosis Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide.

See also: Aquazide H side effects (in more detail)


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niacin and simvastatin


Generic Name: niacin and simvastatin (NYE a sin and SIM va stat in)
Brand Names: Simcor

What is niacin and simvastatin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

The combination of niacin and simvastatin is used to lower cholesterol and triglycerides (types of fat) in the blood.

Niacin and simvastatin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about niacin and simvastatin? You should not take this medication if you are allergic to niacin (Niaspan, Niacor, and others) or simvastatin (Zocor, Vytorin), if you are pregnant or breast-feeding, or if you have liver disease, severe bleeding, or a stomach ulcer. In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Never take niacin and simvastatin in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

There are many other drugs that should not be used together with niacin and simvastatin. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Simvastatin can harm an unborn baby or cause birth defects. Do not use niacin and simvastatin if you are pregnant.

Before taking niacin and simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, gout, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

What should I discuss with my healthcare provider before taking niacin and simvastatin? You should not take this medication if you are allergic to niacin (Niaspan, Niacor, and others) or simvastatin (Zocor, Vytorin), if you are pregnant or breast-feeding, or if you have liver disease, severe bleeding, or a stomach ulcer. In rare cases, niacin and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid). You may also be more likely to develop this condition if you are of Chinese descent

The following drugs can increase your risk of serious muscle problems if you take them together with simvastatin. These drugs should not be used while you are taking niacin and simvastatin:

amiodarone (Cordarone, Pacerone);

cyclosporine (Gengraf, Neoral, Sandimmune);

danazol (Danocrine);

diltiazem (Cartia, Cardizem, Tiazac);

gemfibrozil (Lopid);

nefazodone (an antidepressant);

verapamil (Calan, Covera, Isoptin, Verelan);

the antibiotics clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), and telithromycin (Ketek);

the antifungal medications itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); or

the HIV/AIDS medications atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and tipranavir (Aptivus).

Before you start taking niacin and simvastatin, tell your doctor if you are already using any of these other medicines:

amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide); or

ranolazine (Ranexa).

To make sure you can safely take niacin and simvastatin at any dose, tell your doctor if you have any of these other conditions:

history of liver disease; history of kidney disease;

diabetes;

gout;

a thyroid disorder;

if you drink more than 2 alcoholic beverages daily; or

if you are switched to this medication from regular niacin, nicotinic acid, or nicotinamide (or vitamin supplements that contain niacin).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take niacin and simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking niacin and simvastatin. Niacin and simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking niacin and simvastatin. How should I take niacin and simvastatin?

Take exactly as prescribed. Never take this medicine in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

Niacin and simvastatin is usually taken at bedtime with a low-fat snack. Follow your doctor's instructions. Do not take niacin and simvastatin on an empty stomach.

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

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Niacin can cause certain side effects such as dizziness, sweating, chills, flushing (warmth, redness, or tingly feeling under your skin), fast or pounding heartbeats, shortness of breath, or feeling like you might pass out. These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin and simvastatin. These effects should disappear over time as you keep taking the medicine.

Your doctor may recommend you take aspirin 30 minutes before you take niacin and simvastatin to prevent certain side effects. Do not take aspirin without your doctor's advice. Follow the label directions or your doctor's instructions about how much aspirin to take.

You may need to stop using niacin and simvastatin for a short time if you have:

uncontrolled seizures;

an electrolyte imbalance (such as high or low potassium levels in your blood);

severely low blood pressure;

a severe infection or illness;

dehydration; or

surgery or a medical emergency.

If you stop taking niacin and simvastatin for longer than 7 days in a row, talk with your doctor before restarting the medication. You may need to start with a lower dose.

Niacin can raise your blood sugar, and may cause unusual results with certain medical tests. Tell any doctor who treats you that you are using niacin and simvastatin.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function should be tested every 3 to 6 months. Visit your doctor regularly. You may need to take niacin and simvastatin on a long-term basis for the treatment of high cholesterol. Do not stop taking this medication unless your doctor tells you to.

Niacin and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

See also: Niacin and simvastatin 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.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking niacin and simvastatin? Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not drink more than 1 quart of grapefruit juice daily.

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 4 to 6 hours before or after you take niacin and simvastatin.

Avoid eating foods that are high in fat or cholesterol. Niacin and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage. Niacin and simvastatin 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 taking niacin and simvastatin and call your doctor at once if you have any of these serious side effects:

unexplained muscle pain, tenderness, or weakness;

fever, unusual tiredness, and dark colored urine;

swelling, weight gain, urinating less than usual or not at all; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache, mild dizziness;

diarrhea, mild nausea;

mild skin rash;

back pain; or

flushing (warmth, redness, or tingly feeling).

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.

Niacin and simvastatin Dosing Information

Usual Adult Dose for Hyperlipidemia:

Initial (for patients not currently on niacin extended-release and patients currently on niacin products other than niacin extended-release): 500 mg-20 mg orally once daily at bedtime with a low fat snack.
Patients already taking simvastatin 20 to 40 mg who need additional management of their lipid levels may be started on a niacin-simvastatin dose of 500 mg-40 mg once daily at bedtime.
Maintenance (depending on patient tolerability and lipid levels): 1000 mg-20 mg to 2000 mg-40 mg once daily at bedtime with a low fat snack
The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks. The efficacy and safety of doses of niacin-simvastatin greater than 2000 mg-40 mg daily have not been studied and are therefore not recommended. If niacin-simvastatin therapy is discontinued for an extended period of time (greater than 7 days), re-titration as tolerated is recommended.

What other drugs will affect niacin and simvastatin?

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

colchicine (Colcrys);

digoxin (Lanoxin);

blood pressure medication;

a blood thinner such as warfarin (Coumadin, Jantoven);

other medicines that contain niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others); or

any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Vytorin).

This list is not complete and other drugs may interact with niacin and simvastatin. 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 niacin and simvastatin resources Niacin and simvastatin Dosage Niacin and simvastatin Use in Pregnancy & Breastfeeding Niacin and simvastatin Drug Interactions Niacin and simvastatin Support Group 8 Reviews for Niacin and simvastatin - Add your own review/rating Compare niacin and simvastatin with other medications High Cholesterol Hyperlipoproteinemia Hyperlipoproteinemia Type IIa, Elevated LDL Hyperlipoproteinemia Type IIb, Elevated LDL VLDL Hyperlipoproteinemia Type IV, Elevated VLDL Where can I get more information? Your pharmacist can provide more information about niacin and simvastatin.
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Co-amilofruse 80 / 10mg Tablets


1. Name Of The Medicinal Product

Co-Amilofruse 10/80mg Tablets

2. Qualitative And Quantitative Composition

Furosemide 80.00mg

Amiloride Hydrochloride (dihydrate) 11.36mg

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet for oral use.

Pale orange circular, flat faced beveled edge tablets debossed with 'ARD' '|' 80 on one side and plain on the other side.

4. Clinical Particulars 4.1 Therapeutic Indications

Co-amilofruse is indicated where a prompt diuresis is required especially in conditions where potassium conservation is important: congestive cardiac failure, nephrosis, fluid retention due to corticosteroid or oestrogen therapy and ascite.

4.2 Posology And Method Of Administration

The starting dose is usually 5/40mg, subsequent dosage being adjusted to suit the needs of the patient.

Adults:

One to two tablets to be taken in the morning.

Children:

Not indicated for children.

Elderly:

The dosage should be adjusted according to diuretic response. Serum electrolytes and urea should be carefully monitored.

4.3 Contraindications

Known hypersensitivity to the active ingredients or any of the excipients. Hyperkalaemia (serum potassium> 5.5 mmol/litre), Addison's disease, acute renal failure, anuria, severe progressive renal disease, precomatose states associated with cirrhosis, concomitant potassium supplements or potassium sparing diuretics, electrolyte imbalance.

Co-amilofruse is contraindicated in children, as safety in this age group has not been established.

4.4 Special Warnings And Precautions For Use

Hyperkalaemia has been observed in patients receiving amiloride hydrochloride. Clinical condition and serum electrolytes must be carefully and continuously monitored if combination with an ACE inhibitor is deemed essential (see Interactions).

Serum uric acid levels may rise during treatment with Co-amilofruse and acute attacks of gout may be precipitated. Furosemide may cause latent diabetes to become manifest.

Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute urinary retention during diuretic therapy.

Patients who are being treated with this preparation require regular supervision, with monitoring of electrolyte status and fluid status to avoid excessive loss of fluid.

Co-amilofruse should be used with caution in elderly or those with potential obstruction of the urinary tract or disorders rendering electrolyte balance precarious.

Hyponatraemia, hypochloremia and raised blood urea nitrogen may occur during vigorous diuresis, especially in seriously ill patients. Careful monitoring of serum electrolytes and urea should therefore be undertaken in these patients. The haematopoietic state should be monitored regularly during treatment.

Co-amilofruse should be discontinued before a glucose tolerance test.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

ACE inhibitors may elevate serum potassium levels especially in the presence of renal impairment, and combination with Co-amilofruse is best avoided in elderly patients or in any others in whom renal function may be compromised. The dosage of concurrently administered antihypertensive agents, cardiac glycosides, lithium or non-depolarising muscle relaxants may require adjustment. It may be necessary to increase the dose of hypoglycaemic agents in diabetic patients. Concomitant use of Co-amilofruse with cephaloridine may increase cephaloridine-induced nephrotoxicity. Likewise, use with amino-glycoside antibiotics may increase the associated ototoxicity. Some NSAIDs e.g. indometacin, may antagonise the action of Furosemide.

4.6 Pregnancy And Lactation

There is no evidence of safety in either human pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Nausea, vomiting, malaise, gastric upset, diarrhoea and constipation may occur. If skin rashes or pruritus occurs, treatment should be withdrawn.

Rare complications may include disturbances in liver function tests, ototoxicity and minor psychiatric disturbances. Bone marrow depression occasionally complicates treatment, necessitating withdrawal of the product.

4.9 Overdose

Treatment should be aimed at reversing dehydration and correcting electrolyte imbalance, particularly hyperkalaemia. If hyperkalaemia is seen, appropriate measures to reduce serum potassium must be instituted. Emesis should be induced or gastric lavage performed. Treatment is symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furosemide is a potent loop diuretic with a rapid action. Its effects are evident within one hour when administered orally, lasting four to six hours, and onset five minutes after intravenous injection, persisting for up to two hours. It has been reported to exert inhibiting effects on electrolyte reabsorption in the proximal and distal renal tubules, and in the ascending loop of Henle. Excretion of sodium, potassium and chloride ions is increased and water excretion enhanced.

Amiloride hydrochloride is a mild diuretic, which appears to act mainly on the distal renal tubules. It takes effect about two hours after oral administration and persists for up to 24 hours. The full effect may be delayed until after several days of treatment. It increases the excretion of sodium and chloride and reduces the excretion of potassium. Amiloride adds to the natriuretic but diminishes the kaliuretic effects of other diuretics and is used as an adjunct to Furosemide to conserve potassium.

5.2 Pharmacokinetic Properties

Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It has a biphasic half-life in the plasma with a terminal elimination phase that has been estimated to range up to one and a half-hours. It is up to 99% bound to plasma proteins, and is mainly excreted in the urine, largely unchanged, but also in the form of the glucuronide and free amine metabolites. Variable amounts are also excreted in bile, non-renal elimination being considerably increased in renal failure. Furosemide crosses the placental barrier and is excreted in milk.

Amiloride is incompletely absorbed from the gastrointestinal tract; peak serum concentrations are achieved about three to four hours after oral administration. It is excreted unchanged in the urine, and animal studies have shown little evidence of any biliary excretion. Amiloride has been estimated to have a serum half-life of about six hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of any relevance to the prescriber, which are additional to those already included in other sections.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose monohydrate

Microcrystalline Cellulose

15005 Dispersed Sunset Yellow FCF Lake

Povidone K30

Sodium Starch Glycollate

Magnesium Stearate

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Opaque white blister packs manufactured from UPVC and aluminium foil containing 28, 30, 56, or 60 tablets.

Polypropylene or polyethylene tablet containers with a lid containing 100 or 500 tablets.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Aurobindo Pharma Limited

Ares Block

Odyssey Business Park

West End Road

South Ruislip

HA4 6QD

United Kingdom

8. Marketing Authorisation Number(S)

PL 20532/0085

9. Date Of First Authorisation/Renewal Of The Authorisation

19/03/2009

10. Date Of Revision Of The Text

19/03/2009


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hydrochlorothiazide and spironolactone


Generic Name: hydrochlorothiazide and spironolactone (HYE dro KLOR oh THY a zide and spir ON oh LAK tone)
Brand Names: Aldactazide

What is hydrochlorothiazide and spironolactone?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Spironolactone is a potassium-sparing diuretic that also prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

The combination of hydrochlorothiazide and spironolactone is used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome. This medication also treats high blood pressure (hypertension).

Hydrochlorothiazide and spironolactone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrochlorothiazide and spironolactone? You should not use this medication if you have kidney disease, urination problems, or high levels of potassium in your blood. Do not use potassium supplements while you are taking hydrochlorothiazide and spironolactone.

Before using this medication, tell your doctor if you have heart or liver disease, glaucoma, diabetes, a breathing disorder, gout, lupus, a pancreas disorder, an allergy to sulfa drugs or penicillin. Tell your doctor if you use a steroid or another blood pressure medicine.

Drinking alcohol can increase certain side effects of hydrochlorothiazide and spironolactone.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking hydrochlorothiazide and spironolactone.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. What should I discuss with my doctor before taking hydrochlorothiazide and spironolactone? You should not use this medication if you are allergic to hydrochlorothiazide or spironolactone, or if you have: kidney disease or are unable to urinate;

high potassium levels (hyperkalemia); or

if you are taking potassium supplements.

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

diabetes;

heart disease;

cirrhosis or other liver disease;

glaucoma;

a breathing disorder;

gout;

lupus;

an allergy to sulfa drugs or penicillin;

a pancreas disorder; or

if you are using another blood pressure medication or a steroid.

FDA pregnancy category C. It is not known whether hydrochlorothiazide and spironolactone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hydrochlorothiazide passes into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take hydrochlorothiazide and spironolactone?

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.

Take each dose with a full glass of water.

To be sure this medication is not causing harmful effects, your blood will need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and spironolactone. You may need to stop using the medicine for a short time. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Hydrochlorothiazide and spironolactone 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.

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

Overdose symptoms may include drowsiness, confusion, red skin rash, nausea, vomiting, or diarrhea.

What should I avoid while taking hydrochlorothiazide and spironolactone? Drinking alcohol can increase certain side effects of hydrochlorothiazide and spironolactone. Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking hydrochlorothiazide and spironolactone.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Hydrochlorothiazide and spironolactone 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 this medication and call your doctor at once if you have a serious side effect such as:

eye pain, vision problems;

numbness or tingly feeling;

muscle pain or weakness;

slow, fast, or uneven heartbeat;

feeling drowsy, restless, or light-headed;

urinating less than usual or not at all;

shallow breathing;

tremors, confusion;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

mild nausea or vomiting;

dizziness, headache;

gas, stomach pain; or

skin rash.

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.

Hydrochlorothiazide and spironolactone Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 2 tablets (hydrochlorothiazide 25 mg-spironolactone 25 mg) orally once a day or 1 tablet (hydrochlorothiazide 50 mg-spironolactone 50 mg) orally once a day.
Maintenance dose: The initial dosage may be divided into two daily doses, and increased as tolerated approximately every two to four days to a maximum recommended total daily dose of hydrochlorothiazide 100 mg-spironolactone 100 mg.

Usual Adult Dose for Edema:

Initial dose: 4 tablets (hydrochlorothiazide 25 mg-spironolactone 25 mg) orally once a day or 2 tablets (hydrochlorothiazide 50 mg-spironolactone 50 mg) orally once a day.
Maintenance dose: The initial dosage may be divided into two to four daily doses, and increased as tolerated approximately every two to four days to a maximum recommended total daily dose of hydrochlorothiazide 200 mg-spironolactone 200 mg. The risk of side effects increases significantly with dosages greater than the maximum recommended dose.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 4 tablets (hydrochlorothiazide 25 mg-spironolactone 25 mg) orally once a day or 2 tablets (hydrochlorothiazide 50 mg-spironolactone 50 mg) orally once a day.
Maintenance dose: The initial dosage may be divided into two to four daily doses, and increased as tolerated approximately every two to four days to a maximum recommended total daily dose of hydrochlorothiazide 200 mg-spironolactone 200 mg. The risk of side effects increases significantly with dosages greater than the maximum recommended dose.

Usual Adult Dose for Ascites:

Initial dose: 4 tablets (hydrochlorothiazide 25 mg-spironolactone 25 mg) orally once a day or 2 tablets (hydrochlorothiazide 50 mg-spironolactone 50 mg) orally once a day.
Maintenance dose: If there is inadequate diuresis after two to four days, this dosage should be increased as tolerated approximately every two to three days to a maximum recommended total daily dose of hydrochlorothiazide 200 mg-spironolactone 200 mg.

Usual Adult Dose for Nephrotic Syndrome:

Initial dose: 4 tablets (hydrochlorothiazide 25 mg-spironolactone 25 mg) orally once a day or 2 tablets (hydrochlorothiazide 50 mg-spironolactone 50 mg) orally once a day.
Maintenance dose: The initial dosage may be divided into two to four daily doses, and increased as tolerated approximately every two to four days to a maximum recommended total daily dose of hydrochlorothiazide 200 mg-spironolactone 200 mg. The risk of side effects increases significantly with dosages greater than the maximum recommended dose.

What other drugs will affect hydrochlorothiazide and spironolactone? Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to light-headedness caused by hydrochlorothiazide and spironolactone. Tell your doctor if you regularly use any of these medicines, or any other blood pressure medications.

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

lithium (Eskalith, Lithobid);

digoxin (Lanoxin);

steroids (prednisone and others);

a blood thinner such as warfarin (Coumadin, Jantoven);

insulin or diabetes medicine taken by mouth;

an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others; or

indomethacin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with hydrochlorothiazide and spironolactone. 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 hydrochlorothiazide and spironolactone resources Hydrochlorothiazide and spironolactone Side Effects (in more detail) Hydrochlorothiazide and spironolactone Dosage Hydrochlorothiazide and spironolactone Use in Pregnancy & Breastfeeding Drug Images Hydrochlorothiazide and spironolactone Drug Interactions Hydrochlorothiazide and spironolactone Support Group 2 Reviews for Hydrochlorothiazide and spironolactone - Add your own review/rating Compare hydrochlorothiazide and spironolactone with other medications Ascites Edema Heart Failure High Blood Pressure Nephrotic Syndrome Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and spironolactone.

See also: hydrochlorothiazide and spironolactone side effects (in more detail)


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Dytac 50mg Capsules


1. Name Of The Medicinal Product

Dytac 50mg Capsules

Triamterene 50mg Capsules

2. Qualitative And Quantitative Composition

Each capsule contains 50mg triamterene EP.

3. Pharmaceutical Form

Opaque, maroon-coloured capsules containing as a yellow, granular powder.

4. Clinical Particulars 4.1 Therapeutic Indications

Triamterene is a potassium-conserving diuretic, thought to act by directly inhibiting the exchange of sodium for potassium and hydrogen in the distal renal tubule.

Potassium-conserving diuretic for the control of oedema in cardiac failure, cirrhosis of the liver or the nephrotic syndrome, and in that associated with corticosteroid treatment. When Dytac is used as an adjuvant to potassium-depleting diuretics, such loss may be inhibited and diuresis enhanced.

4.2 Posology And Method Of Administration

Method of Administration

Oral

Dosage

Adults only: When given alone, the usual dosage range is from 3 to a maximum of 5 Dytac capsules a day. The optimal daily dosage is 4 capsules, given in divided doses after breakfast and lunch. After the first week, treatment should preferably be given on alternate days to ensure satisfactory maintenance diuresis without an increase in blood urea levels. When given with another diuretic, lower dosages of both should be used initially.

Elderly: A lower dosage may be sufficient. The normally occurring reduction in glomerular filtration with age should be borne in mind.

4.3 Contraindications

Hyperkalaemia, progressive renal failure, increasing hepatic dysfunction, addison's disease, known hypersensitivity to the drug and anuria. Routine concomitant administration of potassium supplements, or other potassium-conserving drugs, including ACE inhibitors.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with diabetes mellitus, hepatic or renal insufficiency; in those predisposed to gout since Dytac has been shown in rare instances to elevate uric acid levels; with hypotensive agents since an additive effect may result; and in diabetic nephropathy, due to increased risk of hyperkalaemia.

It is advisable to monitor blood urea, serum potassium levels and electrolytes periodically. This is important in the elderly, those with renal impairment and those receiving concomitant treatment with NSAIDs.

Combinations of folate antagonists and triamterene are not advisable in pregnancy or in patients with hepatic cirrhosis because of the increased theoretical risk of folate deficiency developing.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Use with caution with hypotensive agents. When given with another diuretic, lower dosage of both should be given initially. Triamterene reduces excretion of Lithium and may thus precipitate intoxification.

It is advisable to monitor blood urea and serum potassium levels periodically in patients receiving concomitant treatment with NSAIDs. Renal failure, reversible on stopping treatment, has been reported very rarely which may be due to an interaction between triamterene and some NSAIDs.

It has been suggested that the suppression of urinary prostaglandins by NSAIDs could potentiate the nephrotoxic effects of traimterene.

Occasional reports of reduced renal function when triamterene given with indometacin avoid concomitant use.

Triamterene has the following interaction information:

Drugs likely to increase the risk of severe hyperkalaemia when given with triamterene:

• ACE inhibitors angiotensin-II receptor antagonists.

• tacrolimus

• indometacin

• potassium salts.

• trilostane.

• ciclosporin

• aliskiren

• chlorpropamide

• amiloride

• aldosterone antagonists such as eplerenone and spironolactone

Drugs likely to enhance the hypotensive effect when give with triamterene:

• alprostadil

• ACE inhibitors

• drospirenone (monitor serum potassium during first cycle)

• adrenergic neurone blockers

• alcohol

• aldesleukin

• alpha-blockers , also increased risk of first-dose hypotension with post-synaptic alpha-blockers such as prazosin

• general anaesthetics

• angiotensin-II receptor antagonists

• anxiolytics and hypnotics

• with baclofen

• beta-blockers

• calcium-channel blockers

• clonidine

• hydralazine

• levodopa

• MAOIs

• methyldopa

• minoxidil

• diazoxide

• moxisylyte

• moxonidine

• nitrates

• phenothiazines

• sodium nitroprusside

• tizanidine

Effects of diuretics is antagonised by following drugs:

• ketorolac

• indometacin

• oestrogens

• corticosteroids

Hypokalaemia caused by diuretics increases risk of ventricular arrhythmias with following drugs:

• sertindole

• pimozide (avoid concomitant use)

• platinum compounds

• atomoxetine

• amisulpride

Increased risk of postural hypotension when diuretics given with tricyclics.

Increased risk of hyponatraemia when diuretics given with carbamazepine

4.6 Pregnancy And Lactation

There is no clinical evidence to suggest any associated hazards to the foetus, However triamterene has been found to cross the placenta in humans. Nevertheless, drugs should be avoided in pregnancy unless essential, especially during the first trimester. Triamterene may appear in the breast milk, and if the drug is essential, the patient should stop breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Triamterene:

Blood and lymphatic system disorders

Rare or very rare (<1/1000, including case reports)

megaloblastic anaemia, pancytopenia

Metabolism and nutrition disorders

Very common or common (>1/100)

hyperkalaemia (incidence is reduced by Furosemide)

Uncommon (>1/1,000, <1/100)

hyperuricaemia

 

Nervous system disorders

Uncommon (>1/1,000, <1/100)

Headache

Vascular disorders

Uncommon (>1/1,000, <1/100)

hypovolaemia

Gastrointestinal disorders

Very common or common (>1/100)

nausea, vomiting, diarrhoea

Uncommon (>1/1,000, <1/100)

dry mouth

 

Skin and subcutaneous tissue disorders

Uncommon (>1/1,000, <1/100)

Rashes

Rare or very rare (<1/1000, including case reports)

photosensitivity reactions, pseudoporphyria

 

Renal and urinary disorders

Uncommon (>1/1,000, <1/100)

elevation of s-creatinine, transient renal insufficiency

Rare or very rare (<1/1000, including case reports)

Interstitial nephritis, urinary stones

 

General disorders and administration site conditions

Rare or very rare (<1/1000, including case reports)

serum sickness

Weakness, minor decreases in blood pressure, and rash have been reported. Anaphylaxis is a remote possibility.

Metabolic acidosis occasionally occurs. Electrolyte imbalance may also indicate excessive dosage or be secondary to the condition under treatment.

Renal failure, reversible on stopping treatment, has been reported very rarely and has been due to acute interstitial nephritis or an interaction between triamterene and some NSAIDs.

Triamterene has been found in renal stones both alone and in association with other usual calculus components. There is no evidence that stone formation is increased in patients taking triamterene-containing drugs.

Jaundice and abnormalities of serum levels of liver enzymes, have also been reported.

Triamterene may cause a blue fluorescence of the urine under certain light conditions.

Triamterene interferes with bioassay of folic acid.

4.9 Overdose

Symptoms of electrolyte imbalance, especially hyperkalaemia, are likely. Symptoms include nausea, vomiting, weakness, lassitude, muscular weakness, hypotension and cardiac arrhythmias. Treatment consists of gastric lavage with careful monitoring of electrolytes and fluid balance. Cardiac rhythm should be monitored and appropriate measures taken to correct hyperkalaemia as necessary. There is no specific antidote. Renal dialysis may be of some benefit in cases of severe overdosage.

Triamterene is incompletely but fairly rapidly absorbed from the gastro-intestinal tract. It has been estimated to have a plasma half-life of about 2 hours. Triamterene is extensively metabolised and is mainly excreted in the urine in the form of metabolites with some unchanged triamterene; variable mounts are also excreted in the bile.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Triamterene is a potassium-conserving diuretic thought to act by directly inhibiting the exchange of sodium for potassium and hydrogen in the distal renal tubule.

5.2 Pharmacokinetic Properties

Onset of action is 2-4 hours after ingestion. Diuresis generally tapers off 7-9 hours after administration. Triamterene is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It has been estimated to have a plasma half life of about 2 hours. Triamterene is extensively metabolised and is mainly excreted in the urine in the form of metabolites with some unchanged triamterene; variable amounts are also excreted in the bile.

5.3 Preclinical Safety Data

No further information of relevance.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Magnesium stearate

Lactose

Black Iron oxide E172

Erythrosine E127

Titanium Dioxide E171

Gelatin

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months for blister packs

60 months for securitainers/amber glass bottles/polyethylene vials.

6.4 Special Precautions For Storage

Store in a dry place.

6.5 Nature And Contents Of Container

Polypropylene securitainers/amber glass bottles/polyethylene vials contain 30 or 250 capsules Blister packs contain 30 capsules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Goldshield Group Limited

NLA Tower

Croydon

Surrey

CR0 0XT

Trading as: Goldshield Pharmaceuticals

8. Marketing Authorisation Number(S)

PL 10972/0017

9. Date Of First Authorisation/Renewal Of The Authorisation

January 1994

10. Date Of Revision Of The Text

28/09/2010


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labetalol


Generic Name: labetalol (la BAY ta lol)
Brand Names: Normodyne, Trandate

What is labetalol?

Labetalol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Labetalol is used to treat hypertension (high blood pressure).

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

What is the most important information I should know about labetalol? Do not stop taking labetalol without first talking to your doctor. Stopping suddenly may make your condition worse. If you need surgery, tell the surgeon ahead of time that you are using labetalol. You may need to stop using the medicine for a short time.

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

Labetalol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Labetalol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

What should I discuss with my healthcare provider before taking labetalol? You should not take labetalol if you are allergic to it, or if you have:

asthma or chronic obstructive pulmonary disease (COPD;

certain serious heart conditions such as"AV block" or slow heart rhythm; or

conditions that cause very low blood pressure.

If you have any of these other conditions, you may need a labetalol dose adjustment or special tests:

bronchitis, emphysema, sleep apnea, or other breathing problem;

congestive heart failure;

liver or kidney disease;

diabetes; or

pheochromocytoma (tumor of the adrenal gland).

FDA pregnancy category C. It is not known whether labetalol will harm an unborn baby. Labetalol may cause heart or lung problems in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Labetalol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take labetalol?

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.

Your blood pressure will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Do not skip doses or stop taking labetalol without first talking to your doctor. Stopping suddenly may make your condition worse. If you need surgery, tell the surgeon ahead of time that you are using labetalol. You may need to stop using the medicine for a short time.

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

Taking labetalol can make it harder for you to tell when your blood sugar is low. If you have diabetes, check your blood sugar regularly.

This medication can cause false results with certain lab tests of the urine. Tell any doctor who treats you that you are using labetalol.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Labetalol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Store at room temperature away from moisture and heat.

See also: Labetalol 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 your next dose is less than 8 hours away. 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.

Overdose symptoms may include slow heart rate, extreme dizziness, or fainting.

What should I avoid while taking labetalol? Labetalol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can further lower your blood pressure and may increase certain side effects of labetalol. Labetalol 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. Call your doctor at once if you have a serious side effect such as:

slow or uneven heartbeats;

feeling like you might pass out;

feeling short of breath, even with mild exertion;

swelling or rapid weight gain; or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

tingly feeling in your scalp;

dizziness, spinning sensation;

mild nausea, upset stomach;

tired feeling;

stuffy nose; 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.

Labetalol Dosing Information

Usual Adult Dose for Hypertension:

Oral:
Initial dose: 100 mg orally twice a day whether used alone or added to a diuretic regimen.
Maintenance dose: 200 to 400 mg orally twice a day.
Parenteral:
Repeated IV Injection: Initial dose: 20 mg (0.25 mg/kg) by slow IV injection over a 2 minute period.
Additional injections of 40 to 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg of labetalol has been injected.
The maximum effect usually occurs within 5 minutes of each injection.
Slow continuous IV Infusion: Add 40 mL of labetalol Injection to 160 mL of a commonly used IV fluid such that the resultant 200 mL of solution contains 200 mg of labetalol, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.
Alternatively, add 40 mL of labetalol Injection to 250 mL of a commonly used IV fluid. The resultant solution will contain 200 mg of labetalol, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

Usual Adult Dose for Hypertensive Emergency:

Oral:
Initial dose: 100 mg orally twice a day whether used alone or added to a diuretic regimen.
Maintenance dose: 200 to 400 mg orally twice a day.
Parenteral:
Repeated IV Injection: Initial dose: 20 mg (0.25 mg/kg) by slow IV injection over a 2 minute period.
Additional injections of 40 to 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg of labetalol has been injected.
The maximum effect usually occurs within 5 minutes of each injection.
Slow continuous IV Infusion: Add 40 mL of labetalol Injection to 160 mL of a commonly used IV fluid such that the resultant 200 mL of solution contains 200 mg of labetalol, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.
Alternatively, add 40 mL of labetalol Injection to 250 mL of a commonly used IV fluid. The resultant solution will contain 200 mg of labetalol, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

Usual Adult Dose for Pheochromocytoma:

Oral:
Initial dose: 100 mg orally twice a day whether used alone or added to a diuretic regimen.
Maintenance dose: 200 to 400 mg orally twice a day.
Parenteral:
Repeated IV Injection: Initial dose: 20 mg (0.25 mg/kg) by slow IV injection over a 2 minute period.
Additional injections of 40 to 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg of labetalol has been injected.
The maximum effect usually occurs within 5 minutes of each injection.
Slow continuous IV Infusion: Add 40 mL of labetalol Injection to 160 mL of a commonly used IV fluid such that the resultant 200 mL of solution contains 200 mg of labetalol, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.
Alternatively, add 40 mL of labetalol Injection to 250 mL of a commonly used IV fluid. The resultant solution will contain 200 mg of labetalol, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

Usual Geriatric Dose for Hypertension:

Initial dose: 50 mg to 100 mg orally twice a day.
May be titrated upwards in increments of 50 mg to 100 mg twice daily as required for control of blood pressure.
Maintenance dose: 100 to 200 mg orally twice a day.

What other drugs will affect labetalol?

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

cimetidine (Tagamet);

digoxin (digitalis, Lanoxin);

a diuretic (water pill);

insulin or oral diabetes medication;

nitroglycerin (Nitro-Dur, Nitrolingual, Nitrostat, Transderm-Nitro, and others);

an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

heart or blood pressure medication such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl).

This list is not complete and other drugs may interact with labetalol. 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 labetalol resources Labetalol Side Effects (in more detail) Labetalol Dosage Labetalol Use in Pregnancy & Breastfeeding Drug Images Labetalol Drug Interactions Labetalol Support Group 2 Reviews for Labetalol - Add your own review/rating labetalol Advanced Consumer (Micromedex) - Includes Dosage Information Labetalol MedFacts Consumer Leaflet (Wolters Kluwer) Labetalol Prescribing Information (FDA) Labetalol Hydrochloride Monograph (AHFS DI) Trandate Prescribing Information (FDA) Compare labetalol with other medications High Blood Pressure Hypertensive Emergency Mitral Valve Prolapse Pheochromocytoma Where can I get more information? Your pharmacist can provide more information about labetalol.

See also: labetalol side effects (in more detail)


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Moduretic


Pronunciation: a-MILL-oh-ride/hye-droe-klor-oh-THYE-a-zide
Generic Name: Amiloride/Hydrochlorothiazide
Brand Name: Moduretic

Moduretic can increase potassium levels in your body. This is more likely to occur in elderly patients, patients who are severely ill, or patients with kidney problems and diabetes. If not treated, high potassium levels can be fatal. Potassium levels must be closely monitored in people with any of these problems or illnesses. Lab tests will be required so be sure to keep appointments. If you develop muscle weakness or an unusual heartbeat, notify your doctor immediately.


Moduretic is used for:

Treating fluid retention (edema) and high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Moduretic is a diuretic (water pill) and is a combination of a potassium-sparing diuretic (amiloride) and a thiazide diuretic (hydrochlorothiazide). It works by making the kidneys eliminate sodium (salt) and water from the body, which helps to lower blood pressure. The amiloride component helps minimize potassium loss.

Do NOT use Moduretic if: you are allergic to any ingredient in Moduretic or any other sulfonamide (eg, sulfamethoxazole) you are unable to urinate, have severely decreased kidney function, or high blood potassium you are taking other potassium-sparing diuretics (eg, spironolactone), potassium supplements, salt substitutes containing potassium, or dofetilide

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

Before using Moduretic:

Some medical conditions may interact with Moduretic. 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 cirrhosis or liver problems, diabetes, gout, kidney problems or kidney stones, asthma, heart problems, or systemic lupus erythematosus (SLE or lupus) if you have elevated blood acid, low folic acid levels, or electrolyte problems, or are dehydrated

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

Potassium-sparing diuretics (eg, spironolactone), potassium supplements, or salt substitutes containing potassium because high blood potassium levels may occur and cause listlessness, confusion, abnormal skin sensations of the arms and legs, heaviness of limbs, slowed heart rate, irregular heart rhythm, or stopping of the heart Cholestyramine or colestipol because they may decrease Moduretic's effectiveness Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin) because they may decrease Moduretic's effectiveness of Moduretic may be decreased and the risk of kidney problems may be increased Barbiturates (eg, phenobarbital), certain chemotherapy medicines, corticosteroids (eg, prednisone), digoxin, dofetilide, ketanserin, narcotic pain medicines (eg, codeine), or medicines for high blood pressure because the risk of their side effects may be increased by Moduretic Diazoxide, lithium, or nondepolarizing neuromuscular blockers (eg, pancuronium) because their actions and the risk of their side effects may be increased by Moduretic Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) because the risk of high blood potassium and kidney problems may be increased by Moduretic Diabetes medicines (eg, glipizide) or insulin because their effectiveness may be decreased by Moduretic

This may not be a complete list of all interactions that may occur. Ask your health care provider if Moduretic 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 Moduretic:

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

Take Moduretic by mouth with food. Moduretic may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm. If you miss a dose of Moduretic, 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 Moduretic.

Important safety information: Moduretic may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Moduretic with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Moduretic may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms. Moduretic may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Moduretic. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Tell your doctor or dentist that you take Moduretic before you receive any medical or dental care, emergency care, or surgery. Diabetes patients - Moduretic may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests, including liver function, kidney function, lung function, blood pressure, and fasting blood glucose, may be performed while you use Moduretic. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Moduretic should not be used 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 Moduretic while you are pregnant. It is not known if Moduretic is found in breast milk. Do not breast-feed while taking Moduretic. Possible side effects of Moduretic:

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:

Changes in blood sugar; constipation; dizziness; fatigue; headache; inflammation of a salivary gland; loss of appetite; nausea; sensitivity to sunlight; stomach pain; weakness.

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); dry mouth; excessive thirst; impotence; leg or muscle cramps; mental confusion; rapid, weak, or irregular heartbeat; stomach pain; urination problems; vomiting; yellowing of skin or eyes.

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: Moduretic 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 excessive urination; flushed face; lightheadedness especially upon standing; nausea; vomiting; weakness.

Proper storage of Moduretic:

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

General information: If you have any questions about Moduretic, please talk with your doctor, pharmacist, or other health care provider. Moduretic 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 Moduretic. 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 Moduretic resources Moduretic Side Effects (in more detail) Moduretic Use in Pregnancy & Breastfeeding Moduretic Drug Interactions Moduretic Support Group 0 Reviews for Moduretic - Add your own review/rating Compare Moduretic with other medications Heart Failure High Blood Pressure
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Hydra-Zide


Generic Name: hydrochlorothiazide and hydralazine (HYE droe KLOR oh THYE a zide and hye DRAL a zeen)
Brand Names: Hydra-Zide

What is Hydra-Zide (hydrochlorothiazide and hydralazine)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Hydralazine is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries.

The combination of hydrochlorothiazide and hydralazine is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and hydralazine is usually given after other blood pressure medications have been tried without successful treatment.

Hydrochlorothiazide and hydralazine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hydra-Zide (hydrochlorothiazide and hydralazine)? You should not use this medication if you are allergic to hydralazine (Apresoline) or hydrochlorothiazide, or if you have coronary artery disease, rheumatic heart disease affecting the mitral valve, or if you are unable to urinate.

Before using this medication, tell your doctor if you have liver disease, kidney disease, glaucoma, angina pectoris (chest pain), asthma or allergies, gout, lupus, diabetes, an allergy to sulfa drugs or penicillin, or if you have ever had a stroke.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and hydralazine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

There are many other drugs that can interact with hydrochlorothiazide and hydralazine. 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.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my doctor before taking Hydra-Zide (hydrochlorothiazide and hydralazine)? You should not use this medication if you are allergic to hydralazine (Apresoline) or hydrochlorothiazide, or if you have:

coronary artery disease;

rheumatic heart disease affecting the mitral valve; or

if you are unable to urinate.

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

kidney disease; liver disease;

glaucoma;

angina pectoris (chest pain);

asthma or allergies;

gout;

lupus;

diabetes;

an allergy to sulfa drugs or penicillin; or

if you have ever had stroke.

FDA pregnancy category C. It is not known whether hydrochlorothiazide and hydralazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrochlorothiazide and hydralazine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using hydrochlorothiazide and hydralazine. How should I take Hydra-Zide (hydrochlorothiazide and hydralazine)?

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.

Conditions that may cause very low blood pressure include: 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.

Your blood pressure will need to be checked often. Your blood and urine may both be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture, heat, and light. 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.

Overdose symptoms may include headache, thirst, fast heart rate, nausea, vomiting, weakness, dizziness, feeling like you might pass out, leg pain, numbness or tingling, and urinating less than usual or not at all.

What should I avoid while taking Hydra-Zide (hydrochlorothiazide and hydralazine)? This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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 further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and hydralazine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Hydra-Zide (hydrochlorothiazide and hydralazine) 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 this medication and call your doctor at once if you have a serious side effect such as:

eye pain, vision problems;

dry mouth, thirst, nausea, vomiting;

feeling weak, drowsy, restless, or light-headed;

fast or uneven heart rate;

muscle pain or weakness;

confusion, unusual thoughts or behavior;

pale skin, easy bruising or bleeding;

painful or difficult urination;

urinating less than usual or not at all;

swelling in your face, stomach, hands, or feet;

numbness, burning, pain, or tingly feeling;

a red, blistering, peeling skin rash;

dark-colored urine, jaundice (yellowing of the skin or eyes); or

joint pain or swelling with fever, chest pain, weakness or tired feeling.

Less serious side effects may include:

loss of appetite, diarrhea, constipation;

headache;

dizziness, spinning sensation;

blurred vision;

muscle or joint pain; or

mild itching or skin rash.

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 Hydra-Zide (hydrochlorothiazide and hydralazine)?

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

lithium (Eskalith, LithoBid);

diazoxide (Hyperstat, Proglycem);

digoxin (Lanoxin);

insulin or oral diabetes medication;

steroids (prednisone and others);

other blood pressure medications;

an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with hydrochlorothiazide and hydralazine. 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 Hydra-Zide resources Hydra-Zide Side Effects (in more detail) Hydra-Zide Use in Pregnancy & Breastfeeding Drug Images Hydra-Zide Drug Interactions Hydra-Zide Support Group 0 Reviews for Hydra-Zide - Add your own review/rating Apresazide Advanced Consumer (Micromedex) - Includes Dosage Information Compare Hydra-Zide with other medications Heart Failure High Blood Pressure Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and hydralazine.

See also: Hydra-Zide side effects (in more detail)


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Accuretic


Generic Name: hydrochlorothiazide and quinapril (HYE droe klor oh THY a zide and KWIN a pril)
Brand Names: Accuretic

What is Accuretic (hydrochlorothiazide and quinapril)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Quinapril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Quinapril lowers blood pressure and also relieves symptoms of fluid retention.

The combination of hydrochlorothiazide and quinapril is used to treat hypertension (high blood pressure).

Hydrochlorothiazide and quinapril may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Accuretic (hydrochlorothiazide and quinapril)? Do not use this medication if you are unable to urinate.

You should not use this medication if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

Before taking hydrochlorothiazide and quinapril, tell your doctor if you have kidney disease (or are on dialysis), liver disease, glaucoma, congestive heart failure, gout, lupus, diabetes, or an allergy to sulfa drugs or penicillin.

Do not use this medication if you are pregnant. It could harm the unborn baby.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and quinapril, unless your doctor has told you to.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and quinapril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What should I discuss with my healthcare provider before taking Accuretic (hydrochlorothiazide and quinapril)? Do not use this medication if you are allergic to hydrochlorothiazide or quinapril, or if you are unable to urinate.

You should not use this medication if you are allergic to other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

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

kidney disease (or if you are on dialysis); liver disease;

glaucoma;

congestive heart failure;

gout;

lupus;

diabetes; or

an allergy to sulfa drugs or penicillin.

FDA pregnancy category D. Do not use hydrochlorothiazide and quinapril if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Use effective birth control while taking hydrochlorothiazide and quinapril. Hydrochlorothiazide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Accuretic (hydrochlorothiazide and quinapril)?

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.

Take this medicine with a full glass of water.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and quinapril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

Keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

See also: Accuretic 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.

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

Overdose symptoms may include nausea, weakness, dizziness, dry mouth, thirst, muscle pain or weakness, or feeling like you might pass out.

What should I avoid while taking Accuretic (hydrochlorothiazide and quinapril)?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

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 further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and quinapril.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and quinapril, unless your doctor has told you to.

Accuretic (hydrochlorothiazide and quinapril) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

eye pain, vision problems;

high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

dry mouth, thirst, nausea, vomiting;

feeling weak, drowsy, restless, or light-headed;

a red, blistering, peeling skin rash;

jaundice (yellowing of the skin or eyes);

urinating less than usual or not at all;

swelling, weight gain, feeling short of breath; or

fever, chills, body aches, flu symptoms.

Less serious side effects may include:

cough;

dizziness, headache, tired feeling;

muscle or back pain;

runny nose;

sleep problems (insomnia);

diarrhea, constipation, upset stomach; or

mild skin rash, increased sweating.

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 Accuretic (hydrochlorothiazide and quinapril)? Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to some of the side effects of hydrochlorothiazide and quinapril. Tell your doctor if you regularly use any of these medicines.

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

other diuretics (water pills) or blood pressure medications;

gold injections to treat arthritis;

lithium (Lithobid, Eskalith);

a tetracycline antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

cholestyramine (Prevalite, Questran) or colestipol (Colestid);

steroids (prednisone and others);

NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

insulin or oral diabetes medication.

This list is not complete and other drugs may interact with hydrochlorothiazide and quinapril. 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 Accuretic resources Accuretic Side Effects (in more detail) Accuretic Dosage Accuretic Use in Pregnancy & Breastfeeding Drug Images Accuretic Drug Interactions Accuretic Support Group 0 Reviews for Accuretic - Add your own review/rating Accuretic MedFacts Consumer Leaflet (Wolters Kluwer) Accuretic Prescribing Information (FDA) Quinaretic Prescribing Information (FDA) Compare Accuretic with other medications High Blood Pressure Where can I get more information? Your pharmacist can provide more information about hydrochlorothiazide and quinapril.

See also: Accuretic side effects (in more detail)


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