Ordered: Plicamycin (Mithracin) 2.5 mg IV daily.      Patient’s weight: 98 kg             Therapeutic dosage range: 25 to 30 mcg/kg/day.Dosage range per day:
 

Pills
 

ED Pills

ED Drugs
 

Hypercalciuria Medications


Definition of Hypercalciuria: The excretion of abnormally large amounts of calcium in the urine, seen in cases of hyperparathyroidism.

Drugs associated with Hypercalciuria

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


Drug List: Mithracin
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plicamycin


Generic Name: plicamycin (plih CA my sin)
Brand Names: Mithracin

What is plicamycin?

Plicamycin is a cancer (antineoplastic) medication. Plicamycin interferes with the growth of cancer cells and slows their growth and spread in the body.

Plicamycin is used to treat cancer of the testicles. Plicamycin is also used in the treatment of treat too much calcium in the blood (hypercalcemia) and too much calcium in the urine (hypercalciuria) associated with a variety of advanced forms of cancer.

Plicamycin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about plicamycin?

Plicamycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of plicamycin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with plicamycin.

Plicamycin should not be used in women who are or may become pregnant. Who should not take plicamycin?

Before taking plicamycin, tell your doctor if you have

liver disease; kidney disease;

bone marrow problems; or

a bleeding disorder.

You may not be able to take plicamycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Plicamycin is in the FDA pregnancy category X. This means that plicamycin is known to cause birth defects in an unborn baby. Plicamycin may also affect egg production in women and sperm production in men. Do not take plicamycin if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with plicamycin. It is not known whether plicamycin passes into breast milk. Do not take plicamycin without first talking to your doctor if you are breast feeding a baby. How should I take plicamycin?

Plicamycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with plicamycin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with plicamycin to monitor progress and side effects.

Your healthcare provider will store cladribine as directed by the manufacturer. If you are storing cladribine, follow the directions provided by your healthcare provider.

See also: Plicamycin dosage (in more detail)

What happens if I miss a dose?

Contact your doctor if you miss a dose of plicamycin injection.

What happens if I overdose? If for any reason an overdose of plicamycin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a plicamycin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while taking plicamycin?

Plicamycin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with plicamycin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Plicamycin side effects If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);

blood in the urine;

black or tarry stools;

signs of infection such as fever; chills, or sore throat;

nose bleed (epistaxis) or vomiting blood (hematemesis); or

unusual bleeding or bruising.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:

nausea, vomiting, diarrhea, or decreased appetite;

mouth sores;

drowsiness and extremely deep sleep;

a general discomfort or uneasiness;

headache or depression;

a rash; or

facial flushing..

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Plicamycin Dosing Information

Usual Adult Dose for Testicular Cancer:

For the treatment of carefully selected hospitalized patients with malignant tumors of the testis in whom successful treatment by surgery and/or radiation is impossible:
25 to 30 mcg (0.025-0.030 mg) per kilogram of body weight. Therapy should be continued for a period of 8 to 10 days unless significant side effects or toxicity occur during therapy. A course of therapy consisting of more than 10 daily doses is not recommended. Individual daily doses should not exceed 30 mcg (0.030 mg) per kilogram of body weight.
In those patients with responsive tumors, some degree of tumor regression is usually evident within 3 or 4 weeks following the initial course of therapy. If tumor masses remain unchanged following an initial course of therapy, additional courses of therapy at monthly intervals are warranted.
When a significant tumor regression is obtained, it is suggested that additional courses of therapy be given at monthly intervals until a complete regression of tumor masses is achieved or until definite tumor progression or new tumor masses occur in spite of continued courses of therapy.

Usual Adult Dose for Hypercalcemia:

In hypercalcemia associated with advanced malignancy the recommended course of treatment with plicamycin is 25 mcg (0.025 mg) per kilogram of body weight per day for 3 or 4 days.
If the desired degree of reversal of hypercalcemia is not achieved with the initial course of therapy, additional courses of therapy may then be administered at intervals of one week or more to achieve the desired result or to maintain serum calcium and urinary calcium excretion at normal levels. It may be possible to maintain normal calcium balance with single, weekly doses or with a schedule of 2 or 3 doses per week.

Usual Adult Dose for Hypercalciuria:

In hypercalciuria associated with advanced malignancy the recommended course of treatment with plicamycin is 25 mcg (0.025 mg) per kilogram of body weight per day for 3 or 4 days.
If the desired degree of reversal of hypercalciuria is not achieved with the initial course of therapy, additional courses of therapy may then be administered at intervals of one week or more to achieve the desired result or to maintain serum calcium and urinary calcium excretion at normal levels. It may be possible to maintain normal calcium balance with single, weekly doses or with a schedule of 2 or 3 doses per week.

What other drugs will affect plicamycin? Do not receive "live" vaccines during treatment with plicamycin. Administration of a live vaccine may be dangerous during treatment with plicamycin.

Other drugs may interact with plicamycin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with plicamycin.

More plicamycin resources Plicamycin Side Effects (in more detail) Plicamycin Dosage Plicamycin Use in Pregnancy & Breastfeeding Plicamycin Drug Interactions Plicamycin Support Group 0 Reviews for Plicamycin - Add your own review/rating plicamycin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Compare plicamycin with other medications Hypercalcemia Hypercalciuria Testicular Cancer Where can I get more information? Your pharmacist has additional information about plicamycin written for health professionals that you may read. What does my medication look like?

Plicamycin is available with a prescription under the brand name Mithracin. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: plicamycin side effects (in more detail)


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Fungizone For Tissue Culture


Generic Name: amphotericin B (am foe TER i sin)
Brand Names: Fungizone, Fungizone For Tissue Culture

What is Fungizone For Tissue Culture (amphotericin B)?

Amphotericin B is an antibiotic that fights fungal infections in the body.

Amphotericin B is used to treat serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.

Amphotericin is usually given after other antifungal antibiotics have been tried without successful treatment of symptoms.

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

What is the most important information I should know about Fungizone For Tissue Culture (amphotericin B)? Do not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have kidney disease or heart disease.

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if have a slow heartbeat, chest tightness, or trouble breathing. What should I discuss with my health care provider before I receive Fungizone For Tissue Culture (amphotericin B)? You should not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease; or

heart disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive amphotericin B.

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. It is not known whether amphotericin B passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. How is amphotericin B given?

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

While you are receiving your amphotericin B infusion, your caregivers will check your blood pressure, pulse, temperature, and lung function about every 30 minutes.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Amphotericin B can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

What happens if I miss a dose?

Since amphotericin B is usually given while you are in the hospital, it is not likely you will miss a dose of this medication.

If you are receiving amphotericin B in an outpatient clinic, call your doctor if you will miss an appointment for your amphotericin B injection.

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

Overdose symptoms may include slow heart rate, and shallow breathing that slows or stops.

What should I avoid while receiving Fungizone For Tissue Culture (amphotericin B)?

Amphotericin B may lower the blood cells that help your body fight other infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Fungizone For Tissue Culture (amphotericin B) side effects Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if you have a slow heartbeat, chest tightness, or trouble breathing. 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. Tell your doctor at once if you have any of these serious side effects:

dry mouth, increased thirst, nausea, vomiting;

extreme drowsiness, restless feeling, confusion;

urinating more or less than usual, or not at all;

muscle pain or weakness, fast or uneven heart rate, feeling light-headed, fainting;

seizure (convulsions);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising or bleeding, unusual weakness; or

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

Less serious side effects may include:

pain, swelling, or other irritation where the needle is placed;

mild nausea, vomiting, diarrhea, upset stomach, loss of appetite;

weight loss;

muscle or joint aches;

headache;

warmth, redness, or tingly feeling under your skin; or

skin itching or mild rash.

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 Fungizone For Tissue Culture (amphotericin B)?

Before receiving amphotericin B, tell your doctor if you are using any of the following drugs:

flucytosine (Ancobon);

digoxin (digitalis, Lanoxin, Lanoxicaps);

pentamidine (Nebupent, Pentam);

tacrolimus (Prograf);

muscle relaxers;

steroids (prednisone and others);

antifungal antibiotics such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with amphotericin B. 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 Fungizone For Tissue Culture resources Fungizone For Tissue Culture Side Effects (in more detail)Fungizone For Tissue Culture Use in Pregnancy & BreastfeedingFungizone For Tissue Culture Drug Interactions0 Reviews for Fungizone For Tissue Culture - Add your own review/rating Amphocin MedFacts Consumer Leaflet (Wolters Kluwer) Amphocin Advanced Consumer (Micromedex) - Includes Dosage Information Amphotericin B Prescribing Information (FDA) Amphotericin B Monograph (AHFS DI) Amphotericin B Professional Patient Advice (Wolters Kluwer) Fungizone Prescribing Information (FDA) Compare Fungizone For Tissue Culture with other medications Aspergillosis, AspergillomaAspergillosis, InvasiveBlastomycosisCandida Infections, SystemicCandida Urinary Tract InfectionCoccidioidomycosisCoccidioidomycosis, MeningitisCryptococcal Meningitis, Immunocompetent HostCryptococcal Meningitis, Immunosuppressed HostCryptococcosisEsophageal CandidiasisFungal EndocarditisFungal Infection ProphylaxisHistoplasmosis, Immunocompenent HostHistoplasmosis, MeningitisLeishmaniasisOral ThrushParacoccidioidomycosisSporotrichosis Where can I get more information? Your pharmacist can provide more information about amphotericin B.

See also: Fungizone For Tissue Culture side effects (in more detail)


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Fungizone


Generic Name: amphotericin B (am foe TER i sin)
Brand Names: Fungizone, Fungizone For Tissue Culture

What is Fungizone (amphotericin B)?

Amphotericin B is an antibiotic that fights fungal infections in the body.

Amphotericin B is used to treat serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.

Amphotericin is usually given after other antifungal antibiotics have been tried without successful treatment of symptoms.

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

What is the most important information I should know about Fungizone (amphotericin B)? Do not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have kidney disease or heart disease.

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if have a slow heartbeat, chest tightness, or trouble breathing. What should I discuss with my health care provider before I receive Fungizone (amphotericin B)? You should not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease; or

heart disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive amphotericin B.

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. It is not known whether amphotericin B passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. How is amphotericin B given?

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

While you are receiving your amphotericin B infusion, your caregivers will check your blood pressure, pulse, temperature, and lung function about every 30 minutes.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Amphotericin B can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

What happens if I miss a dose?

Since amphotericin B is usually given while you are in the hospital, it is not likely you will miss a dose of this medication.

If you are receiving amphotericin B in an outpatient clinic, call your doctor if you will miss an appointment for your amphotericin B injection.

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

Overdose symptoms may include slow heart rate, and shallow breathing that slows or stops.

What should I avoid while receiving Fungizone (amphotericin B)?

Amphotericin B may lower the blood cells that help your body fight other infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Fungizone (amphotericin B) side effects Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if you have a slow heartbeat, chest tightness, or trouble breathing. 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. Tell your doctor at once if you have any of these serious side effects:

dry mouth, increased thirst, nausea, vomiting;

extreme drowsiness, restless feeling, confusion;

urinating more or less than usual, or not at all;

muscle pain or weakness, fast or uneven heart rate, feeling light-headed, fainting;

seizure (convulsions);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising or bleeding, unusual weakness; or

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

Less serious side effects may include:

pain, swelling, or other irritation where the needle is placed;

mild nausea, vomiting, diarrhea, upset stomach, loss of appetite;

weight loss;

muscle or joint aches;

headache;

warmth, redness, or tingly feeling under your skin; or

skin itching or mild rash.

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 Fungizone (amphotericin B)?

Before receiving amphotericin B, tell your doctor if you are using any of the following drugs:

flucytosine (Ancobon);

digoxin (digitalis, Lanoxin, Lanoxicaps);

pentamidine (Nebupent, Pentam);

tacrolimus (Prograf);

muscle relaxers;

steroids (prednisone and others);

antifungal antibiotics such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with amphotericin B. 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 Fungizone resources Fungizone Side Effects (in more detail) Fungizone Use in Pregnancy & Breastfeeding Fungizone Drug Interactions Fungizone Support Group 0 Reviews for Fungizone - Add your own review/rating Fungizone Prescribing Information (FDA) Fungizone MedFacts Consumer Leaflet (Wolters Kluwer) Fungizone Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Amphotericin B Prescribing Information (FDA) Amphotericin B Monograph (AHFS DI) Amphotericin B Professional Patient Advice (Wolters Kluwer) Compare Fungizone with other medications Aspergillosis, Aspergilloma Aspergillosis, Invasive Blastomycosis Candida Infections, Systemic Candida Urinary Tract Infection Coccidioidomycosis Coccidioidomycosis, Meningitis Cryptococcal Meningitis, Immunocompetent Host Cryptococcal Meningitis, Immunosuppressed Host Cryptococcosis Esophageal Candidiasis Fungal Endocarditis Fungal Infection Prophylaxis Histoplasmosis, Immunocompenent Host Histoplasmosis, Meningitis Leishmaniasis Oral Thrush Paracoccidioidomycosis Sporotrichosis Where can I get more information? Your pharmacist can provide more information about amphotericin B.

See also: Fungizone side effects (in more detail)


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AccessPak for HIV PEP Basic


Generic Name: emtricitabine and tenofovir (em trye SYE ta been and ten OF oh vir)
Brand Names: AccessPak for HIV PEP Basic, Truvada

What is AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine and tenofovir is not a cure for HIV or AIDS.

Emtricitabine and tenofovir may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread).

Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

Some people develop lactic acidosis while taking emtricitabine and tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Emtricitabine and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). What should I discuss with my healthcare provider before taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

If you have any of these other conditions, you may need an emtricitabine and tenofovir dose adjustment or special tests:

liver or kidney disease;

osteopenia (low bone mineral density); or

if you also have hepatitis B infection.

Some people develop a life-threatening condition called lactic acidosis while taking emtricitabine and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. FDA pregnancy category B. Emtricitabine and tenofovir is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of emtricitabine and tenofovir on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to anyone under 18 without the advice of a doctor. How should I take AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

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.

You may take this medication with or without food.

Use emtricitabine and tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

If you have hepatitis B you may develop liver symptoms after you stop taking emtricitabine and tenofovir, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using the medicine. Do not miss any follow-up visits to your doctor.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet of moisture-absorbing preservative that comes with emtricitabine and tenofovir. 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 AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. AccessPak for HIV PEP Basic (emtricitabine and tenofovir) 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. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

muscle pain or weakness;

numb or cold feeling in your arms and legs;

trouble breathing;

feeling dizzy, light-headed, tired, or very weak;

stomach pain, nausea with vomiting; or

fast or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

increased thirst, urinating more or less than usual or not at all;

swelling, rapid weight gain, feeling short of breath; or

signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

diarrhea, mild nausea;

headache, tired feeling;

dizziness, depressed mood;

sleep problems (insomnia), strange dreams;

mild itching or skin rash;

runny or stuffy nose, cough; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Emtricitabine and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

an IV antibiotic such as gentamicin (Garamycin), vancomycin (Vancocin, Vancoled), and others;

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

You may need dose adjustments or special tests when taking any of these medications together with emtricitabine and tenofovir.

Other medications that can affect emtricitabine and tenofovir include:

the herpes medications acyclovir (Zovirax) or valacyclovir (Valtrex);

medications to treat cytomegalovirus (CMV) such as cidofovir (Vistide), ganciclovir (Cytovene) or valganciclovir (Valcyte); or

certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), or ritonavir (Norvir).

This list is not complete and other drugs may interact with emtricitabine and tenofovir. 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 AccessPak for HIV PEP Basic resources AccessPak for HIV PEP Basic Side Effects (in more detail)AccessPak for HIV PEP Basic Use in Pregnancy & BreastfeedingAccessPak for HIV PEP Basic Drug Interactions0 Reviews for AccessPak for HIV PEP Basic - Add your own review/rating Truvada Prescribing Information (FDA) Truvada Advanced Consumer (Micromedex) - Includes Dosage Information Truvada MedFacts Consumer Leaflet (Wolters Kluwer) Truvada Consumer Overview Compare AccessPak for HIV PEP Basic with other medications HIV InfectionNonoccupational Exposure Where can I get more information? Your pharmacist can provide more information about emtricitabine and tenofovir.

See also: AccessPak for HIV PEP Basic side effects (in more detail)


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CX Powder (Ecolab)


1. Name Of The Medicinal Product

CX POWDER

2. Qualitative And Quantitative Composition

Chlorhexidine Acetate BP 1% w/w

3. Pharmaceutical Form

Powder

4. Clinical Particulars 4.1 Therapeutic Indications

General skin disinfection and antisepsis for topical application only.

4.2 Posology And Method Of Administration

Apply lightly to the affected area up to three times daily. The dosage schedule does not require adjustment for adults, children or the elderly. The dosage is as stated for both the clinical indications, vis skin disinfection and antisepsis.

4.3 Contraindications

Known hypersensitivity to chlorhexidine.

4.4 Special Warnings And Precautions For Use

Skin sensitivity to Chlorhexidine salts has occurred occasionally, Chlorhexidine salts are irritant to the conjunctiva and other sensitive tissue.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No special precautions need to be taken when used in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

None known

4.9 Overdose

Not applicable. Ingestion of Chlorhexidine salts should be treated symptomatically, unless gastric lavage is required from other clinical considerations.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Chlorhexidine Acetate is an antibacterial substance which is effective against a wide range of gram-positive and gram-negative bacteria. It has limited activity against some viruses and fungi. It is inactive against bacterial spores at room temperature and some strains of pseudomonas and proteus tend to be less susceptible than other bacteria.

Sterilisable Maize Starch BP is an absorbent powder.

5.2 Pharmacokinetic Properties

Not applicable. The product is for topical application and significant systematic absorption does not occur.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sterilisable Maize Starch BP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

CX Powder is packed in LDPE bottles fitted with a nozzle plug and white plastic cap. Pack size 15g.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

05/12/2008

10. Date Of Revision Of The Text

05/12/2008


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Hydantoin anticonvulsants


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Hydantoin anticonvulsants are structurally related to barbiturates. They have an allantoin heterocyclic base. Hydantoins slow the synaptic transmission by blocking sodium channels from recovering from the inactivated state, and inhibits neurons from firing. This stops the repeated excitation of cells that results in seizures.

Hydantoin anticonvulsants are used to treat a wide range of seizures types.

See also

Medical conditions associated with hydantoin anticonvulsants:

Anxiety Arrhythmia Epilepsy Neurosurgery Peripheral Neuropathy Rheumatoid Arthritis Seizure Prevention Seizures Status Epilepticus Trigeminal Neuralgia Drug List: Phenytoin-Sodium-Prompt Phenytek-Extended-Release-Capsules Dilantin Cerebyx Mesantoin Peganone
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tobramycin injection


Generic Name: tobramycin (injection) (toe bra MYE sin)
Brand Names: Nebcin

What is tobramycin injection?

Tobramycin is in a group of antibiotics called aminoglycosides (ah-meen-oh-GLY-ko-sides). Tobramycin fights infections that are caused by bacteria.

Tobramycin injection is used to treat bacterial infections of the skin, heart, stomach, brain and spinal cord, respiratory system, and urinary tract. It is also used in the treatment of cystic fibrosis. Tobramycin injection is sometimes used together with other antibiotics.

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

What is the most important information I should know about tobramycin injection? Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

There may be other drugs that can affect tobramycin injection. 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.

Contact your doctor promptly if you have any hearing loss or ringing in your ears, even if these side effects occur long after you have stopped using tobramycin injection.

Other serious side effects include urinating less than usual or not at all, muscle stiffness or uncontrolled twitching, and wheezing, chest tightness, or trouble breathing.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Tobramycin injection will not treat a viral infection such as the common cold or flu. Tobramycin injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. What should I discuss with my health care provider before using tobramycin injection? Do not use this medication if you are allergic to tobramycin or other aminoglycosides such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), netilmicin (Netromycin), or streptomycin.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

a muscle disorder such as myasthenia gravis;

Parkinson's disease;

asthma; or

a metabolic disorder such as high or low levels of potassium, calcium, or magnesium in your blood.

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

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use tobramycin injection without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Tobramycin 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. Older adults may be more likely to have side effects from this medication. How should I use tobramycin injection?

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

Tobramycin is given as an injection through a needle placed into a vein or as a shot given into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Drink 6 to 8 full glasses of water each day while you are using tobramycin injection. You may become easily dehydrated while using this medication. Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Tobramycin injection will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your doctor will need to check your progress on a regular basis. Your hearing and kidney function may also need to be tested. Do not miss any scheduled appointments.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using tobramycin injection. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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 dizziness, ringing in your ears, and urinating more or less than usual, or not at all.

What should I avoid while using tobramycin injection?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using tobramycin.

Tobramycin injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Tobramycin injection 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 any of these serious side effects:

hearing loss or ringing in your ears (even after you have stopped using tobramycin injection);

urinating less than usual or not at all;

muscle stiffness or uncontrolled twitching;

wheezing, chest tightness, trouble breathing;

confusion, seizure (convulsions); or

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

Less serious side effects may include:

muscle weakness; or

numbness or tingly feeling.

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.

Tobramycin Dosing Information

Usual Adult Dose for Bacterial Infection:

1.5 to 2 mg/kg loading dose, followed by 1 to 1.7 mg/kg IV or IM every 8 hours, or 5 to 7 mg/kg IV every 24 hours
Duration: 7 to 21 days, depending on the nature and severity of the infection
Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Adult Dose for Bacteremia:

1.5 to 2 mg/kg loading dose, followed by 1 to 1.7 mg/kg IV or IM every 8 hours or 5 to 7 mg/kg IV every 24 hours
Duration: 14 days, depending on the site, nature and severity of the bacteremia
Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Adult Dose for Burns - External:

2 to 2.5 mg/kg loading dose, followed by 1.7 to 2 mg/kg IV every 8 hours
Duration: 10 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Cystic Fibrosis:

IV: 5 to 10 mg/kg/day IV in 2 to 4 divided doses or 10 to 15 mg/kg/day IV in 3 to 4 divided doses; alternatively, 7 to 15 mg/kg IV every 24 hours has been used
Duration: 14 to 21 days, depending on the nature and severity of the infection and improvement of pulmonary function
Solution for inhalation:
Initial dose: 300 mg via nebulizer over approximately 15 minutes twice daily (every 12 hours) for 28 days
Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off. If patient is on multiple therapies, the following order of administration is recommended: Bronchodilator, chest physiotherapy, other inhaled medications, and lastly, tobramycin solution.

Usual Adult Dose for Endocarditis:

1.5 to 2 mg/kg loading dose, followed by 1 to 1.7 mg/kg IV every 8 hours for the first 2 weeks
Duration: Antibiotic therapy for enterococcal endocarditis should be continued for 4 to 6 weeks and for more than 6 weeks in patients with Gram-negative endocarditis, depending on the nature and severity of the infection.

Usual Adult Dose for Febrile Neutropenia:

2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours
Duration: Once the patient is stable, afebrile for 24 hours, and the absolute neutrophil count is greater than 500/mm3, oral antibiotics may be substituted if antibiotic therapy is to be continued.

Usual Adult Dose for Intraabdominal Infection:

2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 mg/kg IV every 24 hours
Duration: 14 days, depending on the nature and severity of the infection
Less toxic antibiotics may be substituted once the patient is stable for at least 48 hours.

Usual Adult Dose for Meningitis:

IV or IM: 2 mg/kg loading dose, followed by 1.7 mg/kg IV or IM every 8 hours
Duration: Parenteral therapy should be continued for at least one week after the patient becomes afebrile and cerebrospinal fluid normalizes.
Intracerebroventricular: 4 to 8 mg intracerebroventricularly (preservative-free formulation) up to every 24 hours, in addition to parenteral antibiotic therapy
Subsequent doses should be based on the CSF concentration.

Usual Adult Dose for Osteomyelitis:

1.5 to 2 mg/kg loading dose, followed by 1 to 1.7 mg/kg IV or IM every 8 hours or 5 to 7 mg/kg IV every 24 hours
Duration: 4 to 6 weeks, depending on the nature and severity of the infection
Chronic osteomyelitis may require an additional 1 to 2 months of oral antibiotics. Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Adult Dose for Peritonitis:

Intravenous: 2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 mg/kg IV every 24 hours
Duration: 14 days, depending on the nature and severity of the infection
Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.
Intraperitoneal in CAPD patients: 0.6 to 0.75 mg/kg intraperitoneally once daily or 16 to 20 mg per every 2 L dialysate

Usual Adult Dose for Pneumonia:

2 mg/kg loading dose, followed by 1.7 mg/kg IV or IM every 8 hours or 5 mg/kg IV every 24 hours
Duration: 14 to 21 days, depending on the nature and severity of the infection
Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Adult Dose for Pyelonephritis:

2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 mg/kg IV every 24 hours
Duration: 7 to 14 days, depending on the nature and severity of the infection
Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Adult Dose for Sepsis:

2 mg/kg loading dose, followed by 1.7 mg/kg IV every 8 hours or 5 to 7 mg/kg IV every 24 hours
Duration: 10 to 14 days, depending on the nature and severity of the infection
A longer duration may be necessary in immunocompromised or neutropenic patients.

Usual Adult Dose for Shunt Infection:

4 to 8 mg intracerebroventricularly (preservative-free formulation) up to every 24 hours, in addition to parenteral antibiotic therapy
Subsequent doses should be based on the CSF concentration. Shunt removal is usually necessary to achieve a cure.

Usual Adult Dose for Skin or Soft Tissue Infection:

1.5 to 2 mg/kg loading dose, followed by 1 to 1.7 mg/kg IV or IM every 8 hours or 5 to 7 mg/kg IV every 24 hours
Duration: 10 to 14 days, or until 3 days post acute inflammation, depending on the nature and severity of the infection
For severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required. Limiting the duration of tobramycin therapy may help limit toxicity. Once the patient is stable for at least 48 hours, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Adult Dose for Tularemia:

1.5 to 2 mg/kg loading dose, followed by 1 to 1.7 mg/kg IV or IM every 8 hours or 5 to 7 mg/kg IV every 24 hours
Duration: 10 to 14 days, depending on the nature and severity of the infection
Once the patient's condition improves, less toxic intravenous or oral antibiotic therapy may be considered according to microbiology sensitivity data.

Usual Pediatric Dose for Bacterial Infection:

Preterm neonate, 999 g or less: 3.5 mg/kg IV or IM every 24 hours
0 to 4 weeks, 1199 g or less: 2.5 mg/kg IV or IM every 18 to 24 hours
7 days or less, 1200 g or more: 2.5 mg/kg IV or IM every 12 hours
8 days to 4 weeks, 1200 to 2000 g: 2.5 mg/kg IV or IM every 8 to 12 hours
8 days to 4 weeks, 2001 g or more: 2.5 mg/kg IV or IM every 8 hours
1 month to 4 years: 1 to 2.5 mg/kg IV or IM every 8 hours
5 years or older: 2 to 2.5 mg/kg IV or IM every 8 hours

Usual Pediatric Dose for Cystic Fibrosis:

IV or IM: 2.5 to 3.3 mg/kg every 6 to 8 hours
Solution for Inhalation:
5 years or less: 40 to 80 mg via nebulizer 2 to 3 times daily
6 to 18 years:
Initial dose: 300 mg via nebulizer over approximately 15 minutes twice daily (every 12 hours) for 28 days
Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off. If patient is on multiple therapies, the following order of administration is recommended: Bronchodilator, chest physiotherapy, other inhaled medications, and lastly, tobramycin solution.

What other drugs will affect tobramycin injection?

Before using tobramycin injection, tell your doctor if you are using any of the following drugs:

pentamidine (Nebupent, Pentam);

tacrolimus (Prograf);

amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);

a diuretic (water pill);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with tobramycin injection. 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 tobramycin resources Tobramycin Use in Pregnancy & Breastfeeding Tobramycin Drug Interactions Tobramycin Support Group 0 Reviews for Tobramycin - Add your own review/rating Compare tobramycin with other medications Bacteremia Bacterial Infection Bone infection Burns, External Cystic Fibrosis Endocarditis Febrile Neutropenia Intraabdominal Infection Kidney Infections Meningitis Peritonitis Pneumonia Rabbit Fever Sepsis Shunt Infection Skin Infection Where can I get more information? Your pharmacist can provide more information about tobramycin injection.
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Clarityn Allergy 10mg Tablets


1. Name Of The Medicinal Product

Clarityn Allergy 10mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 10mg loratadine.

The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 71.3 mg.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablet: White to off-white, oval tablet with flask and bowl, score and “10” on one side, plain on the other side.

Tablet: The scoreline of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars 4.1 Therapeutic Indications

Clarityn Allergy Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

4.2 Posology And Method Of Administration

Adults and children over 12 years of age:

10mg once daily (one tablet once daily).

The tablet may be taken without regard to mealtime.

Children 2 to 12 years of age are dosed by weight:

Bodyweight more than 30kg: 10mg once daily (one tablet once daily).

The 10mg strength tablet is not appropriate in children with a bodyweight less than 30kg.

Efficacy and safety of Clarityn Allergy Tablets in children under 2 years of age has not been established.

Patients with severe liver impairment should be administered a lower initial dose because they have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg, and for children weighing 30 kg or less, 5 mg every other day is recommended.

No dosage adjustments are required in the elderly or in patients with renal insufficiency.

4.3 Contraindications

Clarityn Allergy Tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.

4.4 Special Warnings And Precautions For Use

Clarityn Allergy Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).

This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The administration of Clarityn Allergy Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

When administered concomitantly with alcohol, Clarityn Allergy Tablets have no potentiating effects as measured by psychomotor performance studies.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.

4.6 Pregnancy And Lactation

Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of Clarityn Allergy Tablets during pregnancy is therefore not recommended.

Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women.

4.7 Effects On Ability To Drive And Use Machines

In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

4.8 Undesirable Effects

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.

Immune system disorders

Anaphylaxis

Nervous system disorders

Dizziness

Cardiac disorders

Tachycardia, palpitation

Gastrointestinal disorders

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Abnormal hepatic function

Skin and subcutaneous tissue disorders

Rash, alopecia

General disorders and administration site conditions

Fatigue

4.9 Overdose

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.

In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group : antihistamines – H1 antagonist, ATC code : R06A X13.

Loratadine, the active ingredient in Clarityn Allergy Tablets, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.

Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.

Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.

5.2 Pharmacokinetic Properties

After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desloratadine (DL)- is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively.

Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).

Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.

In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.

Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL.

The bioavailability parameters of loratadine and of the active metabolite are dose proportional.

The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy volunteers and in healthy geriatric volunteers.

Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect.

In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.

In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

Loratadine and its active metabolite are excreted in the breast milk of lactating women.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose Monohydrate;

Maize Starch;

Magnesium Stearate

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Blister strip consisting of a 20 ?m aluminium foil with vinyl heat coating and a 250 ?m clear, transparent polyvinylchloride film.

Pack sizes of 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, 60, or 100 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 0025/0585

9. Date Of First Authorisation/Renewal Of The Authorisation

10th June 1992/8th November 2007

10. Date Of Revision Of The Text

DECEMBER 2010

Clarityn Tablets-Final-CoO-Feb0711 CLARITYN ALLERGY 10 MG/UK/01-11/001


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coagulation factor IX


Generic Name: coagulation factor IX (koh AG yoo LAY shun FAK tor)
Brand names: AlphaNine SD, BeneFIX, Mononine, BeneFIX 250 Int'l Units

What is coagulation factor IX?

Coagulation factor IX is a man-made protein that is similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VII deficiency.

Coagulation factor IX may also be used for purposes other than those listed here.

What is the most important information I should know about coagulation factor IX? Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have liver disease, coronary artery disease (hardening of the arteries), or a history of stroke or heart attack.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition. What should I discuss with my healthcare provider before using coagulation factor IX? Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have:

liver disease;

coronary artery disease (hardening of the arteries); or

history of stroke or heart attack.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coagulation factor IX passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use coagulation factor IX?

Coagulation factor IX is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home.

Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

Use each disposable needle only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Coagulation factor IX is a powder medication that must be mixed with a liquid (diluent) before injecting it. Use the injection within 3 hours after mixing your dose.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition. If you store this medication at home, keep the powder medicine in the refrigerator. Do not freeze. Avoid exposing the medication to sunlight. The diluent can be stored at room temperature. You may also coagulation factor IX powder at cool room temperature for up to 6 months. What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

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

An overdose of coagulation factor IX is not expected to produce life-threatening symptoms.

What should I avoid while using coagulation factor IX?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using coagulation factor IX.

Coagulation factor IX 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 any of these serious side effects:

fever or chills;

continued bleeding after treatment;

feeling like you might pass out;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance; or

swelling in your feet or ankles, weight gain, loss of appetite.

Less serious side effects may be more likely to occur, such as:

headache;

warmth, redness, or tingly feeling under your skin;

nausea, vomiting;

dizziness; or

pain, redness, or swelling where the medicine was injected.

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.

Coagulation factor IX Dosing Information

Usual Adult Dose for Factor IX Deficiency:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.8 + or - 0.2 IU/dL [range 0.4 to 1.2 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Usual Adult Dose for Hemophilia B:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.8 + or - 0.2 IU/dL [range 0.4 to 1.2 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Usual Pediatric Dose for Factor IX Deficiency:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.7 + or - 0.3 IU/dL [range 0.2 to 2.1 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

Usual Pediatric Dose for Hemophilia B:

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.
In general, one IU of coagulation factor IX per kilogram of body weight increased the circulating activity of factor IX as follows: 0.7 + or - 0.3 IU/dL [range 0.2 to 2.1 IU/dL].
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue:
Circulating Factor IX Activity Required: 20-30 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 1 to 2 days
Moderate
Intramuscular or soft tissue with dissection, mucous membranes, dental extractions, or hematuria:
Circulating Factor IX Activity Required: 25 to 50 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: Treat until bleeding stops and healing begins, about 2 to 7 days
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery:
Circulating Factor IX Activity Required: 50 to 1000 [% or (IU/dL)]
Dosing Interval: 12 to 24 hours
Duration of Therapy: 7 to 10 days

What other drugs will affect coagulation factor IX?

There may be other drugs that can interact with coagulation factor IX. 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 coagulation factor IX resources Coagulation factor IX Side Effects (in more detail) Coagulation factor IX Use in Pregnancy & Breastfeeding Coagulation factor IX Support Group 1 Review for Coagulation factor IX - Add your own review/rating AlphaNine SD MedFacts Consumer Leaflet (Wolters Kluwer) Alphanine SD Prescribing Information (FDA) Alphanine SD Advanced Consumer (Micromedex) - Includes Dosage Information BeneFIX Monograph (AHFS DI) BeneFIX Prescribing Information (FDA) BeneFix MedFacts Consumer Leaflet (Wolters Kluwer) Mononine Prescribing Information (FDA) Mononine MedFacts Consumer Leaflet (Wolters Kluwer) Compare coagulation factor IX with other medications Factor IX Deficiency Hemophilia B Where can I get more information? Your pharmacist can provide more information about coagulation factor IX.

See also: coagulation factor IX side effects (in more detail)


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Corsodyl Mouthwash (original)


1. Name Of The Medicinal Product

Corsodyl Original Mouthwash

Corsodyl Mouthwash Original

2. Qualitative And Quantitative Composition

Chlorhexidine Digluconate 0.2% w/v

(equivalent to Chlorhexidine Digluconate Solution Ph Eur 1.0% v/v)

3. Pharmaceutical Form

Oromucosal solution

4. Clinical Particulars 4.1 Therapeutic Indications

Corsodyl Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque.

It is indicated as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery, in mentally or physically handicapped patients).

It may also be used in a post-peridontal surgery or treatment* regimen to promote gingival healing.

*NB: Use as part of a post-periodontal treatment regimen has only been adequately studied over the short term and following standard root surface instrumentation.

It is useful in the management of aphthous ulceration and oral candidal infections (eg denture stomatitis and thrush).

4.2 Posology And Method Of Administration

Adults:

Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment.

Corsodyl is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl (rinsing the mouth between applications) or at a different time of day.

For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in Corsodyl mouthwash for fifteen minutes twice daily.

Children and the Elderly:

The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician.

Children under 12 years of age should not use the product unless recommended by a healthcare professional.

Route of administration

External (oral) use. [This product is not intended to be swallowed].

4.3 Contraindications

Corsodyl is contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine or to any of the excipients in the formulation. However, such reactions are extremely rare.

4.4 Special Warnings And Precautions For Use

For oral (external) use only. Do not swallow. Keep out of the eyes and ears.

If the mouthwash comes into contact with the eyes, wash out promptly and thoroughly with water.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects on the foetus arising from the use of Corsodyl during pregnancy or on infants during lactation. Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

None have been reported or are known.

4.8 Undesirable Effects

Discoloration: A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily before using the mouthwash or, in the case of dentures, cleaning with a conventional denture cleanser. However, in certain cases a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement. Similarly where normal toothbrushing is not possible, for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying condition has been resolved.

Taste: Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continued use.

Oral desquamation: In cases where oral desquamation occurs dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash.

Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine mouthrinses has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.

Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions: Allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

4.9 Overdose

This has not been reported.

Due to the alcohol content (7.0 % v/v) ingestion of large amounts by children requires attention. Seek medical advice for appropriate action.

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large volumes are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common dental conditions.

5.2 Pharmacokinetic Properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ethanol (96 per cent), Macrogolglycerol Hydroxystearate, Ponceau 4R (E124), Aniseed Flavouring Oil, Peppermint oil, Purified water.

6.2 Incompatibilities

Hypochlorite bleaches may cause brown stains to develop in fabrics that have previously been in contact with preparations containing chlorhexidine.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Oriented amber polyethylene terephthalate bottle with plastic screw cap made from white food grade polypropylene.

Each bottle contains 300 ml or 600 ml.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as:

GlaxoSmithKline Consumer Healthcare

Brentford

TW8 9BD, UK

8. Marketing Authorisation Number(S)

PL 0079/0313

9. Date Of First Authorisation/Renewal Of The Authorisation

10 February 1994

10. Date Of Revision Of The Text

March 2009


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Sapropterin Dihydrochloride


Class: Other Miscellaneous Therapeutic Agents
Chemical Name: (6R)-2-amino-6-[(1R, 2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride
Molecular Formula: C9H15N5O3 • 2HCl
CAS Number: 69056-38-8
Brands: Kuvan

Introduction

Synthetic dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4); cofactor in the metabolism of phenylalanine.1 4 5 6

Uses for Sapropterin Dihydrochloride Phenylketonuria

Used to reduce blood phenylalanine concentrations in patients with hyperphenylalaninemia associated with tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU).1 4 5 6 Use in conjunction with a phenylalanine-restricted diet.1 Designated an orphan drug by FDA for this use.3

Sapropterin Dihydrochloride Dosage and Administration General

Carefully monitor blood phenylalanine concentrations during therapy.1 Measure blood phenylalanine concentrations after 1 week of treatment and periodically for up to 1 month to evaluate response to therapy.1

Dietary phenylalanine intake must not be modified while response to sapropterin therapy is being evaluated so that the drug’s effect on phenylalanine concentrations can be accurately assessed.1 (See Response to Treatment under Cautions.)

Administration Oral Administration

Administer orally once daily with food, preferably at the same time each day.1 2

Dissolve tablets in 4–8 ounces of water or apple juice and consume within 15 minutes of dissolution.1 2 Dissolution may take several minutes; stirring the mixture or crushing the tablets may increase rate of dissolution, but complete dissolution may not occur.1 2 If visible tablet fragments remain in the glass after mixture has been consumed, rinse the glass with additional water or apple juice then swallow the rinse to ensure that entire dose is consumed.1 2

Take a missed dose as soon as possible, but avoid taking 2 doses on the same day.1 2

Dosage

Available as sapropterin dihydrochloride; dosage expressed in terms of the salt.1

Response to therapy is determined by change in blood phenylalanine concentrations.1

Pediatric Patients Phenylketonuria Oral

Children ?4 years of age: Initially, 10 mg/kg once daily.1 2 6 8 If blood phenylalanine concentrations do not decrease from baseline after 1 month of treatment, increase dose to 20 mg/kg once daily.1 6 If blood phenylalanine concentrations do not decrease after 1 month of treatment at 20 mg/kg once daily, consider the patient a nonresponder and discontinue therapy.1 6

For responders, adjust dose within the range of 5–20 mg/kg once daily based on blood phenylalanine concentrations.1

Dosages >20 mg/kg once daily not studied.1

Adults Phenylketonuria Oral

Initially, 10 mg/kg once daily.1 2 6 8 If blood phenylalanine concentrations do not decrease from baseline after 1 month of treatment, increase dose to 20 mg/kg once daily.1 6 If blood phenylalanine concentrations do not decrease after 1 month of treatment at 20 mg/kg once daily, consider the patient a nonresponder and discontinue therapy.1 6

For responders, adjust dose within the range of 5–20 mg/kg once daily based on blood phenylalanine concentrations.1

Dosages >20 mg/kg once daily have not been studied.1

Prescribing Limits Pediatric Patients Phenylketonuria Oral

Safety and efficacy of dosages >20 mg/kg daily not established.1

Adults Phenylketonuria Oral

Safety and efficacy of dosages >20 mg/kg daily not established.1

Special Populations

No special population dosage recommendations at this time.1

Cautions for Sapropterin Dihydrochloride Contraindications

Known severe hypersensitivity to sapropterin or any ingredient in the formulation.1

Warnings/Precautions Sensitivity Reactions

Consider risks and benefits of continued treatment if mild to moderate allergic reactions (e.g., rash) occur.1 However, severe allergic reactions not reported in clinical trials.1

Patient Evaluation and Monitoring

Treatment should be directed by clinicians knowledgeable in the management of patients with PKU.1

Carefully monitor blood phenylalanine concentrations during therapy.1 All patients should follow a phenylalanine-restricted diet; use of sapropterin does not eliminate the need for ongoing dietary management.1

Prolonged elevations of phenylalanine can lead to severe cognitive, behavioral, and other neurologic complications (e.g., severe mental retardation, microcephaly, delayed speech, seizures).1 6 Long-term data not available on neurocognitive outcomes in patients receiving sapropterin.1

Prolonged blood concentrations of phenylalanine that are too low have been associated with catabolism and protein breakdown.1

Response to Treatment

Approximately 20–56% of patients with PKU respond to sapropterin.1 4 A therapeutic trial of the drug with close monitoring of blood phenylalanine concentrations is needed to identify responders.1 4 5 6 Response cannot be predicted based on laboratory testing (e.g., genetic testing).1 5 Discontinue treatment in patients who do not respond.1 8 (See Dosage under Dosage and Administration.)

Interactions

Concomitant use with certain drugs requires caution (e.g., methotrexate, PDE-5 inhibitors, levodopa).1 (See Specific Drugs under Interactions.)

Specific Populations Pregnancy

Category C.1 Pregnant women are encouraged to enroll in manufacturer’s sapropterin pregnancy registry (The Maternal Phenylketonuria Observational Program [PKU MOMS Subregistry]), which monitors pregnant women and fetal outcomes of pregnant women exposed to sapropterin.1 7

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not evaluated in children <4 years of age in clinical studies.1 Blood phenylalanine concentrations should be frequently monitored to ensure adequate control.1

Geriatric Use

Insufficient experience in patients ?65 years of age to determine whether they respond differently from younger patients.1

Hepatic Impairment

Not studied in patients with hepatic impairment.1 8 Hepatic damage has been associated with impaired phenylalanine metabolism; careful monitoring is recommended.1 8

Renal Impairment

Not studied in patients with renal impairment; monitor carefully.1 8

Common Adverse Effects

Headache, diarrhea, abdominal pain, upper respiratory tract infection, pharyngolaryngeal pain, nausea, vomiting, rhinorrhea, nasal congestion, cough, pyrexia, contusion, rash, mild to moderate neutropenia.1 2

Interactions for Sapropterin Dihydrochloride Inhibitors of Folate Metabolism

Possible decreased tetrahydrobiopterin (BH4) concentrations with drugs that affect folate metabolism and their derivatives.1 Use with caution.1

Drugs Affecting Nitric Oxide-Mediated Vascular Relaxation

Possible additive vascular relaxation and reduction in BP.1 Use with caution.1

Specific Drugs

Drug

Interaction

Comments

Levodopa

Seizures, exacerbation of seizures, overstimulation, or irritability reported rarely in patients with neurologic disorders1

Use concomitantly with caution1

Methotrexate

Possible decreased BH4 concentrations due to inhibition of dihydropteridine reductase1

Use concomitantly with caution1

Phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil)

Possible hypotensive effect and additive vasorelaxation1

Use concomitantly with caution1

Sapropterin Dihydrochloride Pharmacokinetics Absorption Onset

Phenylalanine concentrations decrease within 24 hours following a single dose; maximal reductions occur within 1 month with daily administration.1

Duration

Phenylalanine concentrations remain stable over a 24-hour period following a single daily dose.1

Food

Absorption comparable when tablets are dissolved in water or orange juice under fasted conditions.1 Phenylalanine concentrations do not substantially increase with food intake following a single dose.1

High-fat/high-calorie meal may increase absorption of sapropterin.1

Distribution Extent

Distributed into milk in rats; not known whether distributed into human milk.1

Elimination Half-life

Approximately 6.7 hours.1

Special Populations

Pharmacokinetics unaffected by age within the range of 9–49 years of age; not studied outside this range.1

Hepatic damage may impair phenylalanine metabolism.1

Stability Storage Oral Tablets

Tight containers at 20–25°C (may be exposed to 15–30°C).1 Protect from moisture.1

ActionsActions

Cofactor for phenylalanine hydroxylase (PAH), the enzyme that hydroxylates phenylalanine through an oxidative reaction to form tyrosine.1 4 5

Enhances activity of residual PAH in patients with PKU, which improves the normal oxidative metabolism of phenylalanine and thus decreases blood phenylalanine concentrations in some patients with PKU.1 4 5

Advice to Patients

Importance of providing patient or caregivers a copy of manufacturer’s patient information.1

Importance of informing patients that not all patients with PKU will respond to therapy with sapropterin.1 2 6

Importance of patients following a phenylalanine-restricted diet.1 2

Importance of monitoring blood phenylalanine concentrations.1 2

If a dose is missed, the missed dose should be taken as soon as possible.1 2 Two doses should not be taken on the same day.1 2

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant medical conditions .1 2

Importance of informing clinicians of concomitant medical conditions.1 2

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Sapropterin Dihydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, dispersible

100 mg

Kuvan

BioMarin

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. BioMarin Pharmaceutical Inc. Kuvan (sapropterin dihydrochloride) tablets prescribing information. Novato, CA; 2007 Dec.

2. BioMarin Pharmaceutical Inc. Kuvan (sapropterin dihydrochloride) tablets patient information. Novato, CA; 2007 Dec.

3. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2008 May 16. From FDA website. Accessed 2008 Jul 22.

4. Burton BK, Grange DK, Milanowski A, et al. The response of patients with phenylketonuria and elevated serum phenylalanine to treatment with oral sapropterin dihydrochloride (6R-tetrahydrobiopterin): a phase II, multicentre, open-label, screening study. J Inherit Metab Dis. 2007; 30:700-7. [PubMed 17846916]

5. Levy HL, Milanowski A, Chakrapani A, et al. Efficacy of sapropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study. Lancet. 2007; 370:504-10. [PubMed 17693179]

6. Anon. Sapropterin (Kuvan) for phenylketonuria. Med Lett Drugs Ther. 2008; 50:43-4. [PubMed 18509266]

7. BioMarin Pharmaceutical Inc. The Phenylketonuria Demographics, Outcomes, and Safety (PKUDOS) registry: information for patients. From Kuvan website. Accessed 2008 Oct 9.

8. BioMarin, Novato, CA: Personal communication.

More Sapropterin Dihydrochloride resources Sapropterin Dihydrochloride Side Effects (in more detail) Sapropterin Dihydrochloride Use in Pregnancy & Breastfeeding Sapropterin Dihydrochloride Drug Interactions Sapropterin Dihydrochloride Support Group 0 Reviews for Sapropterin Dihydrochloride - Add your own review/rating Compare Sapropterin Dihydrochloride with other medications Phenylketonuria
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Nystan Oral Suspension (Ready -Mixed )


1. Name Of The Medicinal Product

NYSTAN ORAL SUSPENSION (READY-MIXED)

2. Qualitative And Quantitative Composition

Ready mixed oral suspension containing 100,000 units nystatin per ml.

3. Pharmaceutical Form

Oral suspension

4. Clinical Particulars 4.1 Therapeutic Indications

The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. The suspension provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.

4.2 Posology And Method Of Administration

Adults:

For the treatment of denture sores, and oral infections in adults caused by C.albicans, 1ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible.

Children:

In intestinal and oral candidosis (thrush) in infants and children, 1ml should be dropped into the mouth four times a day. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.

For prophylaxis in the newborn the suggested dose is 1ml once daily.

Elderly:

No specific dosage recommendations or precautions.

4.3 Contraindications

Contra-indicated in patients with a history of hypersensitivity to any of the components.

4.4 Special Warnings And Precautions For Use

Nystan Oral Suspension contains sugar.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Nystan oral preparations should not be used for treatment of systemic mycoses.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Animal reproductive studies have not been conducted with nystatin.

It is not known whether nystatin can cause foetal harm when administered to a pregnant women, however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved.

Nursing Mothers:

Though gastro-intestinal absorption is insignificant, it is not known whether nystatin is excreted in human breast milk and caution should be exercised when nystatin is prescribed for nursing women.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nystatin is generally well tolerated by all age groups, even during prolonged use. Rarely hypersensitivity,oral irritation or sensitisation may occur. Nausea has been reported occasionally during therapy.

Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, and face oedema has been reported rarely. Steven-Johnson Syndrome has been reported very rarely.

4.9 Overdose

Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

5.2 Pharmacokinetic Properties

Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations.

5.3 Preclinical Safety Data

No further relevant information.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ethanol, flavours, glycerin, methyl parahydroxybenzoate, pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate, sodium carboxymethylcellulose, sodium phosphate, sucrose, water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

30ml amber glass bottle, packed in a cardboard carton with a graduated, polyethylene dropper.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

7. Marketing Authorisation Holder

E. R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

PL 0034/0130R

9. Date Of First Authorisation/Renewal Of The Authorisation

08/02/2010

10. Date Of Revision Of The Text

08/02/2010


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Melioidosis Medications


Definition of Melioidosis: A disease of humans and animals that resembles glanders. It is caused by burkholderia pseudomallei and may range from a dormant infection to a condition that causes multiple abscesses, pneumonia, and bacteraemia.

Drugs associated with Melioidosis

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


Drug List: Amoclan-Suspension Augmentin Augmentin-Es-600-Suspension Augmentin-Xr-Extended-Release-Tablets Bactrim Bactrim-Ds Ceptaz Co-Trimoxazole Cotrim Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Fortaz Monodox Ocudox-Convenience-Kit Oraxyl Septra Septra-Ds Smz-Tmp-Ds Sulfatrim-Suspension Sulfatrim-Pediatric Tazicef Vibra-Tabs Vibramycin
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Penbritin 250 mg Capsules


1. Name Of The Medicinal Product

Penbritin 250mg Capsules

2. Qualitative And Quantitative Composition

(Ampicillin Capsules): 250mg ampicillin as Ampicillin Trihydrate

3. Pharmaceutical Form

Black and red capsules overprinted Penbritin 250

4. Clinical Particulars 4.1 Therapeutic Indications

Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.

Parenteral usage is indicated where oral dosage is inappropriate.

4.2 Posology And Method Of Administration

Usual adult dosage (including elderly patients):

   

Ear, nose and throat infections:

250mg four times a day.

 

Bronchitis:

Routine therapy:

250mg four times a day.

High-dosage therapy:

1 g four times a day.

 

Pneumonia:

500 mg four times a day.

 

Urinary tract infections:

500 mg three times a day.

 

Gonorrhoea:

2 g orally with 1 g probenecid as a single dose.

 

Repeated doses are recommended for the treatment of females.

   

Gastro-intestinal infections:

500-750 mg three to four times daily.

 

Enteric:

Acute:

1-2 g four times a day for two weeks.

Carriers:

1-2 g four times a day for four to twelve weeks

 

Usual children's dosage (under 10 years):

   

Half adult routine dosage.

   

All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals.

Renal Impairment

In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.

4.3 Contraindications

Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.

4.4 Special Warnings And Precautions For Use

Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.

Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Dosage should be adjusted in patients with renal impairment (see section 4.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.

In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.

Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.

It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

Pregnancy:

Animal studies with Ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Ampicillin may be considered appropriate.

Lactation:

During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of Ampicillin during lactation are not available.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

Hypersensitivity reactions:

If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely.

Renal effects:

Interstitial nephritis can occur rarely.

Gastrointestinal reactions:

Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.

Hepatic effects:

As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.

Haematological effects:

As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Ampicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.

5.2 Pharmacokinetic Properties

Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.

5.3 Preclinical Safety Data

No further information of relevance to add.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Magnesium stearate, gelatin, black and red iron oxides (E172), titanium dioxide (E171) and erythrosine (E127).

6.2 Incompatibilities

None.

6.3 Shelf Life

Blister packs:

five years

Others:

three years

6.4 Special Precautions For Storage

Containers: Do not store above 25°C. Keep the container tightly closed.

Blisters: Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Aluminium canister

Glass bottle fitted with a screw cap

Polypropylene tube with a polyethylene closure

Aluminium foil pack - 4, 16, 50, 100, 500

Aluminium/PVC tray foil blister pack - 28

Aluminium/PVC/PVdC blister pack - 28

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Chemidex Pharma Ltd

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

United Kingdom

8. Marketing Authorisation Number(S)

PL 17736/0071

9. Date Of First Authorisation/Renewal Of The Authorisation

4th March 2005

10. Date Of Revision Of The Text

26/09/2007


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Brolene Eye Drops


1. Name Of The Medicinal Product

Brolene Eye Drops.

2. Qualitative And Quantitative Composition

Propamidine isetionate 0.1% w/v.

3. Pharmaceutical Form

Eye drops.

4. Clinical Particulars 4.1 Therapeutic Indications

Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.

4.2 Posology And Method Of Administration

One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.3 Contraindications

Hypersensitivity to propamidine or any other component of the preparation.

4.4 Special Warnings And Precautions For Use

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days' therapy, discontinue use and consult a physician.

The eye drops are unsuitable for use with hard or soft contact lenses.

The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable Effects

Hypersensitivity may occur.

Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.

4.9 Overdose

Topical overdosage not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Propamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of organisms. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli, the activity of the diamidines being retained in the presence of organic matter such as tissue fluids, pus and serum.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

Once opened the drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, 7 days after first opening.

6.4 Special Precautions For Storage

Store below 25oC.

6.5 Nature And Contents Of Container

10 ml plastic dropper bottle and tamper-proof cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

PL 04425/0197

9. Date Of First Authorisation/Renewal Of The Authorisation

07 November 2002

10. Date Of Revision Of The Text

12 April 2010

LEGAL CLASSIFICATION

P


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Naftidrofuryl Capsules 100mg


1. Name Of The Medicinal Product

NAFTIDROFURYL CAPSULES BP 100mg

2. Qualitative And Quantitative Composition

Each hard gelatin capsule contains 100mg Naftidrofuryl oxalate PhEur.

3. Pharmaceutical Form

Pink hard gelatin capsules.

Pink hard gelatin capsules (size 2) printed “C” and “NL” in black.

4. Clinical Particulars 4.1 Therapeutic Indications

1) Peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's syndrome, diabetic arteriopathy and acrocyanosis).

2) Cerebral vascular disorders (cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly).

4.2 Posology And Method Of Administration

Posology

The capsules should be administered with a sufficient amount of water (one glass) during or after food.

Adults and the elderly:

Peripheral vasular disorders: One or two 100mg capsules three times daily for a minimum of three months, or at the discretion of the physician.

In patients with renal impairment a dose adjustment may be considered.

Cerebral vasular disorders: One 100mg capsule three times daily for a minimum of three months, or at the discretion of the physician.

Method of Administration

For oral use (swallowing).

4.3 Contraindications

Known hypersensitivity to naftidrofuryl oxalate or other ingredients in the capsule.

Patients with a history of hyperoxaluria or recurrent calcium-containing stones.

Contains soya lecithin. Purified soya oil may contain peanut protein. Therefore, Naftidrofuryl capsules are contraindicated in patients who are allergic to peanut of soya.

4.4 Special Warnings And Precautions For Use

Should be used with caution in patients with renal or hepatic disorders as the drug is metabolised in the liver and excreted mainly in the urine.

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no, or inadequate evidence of safety of naftidrofuryl oxalate in human pregnancy, but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, the benefits should be weighed against the potential risks.

There is no information available on the secretion of this drug in breast milk, and its use is therefore best avoided.

4.7 Effects On Ability To Drive And Use Machines

As Naftidrofuryl can cause dizziness patient should make sure they are not affected before driving or operating machinery.

4.8 Undesirable Effects

Naftidrofuryl is normally well tolerated in the dosage recommended. Occasionally nausea, epigastric pain, diarrhoea and rashes have been noted. Rarely has hepatitis and hepatic failure been reported.

Central Nervous System symptoms of dizziness, headache, agitation and sleep disorders have been reported.

Very rarely the presence of calcium oxalate kidney stones has been reported.

4.9 Overdose

Depression of cardiac conduction and convulsions may occur. The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed with diazepam.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code: C04A X 21

Naftidrofuryl oxalate is a powerful vasodilator agent with an antagonist effect on 5-HT2 receptors of the smooth muscle cells. The vasodilator effect, which occurs in both the cerebral and peripheral circulation, is probably the main action. However, the drug has also been shown to activate intracellular aerobic metabolism as demonstrated by a reduction in the level of lactic acid level and an increased level of ATP. It is claimed that this action protects cells against the metabolic effects of ischaemia.

5.2 Pharmacokinetic Properties

Peak plasma levels are attained at 0.5-0.75 hours after oral dose. Some 24% of the drug (range 17-32%) is absorbed from the gastrointestinal tract. There is some pre-systemic metabolism. The plasma half life is approximately 1 hour (range 0.8-1.6 hours). The drug penetrates brain and other tissues. It is, however, 80% bound to albumin. Cumulation does not occur at a dose level of 200mg three times daily.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

The capsule contains: maize starch, microcrystalline cellulose (E460), sodium starch glycollate, colloidal silica, stearic acid, magnesium stearate, water.

The capsule shell contains: erythrosine (E127), titanium dioxide (E171), water, gelatin.

The printing ink contains: IMS 74OP, shellac (E904), iron oxide black (E172), N-Butyl alcohol, soya lecithin MC thin (E322), antifoam DC 1510, water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Two 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 containers with snap-on polyethylene lids.

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/PVdC. (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

Al/PVC/PVDC: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s

PP Tablet Container: 100s, 250s, 500s, 1000s

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 0142/0429.

9. Date Of First Authorisation/Renewal Of The Authorisation

22.12.98

10. Date Of Revision Of The Text

09/09/2010


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Corsodyl 0.2% Mouthwash


1. Name Of The Medicinal Product

Corsodyl 0.2% Mouthwash

2. Qualitative And Quantitative Composition

Chlorhexidine Digluconate 0.2% w/v

(equivalent to Chlorhexidine Digluconate Solution 1.028% w/w)

Also contains macrogolglycerol hydroxystearate. For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oromucosal solution

A clear to slightly opalescent, transparent solution with an odour of peppermint.

4. Clinical Particulars 4.1 Therapeutic Indications

For inhibition of the formation of dental plaque.

As an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery, in mentally or physically handicapped patients).

Also for use in a post-peridontal surgery or treatment* regimen to promote gingival healing.

*NB: Use as part of a post-periodontal treatment regimen has only been adequately studied over the short term and following standard root surface instrumentation.

It is useful in the management of aphthous ulceration and oral candidal infections (eg denture stomatitis and thrush).

4.2 Posology And Method Of Administration

Adults:

Thoroughly rinse the mouth for about one minute with 10 ml twice daily. In the dental surgery the patient should be instructed to rinse the mouth for one minute prior to treatment.

Corsodyl 0.2% Mouthwash is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Corsodyl 0.2% Mouthwash (rinsing the mouth between applications) or at a different time of day.

For the treatment of gingivitis a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections treatment should be continued for 48 hours after clinical resolution. For the treatment of dental stomatitis the dentures should be cleansed and soaked in Corsodyl 0.2% Mouthwash for fifteen minutes twice daily.

Children and the Elderly:

The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician.

Children under 12 years of age should not use the product unless recommended by a healthcare professional.

Route of administration

Oromucosal use. [This product is not intended to be swallowed].

4.3 Contraindications

Corsodyl 0.2% Mouthwash is contraindicated for patients who have previously shown a hypersensitivity reaction to Chlorhexidine or to any of the excipients in the formulation. However, such reactions are extremely rare.

4.4 Special Warnings And Precautions For Use

For oromucosal use only. Do not swallow. Keep out of the eyes and ears.

If the mouthwash comes into contact with the eyes, wash out promptly and thoroughly with water.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional.

Macrogolglygerol hydroxystearate may cause skin reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects on the foetus arising from the use of chlorhexidine digluconate during pregnancy or on infants during lactation. Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

None have been reported or are known.

4.8 Undesirable Effects

Discoloration: A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily before using the mouthwash, or, in the case of dentures, cleaning with a conventional denture cleaner. However, in certain cases a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement. Similarly where normal toothbrushing is not possible, for example with intermaxillary fixation, or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying condition has been resolved.

Taste: Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continued use.

Oral desquamation: In cases where oral desquamation occurs dilution of the mouthwash with an equal volume of tap water, freshly mixed, will often allow continued use of the mouthwash.

Parotid gland swelling: Very occasionally, swelling of the parotid glands during the use of chlorhexidine mouthrinses has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.

Irritative skin reactions: Irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions: allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

4.9 Overdose

This has not been reported.

Accidental ingestion: Chlorhexidine taken orally is poorly absorbed. Systemic effects are unlikely even if large volumes are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: anti-infectives and antiseptics for local oral treatment

ATC code: A01AB03

Corsodyl 0.2% Mouthwash contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common dental conditions.

5.2 Pharmacokinetic Properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol

Macrogolglycerol Hydroxystearate

Sorbitol liquid (non-crystallising)

Peppermint flavour

Purified water.

6.2 Incompatibilities

Hypochlorite bleaches may cause brown stains to develop in fabrics that have previously been in contact with preparations containing chlorhexidine.

6.3 Shelf Life

30 months.

Shelf-life after opening: 3 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Oriented amber polyethylene terephthalate bottle with plastic screw cap made from white food grade polypropylene.

Each bottle contains 300 ml or 600 ml.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as:

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0608

9. Date Of First Authorisation/Renewal Of The Authorisation

26/04/2007

10. Date Of Revision Of The Text

10/03/2010


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voriconazole


Generic Name: voriconazole (vor i KON a zole)
Brand Names: VFEND

What is voriconazole?

Voriconazole is an antifungal medication.

Voriconazole is used to treat infections caused by yeast or other types of fungus.

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

What is the most important information I should know about voriconazole? Do not use voriconazole if you are pregnant. It could harm the unborn baby.

There are many other medicines that can cause serious or life-threatening drug interactions with voriconazole. Tell your doctor about all the prescription and over-the-counter medications you use.

Before taking voriconazole, tell your doctor if you have heart rhythm problems, an electrolyte imbalance, liver or kidney disease, or a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Voriconazole will not treat a viral infection such as the common cold or flu.

Voriconazole can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

What should I discuss with my healthcare provider before taking voriconazole? You should not take this medication if you are allergic to voriconazole, or if you are taking any of the following drugs:

carbamazepine (Carbatrol, Equetro, Tegretol);

cisapride (Propulsid);

pimozide (Orap);

quinidine (Quin-G);

sirolimus (Rapamune);

mephobarbital (Mebaral) or phenobarbital (Solfoton);

ritonavir (Norvir, Kaletra) in high doses;

rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);

St. John's wort; or

an ergot medicine such as ergotamine (Ergomar, Cafergot, Ercaf, Wigraine, others) or dihydroergotamine (D.H.E., Migranal).

The drugs listed above can cause dangerous serious or life-threatening drug interactions with voriconazole. Tell your doctor about all other medicines you are using.

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

heart rhythm problems;

a metabolic disorder such as high or low levels of calcium, potassium, or magnesium;

liver disease; kidney disease; or

a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

Voriconazole tablets contain lactose. Before taking a voriconazole tablet, tell your doctor if you have a hereditary form of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

FDA pregnancy category D. Do not use voriconazole if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known if voriconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take voriconazole?

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.

Take voriconazole at least one hour before or after eating a meal. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Do not mix the oral suspension with any other medicine or liquid. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Voriconazole will not treat a viral infection such as the common cold or flu.

To be sure voriconazole is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Voriconazole can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

Store voriconazole tablets at room temperature away from moisture and heat. Store the oral liquid at room temperature for up to 14 days. Throw away any unused liquid after 14 days. 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 vision problems, excessive mouth watering, enlarged pupils, weakness, loss of balance, shortness of breath, or seizure (convulsions).

What should I avoid while taking voriconazole? Voriconazole may cause changes in vision including blurred vision and sensitivity to light. Wear sunglasses during the day to protect your eyes from bright light. Be careful if you drive or do anything that requires you to have clear vision. Avoid exposure to sunlight or tanning beds. Voriconazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Voriconazole 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 any of these serious side effects:

sudden behavior changes, problems with thinking or speech;

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

urinating less than usual or not at all;

bone pain, swelling;

uneven heart rate, chest pain, general ill feeling; 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:

vision problems such as blurred vision, eyes being more sensitive to light;

fever;

mild nausea, vomiting, or diarrhea;

headache; or

swelling in your hands, ankles, or feet.

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.

Voriconazole Dosing Information

Usual Adult Dose for Aspergillosis -- Invasive:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Candidemia:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Fungal Pneumonia:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Pseudoallescheriosis:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Ocular Fungal Infection:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Systemic Fungal Infection:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Cutaneous Fungal Infection:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Fungal Infection -- Disseminated:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Fungal Meningitis:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Fusariosis:

Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Treatment must be started with the IV loading dose on Day 1 followed by the maintenance dose. IV therapy should continue for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Invasive aspergillosis: In a clinical trial, the median duration of IV therapy was 10 days (range 2 to 90 days) and of oral therapy was 76 days (range 2 to 232 days).
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Esophageal Candidiasis:

Less than 40 kg: 100 mg orally twice daily
40 kg or more: 200 mg orally twice daily
Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Usual Adult Dose for Blastomycosis:

(Not approved by FDA)
Case report (n=1) - Cerebral blastomycosis
200 mg orally twice a day, then dose was increased to 300 mg orally twice a day after 4 weeks in an attempt to achieve a higher CNS concentration
Therapy was continued for a 12-month course.

Usual Adult Dose for Coccidioidomycosis -- Meningitis:

(Not approved by FDA)
Case report (n=1) - Coccidioides posadasii
400 mg orally twice a day for 2.5 years; thereafter, 200 mg orally twice a day and lifelong therapy is planned

Usual Adult Dose for Eumycetoma:

(Not approved by FDA)
Case report (n=1)
200 mg orally twice a day for 3 months, followed by 300 mg orally twice a day for 13 months

Usual Pediatric Dose for Aspergillosis -- Invasive:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Candidemia:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Fungal Pneumonia:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Pseudoallescheriosis:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Ocular Fungal Infection:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Systemic Fungal Infection:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Cutaneous Fungal Infection:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Fungal Infection -- Disseminated:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Fungal Meningitis:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Fusariosis:

2 to 11 years:
IDSA guidelines for invasive aspergillosis: 5 to 7 mg/kg IV every 12 hours
12 years or older:
Loading dose: 6 mg/kg IV every 12 hours for 2 doses
Maintenance dose:
IV:
Invasive aspergillosis and serious fungal infections due to Fusarium species and Scedosporium apiospermum: 4 mg/kg IV every 12 hours
Once the patient can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized.
Candidemia in nonneutropenic patients and other deep tissue Candida infections: 3 to 4 mg/kg IV every 12 hours
During clinical trials, patients with candidemia received 3 mg/kg IV every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the nature and severity of the infection.
Oral:
Less than 40 kg: 100 mg orally every 12 hours
40 kg or more: 200 mg orally every 12 hours
Duration:
Candidemia in nonneutropenic patients and other deep tissue Candida infections: Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
Case (n=1) - Fusariosis
Greater than 16 years: 6 mg/kg orally twice a day for 8 weeks
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Pediatric Dose for Esophageal Candidiasis:

12 years or older:
Less than 40 kg: 100 mg orally twice daily
40 kg or more: 200 mg orally twice daily
Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

What other drugs will affect voriconazole?

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

clopidogrel (Plavix);

cyclosporine (Sandimmune, Neoral);

phenytoin (Dilantin);

prednisolone (Orapred, Pediapred, Predalone, Veripred, and others);

tacrolimus (Prograf);

warfarin (Coumadin, Jantoven);

birth control pills;

medication to treat HIV or AIDS, especially efavirenz (Atripla, Sustiva);

alfentanil (Alfenta) or fentanyl (Abstral, Actiq, Fentora, Duragesic, Lazanda, Onsolis);

omeprazole (Prilosec) and other stomach acid reducers;

cancer medicine such as vinblastine (Velban), vincristine (Oncovin), or vinorelbine (Navelbine);

methadone (Diskets, Methadose, Dolophine) or oxycodone (OxyContin, Combunox, Roxicodone, Percocet);

non-steroidal anti-inflammatory drugs (NSAIDs) 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;

tranquilizers or sedatives such as alprazolam (Xanax), midazolam (Versed), triazolam (Halcion), and others;

cholesterol-lowering medicines such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor, Simcor, Vytorin);

heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), and others; or

an oral diabetes medicine such as glipizide (Glucotrol, Metaglip), glyburide (DiaBeta, Micronase, Glucovance), or tolbutamide (Orinase).

This list is not complete and there are many other drugs that can interact with voriconazole. 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 voriconazole resources Voriconazole Side Effects (in more detail) Voriconazole Use in Pregnancy & Breastfeeding Drug Images Voriconazole Drug Interactions Voriconazole Support Group 1 Review for Voriconazole - Add your own review/rating voriconazole Advanced Consumer (Micromedex) - Includes Dosage Information Voriconazole Professional Patient Advice (Wolters Kluwer) Voriconazole Prescribing Information (FDA) Voriconazole MedFacts Consumer Leaflet (Wolters Kluwer) Voriconazole Monograph (AHFS DI) Vfend Advanced Consumer (Micromedex) - Includes Dosage Information Vfend Prescribing Information (FDA) Vfend Consumer Overview Compare voriconazole with other medications Aspergillosis, Invasive Blastomycosis Candida Infections, Systemic Coccidioidomycosis, Meningitis Cutaneous Fungal Infection Esophageal Candidiasis Eumycetoma Fungal Infection, Internal and Disseminated Fungal Meningitis Fungal Pneumonia Fusariosis Ocular Fungal Infection Pseudoallescheriosis Systemic Fungal Infection Where can I get more information? Your pharmacist can provide more information about voriconazole.

See also: voriconazole side effects (in more detail)


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Tambocor 50mg Tablets


1. Name Of The Medicinal Product

Tambocor™ 50mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains flecainide acetate 50mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below:

The effect on the JT interval is insignificant at therapeutic levels.

4.1 Therapeutic Indications

Tambocor tablets are indicated for:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.

b) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see 4.4, Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily.

c) Symptomatic sustained ventricular tachycardia.

d) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated.

Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means.

Tambocor tablets are for oral administration.

4.2 Posology And Method Of Administration

Adults: Supraventricular arrhythmias: The recommended starting dosage is 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily.

Ventricular arrhythmias: The recommended starting dosage is 100mg twice daily. The maximum daily dose is 400mg and this is normally reserved for patients of large build or where rapid control of the arrhythmia is required.

After 3-5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the arrhythmia. It may be possible to reduce dosage during long-term treatment.

Children: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group.

Elderly Patients: The rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments.

Plasma levels: Based on PVC suppression, it appears that plasma levels of 200-1000 ng/ml may be needed to obtain the maximum therapeutic effect. Plasma levels above 700-1000 ng/ml are associated with increased likelihood of adverse experiences.

Dosage in impaired renal function: In patients with significant renal impairment (creatinine clearance of 35ml/min/1.73 sq.m. or less) the maximum initial dosage should be 100mg daily (or 50mg twice daily).

When used in such patients, frequent plasma level monitoring is strongly recommended.

It is recommended that intravenous treatment with Tambocor should be administered in hospitals.

Treatment with oral Tambocor should be under direct hospital or specialist supervision for patients with:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways

b) Paroxysmal atrial fibrillation in patients with disabling symptoms.

Treatment for patients with other indications should continue to be initiated in hospital.

4.3 Contraindications

Tambocor is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.

It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease.

Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.

4.4 Special Warnings And Precautions For Use

Electrolyte disturbances should be corrected before using Tambocor.

Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks. Plasma level monitoring is strongly recommended in these circumstances.

Tambocor is known to increase endocardial pacing thresholds - ie to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic. Tambocor should thus be used with caution in all patients with permanent pacemakers or temporary pacing electrodes, and should not be administered to patients with existing poor thresholds or non-programmable pacemakers unless suitable pacing rescue is available.

Generally, a doubling of either pulse width or voltage is sufficient to regain capture, but it may be difficult to obtain ventricular thresholds less than 1 Volt at initial implantation in the presence of Tambocor.

The minor negative inotropic effect of flecainide may assume importance in patients predisposed to cardiac failure. Difficulty has been experienced in defibrillating some patients. Most of the cases reported had pre-existing heart disease with cardiac enlargement, a history of myocardial infarction, arterio-sclerotic heart disease and cardiac failure.

Tambocor should be avoided in patients with structural organic heart disease or abnormal left ventricular function.

Tambocor should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.

In a large scale, placebo-controlled clinical trial in post-myocardial infarction patients with asymptomatic ventricular arrhythmia, oral flecainide was associated with a 2.2 fold higher incidence of mortality or non-fatal cardiac arrest as compared with its matching placebo. In that same study, an even higher incidence of mortality was observed in flecainide-treated patients with more than one myocardial infarction. Comparable placebo-controlled clinical trials have not been done to determine if flecainide is associated with higher risk of mortality in other patient groups.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may intereact with flecainide:

Cardiac glycosides; Flecainide can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.

Class II anti-arrhythmics; the possibility of additive negative inotropic effects of beta-blockers, and other cardiac depressants such as verapamil, with flecainide should be recognised.

Class III anti-arrhythmics; when flecainide is given in the presence of amiodarone, the usual flecainide dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances

Class IV anti-arrhythmics; use of flecainide with other sodium channel blockers is not recommended.

Anti-depressants; fluoxetine increases plasma flecainide concentration; increased risk of arrhythmias with tricyclics; manufacturer of reboxetine advises caution.

Anti-epileptics; limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.

Anti-psychotics: clozapine– increased risk of arrhythmias

Anti-histamines; increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use)

Anti-malarials: quinine increases plasma concentration of flecainide.

Antivirals: plasma concentration increased by ritonavir, lopinavar and indinavir (increased risk of ventricular arrhythmias (avoid concomitant use)

Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.

Ulcer healing drugs: cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for one week, plasma flecainide levels increased by about 30% and the half-life increased by about 10%.

Anti-smoking aids: Co-administration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including flecainide, should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide, the need to decrease the dose of the original medication should be considered.

Treatment with Tambocor is compatible with use of oral anti-coagulants.

4.6 Pregnancy And Lactation

There is no evidence as to drug safety in human pregnancy. In New Zealand White rabbits high doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats. The relevance of these findings to humans has not been established. Data have shown that flecainide crosses the placenta to the foetus in patients taking flecainide during pregnancy.

Flecainide is excreted in human milk and appears in concentrations which reflect those in maternal blood. The risk of adverse effects to the nursing infant is very small.

4.7 Effects On Ability To Drive And Use Machines

No effect.

4.8 Undesirable Effects

Body as a Whole: Asthenia, fatigue, fever,oedema.

Cardiovascular: Pro-arrhythmic effects occur but are most likely in patients with structural heart disease and/or significant left ventricular impairment.

In patients with atrial flutter the use of Tambocor has been associated with

1:1 AV conduction following initial atrial slowing with resultant ventricular acceleration. This has been seen most commonly following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy.

The following adverse effects have also been reported.

AV block-second-degree and third degree, bradycardia, cardiac failure/congestive cardiac failure, chest pain, hypotension, myocardial infarction, palpitation, sinus pause or arrest and tachycardia (AT or VT).

Skin and Appendages: A range of allergic skin reactions have been reported including rashes, alopecia and rare but serious reports of urticaria. There have also been isolated cases of photosensitivity and rash.

Immune System: A small number of cases of increases in anti-nuclear antibodies have been reported, with and without systemic inflammatory involvement.

Haematological: Reductions in red blood cells, white blood cells and platelets have been occasionally reported. These changes are usually mild.

Psychiatric: Rarely, hallucinations, depression, confusion, amnesia, anxiety and insomnia have been reported.

Gastrointestinal: Occasionally nausea and vomiting. The following have also been reported: abdominal pain, anorexia, constipation, diarrhoea, dyspepsia and flatulence (bloating)

Liver and Bilary System: A number of cases of elevated liver enzymes and jaundice have been reported in association with Tambocor treatment. So far this has always been reversible on stopping treatment. Hepatic dysfunction has also been reported.

Neurological: Most commonly giddiness, dizziness and lightheadedness which are usually transient. Rare instances of dyskinesia have been reported, which have improved on withdrawal of flecainide therapy. Rare instances of convulsions, and during long term therapy a few cases of peripheral neuropathy, paraesthesia and ataxia have been reported.There also have been reports of flushing, headache, hypoaesthesia, increased sweating, somnolence, syncope, tinnitus, tremor and vertigo.

Ophthalmological: Visual disturbances, such as double vision and blurring of vision may occur but these are usually transient and disappear upon continuing or reducing the dosage.

Extremely rare cases of corneal deposits have also been reported.

Respiratory: Dyspnoea and rare cases of pneumonitis have been reported.

4.9 Overdose

Overdosage with flecainide is a potentially life threatening medical emergency. No specific antidote is known. There is no known way of rapidly removing flecainide from the system, but forced acid diuresis may theoretically be helpful. Neither dialysis nor haemoperfusion is helpful and injections of anticholinergics are not recommended.

Treatment may include therapy with an inotropic agent, intravenous calcium, giving circulatory assistance (eg balloon pumping), mechanically assisting respiration, or temporarily inserting a transvenous pacemaker if there are severe conduction disturbances or the patient's left ventricular function is otherwise compromised.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tambocor is a Class 1 anti-arrhythmic (local anaesthetic) agent.

Tambocor slows conduction through the heart, having its greatest effect on His Bundle conduction. It also acts selectively to increase anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be reflected in the ECG by prolongation of the PR interval and widening of the QRS complex. The effect on the JT interval is insignificant.

5.2 Pharmacokinetic Properties

Oral administration of flecainide results in extensive absorption, with bioavailability approaching 90 to 95%. Flecainide does not appear to undergo significant hepatic first-pass metabolism. In patients, 200 to 600 mg flecainide daily produced plasma concentrations within the therapeutic range of 200-1000 µg/L. Protein binding of flecainide is within the range 32 to 58%.

Recovery of unchanged flecainide in urine of healthy subjects was approximately 42% of a 200mg oral dose, whilst the two major metabolites (Meta-O-Dealkylated and Dealkylated Lactam Metabolites) accounted for a further 14% each. The elimination half-life was 12 to 27 hours.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Pregelatinised Starch, USNF

Croscarmellose Sodium, USNF

Microcrystalline Cellulose, Ph Eur

Hydrogenated Vegetable Oil, USNF

Magnesium Stearate, Ph Eur

6.2 Incompatibilities

None known

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Do not store above 30°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

UPVC/PVDC blister packs containing 60 tablets

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

United Kingdom

8. Marketing Authorisation Number(S)

PL 15142/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

22 May 1997/ 16 March 2001

10. Date Of Revision Of The Text

13th July 2010


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