Indications:

Hepatovirin is indicated to treat chronic viral hepatitis "C" in patients who have compensated liver dieses

Dosage:

Dosage is dependant on body weight on two divided daily dose. Duration of treatment should be from 12 to 48 weeks

Drug interaction:
Didanosine
Exposure to Didanosine or its active metabolite (Di-deoxyadenosine 5'-triphosphate) is increased when Didanosine is co-administered with Ribavirin, which could cause or worsen clinical toxicities; therefore, co-administration of Hepatovirin Capsules and Didanosine is contraindicated.
Nucleoside Analogues
Hepatic decompensation (some fatal) has occurred in cirrhotic HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon alpha and Ribavirin. Adding treatment with Alpha Interferons alone or in combination with Ribavirin may increase the risk in this patient subset. Patients receiving interferon with Ribavirin and nucleoside reverse transcriptase inhibitors (NRTIs) should be closely monitored for treatment- associated toxicities, especially hepatic decompensation and anemia. Discontinuation of NRTIs should be considered as medically appropriate. Dose reduction or discontinuation of interferon, Ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh >6).
Drugs Metabolized by Cytochrome P-450
Results of in vitro studies using both human and rat liver microsomes preparations indicated little or no Cytochrome P450 enzyme-mediated metabolism of Ribavirin, with minimal potential for P450 enzyme-based drug interactions.
No pharmacokinetic interactions were noted between Intron A for Injection and Hepatovirin Capsules in a multiple-dose pharmacokinetic study.
Azathioprine
The use of Ribavirin for the treatment of chronic hepatitis C in patients receiving Azathioprine has been reported to induce severe pancytopenia and may increase the risk of Azathioprine-related myelotoxicity. Inosine mono phosphate dehydrogenase (IMDH) is required for one of the metabolic pathways of Azathioprine. Ribavirin is known to inhibit IMDH, thereby leading to accumulation of an Azathioprine metabolite, 6-methylthioinosine mono phosphate (6-MTITP), which is associated with myelotoxicity (Neutropenia, thrombocytopenia, and anemia). Patients receiving Azathioprine with Ribavirin should have complete blood counts, including platelet counts, monitored weekly for the first month, twice monthly for the second and third months of treatment, then monthly or more frequently if dosage or other therapy changes are necessary.
• Pregnancy and Lactation:
Pregnancy
Pregnancy Category X
Hepatovirin is contraindicated in women who are or may become pregnant .if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Nursing Mothers
It is not known whether the Hepatovirin product is excreted in human milk. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or to delay or discontinue Hepatovirin.
Pregnancy and lactation:
Pregnancy
Pregnancy Category X
Hepatovirin is contraindicated in women who are or may become pregnant .if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Nursing Mothers
It is not known whether the Hepatovirin product is excreted in human milk. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or to delay or discontinue Hepatovirin.

Packages:
Pack of 10 - 20 - 30 Capsules and insert.

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