& & Ribavirin is a nucleoside analogue.
* Indications && usage:
& & – Adult use: Ribavirin capsules are indicated for the treatment of chronic hepatitis C in
& & combination with Peginterferon alfa in patients with compensated liver disease who have not been
& & previously treated with interferon alfa and at least 18 years of age.
& & – Pediatric use: Ribavirin capsules are indicated in combination with interferon alfa for the treatment
& & of chronic hepatitis C in patients 5 years of age and older with compensated liver disease
& & previously untreated with alfa interferon and in patients who have relapsed following alfa interferon
& & therapy.
& & 1- Ribavirin capsules are contraindicated in patients with a history of hypersensitivity to Ribavirin
& & or any component of the capsule.
& & 2- Patients with autoimmune hepatitis must not be treated with combination (Ribavirin/interferon alfa)
& & because these medicines can make the hepatitis worse.
& & 3- Patients with hemoglobinopathies (e.g. thalasemia major, sickle-cell anemia) should not be
& & treated with Ribavirin capsules.
* Warnings && precautions:
& & – Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and
& & should not be used alone for this indication.
& & – The primary toxicity of Ribavirin is hemolytic anemia, so because the initial drop in hemoglobin may
& & be significant, it is advised that hemoglobin or hematocrit be obtained pretreatment and at week 2
& & and week 4 of therapy.
& & – Patients with pre-existing cardiac disease should have electrocardio-grams administered before
& & treatment with Ribavirin, and should be appropriately monitored during therapy.
& & – Ribavirin therapy should be discontinued in patients with confirmed pancreatitis or pulmonary
& & infiltrates or pulmonary function impairment.
& & – Ribavirin should not be used in patients with creatinine clearance < 50 ml/min. * Pregnancy: & & – Ribavirin capsules may cause birth defects and/or death of the exposed fetus so extreme care & & must be taken to avoid pregnancy in female patients and in female partners of male patients & & receiving Ribavirin. & & – Male patients and their female partners must practice effective contraception (two reliable forms) & & during treatment with Ribavirin and for the 6-month posttherapy period. * Lactation: & & A decision should be made whether to discontinue nursing or to delay or discontinue Ribavirin. * Use under medical prescription only. * Store at a temperature not exceeding 30 degrees C. Keep in dry place away from light
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