Ribacee Capsule

Ribacee in combination with Peginterferon alfa-2a or Interferon alfa is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not be previously treated with interferon alpha. Ribacee as monotherapy is not effective and Ribacee must not be used alone.

Ribavirin is a synthetic nucleoside which has inhibitory action against respiratory syncytial virus, influenza virus and herpes simplex virus. The mechanism of action is not clear. It may act at several sites including cellular enzymes to interfere with viral nucleic acid synthesis. The mono- and triphosphate derivatives are known to be responsible for the antiviral action of the compound.

The recommended duration of treatment for patients previously untreated with Interferon/Peginterferon is 24 to 48 weeks. The daily dose of Ribavirin is 800 mg to 1200 mg administered orally in two divided doses (morning and evening). Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks.

Special dosage instructions: If severe adverse reactions or laboratory abnormalities develop during therapy with ribavirin, modification of the dosages are required until the adverse reactions abate. Because of the recognized heamolysis associated with ribavirin therapy, separate guidelines are provided for patients with a history of cardiovascular disease.

Use in renal impairment: The total daily dose of Ribavirin should be reduced for patients with creatinine clearance less than or equal to 50 ml/minute.

Use in the elderly ( 65 years of age): There is no sufficient clinical studies about the effectiveness and safety of Ribavirin in combination with interferon alfa or pegylated interferon alfa in these patients.

Use in patients under the age of 5 years: Safety and effectiveness of Ribavirin in combination with interferon alfa or pegylated interferon alfa in these patients have not been evaluated.

Ribacee should not be used with following medications: Didanosine, Zidovudine, Azathioprine.

This medicine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, women who are pregnant, men whose female partners are pregnant, patients with haemoglobinopathies ( e.g. thalassemia major or sickle cell anemia), autoimmune hepatitis or hepatic decompensation before or during treatment.

The primary adverse reaction of Ribacee is haemolytic anaemia. Patients who have received combination therapy of interferon alfa or polyglycated interferon alfa with Ribacee are: cough, anxiety, depression, dizziness, nausea, vomiting, flu-like symptoms (e.g. fever, chills, sore throat, muscle aches), headache, abdominal pain, diarrhoea, constipation, chest pain, tachycardia, dyspnoea, neutropenia, thrombocytopenia.

Pregnancy: Ribavirin must not be used by pregnant women or who are expecting child since the drug may have teratogenic effect. Male patients and their female partners of childbearing age must be counselled to use 2 forms of effective contraception during treatment with ribavirin and for 6 months after treatment has been concluded. Ribavirin should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months post therapy.

Brestfeeding: It is not known whether ribavirin is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made either to discontinue nursing or not to initiate therapy.

Ribacee used in combination therapy should be administered under the guidance of a qualified physician experienced in hepatitis C treatment. Sometimes it may lead to moderate to severe adverse reactions requiring dose reduction, temporary dose cessation or discontinuation of further therapy.

Because cardiac disease may be worsened by Ribacee induced anaemia, patients should be assessed before initiation of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, Ribacee therapy should be suspended or discontinued. It is recommended that patients who have pre-existing cardiac abnormalities have an electrocardiogram prior to initiation of Ribacee therapy.

The most common adverse reactions include kidney disease, blood disorders (e.g. sickle cell anemia, low hemoglobin), other types of hepatitis (autoimmune hepatitis), diabetes, allergy etc.

Caution should be taken in the elderly patients. Complete blood count (CBC), differential count, platelet count, electrolytes, serum creatinine, liver function tests and uric acid must be conducted in all patients prior to initiating therapy. After initiation of Ribacee therapy, haematological tests should be performed at 2 and 4 weeks and biochemical tests should be performed at 4 weeks of therapy.

Hepatic viral infections (Hepatitis C)

Store at temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.