Ribavirin-Astrapharm capsules are indicated for the treatment of chronic hepatitis C (CHC) in combination with other medications.
Composition
Active ingredient: ribavirin;
1 capsule contains ribavirin in terms of 100% substance 200 mg;
Excipients: microcrystalline cellulose, potato starch, magnesium stearate, colloidal anhydrous silicon dioxide;
Capsule shell composition: gelatin, titanium dioxide (E 171), indigo carmine blue (E 132), quinoline yellow (E 104).
Contraindication
Hypersensitivity to ribavirin or to any of the excipients. Severe heart disease, including unstable and uncontrolled forms, observed within 6 months before the start of treatment. Severe debilitating diseases. Chronic renal failure or creatinine clearance <50 ml/min and / or conditions requiring hemodialysis. Severe liver dysfunction (grade B or C according to the Child-Pugh classification) or decompensated cirrhosis. The appointment of peginterferon alfa-2b is contraindicated in patients co-infected with hepatitis C virus / HIV, with liver cirrhosis and liver dysfunction> 6 points according to the Child-Pugh classification. The presence of anamnestic or clinical data on severe psychiatric disorders, in particular severe depression, suicidal ideation or suicide attempts in children. Autoimmune hepatitis or other autoimmune diseases in history (due to the combination with peginterferon alfa-2b or interferon alfa-2b). Hemoglobinopathies (e.g. thalassemia, sickle cell anemia). Pregnancy. Treatment with Ribavirin-Astrapharm can be started only after receiving a negative pregnancy test immediately before starting treatment. Breastfeeding. Men whose wives are pregnant.
Method of application
Therapy should be carried out by a doctor who has experience in the treatment of chronic hepatitis C. Ribavirin-Astrapharm should be taken 2 times a day (morning and evening) with food. Due to the teratogenic potential of ribavirin, the capsules should not be broken.
Ribavirin should be used in combination with peginterferon alfa-2a or interferon alfa-2a. The exact dose and duration of use of the drug depends on the interferon used.
For additional information on dosage and duration of use, please refer to the prescribing information for peginterferon alfa-2a or interferon alfa-2a when ribavirin is used in combination with one of these drugs.
Application features
Pregnant women
Contraindicated.
Children
Regarding the use of the drug Ribavirin-Astrapharm in children, a benefit/risk assessment is required in each individual case.
Drivers
With caution.
Overdose
The maximum known overdose of ribavirin in clinical trials was 10 g (50 capsules of 200 mg) together with 39 million IU of interferon alfa-2b solution for injection (13 subcutaneous injections of 3 million IU). This amount was taken by a patient in a single day for suicidal purposes. The patient was observed in the emergency department for 2 days; no adverse reactions related to the overdose were observed during this time.
Due to its large volume of distribution, ribavirin is not significantly removed by hemodialysis.
Treatment: drug withdrawal, symptomatic therapy.
Side effects
Characteristic of the safety profile of ribavirin is hemolytic anemia, which occurs during the first weeks of therapy. Hemolytic anemia associated with ribavirin may lead to deterioration of cardiac function and/or worsening of existing cardiac pathology. Some patients have also experienced increases in uric acid and indirect bilirubin levels associated with hemolysis.
Interaction
Didanosine. Coadministration of ribavirin and didanosine is not recommended. In vitro exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased when didanosine and ribavirin are coadministered. Concomitant use of these drugs may result in fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia or lactic acidosis.
Azathioprine. Ribavirin, by inhibiting inosine monophosphate dehydrogenase, may affect the metabolism of azathioprine, which may lead to the accumulation of 6-methylthioinosine monophosphate, associated with myelotoxicity in patients receiving azathioprine. The simultaneous use of Ribavirin-Astrafarm and peginterferon alfa-2a with azathioprine should be avoided. In some cases, if the benefit of the simultaneous use of ribavirin and azathioprine outweighs the potential risk, careful monitoring of hematological parameters is recommended in order to detect myelotoxicity, in the development of which treatment with these drugs should be discontinued.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
