Composition: Each caplet contains:
Ribavirin . . . . . . . . . . . . . . . . . . . . . . . . 500 mg
2 blisters of 10 caplets in a carton box.
Ribavirin is indicated for treatment of chronic hepatitis C in patients with compensated liver disease who have not been treated with interferon or who have relapsed after previous treatment with interferon alpha-2b.
Ribavirin should be used in combination with interferon alpha-2b or peginterferon alpha-2b, ribavirin monotherapy is ineffective. This combination therapy is also effective in hepatitis C virus patients with HIV coinfection.
|Dosage and administration||
Hypersensitivity to ribavirin or to any of the excipients of the medicine.
|Warnings and precautions for use||
Ribavirin should be used cautiously in patients below the age of 18 years, particularly when it is combined with interferon alpha-2b, because safety and effect have not been known.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
There is no evidence to prove ribavirin has influence on the ability to drive or use machines. However, caution should be considered since ribavirin can cause headache, fatigue, dizziness, decreased concentration.
|Interactions, incompatibilities of medicine||
Ribavirin is not inhibited and metabolized by the cytochrome P450 enzyme system. Thus, it is unlikely to interact with P450 enzyme-induced drugs or to be metabolized by this enzyme system.
|Undesirable effects (ADRs)||
Orally, undesirable effects of ribavirin occur primarily in combination with interferon alpha-2b for the treatment of chronic hepatitis C. Although this combination was well tolerated, 19% of interferon alpha-2b treatment-naive patients and 6% of treatment-experienced patients had relapse, then, the combination therapy was discontinued due to adverse effects. Toxicohemia (as hemolytic anemia) is one of the primary unwanted effects and about 10% of patients on combination therapy had heart and respiratory events due to anemia.
|Overdose and management||
Ribavirin is a synthetic nucleoside analogue structurally related to guanosine. It acts by hindering viral RNA and DNA synthesis and then inhibits protein synthesis and virus replication.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.