Description

Nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity.

The most common adverse reactions in adults receiving combination therapy are psychiatric and central nervous system effects, severe ocular disorder, dental and periodontal disorders & growth inhibition in children and adolescents that may be irreversible in some patients. The most common adverse reactions in pediatric subjects were similar to those seen in adults.

Pregnancy Category X. Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced. Nursing Mothers: It is not known whether Ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with Ribavirin, based on the importance of the therapy to the mother.

Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment. Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests. For a male patient, it is very important for his female partner to avoid becoming pregnant during treatment and during the 7 months after treatment and do not have sex with a pregnant women.

Pediatric Use: Safety and effectiveness of Ribavirin in combination with Peginterferon has not been established in pediatric patients below the age of 3 years. Geriatric Use: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. The dose of Ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 ml/min; and the dose of Interferon should be reduced in patients with creatinine clearance less than 30 ml/min.

Hepatic viral infections (Hepatitis C)

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.