Rebetol (Ribavirin) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Didanosine

Co-administration of REBETOL Capsules or Oral Solution and didanosine is not recommended. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactactemia/lactic acidosis have been reported in clinical trials (see CLINICAL PHARMACOLOGY, Drug Interactions section).

Stavudine and Zidovudine

Ribavirin may antagonize the in vitro antiviral activity of stavudine and zidovudine against HIV. Therefore, concomitant use of ribavirin with either of these drugs should be used with caution (see CLINICAL PHARMACOLOGY, Drug Interactions section ).

OVERDOSAGE

There is limited experience with overdosage. Acute ingestion of up to 20 grams of REBETOL® Capsules, INTRON® A ingestion of up to 120 million units, and subcutaneous doses of INTRON A up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse events related to the therapeutic use of INTRON A and REBETOL. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of INTRON A that exceed dosing recommendations.

There is no specific antidote for INTRON A or REBETOL overdose, and hemodialysis and peritoneal dialysis are not effective for treatment of overdose of either agent.

CONTRAINDICATIONS

Pregnancy

REBETOL® Capsules and Oral Solution may cause birth defects and/or death of the exposed fetus. REBETOL therapy is contraindicated for use in women who are pregnant or in men whose female partners are pregnant (see WARNINGS and PRECAUTIONS, Information for Patients and Pregnancy Category X sections).

REBETOL Capsules and Oral Solution are contraindicated in patients with a history of hypersensitivity to ribavirin or any component of the capsule.

Patients with autoimmune hepatitis must not be treated with combination REBETOL/INTRON A therapy because using these medicines can make the hepatitis worse.

Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia) should not be treated with REBETOL Capsules or Oral Solution.