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

 
 



DRUG INTERACTIONS

Drug Interactions

Ribavirin has been shown in vitro to inhibit phosphorylation of zidovudine and stavudine which could lead to decreased antiretroviral activity. Exposure to didanosine or its active metabolite (dideoxyadenosine 5’-triphosphate) is increased when didanosine is coadministered with ribavirin, which could cause or worsen clinical toxicities (see PRECAUTIONS: Drug Interactions).

OVERDOSAGE

There is limited experience with overdosage. Acute ingestion of up to 20 grams of ribavirin 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 ribavirin. 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 ribavirin, and hemodialysis and peritoneal dialysis are not effective treatment of overdose of either agent.

OVERDOSAGE

There is limited experience with overdosage. Acute ingestion of up to 20 grams of ribavirin 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 ribavirin capsules. 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 ribavirin capsules, and hemodialysis and peritoneal dialysis are not effective for treatment of overdose of either agent.

CONTRAINDICATIONS

Pregnancy

Ribavirin capsules may cause birth defects and/or death of the exposed fetus. Ribavirin therapy is contraindicated for use in women who are pregnant or in men whose female partners are pregnant. (See WARNINGS, PRECAUTIONS: Information for Patients and Pregnancy Category X).

Ribavirin capsules 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 ribavirin/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 ribavirin capsules.

CONTRAINDICATIONS

Combination ribavirin capsules/INTRON A therapy must not be used by females who are pregnant or by males whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking combination ribavirin capsules/INTRON A therapy. Combination ribavirin capsules/INTRON A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Females of childbearing potential and males must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin capsules. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling the Ribavirin Pregnancy Registry at 1-800-593-2214. See boxed CONTRAINDICATIONS AND WARNINGS. See WARNINGS.

Ribavirin capsules in combination with INTRON A Injection is contraindicated in patients with a history of hypersensitivity to ribavirin and/or alpha interferon or any component of the capsule and/or injection.

Patients with autoimmune hepatitis must not be treated with combination ribavirin capsules/INTRON A therapy.

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