Rebetol (Ribavirin) Drug Information: Overdosage and Contraindications

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May 27, 2012

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HCV is one of several viruses that cause hepatitis (inflammation of the liver).
Up to 85% of individuals who are initially (acutely) infected with HCV will fail to eliminate the virus and will become chronically infected.
HCV is spread most commonly through inadvertent exposure to infected blood. Intravenous drug abuse is the most common mode of transmission. The risk of acquiring HCV through sexual contact is low.
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In the U.S., Infection with HCV is the most common cause of chronic hepatitis and the most common reason for liver transplantation.
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OVERDOSE

There is limited experience with overdosage. Acute ingestion of up to 20 g of REBETOL (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 reactions related to the therapeutic use of INTRON A and REBETOL (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 REBETOL (ribavirin) overdose, and hemodialysis and peritoneal dialysis are not effective for treatment of overdose of these agents.

CONTRAINDICATIONS

REBETOL (ribavirin) combination therapy is contraindicated in:

women who are pregnant. REBETOL (ribavirin) may cause fetal harm when administered to a pregnant women. REBETOL (ribavirin) is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and PATIENT INFORMATION]
men whose female partners are pregnant
patients with known hypersensitivity reactions such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product
patients with autoimmune hepatitis
patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
patients with creatinine clearance < 50 mL/min. [see Use in Specific Populations and CLINICAL PHARMACOLOGY]
Coadministration of REBETOL (ribavirin) and didanosine is contraindicated as because exposure to the active metabolite of didanosine (dideoxyadenosine 5'-triphosphate) are increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin [see DRUG INTERACTIONS].