Ribavirin contraindications

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Ribavirin
REBETOL® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Contraindications

REBETOL combination therapy is contraindicated in:

  • women who are pregnant. REBETOL may cause fetal harm when administered to a pregnant woman. REBETOL is contraindicated in women who are or may become pregnant. If REBETOL is used during pregnancy, or if the patient becomes pregnant while taking REBETOL, the patient should be apprised of the potential hazard to her fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17.2)]
  • 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 less than 50 mL/min. [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)]
  • Coadministration of REBETOL and didanosine is contraindicated because exposure to the active metabolite of didanosine (dideoxyadenosine 5'-triphosphate) is increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving didanosine in combination with ribavirin [see Drug Interactions (7.1)].[1]

References

  1. "REBETOL (RIBAVIRIN) CAPSULE REBETOL (RIBAVIRIN) LIQUID [MERCK SHARP & DOHME CORP.]". Retrieved 6 January 2014.

Adapted from the FDA Package Insert.