Ribavirin is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy.
Nucleoside Analogues; Antiviral
Ribavirin is a synthetic nucleoside which has inhibitory action against respiratory syncytial virus, influenza virus and herpes simplex virus. The mechanism of action is not clear. It may act at several sites including cellular enzymes to interfere with viral nucleic acid synthesis. The mono- and triphosphate derivatives are known to be responsible for the antiviral action of the compound.
ORAL Chronic hepatitis C: Adult: Dosing regimens depend on the product used & patient’s body wt. when used w/ peginterferon alfa-2b, recommended dose is 800 mg daily: when used w/ interferon alfa-2b, recommended dose is 1 g daily (for patients 75 kg) or 1.2 g daily (for patients >75 kg). To be given in 2 divided doses. Usual treatment duration: 48 wk (treatment-naive patients) or 24 wk (patients who have failed interferon alfa-2b monotherapy). Copegus ( ): Use in combination w/ peginterferon alfa-2a. Dosing regimens depend on hepatitis C viral genotype. For genotype 1 or 4: 1 g daily (patients <75 kg) or 1.2 g daily (patients 75 kg); for genotype 2 or 3: 800 mg daily. For coinfection w/ HIV, 800 mg daily (regardless of hepatitis C viral genotype). To be given in 2 divided doses. Usual treatment duration: 48 wk (genotype 1 or 4 or HIV coinfection) or 24 wk (genotype 2or3). Child: 3 yr: recommended dosing regimen (Rebetol (Scheririg Plough)): 15 mg/kg daily, given in 2 divided doses. Used in combination w/ interferon alfa-2b. For patients 25 kg or unable to swallow capsules, oral soln should be used. Capsules should not be used in patients <5 yr. Usual treatment duration: 48 wk (treatment-naive patients) or 24 wk (patients who have failed interferon alfa-2b monotherapy). INHALATION Respiratory syncytial viral infections: Child: Usual dose: Mist containing 190 mcg/L delivered to the patient via the SPAG-2 aerosol generator & an O2hood, face mask, or O2tent at a rate of about 12.5 L of mist/min continuously for 12-18 hr daily for 3-7 days.
This drug should not be used with following medications: Didanosine, Zidovudine, Azathioprine.
Hypersensitivity. Pregnancy & lactation. Unstable cardiac disease, haemoglobinopathies or CrCI <50 ml/min. Severe hepatic impairment or decompensated liver cirrhosis. Men whose female partners are pregnant. Children & adolescents w/ a history of, or existing psychiatric disorders. Patients w/ extensive hepatic fibrosis; renal impairment; anaemias. Monitor CBC at the start of, & regularly during treatment. Ensure contraception during treatment & for at least 6 mth after treatment cessation in women & female partners of male patients. Increased risk of fatal & nonfatal MI in patients w/anaemia.
Oral: Increased serum bilirubin & uric acid, haemolytic anaemia, reticulocytosis, anorexia, dyspepsia, nausea, irritability, dyspnoea, pharyngitis, skin rashes, pruritus & headache, abdominal cramps, fatigue, metallic taste, increased thirst, GI complaints, mood changes, insomnia. High dose may cause reduction in haemoglobin, haematocrit & RBC count. Aerosol: Deterioration in pulmonary function, bacterial pneumonia & pneumothorax, BP fall, cardiac arrest, anaemia, reticulocytosis, conjunctivitis, skin rash. Eye irritation due to deposited drug (infrequent).
Ribavirin has been assigned to pregnancy category X by the FDA. Nearly all animal studies have revealed evidence of embryolethality and teratogenicity. There are no controlled data in human pregnancies. One published case reports the uneventful use of ribavirin at 33 weeks gestation. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Female patients receiving ribavirin and the partners of male patients receiving ribavirin must avoid pregnancy, using at least two reliable forms of contraception, during treatment and for 6 months after completion of treatment. There are no data on the excretion of ribavirin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Store at temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.
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