Ribavirin

Indications
Oral
Chronic hepatitis C
Adult: Dosing regimens depend on the product used and patient's body wt. Rebetol (Schering-Plough): when used with peginterferon alfa-2b, recommended dose is 800 mg daily; when used with 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 (Roche): Use in combination with 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 with 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 2 or 3).
Child:
≥3 yr: recommended dosing regimen (Rebetol (Schering Plough)): 15 mg/kg daily, given in 2 divided doses. Used in combination with interferon alfa-2b. For patients ≤25 kg or unable to swallow capsules, oral solution 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).
CrCl (ml/min)Dosage Recommendation
<50Avoid usage.
Hepatic impairment:
Avoid in severe impairment.
Inhalation
Respiratory syncytial viral infections
Child: Usual dose: Mist containing 190 mcg/L delivered to the patient via the SPAG-2 aerosol generator and an oxygen hood, face mask, or oxygen tent at a rate of about 12.5 L of mist per minute continuously for 12-18 hr daily for 3-7 days.
CrCl (ml/min)Dosage Recommendation
<50Avoid usage.
Hepatic impairment: Avoid in severe impairment.

Special Populations: Reduce dose in patients with low Hb concentrations.

Reconstitution: Reconstitute by using at least 75 ml of sterile water for inj or inhalation into a vial containing 6 g of ribavirin. The final concentration should be 20 mg/ml.
Contraindications
Hypersensitivity. Pregnancy and lactation. Unstable cardiac disease, haemoglobinopathies or CrCl <50 ml/min. Severe hepatic impairment or decompensated liver cirrhosis. Men whose female partners are pregnant. Children and adolescents with a history of, or existing psychiatric disorders.
Warnings / Precautions
Patients with extensive hepatic fibrosis; renal impairment; anaemias. Monitor CBC at the start of, and regularly during treatment. Ensure contraception during treatment and for at least 6 mth after treatment cessation in women and female partners of male patients. Increased risk of fatal and nonfatal MI in patients with anaemia.
Adverse Reactions
Oral: Increased serum bilirubin and uric acid, haemolytic anaemia, reticulocytosis, anorexia, dyspepsia, nausea, irritability, dyspnoea, pharyngitis, skin rashes, pruritus and headache, abdominal cramps, fatigue, metallic taste, increased thirst, GI complaints, mood changes, insomnia. High dose may cause reduction in haemoglobin, haematocrit and RBC count. Aerosol: Deterioration in pulmonary function, bacterial pneumonia and pneumothorax, BP fall, cardiac arrest, anaemia, reticulocytosis, conjunctivitis, skin rash. Eye irritation due to deposited drug (infrequent).
Drug Interactions
May worsen neutropenia induced by interferon alfa. May increase risk of adverse effects when used with nucleoside reverse transcriptase inhibitors.
Potentially Fatal: Risk of fatal hepatic failure, peripheral neuropathy and pancreatitis when used with didanosine. Increased risk of severe neutropenia and anaemia when used with zidovudine.
See Below for More ribavirin Drug Interactions
Mechanism of Actions
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.
Absorption: Rapidly absorbed from the GI tract; peak plasma concentrations after 1-2 hr (oral). Oral bioavailability: about 45-65%. Absorbed from the resp tract (inhalation).
Distribution: Crosses the blood-brain barrier; present in sperm and RBC (high concentrations).
Metabolism: Extensively hepatic via phosphorylation; converted to the mono-, di- and triphosphate derivatives.
Excretion: Mainly in the urine (as unchanged drug and metabolites). Elimination half-life: 2 hr (β phase), 20-50 hr (terminal phase).
Administration
Tab: Should be taken with food.
Cap: May be taken with or without food. (Take consistently w/ respect to meals, either always w/ or always w/o meals.)
Storage Conditions
Inhalation: Lyophilised drug powder may be stored at 25°C. Reconstituted solution may be stored at 20-30°C for 24 hr. Oral: Capsule/tablet: Store at 15-30°C. Oral solution: Store at room temperature or refrigerate at 2-8°C.
ATC Classification
J05AB04 - ribavirin ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Storage
Inhalation: Lyophilised drug powder may be stored at 25°C. Reconstituted solution may be stored at 20-30°C for 24 hr. Oral: Capsule/tablet: Store at 15-30°C. Oral solution: Store at room temperature or refrigerate at 2-8°C.
Available As
  • Ribavirin 100 mg
  • Ribavirin 200 mg
  • Ribavirin 50 mg
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