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Drug Information

Drug Generic Name RIBAVIRIN (TRIBAVIRIN)
Drug Class NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.
Chapter Infections

Indications: severe respiratory syncytial virus bronchiolitis in infants and children; in combination with peginterferon alfa or interferon alfa for chronic hepatitis C not previously treated in patients without liver decompensation, or for relapse in adults following previous response to interferon alfa.

Cautions: Specific cautions for oral treatment Exclude pregnancy before treatment; effective contraception essential during treatment and for 6 months after treatment in women and in men; routine monthly pregnancy tests recommended; condoms must be used if partner of male patient is pregnant (ribavirin excreted in semen); renal impairment, cardiac disease (assessment including ECG recommended before and during treatment—discontinue if deterioration); gout; determine full blood count, platelets, electrolytes, serum creatinine, liver function tests and uric acid before starting treatment and then on weeks 2 and 4 of treatment, then as indicated clinically—adjust dose if adverse reactions or laboratory abnormalities develop; test thyroid function before treatment and then every 3 months in children.

Contra-indications: pregnancy (important teratogenic risk); breast-feeding

Specific contra-Indications for oral treatment: Severe cardiac disease, including unstable or uncontrolled cardiac disease in previous 6 months; haemoglobinopathies; severe debilitating medical conditions; severe hepatic dysfunction or decompensated cirrhosis; autoimmune disease (including autoimmune hepatitis); uncontrolled severe psychiatric condition; history of severe psychiatric condition in children.

Specific side effects: for oral treatment: Haemolytic anaemia; nausea, vomiting, dyspepsia, abdominal pain, peptic ulcer, flatulence, diarrhoea, constipation, pancreatitis, appetite changes, weight loss, chest pain, tachycardia, palpitation, syncope, peripheral oedema, changes in blood pressure, flushing, dyspnea, cough, rhinitis, pharyngitis, interstitial pneumonitis, sleep disturbances, abnormal dreams, asthenia, impaired concentration and memory, psychoses, anxiety, depression, suicidal ideation (more frequent in children), dizziness, tremor, hypertonia, ataxia, dysphonia, myalgia, arthralgia, peripheral neuropathy, influenza-like symptoms, headache, hyperglycaemia, thyroid disorders, menstrual disturbances, reduced libido, impotence, prostatitis, micturition disorders, rash (including very rarely Stevens-Johnson syndrome and toxic epidermal necrolysis), pruritus, urticaria, photosensitivity, psoriasis, alopecia, dry skin, increased sweating, dry mouth, stomatitis, glossitis, taste disturbance, eye changes including blurred vision, tinnitus; neutropenia, thrombocytopenia, aplastic anaemia, lymphadenopathy, hypocalcaemia, hyperuricaemia; in children also growth retardation (including decrease in height and weight), Raynaud's disease, hypertriglyceridaemia, hyperkinesia, testicular pain, virilism, tooth disorders, and skin discoloration.

Dose: Chronic hepatitis C, adultover 18 years (in combination with interferon alfa or peginterferon alfa), body-weight under 65 kg, 400 mg twice daily; body- weight 65–85 kg, 400 mg in the morning and 600 mg in the evening; body-weight over 85 kg, 600 mg twice daily; child and adolescent 3–17 years (in combination with interferon alfa), body-weight under 47 kg, 15 mg/kg daily in 2 divided doses; body-weight 47–49 kg, 200 mg in the morning and 400 mg in the evening; body-weight 50–65 kg, 400 mg twice daily; body-weight over 65kg, as adult.

Brand Name
  • Rebetol 200mg Tab
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