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POLYZIDE

ISONIAZID · by POLYFINE

ANTIMYCOBACTERIALS (ANTITUBERCULOSIS) Isonicotinic acid derivative POLYFINE

Composition

Tab 50 mg/100 mg/300 mg: Isoniazid 100 mg/300 mg. Syp: Per 5 ml: Isoniazid 50 mg.

Indications & Dosage

Tuberculosis, in combination with other drugs (standard unsupervised 6-month treatment): Adult: 300 mg daily for 6 months (initial and continuation phases) Children: 10 mg/kg once daily (max. per dose 300 mg) for 6 months (initial and continuation phases) Tuberculosis, in combination with other drugs (intermittent supervised 6-month treatment): Adult: 15 mg/kg 3 times a week (max. per dose 900 mg) for 6 months (initial and continuation phases) Children: 15 mg/kg 3 times a week (max. per dose 900 mg) for 6 months (initial and continuation phases) Prevention of tuberculosis in susceptible close contacts orthose who have become tuberculin positive: Adult & Children above 12 yrs: 300 mg daily for 6 months, alternatively 300 mgdaily for 3 months, to be taken in combination withRifampicin Children 1 month-11 yrs: 10 mg/kg daily (max. per dose 300 mg) for 6 months, alternatively 10 mg/kg daily (max. per dose 300 mg) for 3 months, to be taken incombination with rifampicin

Contraindications

Patients with previous isoniazid associated hepatic injury or other severe adverse reactions with iso-niazid.

Precautions

Patients with active chronic liver disease or severe renal dysfunction. Isoniazid crosses the placental barrier and passes into maternal breast milk, observe neonates, breast fed infants of isoniazid treated mothers for any evidence of adverse effects. Acute porphyrias, diabetes mellitus, epilepsy, history of psychosis, HIV infection, malnutrition, slow acetylator status

Interactions

The effectiveness of isoniazid may be decreased when administered with corticosteroid. The effects of benzodiazepines may be increased. The hepatic toxicity of both isoniazid and/or rifampicin may be increased when administered concomitantly

Pregnancy

Caution advised, use only if potential benefit outweighs risk

Lactation

Caution advised

Side Effects

Peripheral neuropathy, agranulocytosis, aplastic anaemia, blood disorders, constipation, convulsions, difficulty with micturition, dry mouth, fever, gynaecomastia, haemolytic anaemia, hearing loss (in patients with end-stage renal impairment), hyperglycaemia, hyperreflexia, hypersensitivity reactions, interstitial pneumonitis, nausea, optic neuritis, pancreatitis, pellagra, peripheral neuritis with high doses, purpura, Stevens-Johnson syndrome, systemic lupus erythematosus-like syndrome, tinnitus (in patients with end-stage renal impairment),vertigo, vomiting. Rare: Hepatitis, psychotic episodes