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Concise Prescribing Info
Contents
Rifampicin 150 mg, INH 75 mg, pyrazinamide 400 mg, ethambutol HCl 275 mg
Indications/Uses
Initial phase of category I & II pulmonary TB & extrapulmonary TB.
Dosage/Direction for Use
Adult ≥71 kg 5 tab; 55-70 kg 4 tab; 38-54 kg 3 tab; 30-37 kg 2 tab. All doses are to be taken daily.
Administration
Should be taken on an empty stomach: Take at least 30 min before meals.
Contraindications
Hypersensitivity. Optic neuritis, visual defects, hepatic disease. Childn <6 yr.
Special Precautions
Patients w/ hepatitis, severe liver damage, porphyria or known hypersensitivity. Perform ophthalmologic evaluations prior to treatment & periodically thereafter. Determine baseline serum uric acid & liver function. Preexisting liver disease. Discontinue use if hepatocellular damage or hyperuricemia w/ acute gouty arthritis occurs. Impaired renal function, gout or diabetes. Orange-red coloration of urine, saliva & feces may occur. Previous INH-associated injury; acute liver disease. Monitor renal & hepatic system. May affect vision. Pregnancy & lactation.
Adverse Reactions
Heartburn, epigastric distress, anorexia, nausea, vomiting, gas cramps, diarrhea; headache, drowsiness, fatigue, menstrual disturbances, ataxia, dizziness, inability to concentrate, mental confusion, visual disturbances, muscular weakness, fever, pains in the extremities, generalized numbness; hypersensitivity reactions; pruritus, urticaria, rash, pemphigoid reaction, eosinophilia, sore mouth, tongue & exudative conjuctivitis. Transient abnormalities in LFT; thrombocytopenia, transient leucopenia, hemolytic anemia & decreased Hb; elevation in BUN & serum uric acid; immunosuppressive effect; jaundice; chronic liver disease, alcholism; peripheral neuropathy; hepatoxicity; mild arthralgia & myalgia; gout; optic neuritis.
Drug Interactions
Accelerate metabolism of phenytoin, antiarrhythmic (quinidine), oral anti-coagulant, antifungals. Increased phenytoin toxicity. Decrease INH plasma conc w/ prednisolone. Antagonize hypoglycemic action & elevated blood sugar levels w/ insulin. Impaired absorption of ethambutol w/ Al hydroxide.
MIMS Class
Anti-TB Agents
ATC Classification
J04AM06 - rifampicin, pyrazinamide, ethambutol and isoniazid ; Belongs to the class of combination drugs used in the systemic treatment of tuberculosis.
Presentation/Packing
Form
Forecox-Trac FC tab
Packing/Price
4 × 28's
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