Generic Name: Rifampicin + Isioniazid

Regulatory Class: Rx

Dosage or Direction of Use: Fixcom 2 Patient weighing >71 kg 5 tab/day in 4 mth. 55-70 kg 4 tab/day in 4 mth. 38-54 kg 3 tab/day in 4 mth

Indications or Uses: For treatment of pulmonary and extrapulmonary tuberculosis.

Formulations: Rifampicin 150 mg, Isoniazid 75 mg

Administration: Take 1 hr before or 2 hr after meals 

Contraindications: Rifampicin: Patients w/ jaundice. Ethambutol: Optic neuritis

Special Precautions: Pregnancy & lactation. Rifampicin: Monitor liver function & blood count. Preexisting liver disease. W/draw therapy when thrombocytopenia, purpura, hemolytic anemia or renal failure occur. INH: Patients w/ convulsive disorders, history of psychosis, hepatic or renal dysfunction. Patients at risk of neuropathy or pyridoxine deficiency including diabetics, alcoholics, malnourished, uremic, pregnant or infected w/ HIV. Discontinue upon manifestation of symptoms of hepatitis eg, malaise, fatigue, anorexia, nausea & elevated serum AST conc. Perform periodic eye exam. Slow acetylator patients. Ethambutol: Patients w/ visual defects. Discontinue when visual disturbances arise. Reduce dosage in patients w/ impaired kidney function. Childn. Elderly.Fixcom 2 INH: Monitor serum conc of hepatic transaminases in patients w/ preexisting chronic liver disease. Additional pyridoxine should be given in patients at risk of peripheral neuropathy, chronic alcohol dependence or diabetes. Reduced dose of anticonvulsants when given concurrently. Rifampicin: Renal impairment, haemolysis or thrombocytopenia. Alcohol-dependent or hepatic disease. May produce reddish coloration of urine, tears, saliva & sputum & contact lenses may irreversibly stained.

Adverse Reaction: Rifampicin: Cutaneous syndrome, flu syndrome. GI disturbances & bleeding, erosive gastritis. Ulcerative, eosinophilic & pseudomembranous colitis. Transient liver function abnormalities, hepatitis, thrombocytopenia, purpura, eosinophilia, leukopenia, hemolytic anemia, renal failure, menstrual disturbances. Headache, drowsiness, ataxia, dizziness, numbness, edema, myopathy, muscular weakness. Orange-red discoloration of the urine & other body fluids. INH: Peripheral neuritis, psychotic reactions & convulsions, increase in liver enzymes, hepatitis, anemia, agranulocytosis, thrombocytopenia, eosinophilia, skin eruption, fever, vasculitis, nausea, vomiting, pellagra, purpura, hyperglycemia, lupus-like syndrome, urinary retention & gynecomastia. Ethambutol: Retrobulbar neuritis, visual field constriction, central or peripheral scotoma, green-red color blindedness. Confusion, disorientation, hallucination, headache, dizziness, malaise, jaundice, transient liver function, peripheral neuritis, thrombocytopenia, pulmonary infiltrates, eosinophilia, GI disturbances. Hypersensitivity reactions.Fixcom 2 Itching, skin rash; jaundice; confusion. INH: Burning sensation of the feet. Rifampicin: Shock, purpura, acute renal failure. Anorexia, nausea, abdominal pain; orange/red urine.

Interactions: Rifampicin: Antacids, anticholinergics, opioids, ketoconazole, prep containing bentonite. INH: Hepatotoxic drugs, carbamazepine, ethosuximide, phenytoin, diazepam, triazolam, chlorzoxazone, theophylline, enflurane, clofazimine, cycloserine, warfarin, alcohol, Al-containing antacids. Fixcom 2 INH: Raise plasma conc of phenytoin & carbamazepine. Impaired absorption w/ Al hydroxide. Rifampicin: Hepatic enzyme induction of corticosteroids, steroid contraceptives, oral hypoglycemics, oral anticoagulants, phenytoin, cimetidine, cyclosporine & digitalis glycosides. Reduced effectiveness of OC. Increased drug toxicity w/ antiretroviral drugs.

Presentation/Packaging: Fixcom 2 Film coated tablet 80's

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