Generic Name:  Rifampicin + Isoniazid + Pyrazinamide + Ethambutol

Regulatory Class: Rx

Formulations: Rifampicin 150 mg, INH 75 mg, pyrazinamide 400 mg, ethambutol 275 mg

Indications or Uses: For Pulmonary & extrapulmonary TB

Dosage or Directions for use: Fixcom 4 Patient weighing >70 kg 5 tab/day, 55-70 kg 4 tab/day, <55 kg 3 tab/day. Duration: 2 mth.

Administration: Take 1 hr before or 2 hr after meals. 

Contraindications: Fixcom 4 Pyrazinamide: Liver damage, acute gout or hyperuricemia.

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 4 Pyrazinamide: Patients w/ a history of gout; impaired renal function. Increased difficulty in controlling DM.

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 4 Pyrazinamide: Hepatotoxicity.

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 4 Pyrazinamide: Probenecid.

Presentation or Packaging: Fixcom 4 Film coated tablet 80's

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