Fixcom 2/Fixcom 3/Fixcom 4

Fixcom 2/Fixcom 3/Fixcom 4

rifampicin + isoniazid

Manufacturer:

Natrapharm

Distributor:

Natrapharm
Concise Prescribing Info
Contents
Fixcom 2 Rifampicin 150 mg, INH 75 mg. Fixcom 3 Rifampicin 150 mg, INH 75 mg, ethambutol 275 mg. Fixcom 4 Rifampicin 150 mg, INH 75 mg, pyrazinamide 400 mg, ethambutol 275 mg
Indications/Uses
Fixcom 2/Fixcom 4 Pulmonary & extrapulmonary TB. Fixcom 3 For maintenance phase treatment of pulmonary & extrapulmonary TB.
Dosage/Direction for 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. 30-37 kg 2 tab/day in 4 mth. Fixcom 3 Patient weighing >70 kg 5 tab/day, 55-70 kg 4 tab/day, <55 kg 3 tab/day. Duration: 4-6 mth. Fixcom 4 Patient weighing >70 kg 5 tab/day, 55-70 kg 4 tab/day, <55 kg 3 tab/day. Duration: 2 mth.
Administration
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.
Contraindications
Rifampicin: Patients w/ jaundice. Ethambutol: Optic neuritis. 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 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. Fixcom 4 Pyrazinamide: Patients w/ a history of gout; impaired renal function. Increased difficulty in controlling DM.
Adverse Reactions
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. Fixcom 4 Pyrazinamide: Hepatotoxicity.
Drug 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. Fixcom 4 Pyrazinamide: Probenecid.
MIMS Class
Anti-TB Agents
ATC Classification
J04AM07 - rifampicin, ethambutol and isoniazid ; Belongs to the class of combination drugs used in the systemic treatment of tuberculosis.
J04AM06 - rifampicin, pyrazinamide, ethambutol and isoniazid ; Belongs to the class of combination drugs used in the systemic treatment of tuberculosis.
J04AM02 - rifampicin and isoniazid ; Belongs to the class of combination drugs used in the systemic treatment of tuberculosis.
Presentation/Packing
Form
Fixcom 2 FC tab
Packing/Price
80's (P567/box)
Form
Fixcom 3 FC tab
Packing/Price
80's (P787.88/pack)
Form
Fixcom 4 FC tab
Packing/Price
80's (P841.5/pack)
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