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| Pyrazinamide 500mg |
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| Made in: India | ||||||||||
| GENERIC NAME: Pyrazinamide 500 mg
COMPOSITION: EACH TABLET CONTAINS PYRAZINAMIDE 500 MG * PYRAZINAMIDE 500 mg, the pyrazine analogue of nicotinamide, is an anti-tuberculous agent. * It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. * Each Pyrazinamide 500 mg tablet for oral administration contains 500 mg of Pyrazinamide 500 mg and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate (dihydrate), microcrystalline cellulose, and stearic acid. |
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Indications & Dosage: Pyrazinamide 500 mg is indicated for the initial treatment of active tubercuIosis in adults and children when combined with other antitubercu-lous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and Pyrazinamide 500 mg given for 2 months, followed by isoniazid and rifampin for 4 months.*4)(Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide 500 mg frequently will be an important component of such therapy.) (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment.) Pyrazinamide 500 mg should only be used in conjunction with other effective antituber-culous agents. DOSAGE AND ADMINISTRATION: Pyrazinamide 500 mg should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide 500 mg frequently will be an important component of such therapy. Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients. Pyrazinamide 500 mg Usual dose: Pyrazinamide 500 mg is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table). Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluating the twice weekly regimen, doses of Pyrazinamide 500 mg in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported. This table is taken from the CDC-American Thoracic Society joint recommendations. Pyrazinamide 500 mg Side Effects & Drug Interactions : General: Fever, porphyria and dysuria have rarely been reported. Gout (see PRECAUTIONS). Gastrointestinal: The principal adverse effect is a hepatic reaction (see WARNINGS). Hepatotoxicity appears to be dose related, and may appear at any time during therapy. Gl disturbances including nausea, vomiting and anorexia have also been reported. Hematologic and Lymphatic: Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug. Adverse effects on blood clotting mechanisms have also been rarely reported. Other: Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, and pruritis have been reported. Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely. Pyrazinamide 500 mg WARNINGS: Patients started on Pyrazinamide 500 mg should have baseline serum uric acid and liver function determinations. Those patients with preexisting Iiver disease or those at increased risk for drug related hepatitis (e.g., alcohol abusers) should be followed closely. Pyrazinamide 500 mg should be discontinued and not be resumed if signs of hepatocel-lular damage or hyperuricemia accompanied by an acute gouty arthritis appear. Teratogenic Effects - Pregnancy Category C Animal reproduction studies have not been conducted with PYRAZINAMIDE 500 mg. It is also not known whether Pyrazinamide 500 mg can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyrazinamide 500 mg should be given to a pregnant woman only if clearly needed. Pyrazinamide 500 mg has been found in small amounts in breast milk. Therefore, it is advised that Pyrazinamide 500 mg be used with caution in nursing mothers taking into account the risk-benefit of this therapy. Pediatric Use:Pyrazinamide 500 mg regimens employed in adults are probably equally effective in pediatric patients 4,10,11 years. Pyrazinamide 500 mg appears to be well tolerated in pediatric patients. Pyrazinamide 500 mg Overdosage & Contraindications: OVERDOSE: Overdosage experience is limited. In one case report of overdose, abnormal liver function tests developed. These spontaneously reverted to normal when the drug was stopped. Clinical monitoring and supportive therapy should be employed. Pyrazinamide 500 mg is dialyzable. CONTRAINDICATIONS: Pyrazinamide 500 mg is contraindicated in persons: with severe hepatic damage; who have shown hypersensitivity to it; with acute gout. Storage: Store in a well-closed container at controlled room temperature, 15°C to 30°C (59°F to 86°F)." |
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