Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)
Rebel Distributors Corp
ORAL
PRESCRIPTION DRUG
In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American T
Rifampin Capsules, USP 300 mg are supplied as red capsules, imprinted E 799 and are available in bottles of 15, 20 and 30. Store at 20º - 25º C (68º - 77º F) [See USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Avoid excessive heat. Dispense contents with a child resistant closure (as required) and in a tight light-resistant container as defined in the USP/NF. 1. National Committee for Clinical Laboratory Standards, Antimycobacterial Susceptibility Testing. Proposed Standard NCCLS Document M24-P, Vol. 10, No. 10, NNCLS, Villanova, PA, 1990. 2. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993. 3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibly Tests — Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993. 4. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing; Fifth Informational Supplement, NCCLS Document M100-S5, Vol. 14, No. 16, NCCLS, Villanova, PA, December 1994. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for Sandoz Inc., Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Rev. 11/08 MF0799REV11/08 0S7204 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
RIFAMPIN- RIFAMPIN CAPSULE REBEL DISTRIBUTORS CORP ---------- RIFAMPIN CAPSULES, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin capsules USP and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C H N O . The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1- piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-_b_]furan-1,11(2H)-dione 21-acetate. The structural formula is: Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28. CLINICAL PHARMACOLOGY ORAL ADMINISTRATION 43 58 4 12 Rifampin is readily absorbed from the gastrointestinal tract. Peak serum concentrations in healthy adults and pediatric populations vary widely from individual to individual. Following a single 600 mg oral dose of rifampin in healthy adults, the peak serum concentration averages 7 mcg/mL but may vary from 4 to 32 Belgenin tamamını okuyun