Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)
McKesson Corporation dba SKY Packaging
RIFAMPIN
RIFAMPIN 300 mg
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 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 (e.g., RIFATER ® (Sanofi-aventis U.S. LLC)) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council
Rifampin capsules USP, 300 mg are red capsules, imprinted E 799 in black ink on both cap and body. They are available as follows: Boxes of 10x10 UD 100 NDC 63739-415-10 Storage: Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature] Dispense contents in a tight light-resistant container as defined in the USP with a child resistant closure, as required. Store in a dry place. KEEP TIGHTLY CLOSED. Avoid excessive heat. KEEP OUT OF THE REACH OF CHILDREN. Rx only The brands listed are the registered trademarks of their respective owners and are not trademarks of McKesson Corporation. Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Distributed by: McKesson Corporation 4971 Southridge Blvd, Suite 101 Memphis, TN 38141 21494 January 2021
Abbreviated New Drug Application
RIFAMPIN- RIFAMPIN CAPSULE MCKESSON CORPORATION DBA SKY PACKAGING ---------- 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-2,4,12,16,18, 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. Its structural formula is: Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. 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, 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, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28. 43 58 4 12 CLINICAL PHARMACOLOGY ORAL ADMINISTRATION 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 mcg/mL. Absorption of rifampin is reduced by about 30% when the drug is ingested with f Læs hele dokumentet