البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)
Rebel Distributors Corp
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 (eg, RIFATER® 1) 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 A
300 mg: Size # 1 maroon/scarlet capsules imprinted with logo "LANNETT" on the cap and "1315" on the body. Bottles of 30 (NDC #: 42254-039-30) Storage Keep tightly closed. Store in a dry place. Avoid excessive heat. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light. Dispense in a well-closed, light-resistant container as defined in the USP with a child-resistant closure.
Abbreviated New Drug Application
RIFAMPIN- RIFAMPIN CAPSULE REBEL DISTRIBUTORS CORP ---------- RIFAMPIN CAPSULES, USP RX ONLY 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 capsules, USP for oral administration contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules contain a powder that is brick-red in color. The 150 mg and 300 mg capsules also contain, as inactive ingredients: pregelatinized starch, colloidal silicon dioxide, talc, magnesium stearate, D&C Red # 28, FD&C Blue # 1, FD&C Red # 40, gelatin, and titanium dioxide. 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. Its structural formula is: 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 43 58 4 12 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 food. Rifampin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid. Rifampin is about 80% protein bound. Most of the اقرأ الوثيقة كاملة