Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)
Hikma Pharmaceuticals USA Inc.
RIFAMPIN
RIFAMPIN 600 mg
INTRAVENOUS
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 for Injection, USP 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 for Injection, USP and the patient is not responding to therapy, the drug regimen should be modified. Rifampin for Injection, USP 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 f
Rifampin for Injection, USP is available in sterile glass vials containing 600 mg rifampin (NDC 0143-9230-01). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat (temperatures above 40°C or 104°F). Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B - Fervença - 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: December 2021 PIN432-WES/7
Abbreviated New Drug Application
RIFAMPIN- RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- RIFAMPIN FOR INJECTION, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of Rifampin for Injection, 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 for Injection, USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. 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: CLINICAL PHARMACOLOGY INTRAVENOUS ADMINISTRATION 43 58 4 12 INTRAVENOUS ADMINISTRATION After intravenous administration of a 300 or 600 mg dose of rifampin infused over 30 minutes to healthy male volunteers (n=12), mean peak plasma concentrations were 9.0 ± 3.0 and 17.5 ± 5.0 mcg/mL, respectively. Total body clearances after the 300 and 600 mg IV doses were 0.19 ± 0.06 and 0.14 ± 0.03 L/hr/kg, respectively. Volumes of distribution at steady state were 0.66 ± 0.14 and 0.64 ± 0.11 L/kg for the 300 and 600 mg IV doses, respectively. After intravenous administration of 300 or 600 mg doses, rifampin plasma concentrations in these volunteers remained detectable for 8 and 12 hours, respectively (see Table). PLASMA CONCENTRATIONS (MEAN ± STANDARD DEVIATION, MCG/ML) Rifampin Dosage IV 30 min 1 hr 2 hr 4 hr 8 hr 12 hr 300 mg 8.9 ± 2.9 4.9 ± 1.3 4.0 ± 1.32.5 Прочитать полный документ