Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
FOSFOMYCIN TROMETHAMINE (UNII: 7FXW6U30GY) (FOSFOMYCIN - UNII:2N81MY12TE)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.) Fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.
Product: 50090-6130 NDC: 50090-6130-0 1 GRANULE, FOR SOLUTION in a PACKET / 1 in a CARTON
Abbreviated New Drug Application
FOSFOMYCIN TROMETHAMINE - FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION A-S MEDICATION SOLUTIONS ---------- FOSFOMYCIN TROMETHAMINE GRANULES FOR ORAL SOLUTION RX ONLY DESCRIPTION Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: orange flavor, saccharin and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (_1R,2S_)-(1,2- epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3- propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C H O P.C H NO , and its chemical structure is as follows: CLINICAL PHARMACOLOGY ABSORPTION: Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gram dose of fosfomycin tromethamine, the mean (± 1 SD) maximum serum concentration (C ) achieved was 26.1 (± 9.1) mcg/mL within 2 hours. The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gram oral dose of fosfomycin tromethamine with a high-fat meal, the mean C achieved was 17.6 (± 4.4) mcg/mL within 4 hours. Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with fosfomycin tromethamine. Metoclopramide lowers the serum concentrations and urinary excretion of fosfomycin when coadministered with fosfomycin tromethamine. (See PRECAUTIONS, DRUG INTERACTIONS.) DISTRIBUTION: The mean apparent steady-state volume of distribution (V ) is 136.1 (±44.1) L following oral administration of fosfomycin tromethamine. Fosfomycin is not bound to plasma proteins. Fosfom Læs hele dokumentet