FOSFOMYCIN TROMETHAMINE granule, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

FOSFOMYCIN TROMETHAMINE (UNII: 7FXW6U30GY) (FOSFOMYCIN - UNII:2N81MY12TE)

Доступна з:

A-S Medication Solutions

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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.

Огляд продуктів:

Product: 50090-6130 NDC: 50090-6130-0 1 GRANULE, FOR SOLUTION in a PACKET / 1 in a CARTON

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

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