FOSFOMYCIN TROMETHAMINE- granules for oral powder

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

A-S Medication Solutions

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Fosfomycin Tromethamine 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 is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS   and CLINICAL STUDIES   sections.) Fosfomycin Tromethamine is contraindicated in patients with known hypersensitivity to the drug.

Povzetek izdelek:

Product: 50090-5826 NDC: 50090-5826-0 1 POWDER in a DOSE PACK / 1 in a CARTON

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FOSFOMYCIN TROMETHAMINE- GRANULES FOR ORAL POWDER
A-S MEDICATION SOLUTIONS
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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: mandarin flavor,
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.
Fosfomycin is