FOSFOMYCIN TROMETHAMINE granule, for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Bryant Ranch Prepack

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

Fosfomycin Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin. NDC: 63629-9470-1 Single-dose sachet 63629-9470-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

FOSFOMYCIN TROMETHAMINE- FOSFOMYCIN TROMETHAMINE GRANULE, FOR
SOLUTION
BRYANT RANCH PREPACK
----------
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.
Fosfomycin