FOSFOMYCIN TROMETHAMINE powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zambon USA, Ltd

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Fosfomycin tromethamine granules for oral solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin. NDC Single-dose sachet 82036-4274-8 One unit carton 82036-4274-1 Store at 25°C (77°F); excursions permitted to 1 5-30°C (59-86°F). Keep this and all drugs out of the reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FOSFOMYCIN TROMETHAMINE- FOSFOMYCIN TROMETHAMINE POWDER
ZAMBON USA, LTD
----------
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 (1 _R_,2
_S_)-(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.
Fosfomyci