MONUROL- fosfomycin tromethamine powder

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Allergan, Inc.

Designación común internacional (DCI):

FOSFOMYCIN TROMETHAMINE

Composición:

FOSFOMYCIN 3 g

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

MONUROL Granules for Oral Solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin.                                                 NDC Single-dose sachet           0456-4300-08 One unit carton                0456-4300-01 Store at 25°C (77°F); excursions permitted to   15-30°C (59-86°F). Keep this and all drugs out of the reach of children.

Estado de Autorización:

New Drug Application

Ficha técnica

MONUROL- FOSFOMYCIN TROMETHAMINE POWDER
ALLERGAN, INC.
----------
MONUROL
[MON’ UR OL]
(FOSFOMYCIN TROMETHAMINE)
GRANULES FOR ORAL SOLUTION
RX ONLY
DESCRIPTION
MONUROL (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 MONUROL, 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
MONUROL 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
MONUROL. Metoclopramide lowers the serum concentrations and urinary
excretion of fosfomycin
when coadministered with MONUROL. (See PRECAUTIONS, DRUG
INTERACTIONS.)
DISTRIBUTION: The mean apparent steady-state volume of distribution (V
) is 136.1 (±44.1) L
following oral administration of MONUROL. Fosfomycin is not bound to
plasma proteins.
Fosfomycin is distributed to the kidneys, bladder wall, prostate, and
se