FOSFOMYCIN TROMETHAMINE granule, for solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Cipla USA Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 granules for oral solution is contraindicated in patients with known hypersensitivity to the drug.

Product samenvatting:

Fosfomycin tromethamine granules for oral solution is available as a single-dose sachet containing the equivalent of 3 grams of fosfomycin. NDC # 69097-579-67 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature] . Keep this and all drugs out of the reach of children.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FOSFOMYCIN TROMETHAMINE - FOSFOMYCIN TROMETHAMINE GRANULE, FOR
SOLUTION
CIPLA USA INC.
----------
FOSFOMYCIN TROMETHAMINE GRANULES FOR ORAL SOLUTION
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 powder 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 or almost
white, hygroscopic powder with a molecular weight of 259.19. 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
(CMAX) 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 CMAX 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
(VSS) IS
136.1 (±44.1) L FOLLOWING ORAL ADMINISTRATION OF FOSFOMYCIN
TROMETHAMINE.
FOSFOMYCIN IS NOT