FOSFOMYCIN POWDER FOR ORAL SOLUTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE)

Dostępny od:

ENDO VENTURES LTD.

Kod ATC:

J01XX01

INN (International Nazwa):

FOSFOMYCIN

Dawkowanie:

3G

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) 3G

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

URINARY ANTI-INFECTIVES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0137036002; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2023-07-07

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
FOSFOMYCIN POWDER FOR ORAL SOLUTION
(as fosfomycin tromethamine)
3g/sachet
Antibiotic
Endo Ventures Ltd.,
First floor, Minerva House, Simmonscourt Road
Ballsbridge, Dublin 4
Ireland, D04 H9P8
Imported by:
Par Labs, a division of Paladin Labs Inc.
Version: 1.0
100 Boul. Alexis Nihon, Bureau 600
St-Laurent (QC), Canada
Date of Preparation: June 13, 2019
H4M 2P2
Submission Control No: 226090
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_Product Monograph - Fosfomycin powder for oral solution_
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_Page 2 of 24_
PR
FOSFOMYCIN POWDER FOR ORAL SOLUTION
(as fosfomycin tromethamine)
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
FOSFOMYCIN POWDER FOR ORAL SOLUTION (fosfomycin tromethamine), a
phosphonic acid derivative is the
mono-acid salt of fosfomycin with tromethamine.
Fosfomycin is bactericidal in urine at therapeutic doses. Its
bactericidal action is due to inactivation of the
enzyme
enolpyruvyl
transferase,
thereby
blocking
the
condensation
of uridine
diphosphate-N-
acetylglucosamine with p-enolpyruvate, one of the first steps in
bacterial cell synthesis. It also reduces
adherence of bacteria to uroepithelial cells.
Following oral administration, fosfomycin tromethamine is converted to
the free acid, fosfomycin, which
is rapidly absorbed. After a single dose of fosfomycin tromethamine
(equivalent to 3 g fosfomycin), the
mean maximum serum concentration (C
max
) achieved within 2 hours is 26.1 mcg/mL in fasted subjects.
Absolute oral bioavailability of fosfomycin under fasting conditions
is 37% and 30% under fed conditions.
When fosfomycin tromethamine is given with a high fat meal, the mean C
max
achieved is 17.6 mcg/mL
within 4 hours. The mean half-life for elimination (t
½
) in serum is 5.7 hours without food and 5.8 hours
with food.
Fosfomycin is widely distributed in body tissues and is not bound to
plasma proteins. Following a 50 mg/kg
dose of fosfomycin, a concentration of 18 mcg/gram in bladder tissue
is achieved at 3 hours after dosing.
Fosfomycin has been shown to cross the human placental barrier.
Fosfomycin tromethamine