JAMP-FOSFOMYCIN POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE)

Tilgjengelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

J01XX01

INN (International Name):

FOSFOMYCIN

Dosering :

3G

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) 3G

Administreringsrute:

ORAL

Enheter i pakken:

8G

Resept typen:

Prescription

Terapeutisk område:

URINARY ANTI-INFECTIVES

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-03-12

Preparatomtale

PRODUCT MONOGRAPH
PR
JAMP-FOSFOMYCIN
(MANUFACTURER’S STANDARD)
Fosfomycin powder, 3g/sachet
(as fosfomycin tromethamine)
Antibiotic
Jamp Pharma Corporation
Date of Revision: March 08, 2018
1310 rue Nobel
Boucherville, Québec
Canada, J4B 5H3
Submission Control No: 201190
_JAMP-FOSFOMYCIN Product Monograph_
_Page 2 of 25_
P r
JAMP-FOSFOMYCIN
fosfomycin powder, 3g/sachet
(as fosfomycin tromethamine)
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
JAMP-FOSFOMYCIN
(fosfomycin
tromethamine),
a
phosphoric
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
is
not
metabolized
and
is
excreted
unchanged
in
urine
and
feces.
Following
oral
administration of
fosfomycin tromethamine
to fasted patients, the total body clearance (CL
BT
) and
mean