MINOCIN CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)

Dostępny od:

GLAXOSMITHKLINE INC

Kod ATC:

J01AA08

INN (International Nazwa):

MINOCYCLINE

Dawkowanie:

100MG

Forma farmaceutyczna:

CAPSULE

Skład:

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

TETRACYCLINES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131309002; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2012-12-10

Charakterystyka produktu

_2012-04-16/131-pi-pristine-Minocin.doc_
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_Page 1 of 28 _
PRESCRIBING INFORMATION
PR
MINOCIN
®
(MINOCYCLINE HYDROCHLORIDE)
50 MG AND 100 MG CAPSULES
ANTIBIOTIC
GlaxoSmithKline Inc.
Date of Revision:
7333 Mississauga Road
April 16, 2012
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
SUBMISSION CONTROL NO: 153630
_©_
_2012 GlaxoSmithKline Inc., All Rights Reserved _
_®_
_MINOCIN is a registered trademark of Pfizer Canada Inc. _
_2012-04-16/131-pi-pristine-Minocin.doc_
_ _
_Page 2 of 28 _
COMPLETE PRESCRIBING INFORMATION
PR
MINOCIN
®
(minocycline hydrochloride)
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
MINOCIN
®
(minocycline hydrochloride) is a tetracycline with antibacterial
activity
against some Gram-negative and Gram-positive organisms. The action of
MINOCIN
®
is primarily bacteriostatic and it is thought to exert its
antimicrobial
effect by the inhibition of protein synthesis.
INDICATIONS AND CLINICAL USE
MINOCIN
®
(minocycline hydrochloride) may be indicated for the treatment of the
following infections due to susceptible strains of the designated
organisms:
Gall bladder infections caused by _Escherichia coli_.
Urinary tract infections: cystitis, gonorrhea, pyelonephritis caused
by _Escherichia _
_coli_, _ Proteus_ species, _ Klebsiella_ species, _ Enterobacter_ _
aerogenes_, _ Neisseria _
_gonorrhea._
When penicillin is contraindicated, MINOCIN
®
may be employed as an alternative
drug in the treatment of anal and pharyngeal gonorrhea and syphilis.
Skin and soft tissue infections: abscess, cellulitis, furunculosis,
impetigo and
pyoderma caused by: _ Staphylococcus epidermidis. Staphylococcus
aureus, _
_Streptococcus _
_pyogenes, _
_Proteus _
species,
_Escherichia _
_coli_.
Although
tetracyclines are not the drugs of choice in any staphylococcal or
streptococcal
infection, MINOCIN
®
could be useful in circumstances where these organisms
are shown to be resistant to other agents but sensitive to MINOCIN
®
. Bacterial
evaluation of clinical cases involving proteus suggests a relatively
lower success
r