País: Canadà
Idioma: anglès
Font: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
GLAXOSMITHKLINE INC
J01AA08
MINOCYCLINE
100MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG
ORAL
100/500
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309002; AHFS:
CANCELLED POST MARKET
2012-12-10
_2012-04-16/131-pi-pristine-Minocin.doc_ _ _ _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 Llegiu el document complet