Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
RANBAXY PHARMACEUTICALS CANADA INC.
J01AA08
MINOCYCLINE
100MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG
ORAL
10/500
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309002; AHFS:
APPROVED
2012-07-27
_RAN-MINOCYCLINE (minocycline hydrochloride) Product Monograph Page 1 of 35_ PRESCRIBING INFORMATION PR RAN™-MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) CAPSULES 50 MG AND 100 MG MINOCYCLINE (AS MINOCYCLINE HYDROCHLORIDE) USP ANTIBIOTIC Ranbaxy Pharmaceuticals Canada Inc. 126 East Drive Brampton, Ontario L6T 1C1 Date of Revision: November 7, 2018 Submission Control Number: 220690 _ _ RAN trademark owned by Sun Pharmaceutical Industries Ltd. _ _ _ _ _ _ _ _ _RAN-MINOCYCLINE (minocycline hydrochloride) Product Monograph Page 2 of 35_ COMPLETE PRESCRIBING INFORMATION Pr RAN™-MINOCYCLINE (minocycline hydrochloride) THERAPEUTIC CLASSIFICATION Antibiotic ACTIONS Minocycline hydrochloride is a tetracycline with antibacterial activity against some Gram-negative and Gram-positive organisms. The action of RAN-MINOCYCLINE is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. INDICATION AND CLINICAL USES RAN-MINOCYCLINE (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, minocycline 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 minocycline could be useful in circumstances where these organisms are shown to be resistant to other agents but sensitive to minocycline. Bacterial evaluation of clinical cases involving proteus suggests Aqra d-dokument sħiħ