Ország: Kanada
Nyelv: angol
Forrás: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
SANIS HEALTH INC
J01AA08
MINOCYCLINE
100MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG
ORAL
100/250
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309002; AHFS:
CANCELLED POST MARKET
2018-07-16
- 1 - PRODUCT MONOGRAPH PR MINOCYCLINE (Minocycline Hydrochloride Capsules USP) 50 MG & 100 MG AS MINOCYCLINE BASE Antibiotic SANIS HEALTH INC. 1 President's Choice Circle Brampton, Ontario L6Y 5S5 Date of Revision: May 10, 2018 Control#: 215156 - 2 - COMPLETE PRESCRIBING INFORMATION PRODUCT MONOGRAPH PR MINOCYCLINE (Minocycline Hydrochloride Capsules, USP) THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION MINOCYCLINE is a tetracycline with antibacterial activity against some Gram-negative and Gram-positive organisms. The action of MINOCYCLINE is primarily bacteriostatic and it is thought to exert its antimicrobial effect by the inhibition of protein synthesis. The bioavailability study was performed on healthy volunteers using MINOCYCLINE 100 mg capsules. The rate and extent of absorption of Minocycline Hydrochloride after a single dose of 100 mg MINOCYCLINE and the marketed brand was measured and compared. The pharmacokinetic data are presented in the table below: Geometric Mean Arithmetic Mean (C.V. %) PARAMETER MINOCYCLINE 100 MG CAPSULES (SANIS HEALTH INC.) MINOCIN® 100 MG CAPSULES (LEDERLE CYANAMID, CANADA) RATIO OF MEANS % AUC 0-t (ng hr/mL) 10013.46 10290.9 (22. 4%) 10274.29 10541.2 (23.0 %) 97.5 % (97.6%)** 97.6 % AUC inf (ng hr/mL) 12050.56 12292.1 (19.9 %) 10274.29 10541.2 (23.0 %) 97.6 % (97.7 %)** 97.6 % C max (ng/mL) 698.06 711.66 (19.6 %) 737.61 745.30 (14.6 %) 94.6% (94.7%)** 95.5 % T max * (h) 1.729 (47.5%) 1.901 (43.4 %) N/A T ½ * (h) 14.70 (19.8 %) 15.00 (17.4 %) N/A * for Tmax and T½ arithmetic mean (C.V. %) are presented. **the potency corrected ratio of means of the test product - 3 - INDICATIONS AND CLINICAL USE 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_ Olvassa el a teljes dokumentumot