Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
PHARMASCIENCE INC
J01AA08
MINOCYCLINE
100MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG
ORAL
100
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309002; AHFS:
CANCELLED POST MARKET
2019-10-23
PRODUCT MONOGRAPH PR PMS-MINOCYCLINE (Minocycline Hydrochloride Capsules USP) 50 MG & 100 MG AS MINOCYCLINE BASE Antibiotic PHARMASCIENCE INC. 6111 Royalmount Ave., Suite #100 Montréal, Québec H4P 2T4 www.pharmascience.com Date of Revision: September 04, 2018 Control#: 219639 - 2 - COMPLETE PRESCRIBING INFORMATION PRODUCT MONOGRAPH PR PMS-MINOCYCLINE (Minocycline Hydrochloride Capsules, USP) THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION pms-MINOCYCLINE is a tetracycline with antibacterial activity against some Gram- negative and Gram-positive organisms. The action of pms-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 pms-MINOCYCLINE 100 mg capsules. The rate and extent of absorption of Minocycline Hydrochloride after a single dose of 100 mg pms-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 PMS-MINOCYCLINE 100 MG CAPSULES (PHARMASCIENCE 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 INDICATIONS AND CLINICAL USE pms-MINOCYCLINE (minocycline hydrochloride) may be indicated for the treatment of the following infections due to susceptible strains of the designated organisms: - 3 - Gall bladder infections caused by Escherichia coli. Urinary tract infections: cystitis, gonorrhea, pyelonephritis caused by _Escherichia coli, _ _Proteus species, Kl Perskaitykite visą dokumentą