País: Canadà
Idioma: anglès
Font: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
J01AA08
MINOCYCLINE
50MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 50MG
ORAL
100/250
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309001; AHFS:
CANCELLED POST MARKET
2019-09-17
- 1 - PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYLAN-MINOCYCLINE (Minocycline Hydrochloride Capsules USP) 50 MG & 100 MG AS MINOCYCLINE BASE Antibiotic Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Revision: December 14, 2018 Control#: 220688 - 2 - PR MYLAN-MINOCYCLINE (Minocycline Hydrochloride Capsules, USP) THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION MYLAN-MINOCYCLINE is a tetracycline with antibacterial activity against some Gram-negative and Gram-positive organisms. The action of MYLAN-MINOCYCLINE is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. COMPARATIVE BIOAVAILABILITY The bioavailability study was performed on healthy volunteers using MYLAN-MINOCYCLINE 100 mg capsules. The rate and extent of absorption of Minocycline Hydrochloride after a single dose of 100 mg MYLAN-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 MYLAN-MINOCYCLINE 100 MG CAPSULES (MYLAN PHARMACEUTICALS ULC) 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 MYLAN-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 Llegiu el document complet