Država: Kanada
Jezik: engleski
Izvor: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
TEVA CANADA LIMITED
J01AA08
MINOCYCLINE
100MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG
ORAL
10/100/500
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309002; AHFS:
CANCELLED POST MARKET
2020-09-25
PRESCRIBING INFORMATION Pr TEVA-MINOCYCLINE (Minocycline Hydrochloride) 50 mg and 100 mg Capsules USP Antibiotic Teva Canada Limited Date of Revision: 30 Novopharm Court January 24, 2019 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control No.: 220692 – 1 – PRESCRIBING INFORMATION Pr TEVA-MINOCYCLINE (Minocycline Hydrochloride) 50 mg and 100 mg capsules USP THERAPEUTIC CLASSIFICATION Antibiotic ACTION & CLINICAL PHARMACOLOGY TEVA-MINOCYCLINE (minocycline hydrochloride), a tetracycline antibiotic, has activity against some gram-negative and gram-positive organisms. The antibacterial effect of minocycline is primarily bacteriostatic and is thought to act by inhibiting protein synthesis. Two comparative, two-way bioavailability studies were conducted in 13 normal volunteers on two 50 mg minocycline capsule products, TEVA-MINOCYCLINE 50 mg capsules and MINOCIN 50 mg capsules and two 100 mg minocycline capsule products. The pharmacokinetic data calculated for the TEVA-MINOCYCLINE and MINOCIN capsule formulations is tabulated below. 50 mg Formulation: Geometric Mean Arithmetic Mean (C.V.) TEVA- MINOCYCLINE 4 x 50 mg MINOCIN ® 4 x 50 mg Percentage of MINOCIN ® AUC T (ng·h/mL) 48533 49008 (14) 54176 54762 (18) 90 – 2 – AUC I (ng·h/mL) 51021 51552 (15) 56954 57848 (18) 90 Cmax (ng/mL) 2697 2714 (14) 2835 2875 (17) 95 T max * (h) 2.00 (0.79) 2.04 (0.75) -- t ½ * (h) 16.6 (1.5) 17.2 (1.8) -- * These are arithmetic means (Standard Deviation) 100 mg Formulation: Geometric Mean Arithmetic Mean (C.V.) TEVA- MINOCYCLINE 2 x 100 mg MINOCIN ® 2 x 100 mg Percentage of MINOCIN ® AUC T (ng·h/mL) 49021 49931 (22) 51022 51955 (18) 96 AUC I (ng·h/mL) 52052 53145 (23) 54721 55479 (19) 95 Cmax (ng/mL) 2697 2743 (22) 2752 2776 (16) 98 T max * (h) 2.04 (0.75) 2.25 (0.69) -- t ½ * (h) 17.9 (2.9) 18.3 (2.4) -- * These are arithmetic means (Standard Deviation) INDICATIONS & CLINICAL USE TEVA-MINOCYCLINE (minocycline hydrochloride) may be indicated for the treatment of the following infections due to susceptib Pročitajte cijeli dokument