Страна: Канада
Язык: английский
Источник: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
J01AA08
MINOCYCLINE
100MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 100MG
ORAL
100
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309002; AHFS:
CANCELLED POST MARKET
2019-08-01
PRESCRIBING INFORMATION PR SANDOZ MINOCYCLINE Minocycline Hydrochloride Capsules USP 50 mg and 100 mg minocycline Antibiotic USP Sandoz Canada Inc. 110, de Lauzon Street Boucherville, QC J4B 1E6 Date of Revision April 29, 2019 Submission Control Number: 226984 _Sandoz Minocycline _ _ _ _Page 2 of 32_ _ _ COMPLETE PRESCRIBING INFORMATION Pr Sandoz Minocycline minocycline hydrochloride capsules USP 50 mg and 100 mg minocycline THERAPEUTIC CLASSIFICATION Antibiotic ACTION AND CLINICAL PHARMACOLOGY Sandoz Minocycline (minocycline hydrochloride) is a tetracycline with antibacterial activity against some Gram-negative and Gram-positive organisms. The action of minocycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. COMPARATIVE BIOAVAILABILITY STUDIES A comparative two-way cross-over bioavailability study between Sandoz Minocycline 100 mg capsules (Sandoz Canada Inc.) and Minocin 100 mg capsules (GlaxoSmithKline Inc.) was conducted, under fasting conditions, with eighteen (18) healthy male subjects who completed the study. The following results were obtained: MINOCYCLINE (2 X 100 MG) CAPSULES FROM MEASURED DATA ORAL ADMINISTRATION GEOMETRIC MEAN ARITHMETIC MEAN (CV %) PARAMETER TEST * REFERENCE † % RATIO OF GEOMETRIC MEANS CONFIDENCE INTERVALS (90%) AUC T ‡ (mcg·h/mL) 56.09 57.04 (-18.7) 55.54 56.88 (-20.1) 101.0 (91.9-111.0) AUC I (mcg·h/mL) 59.89 61.00 (-19.3) 59.31 60.76 (-20) 101.0 (91.6-111.3) C MAX (mcg·h/mL) 3.67 3.76 (-22.4) 3.75 3.88 (-25) 97.9 (88.1-108.7) T MAX § (h) 1.89 (0.58) 2.03 (-0.4) T ½ 2 (h) 15.8 (-3.24) 16.3 (-2.18) * Sandoz Minocycline, Sandoz Canada Inc. † Minocin, 100 mg capsules, GlaxoSmithKline Inc., formerly known as, Lederle-Cyanamid Canada Inc. §,2 For the T max and T 1/2el parameters these are the arithmetic means with standard deviation in parenthesis. _Sandoz Minocycline _ _ _ _Page 3 of 32_ _ _ INDICATIONS AND CLINICAL USE Sandoz Minocycline (minocycline hydrochloride) may be indicated for the treatment Прочитать полный документ