国家: 加拿大
语言: 英文
来源: Health Canada
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE)
AA PHARMA INC
J01AA08
MINOCYCLINE
50MG
CAPSULE
MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) 50MG
ORAL
100/250
Prescription
TETRACYCLINES
Active ingredient group (AIG) number: 0131309001; AHFS:
APPROVED
2019-09-27
Page 1 of 30 PRESCRIBING INFORMATION PR MINOCYCLINE MINOCYCLINE HYDROCHLORIDE CAPSULES USP 50 MG AND 100 MG ANTIBIOTIC AA PHARMA INC. 1165 CREDITSTONE ROAD, UNIT #1, VAUGHAN, ONTARIO L4K 4N7 CONTROL NUMBER: 230823 DATE OF REVISION: September 27, 2019 Page 2 of 30 COMPLETE PRESCRIBING INFORMATION Pr MINOCYCLINE Minocycline Hydrochloride THERAPEUTIC CLASSIFICATION Antibiotic ACTIONS 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 A single-dose, standard two-way crossover bioavailability study was performed using normal human volunteers. The rate and extent of absorption of minocycline after a single oral dose of 200 mg given as either two 100 mg MINOCIN capsules or as two 100 mg MINOCYCLINE capsules was measured and compared. The results are summarized as follows: MINOCYCLINE MINOCIN PERCENTAGE OF MINOCIN AUC r * (mcg•hr/ml} 62.08 (22) 62.79 (16) -1.1 AUC r * (mcg • hr/ml) 66.56 (23) 66.99 (17) -0.6 C max * {mcg/ml} 3.52 (18) 3.49 (17) +0.9 T max ** (hr} 2.35 (0.71) 2.28 (0.83) +3.1 t 1/2 ** {hr} 18.62 (3.39) 18.11 (3.02) +2.8 INDICATION AND CLINICAL USES 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 gonorrhoeae_. When penicillin is contraindicated, minocycline may be employed as an alternative drug in the treatment of anal and pharyngeal gonorrhea and syphilis. Skin and soft tissue infections: abscess, cellulitis, furunculosis, impetigo and pyoderma caused by: _Staphylococcus epidermidis_. _Staphylococcus aureus, Streptoco 阅读完整的文件