国: カナダ
言語: 英語
ソース: Health Canada
FUSIDIC ACID
AMDIPHARM LIMITED
S01AA13
FUSIDIC ACID
1%
DROPS
FUSIDIC ACID 1%
OPHTHALMIC
0.2G
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0114230001; AHFS:
CANCELLED POST MARKET
2017-07-17
PRODUCT MONOGRAPH PR FUCITHALMIC® Fusidic acid 1% Viscous Eye Drops Topical Ophthalmic Antibiotic Amdipharm Limited Temple Chamber, 3 Burlington Road, Dublin, Dublin 4, Ireland Distributed by: Methapharm Inc. Brantford, Ontario, N3S 7X6 Date of Preparation: MAY 8, 2014 Control No.: 173659 Variation No.: 0 1 Amdipharm is licensed to use the registered trademark Fucithalmic ® _ _ _FUCITHALMIC® (fusidic acid) Product Monograph, version _ _ 1.0 (2014.02.03)_ _ _ _ Page 2 of 28_ PR FUCITHALMIC® Fusidic acid 1% Viscous Eye Drops THERAPEUTIC CLASSIFICATION Topical Ophthalmic Antibiotic ACTION AND CLINICAL PHARMACOLOGY FUCITHALMIC Viscous Eye Drops contain the antibiotic fusidic acid. The antibacterial action of fusidic acid results from the inhibition of bacterial protein synthesis. Fusidic acid interferes with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes. Fusidic acid may be bacteriostatic or bactericidal depending on inoculum size. Although bacterial cells stop dividing almost within two minutes after contact with the antibiotic _in vitro,_ DNA and RNA synthesis continue for 45 minutes and 1- 2 hours, respectively. Fusidic acid has a steroid like structure but does not exhibit any steroid like pharmacological activity (ie. hormonal or anti-inflammatory effects). FUCITHALMIC is a 1% microcrystalline suspension of fusidic acid in a carbomer gel. The sustained release formulation of FUCITHALMIC provides prolonged contact with the eye. Pharmacokinetic studies in humans demonstrated that 1 hour following administration of a single drop of FUCITHALMIC into the fornix of the eye, fusidic acid concentrations in lacrimal fluid ranged between 15.7 to 40 mcg/mL. Fusidic acid concentrations ranged between 1.4 to 5.6 mcg/mL 12 hours after administration. Median antibiotic levels of 0.3 mcg/mL are maintained for 12 hours in aqueous humour. Since high ocular concentrations of fusidic acid are achieved after topical application of FUCITHALMIC, standardized susceptibility tests may not be appropriate to pred 完全なドキュメントを読む