देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ofloxacin (UNII: A4P49JAZ9H) (ofloxacin - UNII:A4P49JAZ9H)
Allergan, Inc.
ofloxacin
ofloxacin 3 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
OCUFLOX® ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: *Efficacy for this organism was studied in fewer than 10 infections OCUFLOX® solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see Warnings).
OCUFLOX® (ofloxacin ophthalmic solution) 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 11980-779-05 Note: Store at 15°-25°C (59°-77°F) Rx only Revised: 04/2017 © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Irvine, CA 92612, U.S.A. Made in the U.S.A. 71589US13
New Drug Application
OCUFLOX- OFLOXACIN SOLUTION/ DROPS ALLERGAN, INC. ---------- OCUFLOX (OFLOXACIN OPHTHALMIC SOLUTION) 0.3% STERILE DESCRIPTION OCUFLOX (ofloxacin ophthalmic solution) 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. CHEMICAL NAME: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7_H_- pyrido[1,2,3-_de_]-1,4-benzoxazine-6-carboxylic acid. CONTAINS: ACTIVE: ofloxacin 0.3% (3 mg/mL). PRESERVATIVE: benzalkonium chloride (0.005%). INACTIVES: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. OCUFLOX solution is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. CLINICAL PHARMACOLOGY PHARMACOKINETICS Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with OCUFLOX solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days. Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin. ® ® ® ® Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g. Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of OCUFLOX ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified. MICROBIOLOGY Ofloxacin has _in vitro_ activity against पूरा दस्तावेज़ पढ़ें