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Ofloxacin Ophthalmic Solution

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Ofloxacin Ophthalmic Solution

OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%

DRUG DESCRIPTION

Ofloxacin Ophthalmic Solution USP, 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-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-car boxy lie acid.

Contains: Active: ofloxacin 0.3% (3 mg/mL);

Preservative: benzalkonium chloride (0.005%);

Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Ofloxacin Ophthalmic Solution USP, 0.3% 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.

Ofloxacin  Structural Formula Illustration

C18H20FN3O4 ...................... Mol wt. 361.37

Last reviewed on RxList: 1/21/2009
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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