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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (O's) » Ofloxacin



DESCRIPTION

Tablets and Intravenous Infusion

Floxin Tablets and IV are a synthetic broad-spectrum antimicrobial agent for oral or intravenous administration. Chemically, ofloxacin, a fluorinated carboxyquinolone, is the racemate, (±)-9- fluoro-2,3-dihydro-3-methyl-10- (4-methyl-1-piperazinyl)-7-oxo-7H- pyrido[1,2,3-de]-1,4-benzoxazine -6- carboxylic acid. Its empirical formula is C18H20FN3O4, and its molecular weight is 361.4. Ofloxacin is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin at room temperature, as defined by USP nomenclature, indicate that ofloxacin is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 and freely soluble in aqueous solutions with pH above 9. Ofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu+2 > Ni+2> Pb+2 > Zn+2 > Mg+2> Ca+2 > Ba+2.

Tablets: Floxin tablets contain the following inactive ingredients: anhydrous lactose, corn starch, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and may also contain synthetic yellow iron oxide.

Intravenous Infusion: Floxin IV IN SINGLE-USE VIALS is a sterile, preservative-free aqueous solution of ofloxacin with pH ranging from 3.5 to 5.5. Floxin IV IN PRE-MIXED BOTTLES and IN PRE-MIXED FLEXIBLE CONTAINERS are sterile, preservative-free aqueous solutions of ofloxacin with pH ranging from 3.8 to 5.8. The color of ofloxacin IV may range from light yellow to amber. This does not adversely affect product potency. Ofloxacin IV IN SINGLE-USE VIALS contains ofloxacin in Water for Injection. Floxin IV IN PRE-MIXED BOTTLES and IN PRE-MIXED FLEXIBLE CONTAINERS are dilute, non-pyrogenic, nearly isotonic pre-mixed solutions that contain ofloxacin in 5% Dextrose (D5W). Hydrochloric acid and sodium hydroxide may have been added to adjust the pH.

The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyester (CR3). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

Ophthalmic Solution

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-7H-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.

Ofloxacin ophthalmic 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.

CATEGORIES, BRAND NAMES

CATEGORIES: Bronchitis; Chlamydia; Bronchitis, Chronic; Cystitis; Gonorrhea; Pneumonia; Prostatitis; Respiratory Tract Infections; Sexually Transmitted Diseases; Infection, Skin; Urethritis; Infection, Urinary Tract; Pregnancy Category C; FDA Class 1C (Little or No Therapeutic Advantage); FDA Approved 1990 Dec; Orphan Drugs; Top 200 Drugs

FDA Drug Class: Antibacterials, Miscellaneous; Ocular Anti-Infective/Anti-Inflammatory; Quinolones/Derivatives

BRAND NAMES: Akilen; Baccidal; Bactocin; Danoflox; Effexin; Exocine; Flobacin; Floxan; Floxil; Floxin; Floxstat; Inoflox; Kinoxacin; Loxinter; Occidal; Ocuflox; Oflocet; Oflocin; Orocin; Qinolon; Tabrin; Taravid; Tarivid; Tarivid Eye Ear
(Foreign brand names outside U.S. in italics)

COST OF THERAPY: $48.46 (Urinary Infections; Tablet; 200 mg; 2/day; 7 days)





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