Drug Information for Ofloxacin (Ranbaxy Pharmaceuticals Inc.): DESCRIPTION

Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent for oral 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. The structural formula is:

Its molecular formula is C ₁₈H₂₀FN₃O₄, and its molecular weight is 361.4. Ofloxacin USP 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 (solubility falls to 4 mg/mL) 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.

Each tablet for oral administration contains 200 mg, 300 mg or 400 mg of ofloxacin USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, anhydrous lactose, magnesium stearate, polyethylene glycol, polysorbate 80, corn starch, sodium starch glycolate, talc and titanium dioxide.