Ofloxacin tablets are indicated for the treatment of mild to moderate infections in adults caused by susceptible organisms.

• Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis, lung abscess, and pneumonia.
• Gastrointestinal Tract: Enteric fever and shigellosis.
• Multi-drug-resistant Tuberculosis: Used as part of combination therapy.
• Skin and Skin Structure Infections: Uncomplicated infections of the skin and related structures.
• Sexually Transmitted Diseases: Acute, uncomplicated urethral and cervical gonorrhoea; nongonococcal urethritis and cervicitis.
• Mixed infections of the urethra and cervix.
• Urinary Tract: Uncomplicated and complicated urinary tract infections.

Ofloxacin Eye & Ear Drops:

Eye: Indicated for the treatment of external eye infections such as acute and sub-acute conjunctivitis, keratitis, keratoconjunctivitis, blepharoconjunctivitis, blepharitis, corneal ulcer, and for pre-operative prophylaxis in ocular surgery.

Ear: Indicated for the treatment of external ear infections (otitis externa) and certain middle ear infections (otitis media).

Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a broad range of Gram-negative and Gram-positive organisms. It exerts its antibacterial effect by inhibiting DNA gyrase, an essential bacterial enzyme involved in the replication, transcription, and repair of bacterial DNA. After oral administration, ofloxacin is rapidly and well absorbed from the gastrointestinal tract. The bioavailability of the tablet formulation is nearly 100%. It is widely distributed throughout body tissues and fluids. The elimination half-life ranges from approximately 4.6 to 6.9 hours. Up to 80% of an oral dose is excreted in the urine as unchanged drug within 48 hours.

General dosage recommendations: The dosage of ofloxacin depends on the type and severity of the infection. For adults, the usual daily dose ranges from 200 mg to 800 mg. Doses of up to 400 mg may be taken as a single dose, preferably in the morning. Higher doses should be administered in two divided doses. Ofloxacin tablets should be swallowed with an adequate amount of liquid. They should not be taken within two hours before or after magnesium- or aluminium-containing antacids, or iron preparations, as these may reduce the absorption of ofloxacin.

• Enteric fever: Adults: 200 mg every 12 hours for 5 days. Children: 15 mg/kg/day in 2 divided doses for 3 days.
• Shigellosis: 400 mg as a single dose.
• Multidrug-resistant tuberculosis: 400 mg twice daily, together with conventional anti-tuberculosis medicines.
• Lower respiratory tract infections: 400 mg daily, which may be increased to 400 mg twice daily if necessary.
• Uncomplicated urinary tract infections: A single dose of 200 mg or 400 mg.
• Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
• Nongonococcal urethritis and cervicitis: 400 mg daily, given either as a single dose or in divided doses.
• Complicated urinary tract infections: 200 mg to 400 mg daily for 7 days.
• Patients with impaired liver function: Excretion of ofloxacin may be reduced in patients with severe hepatic dysfunction.
• Children: Ofloxacin is generally not recommended for children or growing adolescents.
• Elderly: No dosage adjustment is usually required in elderly patients.

Ofloxacin Eye & Ear Drops

• Eye: Instill 1 drop into the affected eye(s) every 2 to 4 hours for the first 2 days, then 4 times daily. The duration of treatment should not exceed 10 days.
• Ear:Instill 1 to 2 drops into the affected ear(s) twice daily, or as directed.

Antacids containing magnesium, aluminium, or calcium may reduce the absorption of ofloxacin. Similarly, iron or zinc preparations may also decrease the oral absorption of ofloxacin.

Ofloxacin should not be used in patients with known hypersensitivity to ofloxacin or other 4-fluoroquinolone antibacterial agents. It is also contraindicated in patients with a history of epilepsy or in those with a reduced seizure threshold. In general, ofloxacin is contraindicated in children and growing adolescents, as well as in pregnant or breastfeeding women.

Ofloxacin tablets are generally well tolerated, and the incidence of clinical side effects is relatively low. The most commonly reported adverse effects involve the gastrointestinal system and the central nervous system. Gastrointestinal side effects: Nausea, vomiting, abdominal pain, diarrhoea, rash, and general gastrointestinal discomfort. Central nervous system side effects: Headache, dizziness, and insomnia.

Eye: Transient ocular irritation, burning, stinging, redness, itching, or photophobia may occur.

Ear: Mild irritation or discomfort in the ear may occur. Signs of an allergic reaction may include rash, itching, swelling, or difficulty breathing.

The safety of ofloxacin during pregnancy has not been established. It is not known with certainty whether ofloxacin is excreted into breast milk, as adequate data are not available.

Patients receiving ofloxacin should avoid unnecessary exposure to strong sunlight and UV radiation. Caution should be exercised when ofloxacin is used in patients with psychotic disorders or in those with a history of psychiatric illness.

Prolonged use of ofloxacin eye drops or ear drops may lead to the overgrowth of non-susceptible organisms and may result in secondary infection.

4-Quinolone preparations; aural antibacterial preparations

Store at a temperature between 15°C and 30°C. Protect from light.