Levobac TS 5ml

Indications

Levobac^TM TS is indicated for the treatment of corneal ulcer caused by susceptible strains of bacteria.

Dosage & Administration

Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring. Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.

Side Effects

The most frequently reported adverse events in the overall study population were headache and a taste disturbance following instillation. These events occurred in approximately 8-10% of patients. Adverse events occurring in approximately 1-2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation. Other reported ocular reactions occuning in less than 1% of patients included chemosis, corneal erosion, corneal ulcer, diplopia, floaters, hyperemia, lid edema, and lid erythema.

Precautions

As with other anti-invectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use in Nursing Mothers: Levofloxacin has not been measured in human milk. Based upon data from Ofloxacin, it can be presumed that Levofloxacin is excreted in human milk. Caution should be exercised when LevobacTM TS is administered to a nursing mother. Pediatric Use: Safety and efficacy in children below the age of 6 years have not been established.

Contraindications

Levobac^TM TS is contraindicated in persons with a known hypersensitivity to Levofloxacin, to other quinolones, or to any other component of this product.