Generic Name

Composition

Therapeutic Category

Division

Ofloxacin E/E drops

Ofloxacin 0.3% w/v Eye/Ear Drops

Fluoroquinolone Antibiotic

TIME

    BRAND COMPOSITION DESCRIPTION
     OFROX E/E Drops Ofloxacin USP                      0.3%w/v Filled volume 5 ml. Clear Colourless solution filled in a 10.25 ml overflow capacity gamma sterilized Lupolene vials plugged with gamma sterilized inner seal and capped with gamma sterilized caps.


    Pharmacology

     Pharmacodynamic Properties:

    Ofloxacin is a fluoroquinolone which inhibits bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination. It has activity against a wide range of gram-negative and gram-positive microorganisms.

     Pharmacokinetic Properties:

    The concentrations ranged from 1.2 to 602 μg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 μg/g, n=13) 30 minutes after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes.

    The mean serum ofloxacin concentration  ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days.

     INDICATIONS

    Bacterial eye infections as conjunctivitis, corneal ulcers, ear infections 

    DOSAGE & ADMINISTRATION

    Bacterial conjunctivitis:  As 0.3% solution: Instill 1-2 drops 2-4 hourly for 1st 2 days, then 4 times/day for the next 5 days. 

    In the treatment of ear infections:Apply 10 drops of 0.3% solution in the affected ear once daily for seven days. Lie with the affected ear upwards for 5 min to facilitate penetration in the ear canal.

     ADVERSE DRUG REACTIONS

    After the ophthalmic use the most frequently reported drug related adverse effects are ocular burning or discomfort. Other effects include stingling, redness, itching, tearing, dryness and eye pain.

    Irritation, dryness, earache, headache, vertigo may occur following otic use of OFROX Drops.

     PRECAUTIONS

    Prolonged use of antibiotic may result in over growth of nonsusceptible organisms. If super infection occurs discontinue use and institute alternate therapy. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

     CONTRAINDICATIONS

    Contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones or to any of the components used in this medication.

     PRESENTATION

    OFROX E/E DROPS: Each vial contains5ml of drops