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Ofly V & Ofly (Ophthalmic Solution & Ointment)

 

COMPOSITION

Ophthalmic solution:
Each ml contains:
Ofloxacin U.S.P. ……………. 3.0 mg.
Polyvinyl Alcohol U.S.P. … 14.0 mg.
with: Benzalkonium chloride 0.005%, sodium chloride, sodium acetate, edetate disodium and purified water.
Ophthalmic Ointment:
Each gm contains:
Ofloxacin U.S.P. ……………. 3.0 mg.
with: Mineral oil, white petrolatum & lanolin alcohol. (Preservative Free)

DESCRIPTION

Ofloxacin is a fluoroquinolone antibacterial agent with a broad spectrum of activity. Chemically it is (±)-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. Polyvinyl alcohol is a synthetic resin. It is a nonionic surfactant that is used as eye lubricant.

INDICATIONS

Ofly-V / Ofly is indicated for the treatment of infections caused by the susceptible strains of micro-organisms in the following conditions.

CONJUNCTIVITIS

Gram positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.
Gram negative bacteria: Enterobacter cloacae, Heaemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa.

CORNEAL ULCERS

Gram positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.
Gram negative bacteria: Pseudomonas aeruginosa, Serratia marcescens.*
Anaerobic species: Propionibacterium acnes.
* Efficacy for this organism was studied in fewer than 10 infections.

CONTRAINDICATIONS

It is contraindicated in patients with a history of hypersensitivity to Polyvinyl alcohol, Ofloxacin and other quinolone derivatives.

ADVERSE EFFECTS

The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.

WARNINGS: NOT FOR INJECTION

It should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

PRECAUTIONS

As with other anti-infectives, prolonged use may result in overgrowth of non susceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

Pregnancy: There are however, no adequate and well controlled studies in pregnant women. Ofloxacin should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Ofloxacin is excreted in human milk following topical ophthalmic adminstration. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established.

DOSAGE

Ophthalmic solution: 1 to 2 drops into the conjunctival sac(s) every 2 to 4 hours for the first two days, and then four times daily in the affected eye(s) for up to one week not exceeding ten days.
Ophthalmic Ointment: Apply a small amount (app. 1/2 inch ribbon) into the conjunctival sac(s) four times daily.

HOW SUPPLIED

Ofly-V Ophthalmic Solution is available as a sterile solution in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated).

Ofly Ophthalmic Ointment is available as a sterile ointment in 3.5 gm ophthalmic tube (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store between 15°C to 30°C. After opening the bottle, use within 4 weeks.