Composition:

Each 1g Sterile Ophthalmic ointment contains Gentamicin sulfate, equivalent to 3mg Gentamicin base.

Pharmacological properties:

Genoph is a sterile, topical anti-infective agent for ophthalmic use. The active ingredient, gentamicin sulfate, is aminoglycoside antibiotic, it is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Indications:

Genoph is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis.

Contraindications:

Gentamicin ophthalmic ointment is contraindicated in patients with known hypersensitivity to any of the components.

Warnings and precautions:

• Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms, including fungi. Bacterial resistance to gentamicin may also develop.
• If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
• If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted.
• Ophthalmic ointments may retard corneal healing.
• To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Use in pregnancy:

Pregnancy category C: Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adverse reactions:

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

The most frequently reported adverse reactions are ocular: burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

Dosage and administration:

Apply a small amount (about 1 cm) of ointment to the affected eye two to three times a day.