Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin. It is also indicated in postoperative infection.

Gentamicin belongs to the group of aminoglycoside antibiotics. It covers a broad spectrum of gram-positive and gram-negative pathogens, including Pseudomonas aeruginosa, Staphylococci, Haemophilus influenzae, H. aegypticus, Klebsiella, Enterobacteria, Proteus, Escherichia coli, Shigella, and Salmonella. It specifically inhibits bacterial protein synthesis. Fluorometholone is a synthetic fluorinated corticosteroid possessing anti-inflammatory properties. The combination brings concomitantly the bacterial treatment or prophylaxis and the anti-inflammatory effect. In addition, the presence of gentamicin protects from the risk of potential aggravation of a bacterial infection due to the steroid.

Sterile Ophthalmic Suspension:

• Bacterial infection: The dosage depends on the severity of the disease. The application of 1 drop 5 times daily into the conjunctival sac of the affected eye is recommended. In severe cases, the dosage can be increased up to 1 drop per hour for 1 to 2 days.
• Ocular postoperative infection: 1 drop 4 times daily into the conjunctival sac for 1 week. Then a reduced application frequency is recommended for the remaining part of the treatment.

Sterile Eye Ointment:

• Bacterial infection: Apply 3-4 times daily into the affected eye.
• Ocular postoperative infection: To support the therapy with Ophthalmic Suspension during the night, apply the ointment before retiring.

• Hypersensitivity to any of the components. Injuries and ulceration of the cornea. Viral infections (e.g., Herpes simplex, Vaccinia) or mycosis.
• Eye tuberculosis.
• Glaucoma.

A transient burning sensation may occur after instillation. Rare: Hypersensitivity reactions including eczema of the eyelid and puncture keratitis. Prolonged use of topical steroids may delay wound healing, increase intraocular pressure (IOP), develop cataracts, and cause thinning of the cornea and sclera.

No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

• Steroids can mask, activate, or aggravate ocular infections.
• Long-term treatment with steroids may enhance thinning of the cornea and sclera, and rarely, perforation of the cornea has been reported.
• If no improvement is observed after 7-8 days of treatment, other therapeutic means should be considered.
• Patients experiencing blurred vision after application of the product, particularly the ointment, should refrain from driving vehicles or operating machinery.
• Contact lenses should be removed before each application.

Ophthalmic steroid - antibiotic combined preparations

Store in a cool and dry place, protect from light. Do not use longer than 30 days after first opening. Keep out of reach of children.