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Fluorometholone + Gentamicin

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 inhibits specifically 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 a risk of potential aggravation of a bacterial infection due to the steroid.

Product Details

Presentation

AFM-Plus Sterile Ophthalmic Suspension: Each ml contains Fluorometholone USP 1 mg & Gentamicin Sulfate USP equivalent to Gentamicin 3 mg.
AFM-Plus Sterile Eye Ointment: Each gram contains Fluorometholone USP 1 mg & Gentamicin Sulfate USP equivalent to Gentamicin 3 mg.

Pharmacology

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 inhibits specifically 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 a risk of potential aggravation of a bacterial infection due to the steroid.

Indication

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

Dosage & Administration

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 ointment before retiring.

Contraindications

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

Eye tuberculosis.

Glaucoma.

Warning & Precautions

Steroids can mask, activate or aggravate ocular infections.

Long term treatment with steroid may enhance thinning of cornea and sclera and rarely perforation of the cornea has been reported.

In case no improvement is observed after 7-8 days of treatment, other therapeutical 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.

Side effects

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 of IOP, develop cataract and cause thinning of cornea & sclera.

Use in special groups

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

Packing

AFM-Plus Sterile Ophthalmic Suspension: Each plastic dropper bottle contains 5 ml ophthalmic suspension.

AFM-Plus Sterile Eye Ointment: Each tube contains 3 g eye ointment.

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