Description
Generics: Fluorometholone + Gentamicin
Dosage Form: Ointment.
Indications:
Inflammation associated with infections in the anterior segment of the eye due to bacteria susceptible to Gentamicin it is also indicated in postoperative infection.
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.
Dosage guideline:
1 drop per hour.
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.
Route of administration: Intraocular.
Interaction:
Specific drug interaction studies have not been conducted.
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.
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.
Pregnancy & Lactation:
No controlled studies in humans are available. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.
Precautions & Warnings:
- 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.
Therapeutic Class:
Ophthalmic steroid – antibiotic combined preparations.
Storage Conditions:
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
Manufactured by: Â Aristopharma Ltd.
