Product Description:

Oftalmolosa® Cusi Gentamicin 0.3%

Used for:

Infections of the anterior pole of the eye caused by germs sensitive to gentamicin; corneal ulcers and

corneal bacterial abscesses. Conjunctivitis. Keratitis. Staphyloccocia. Blepharitis. Dacryocystitis.

Preoperative sterilization of the conjunctiva.

How to use:

Normally two or three applications daily.

The number of daily applications and length of treatment can be modified in accordance with

physician’s criteria.

Paediatric population

Safety and effectiveness in the paediatric population have not been established.

Correct administration procedure:

Application to the inside of the eye:

Separate the eyelids from the eye and apply a small amount (approximately a grain of rice) of ointment

into the conjunctival sac.

Application to the outside of the eye:

Soften and remove crusts with warm water, and apply the product directly onto the affected area.

Application of the ointment should be carried out under hygienic conditions. Do not touch the tube tip

to any surface. Close tube after every application.

Method of administration:

• For ocular use only.

• To prevent contamination of the dropper tip and solutions, care must be taken not to touch the

eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Instruct patients to keep

the bottle tightly closed when not in use.

• If more than one topical ophthalmic product is being used, the products must be administered

at least 5 minutes apart. Eye ointments should be administered last.

Caution & Warnings:

Sensitivity to topically administered aminoglycosides may occur in some patients. Severity of

hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching,

urticarial, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity

develops during use of this medicine, treatment should be discontinued. (See Section 4.8)

• Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who

become sensitized to topical gentamicin may also be sensitive to other topical and/or systemic

aminoglycosides should be considered.

• Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred

in patients receiving systemic aminoglycoside therapy or when applied topically to open wounds or

damaged skin. Although these effects have not been reported following topical ocular use of

gentamicin, caution is advised when used concomitantly.

• Prolonged use of OFTALMOLOSA® CUSÍ Gentamicin 0.3% may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated

Ingredients:

mg/g Ointment: 1 g ointment contains 5 mg gentamicin sulphate (equivalent to 3 mg gentamicin)