Product Monograph - Odan-Gentamicin
INDICATIONS
ODAN-GENTAMICIN is indicated for the treatment of superficial bacterial infections of the conjunctiva, cornea, eye lids, tear ducts and skin adjacent to the eye. Such infections include conjunctivitis, blepharitis, blepharo-conjunctivitis, keratitis, episcleritis, corneal ulcers, dacryocystitis and infected eye sockets. Also, for prophylaxis to prevent ocular infection after burns, laceration or other injury to the eye, lids or adjacent areas vulnerable to infection (whether caused by physical means or chemical agents) or after removal of foreign bodies and before and after surgery.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ODAN-GENTAMICIN and other antibacterial drugs, ODAN-GENTAMICIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
CONTRAINDICATIONS
ODAN-GENTAMICIN is contraindicated to individuals hypersensitive to gentamicin or other components of the product.
PRECAUTIONS
Clinical studies have shown that organisms previously sensitive to gentamicin have become resistant during therapy. Although this has occurred infrequently, the possibility should nevertheless be considered. There is evidence that cross-resistance between gentamicin and the aminoglycoside antibiotics may occur However, gentamicin may be active against clinical isolates of bacteria resistant to other aminoglycosides and other aminoglycoside may be active against resistant strains. Patients should be advised to avoid contaminating the applicator tip during use.
Pregnancy & Lactation
The safety of gentamicin for use during pregnancy has not been established. Since it is not known whether components of gentamicin Ophthalmic Solution are excreted in human milk, caution should be exercised when administered to a nursing woman.
Use in Children
Safety and effectiveness in children below the age of six years have not been established.
Susceptibility/Resistance
Development of Drug Resistant bacteria
Prescribing ODAN-GENTAMICIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant organisms.
Potential for Microbial Overgrowth
Use of topical antibiotics occasionally allows overgrowth of non-susceptible organisms, such as fungi. If this occurs, or if irritation or sensitization develops, use should be discontinued and appropriate therapy instituted.
ADVERSE REACTIONS
ODAN-GENTAMICIN may sting briefly on application. After application, sensitization or allergy is unlikely, however the possibility of such an adverse effect should be kept in mind, and the patient observed accordingly.
OVERDOSE
Symptoms: A single overdose of gentamicin would not be expected to produce symptoms.
Treatment: Although a single overdose is not expected to require treatment, gentamicin can be removed from the blood by hemodialysis or peritoneal dialysis.
DOSAGE AND ADMINISTRATION
Instill 2 drops into the conjunctival sac or apply a small quantity of the ointment to the affected eye(s) 3 or 4 times daily. Dosage may be increased in severe infections and reduced at the end of treatment. In the infections that may intermittently develop in the immature tear ducts of children (dacryocystitis), hot compresses and massage of the area over the tear duct may be useful adjuncts to ODAN-GENTAMICIN therapy.
AVAILABILITY
ODAN-GENTAMICIN Ophthalmic Solution: (5mg gentamicin sulfate/ml, equivalent to 3 mg gentamicin /mL (0.3%)) is supplied in in plastic dropper bottles of 5 ml.
ODAN-GENTAMICIN Ophthalmic Ointment: contains 5 mg/g gentamicin sulfate, equivalent to 3 mg/g gentamicin (0.3%) and supplied in a tube of 3.5 g.
STORAGE
Store between 2 and 30°C.