Product Monograph - Optimyxin
INDICATIONS
Optimyxin is used topically in the treatment of superficial infection of the eye involving the conjunctiva and cornea. Topical therapy alone is usually adequate for the treatment of blepharitis, conjunctivitis and keratitis. It can also be used before and after eye surgery or removal of foreign bodies in the eye.
Optimyxin is also used topically in the treatment of superficial and ear infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OPTIMYXIN and other antibacterial drugs, OPTIMYXIN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
CONTRAINDICATIONS
Hypersensitivity to any of the components. Not to be administered subconjunctivally.
Patients who have glaucoma, should not use this product except under the advice and supervision of a physician.
WARNINGS AND PRECAUTIONS
As with any medication containing an antibiotic, prolonged use may result in the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, the preparation should be discontinued and/or appropriate therapy instituted.
If the symptoms do not start to clear in 48 hours, discontinue use and medical consultation is indicated.
The overuse of this product may increase redness of the eye.
Patients who experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists should consult a physician.
The vision may be blurred for a few minutes after using the product. Patient should not drive or operate machinery until vision returns.
Susceptibility/Resistance
Development of Drug Resistant Bacteria
Prescribing OPTIMYXIN 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
Prolonged use of OPTIMYXIN may result in overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy.
DOSAGE AND ADMINISTRATION
Optimyxin is a clear, non-irritation solution. It can be safely used in children and adults. The suggested dosage is one or two drops in the infected eye or ear, two to four times a day or more frequently as required.
If the appearance of the solution changes colour or becomes cloudy, discontinue use of the solution.
Optimyxin should be used only externally.
Administration
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of the solution.
To prevent the eye drops from being drained from the eye, a gentle pressure to the inside corner of the eye with the fingers should be applied for a minute.
To administer the drops into the ear, tilt the head or lie on the side, remain in this position for two minutes after administering the drops. For therapy to be most effective, the ear canal should be clean and dry.
DOSAGE FORMS, COMPOSITION AND PACKAGING
Medicinal ingredients: Each mL contains Polymyxin B (as sulfate) 10000 units and gramicidin 0.025 mg.
Non-medicinal ingredients: benzalkonium chloride 0.005% (preservative), boric acid, ethyl alcohol, poloxamer 188, sodium hydroxide, water for injection.
Optimyxin is available in a 10 mL plastic dropper bottle.
Store between 15 and 30 oC.
Discard within 30 days from opening.