Product Monograph - Optimyxin Ophthalmic Ointment
INDICATIONS
For treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to polymyxin B and bacitracin zinc.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Optimyxin Opthalmic Ointment and other antibacterial drugs, Optimyxin Opthalmic Ointment 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.
Patients who have glaucoma, should not use this product except under the advice and supervision of a physician.
WARNINGS AND PRECAUTIONS
Ophthalmic ointments may retard corneal healing.
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.
Geriatrics: No specific information is available regarding the use of Optimyxin Ophthalmic Ointment in the elderly; however, the maximum dosage should be reduced in cases where a decrease in renal function may exist.
Pregnancy: The clinical benefit of treatment to the patient must be balanced against any possible, but unknown hazards to the fetus. Do not use unless advised by your doctor.
Susceptibility/Resistance
Development of Drug-Resistant Bacteria
Prescribing Optimyxin Opthalmic Ointment in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of resistant organisms.
Potential for Microbial Overgrowth
Prolonged use of Optimyxin Opthalmic Ointment may result in the overgrowth of nonsusceptible organisms and fungi. If such infections occur, discontinue use and institute alternative therapy.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
If toxic symptoms develop following significant systemic absorption, treatment with Optimyxin Ophthalmic Ointment should be stopped and the patient's general status, renal function and neuromuscular function should be monitored and blood levels of polymyxin B sulfate and bacitracin zinc determined.
DOSAGE AND ADMINISTRATION
Adult Dose: 2 to 5 applications daily for 7 days.
Optimyxin Ophthalmic Ointment 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.
DOSAGE FORMS, COMPOSITION AND PACKAGING
Medicinal ingredients: Each g contains polymyxin B (as sulfate) 10 000 units and bacitracin (as zinc) 500 units.
Nonmedicinal ingredients: Light mineral oil, petrolatum.
Optimyxin Ophthalmic Ointment is available in tube of 3.5 g.
Store between 15 and 30°C.
Discard within 30 days from opening.