MYDRIACYL

What it is

MYDRIACYL is available as tropicamide 0.5% eye drops or 1.0% eye drops . The product is a sterile, multi-dose ophthalmic solution for topical administration in the eye . The solution is preserved with benzalkonium chloride (0.01%) .

Approved indications

— Mydriasis and cycloplegia for diagnostic purposes .

Dosing overview

For refraction, instil one or two drops of 1% solution in the eye(s), repeated in five minutes . If the patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong the mydriatic effect . For examination of fundus, instil one or two drops of 0.5% solution, 15 or 20 minutes prior to examination . Individuals with heavily pigmented irides may require higher strength or more doses . To minimise systemic absorption, apply pressure to the tear duct for one minute immediately after administration . If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart .

Key safety warnings

Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma and the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure should be considered, and an estimate of the depth of the angle of the anterior chamber should be made before use . Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Parents should be warned of the oral toxicity of this preparation for children and advised to wash their hands and the child's hands after use . Use with extreme caution in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage. Do not use in concentrations greater than 0.5% in small infants . Tropicamide may cause drowsiness and blurred vision. Patients are advised not to drive or engage in potentially hazardous activities whilst the pupils are dilated unless vision is clear. Patients may experience sensitivity to light and should protect their eyes in bright illumination when their pupils are dilated . MYDRIACYL contains the preservative benzalkonium chloride which may cause eye irritation and is known to discolour and may be deposited in soft (hydrophilic) contact lenses. Patients who wear soft contact lenses should remove their lenses prior to instilling MYDRIACYL Eye Drops and should not reinsert their lenses until at least 15 minutes after instillation of the eye drops .

Contraindications

MYDRIACYL should not be used in patients with glaucoma or with a narrow anterior chamber angle or in individuals known to be hypersensitive to any component of the preparation .

Regulatory history

MYDRIACYL tropicamide 0.5% and 1% eye drops were first listed on the ARTG on 15 October 1991 . The product was first approved on 14 July 2003 .