INFORMATION FOR HEALTH PROFESSIONALS
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MYDRIACYL is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths.
Each mL contains: Active: Tropicamide 0.5% or 1.0%. Preservative: Benzalkonium Chloride 0.01%. Inactives: Sodium Chloride, Disodium Edetate, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. pH range 4.0-5.8.
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful In producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.
Unknown.
For mydriasis and cycloplegia for diagnostic procedures.
For refraction, instil one or two drops of 1% solution in the eye(s), repeated five minutes. If patient Is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong 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. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
Contraindicated in narrow-angle glaucoma and in persons showing hypersensitivity to any component of this preparation.
For topical ophthalmic use only. Not for injection.
This preparation may cause CNS disturbances which may be dangerous in paediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of Intraocular pressure.
Remove contact lenses before using.
The lacrimal sac should be compressed by digital pressure for two to three minutes after Instillation to reduce excessive systemic absorption.
Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.
There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.
Pregnancy Category C.
Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.
Tropicamide may rarely cause CNS disturbance which may be dangerous in paediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS). Keep this and all medications out of the reach of children.
In the elderly and others where increased intra-ocular pressure may be encountered, mydriatics and cycloplegics should be used cautiously. To avoid inducing angle-closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.
Increased intra-ocular pressure. Psychotic reactions, behavioural disturbances, and cardiorespiratory collapse in children with this class of drug have been reported. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, parasympathetic stimulation, or allergic reaction may occur.
A severe reaction to tropicamide is rapid in onset and of short duration. In such an event give immediate IV injection of quick acting a-adrenergic blocking agent such as 5 to 10 mg pentolamine mesylate followed by a b-blocking agent such as 2.5 mg propanolol
Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Unknown.
Store below 25°C. Do not refrigerate.
Protect from light. Keep container tightly closed.
Discard 4 weeks after opening.
Prescription Medicine.
In 15 mL plastic DROP-TAINER® dispensers.
The active ingredient is represented by the chemical structure:
Established name:
Tropicamide
Chemical name:
Benzeneacetamide, N -ethyl-%-(hydroxymethyl)- N -(4-pyridinylmethyl)-.
Alcon New Zealand Limited
c/- Pharmaco (NZ) Ltd
49 George Street
Newmarket AUCKLAND
1st December 2007
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