MYDRIACYL™

MIMS Revision Date: 01 March 2023

1 Name of Medicine

Tropicamide 0.5% Eye Drops.
Tropicamide 1.0% Eye Drops.

2 Qualitative and Quantitative Composition

Mydriacyl Eye Drops contain either 5 mg/mL (0.5%) or 10 mg/mL (1.0%) tropicamide.
The solution is preserved with benzalkonium chloride (0.01%).
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops.
Mydriacyl Eye Drops is a sterile, multi-dose ophthalmic solution for topical administration in the eye, available in two strengths.

4 Clinical Particulars

4.1 Therapeutic Indications

Mydriacyl Eye Drops are used to produce mydriasis and cycloplegia for diagnostic purposes.

4.2 Dose and Method of Administration

For refraction, instill one or two drops of 1% solution in eye(s), repeated in 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, 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.
In order 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. Eye ointments should be administered last.

4.3 Contraindications

Mydriacyl should not be used:
in patients with glaucoma or with a narrow anterior chamber angle;
in individuals known to be hypersensitive to any component of the preparation (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

For topical ophthalmic use only. Not for injection.
Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma and because of the risk of precipitating angle closure glaucoma in the elderly and others prone to raised intraocular pressure, 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.
This preparation may also cause CNS disturbances, which may be dangerous in paediatric patients. The possibility of psychotic reactions and behavioural disturbances due to hypersensitivity to anticholinergic drugs should be considered.
Excessive use in children may produce systemic toxic symptoms. 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.
Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption.
To reduce systemic absorption the lacrimal sac should be compressed at the medial canthus by digital pressure for one minute after instillation of the drops.
In refractions where prolongation of cycloplegia is desirable only one additional drop is recommended.
Use in hepatic impairment. The safety and efficacy of Mydriacyl in patients with hepatic impairment have not been established.
Use in renal impairment. The safety and efficacy of Mydriacyl in patients with renal impairment have not been established.
Use in the elderly. No data available.
Paediatric use. No controlled clinical studies have been performed in children, thus the safety and efficacy of Mydriacyl use in children has not been established. In rare cases, tropicamide has been known to cause CNS disturbances which may be dangerous in paediatric patients. Psychotic reactions, behavioural disturbances and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
Effects on laboratory tests. No data available.
Instructions for patients. Mydriacyl contains the preservative benzalkonium chloride which may cause eye irritation, 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.
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. Complete recovery may take up to 24 hours in some individuals.
To prevent contamination, care should be taken not to touch the dropper tip to any surface, including the eye. The bottle should be tightly closed when not in use.
Mydriacyl Eye Drops should be discarded within 28 days of opening.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effects of tropicamide may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics, and tricyclic antidepressants. Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine or ophthalmic cholinesterase inhibitors.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. Reproductive studies with tropicamide have not been performed in animals. Therefore, the potential effects on male or female fertility have not been investigated.
Use in pregnancy. (Category B2)
There is no data from the use of tropicamide in pregnant women. There have been no animal reproduction studies conducted or well-controlled studies performed in pregnant women, therefore, Mydriacyl use is not recommended during pregnancy.
Use in lactation. Caution should be exercised when tropicamide is administered to a breastfeeding mother as it is not known whether tropicamide topically administered is excreted in human milk. A risk to the suckling child cannot be excluded.

4.7 Effects on Ability to Drive and Use Machines

Tropicamide may cause drowsiness, blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear.

4.8 Adverse Effects (Undesirable Effects)

Ocular. An increase in intraocular pressure, especially in patients with angle-closure glaucoma, transient stinging, blurred vision, punctate keratitis and sensitivity to light secondary to pupillary dilation may occur. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.
Systemic. Systemic toxicity can occur with the use of anti-muscarinic eye drops, particularly in children and the elderly. Symptoms include dryness of the mouth, flushing, nausea, vomiting, giddiness, headache, pallor, staggering, dryness of the skin (a rash may be present in children), bradycardia followed by tachycardia with palpitation and arrhythmias, urinary urgency, difficulty and retention, reduction in the tone and motility of the gastrointestinal tract leading to constipation (abdominal distention may occur in infants).
Psychotic reactions, behavioural disturbances and vasomotor or cardio-respiratory collapse may occur in children.
Post marketing events. The following adverse reactions have been reported following use of tropicamide topical ophthalmic preparations. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.
Eye disorders. Vision blurred, photophobia, eye pain, eye irritation, ocular hyperaemia.
Nervous system disorders. Dizziness, headache.
Vascular disorders. Syncope, hypotension.
Gastrointestinal disorders. Nausea.
Skin and subcutaneous tissue disorders. Rash.
General disorders and administration site conditions. Drug effect prolonged (mydriasis).
Cycloplegic drugs may increase intraocular pressure and can precipitate angle closure glaucoma in predisposed patients (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).
Psychotic reactions and behavioural disturbances have been reported with this class of drug, especially in children (see Section 4.4 Special Warnings and Precautions for Use).
Other toxic manifestations of anticholinergic drugs include flushing of the skin, dryness of mucous membranes, tachycardia, decrease secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary retention and decreased nasal, bronchial and lachrymal secretions.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

In the event of a topical overdose, flush from the eye with running water.
Systemic toxicity may occur following topical use, particularly in children. Symptoms include flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular co-ordination. Overdose treatment is supportive. In infants and small children the body surface must be kept moist.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Tropicamide is an anticholinergic drug with a similar pharmacological action to that of atropine. It blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation resulting in mydriasis. At higher concentrations (1%), tropicamide also paralyses accommodation (cycloplegia). These preparations have a more rapid onset and shorter duration of effect than atropine. Mydriasis is produced within 15-30 minutes and the duration of activity is approximately 3-8 hours. Complete recovery in some individuals may require 24 hours. Cycloplegia is maximal within about 30 minutes and is short-lasting, with complete recovery of accommodation normally within 6 hours.
Clinical trials. No data are available.

5.2 Pharmacokinetic Properties

Tropicamide, administered topically to the eye, does not bind to tissues as firmly as does atropine. The wash time for half recovery of carbachol responsiveness was shown to be less than 15 minutes for non-pigmented iris and 30 minutes for pigmented iris.

5.3 Preclinical Safety Data

Genotoxicity. No long-term studies have been conducted in animals to determine the mutagenic potential of ophthalmic tropicamide.
Carcinogenicity. No long-term studies have been conducted in animals to determine the carcinogenic potential of ophthalmic tropicamide.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, disodium edetate, concentrated hydrochloric acid and/or sodium hydroxide (to adjust pH), benzalkonium chloride, purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years. Discard container 28 days after opening.

6.4 Special Precautions for Storage

Store Mydriacyl Eye Drops below 25°C. Do not refrigerate. Protect from light. Keep tightly closed.

6.5 Nature and Contents of Container

Mydriacyl Eye Drops 0.5% and 1% are presented in 15 mL Drop-Tainer dispensers.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure. Structure of tropicamide and enantiomer.

Empirical formula: C₁₇H₂₀N₂O₂.
Chemical name: (2RS) N-ethyl-3-hydroxy-2-phenyl-N-(pyrid-4-ylmethyl) propionamide.
CAS number. CAS Registry Number: 1508-75-4.

7 Medicine Schedule (Poisons Standard)

Prescription only Medicine (Schedule 4).

Date of First Approval

14 July 2003

Date of Revision

03 January 2023

Summary Table of Changes