Odan-Tropicamide: Uses, Side Effects and Dosage

What the medication is used for:

ODAN-TROPICAMIDE is used by a healthcare professional to better see the back of your eye and to test your vision during an eye exam.

What it does:

ODAN-TROPICAMIDE contains tropicamide, which works by enlarging the pupil of your eye (mydriasis) and relaxing the muscles in your eye (cycloplegia).

When it should not be used:

ODAN-TROPICAMIDE should not be administered if you:

• Are allergic (hypersensitive) to tropicamide or any other of the ingredients in ODAN-TROPICAMIDE (see What the important nonmedicinal ingredients are).
• Have or think you may have narrow angle glaucoma.

What the medicinal ingredient is:

Tropicamide 0.5% w/v

What the nonmedicinal ingredients are:

Boric acid, propylene glycol, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), water for injections, and benzalkonium chloride (as preservative).

What dosage forms it comes in:

ODAN-TROPICAMIDE is an eye drop solution.

• Are breastfeeding or planning to breast-feed.

BEFORE ODAN-TROPICAMIDE is administered to your child, talk to your doctor or pharmacist if your child is young or has Down syndrome, spastic paralysis or brain damage. Your child may be at a higher risk of developing serious side effects.

While ODAN-TROPICAMIDE is administered to you or your child

You or your child may have changes in behaviour. Discuss with your doctor.

Contact Lens Wearers

ODAN-TROPICAMIDE contains a preservative, benzalkonium chloride, which is known to affect soft contact lenses. Do not wear contact lenses while ODAN-TROPICAMIDE is being administered to you. Remove your contact lenses before ODAN-TROPICAMIDE treatment and wait at least 15 minutes after treatment before putting your lenses back in.

Driving and Using Machines

ODAN-TROPICAMIDE may cause drowsiness, blurred vision and sensitivity to light. If any of these effects happen to you, wait until your vision clears before driving or using machines.

Tell your doctor or pharmacist about all the medicines you take, recently took or are planning to take, including those without a prescription.

Drugs that may interact with ODAN-TROPICAMIDE include:

• Amantadine (used to treat Parkinson’s disease and some influenza infections).
• Antihistamines (used to treat allergies).
• Antipsychotics.
• Antidepressants.

Usual dose:

The healthcare professional will apply 1 or 2 drops in the eye(s) 15 to 20 minutes before your eye exam.

ODAN-TROPICAMIDE should not be used for injection. It should only be used for dropping in your eye(s).

BEFORE ODAN-TROPICAMIDE is administered, talk to your doctor or pharmacist if you:

• May have glaucoma or have a family history of glaucoma. ODAN-TROPICAMIDE may cause a rise in the pressure in your eye (intraocular pressure). Your doctor should check the pressure in your eye before you start using ODAN-TROPICAMIDE.
• Are taking any other medicines, including antihistamines, amantadine, antipsychotic and antidepressants.
• Are pregnant or may be pregnant. Do not use ODAN-TROPICAMIDE if you are pregnant.

Overdose:

Symptoms following an overdose may include: flushing and dryness of the skin, a rash in children, blurred vision, rapid and irregular pulse, fever, abdominal swelling in children, convulsions, hallucinations or loss of coordination.

ABOUT THIS MEDICATION

INTERACTIONS WITH THIS MEDICATION

If you think you have used too much ODAN-TROPICAMIDE, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

PROPER USE OF THIS MEDICATION

WARNINGS AND PRECAUTIONS

ODAN-TROPICAMIDE should only be for topical instillation in the eye. It should not be used for injection as cases of death have been reported following intravenous injection of this drug.

IMPORTANT: PLEASE READ

Like all medicines, ODAN-TROPICAMIDE may cause side effects, although not everybody gets them.

Side effects seen following use of ODAN-TROPICAMIDE include: blurred vision, sensitivity to light, prolonged increase in pupil size, eye pain, eye irritation, eye redness, dizziness, headache, fainting, low blood pressure, nausea and rash.

This is not a complete list of side effects. For any unexpected effects while taking ODAN-TROPICAMIDE, contact your doctor or pharmacist.

This document plus the full Prescribing Information, prepared for health professionals can be found by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html)

or by contacting the sponsor, Odan Laboratories Limited at 1-888-666-6326.

Store between 15°C and 30°C. Prevent from freezing. Do not refrigerate. Avoid excessive heat. Keep tightly closed. Keep out of the reach and sight of children.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

MORE INFORMATION

HOW TO STORE IT

REPORTING SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.