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ODAN-TROPICAMIDE is a brand name for Tropicamide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Ophthalmologic ODAN-TROPICAMIDE may cause increased intraocular pressure (IOP). The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients. IOP and an estimation of the depth of the angle of the anterior chamber should be determined prior to initiation of therapy.
ODAN-TROPICAMIDE contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of ODAN- TROPICAMIDE and wait at least 15 minutes before reinsertion.
ODAN-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. ODAN-TROPICAMIDE is for topical ophthalmic use only.
It should not be used for intravenous injection. Psychiatric Tropicamide-induced psychotic reactions and behavioural changes may occur in patients with increased susceptibility to anticholinergic drugs.
Special Populations Pregnant Women:
There are no or limited amount of data from the use of tropicamide in pregnant women. ODAN-TROPICAMIDE is not recommended during pregnancy.
Nursing Women:
It is unknown whether tropicamide or its metabolites are excreted in human milk. Because many drugs are excreted in breast milk, a decision must be made whether to discontinue breastfeeding or discontinue ODAN-TROPICAMIDE therapy taking into account the potential benefit to the mother and potential risk to the infant.
Pediatrics:
ODAN-TROPICAMIDE 1% should not be used in small infants. Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children. 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.
ODAN-TROPICAMIDE Prescribing Information Page 5 of 10 Excessive use in children may produce systemic toxic symptoms. ODAN-TROPICAMIDE should be used with extreme caution in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tropicamide in Canada.
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Parents should be warned of the oral toxicity of ODAN-TROPICAMIDE for children and advised to wash their own hands and their child’s hands following administration. ADVERSE REACTIONS Adverse events observed following use of ODAN-TROPICAMIDE include the following: dizziness, drug effect prolonged (mydriasis), eye irritation, eye pain, headache, hypotension, nausea, ocular hyperemia, photophobia, rash, syncope, and vision blurred.
In addition, cycloplegic drugs may increase IOP and can precipitate angle-closure glaucoma in predisposed patients. Psychotic reactions and behavioural disturbances have been reported with this class of drug, especially in children.
Other toxic manifestations of anticholinergic drugs include: flushing of the skin, dryness of mucous membranes, tachycardia, decreased secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary retention and decreased nasal, bronchial and lachrymal secretions.
DRUG 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. DOSAGE AND ADMINISTRATION ODAN-TROPICAMIDE is for topical ophthalmic use only.
5%: Instill 1 or 2 drops topically in the eye(s) 15 or 20 minutes prior to examination.
ODAN-TROPICAMIDE 1%:
Instill 1 or 2 drops topically in the eye(s) and repeat in 5 minutes. OVERDOSAGE An ocular overdose of ODAN-TROPICAMIDE can be flushed from the eye(s) with lukewarm water. Systemic toxicity may occur following topical use, particularly in children.
It is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid ODAN-TROPICAMIDE Prescribing Information Page 6 of 10 and irregular pulse, fever, abdominal distension in infants, convulsions and hallucinations, and the loss of neuromuscular coordination.
Treatment is symptomatic and supportive. In infants and small children, the body surface must be kept moist. STORAGE AND STABILITY 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. 01% w/v (as preservative). ODAN-TROPICAMIDE is available in 10 mL plastic dropper bottles. 5% and 1% w/v, Alcon Canada Inc. Submission No. 215340; Date of Revision: May 16, 2018. For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.
5% w/v This leaflet is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about ODAN- TROPICAMIDE. Contact your doctor or pharmacist if you have any questions about the drug.
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: […]