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Dosage/Direction for Use
Ophthalmic Production of mydriasis Adult: For funduscopic examination: As 0.5% solution: Instil 1 or 2 drops into the eye(s) 15-20 minutes before examination. Higher strength or additional doses may be required in patients with heavily pigmented eyes. Ophthalmic Production of cycloplegia Adult: For refraction: As 1% solution: Instil 1 or 2 drops into the eye(s); repeat after 5 minutes. An additional drop may be administered if the patient is not examined within 20-30 minutes. Additional doses may be required in patients with heavily pigmented eyes. |
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Contraindications
Known or suspected angle-closure glaucoma, narrow anterior chamber angle.
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Special Precautions
Patient with inflamed eye(s), increased intraocular pressure; hypersensitivity to belladonna alkaloids or other anticholinergic drugs. Pregnancy and lactation. Patient Counselling Remove contact lenses before application and wait for at least 15 minutes before reinsertion. This drug may cause drowsiness, blurred vision and sensitivity to light, if affected, do not drive or operate machinery. Monitoring Parameters Determine intraocular pressure and estimate the depth of the angle of the anterior chamber before initiation of therapy.
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Adverse Reactions
Significant: Transient increase in intraocular pressure, CNS disturbances.
Cardiac disorders: Tachycardia, bradycardia, palpitations, arrhythmia.
Eye disorders: Blurred vision, photophobia, eye pain or irritation, superficial punctate keratitis, transient stinging, ocular hyperaemia.
Gastrointestinal disorders: Dry mouth, nausea, vomiting, reduced gastrointestinal motility, constipation.
General disorders and administration site conditions: Prolonged mydriatic effect.
Immune system disorders: Allergic reactions.
Musculoskeletal and connective tissue disorders: Muscle rigidity.
Nervous system disorders: Dizziness, headache.
Renal and urinary disorders: Urinary urgency, difficulty, and retention.
Skin and subcutaneous tissue disorders: Rash, dry skin.
Vascular disorders: Hypotension, syncope, flushing, pallor.
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Drug Interactions
May interfere with the ocular antihypertensive effects of pilocarpine, carbachol or ophthalmic cholinesterase inhibitors. Effects may be enhanced when used concomitantly with other drugs having antimuscarinic properties (e.g. amantadine, certain antihistamines, antipsychotics, TCAs).
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Action
Tropicamide is a synthetic tertiary amine antimuscarinic which blocks the responses of the sphincter muscle of the iris and ciliary muscle to cholinergic stimulation resulting in pupillary dilation. It also causes paralysis of accommodation at higher concentrations.
Onset: Mydriasis: Approx 20-40 minutes. Cycloplegia: 20-35 minutes (peak). Duration: Mydriasis: Approx 6-7 hours. Cycloplegia: 50 minutes to 6 hours. |
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Storage
Ophthalmic: Store between 8-27°C. Do not refrigerate or freeze. Protect from light. Storage recommendations may vary among countries or individual products. Refer to specific product guidelines.
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CIMS Class
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ATC Classification
S01FA06 - tropicamide ; Belongs to the class of anticholinergics used as mydriatics and cycloplegics.
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