COMPOSITION: (per dispensing unit of 0,5 mL) Tropicamide 5,0 mg.
PHARMACOLOGICAL CLASSIFICATION: A 15.4 Ophthalmic preparations: Other.
PHARMACOLOGICAL ACTION: Tropicamide is an anticholinergic drug, having mydriatic and some cycloplegic activity. It has a rapid onset of action (15-30 minutes) and a short duration of effect which varies from less than an hour up to four hours. Tropicamide is inadequate for cycloplegia in children.
INDICATIONS: Tropicamide is indicated when mydriasis and cycloplegia of rapid onset and brief duration are required.
CONTRA-INDICATIONS: Tropicamide should not be used in patients with a narrow angle between the iris and cornea.
DOSAGE AND DIRECTIONS FOR USE: Sterile if unopened. Use once and discard.
2 drops at 5 minute intervals, with a further 1 or 2 drops after 30 minutes if required.
At the discretion of the ophthalmologist.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Photophobia; may cause conjunctival irritations in sensitive persons. Although absorption into the bloodstream from the conjunctival sac is minimal, systemic toxicity can occur, particularly in small children. Such side-effects include dryness of the mouth with difficulty in swallowing, bradycardia followed by tachycardia.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT: Toxic effects include tachycardia, and depressant and stimulant action of the central nervous system. Physostigmine salicylate 1-2 mg should be injected subcutaneously, intra-muscularly or intravenously to control toxic effects. Locally, mydriatic effects may be counteracted by the instillation of pilocarpine eye drops, 1% to 4%.
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