INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MINIMS TROPICAMIDE 1% Eye Drops

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME
(and dosage form):

MINIMS TROPICAMIDE 1% Eye Drops

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.
Adults : 2 drops at 5 minute intervals, with a further 1 or 2 drops after 30 minutes if required.
Children: 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%.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Clear, colourless sterile solution.

PRESENTATION:
Sterile, single dose disposable eye drops in cartons of 10 units, each containing approximately 0,5 mL.

STORAGE INSTRUCTIONS:
Store in the refrigerator protected from strong light. DO NOT FREEZE.
Keep out of reach of children.

REGISTRATION NUMBER:
N/15.4/123

NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
PINETOWN.
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 August 1981.

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