Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Alcon Eye Care UK Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Tropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated for topical use for:
Diagnostic purposes for fundoscopy and cycloplegic refraction.
Use in pre- and post-operative states where a short acting mydriatic is required.
One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.
One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.
Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required. Do not use in concentrations greater than 0.5% in small infants (See section 4.4 Special warnings and precautions for use, section 4.8 Undesirable effects and section 4.9 Overdose)
For topical ophthalmic use only.
After cap is removed, if tamper evident nap collar is loose, remove before using product.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.
An ocular overdose of Tropicamide Eye Drops 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 and irregular pulse, fever abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular co-ordination.
Treatment is symptomatic and supportive, (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.
36 months (unopened).
4 weeks (after first opening).
Do not store above 25°C.
Do not refrigerate or freeze.
Keep container in the outer carton.
Keep container tightly closed.
Discard contents 4 weeks after opening.
Pack size – 5 ml.
Drop-Tainer – Natural Low Density Polyethylene Bottle and Plug.
Polystyrene or Polypropylene cap.
Do not touch dropper tip to any surface as this may contaminate the contents.
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