(Tropicamide 0.5%w/v and 1.0%w/v)
COMPOSITION
Drucamid® 0.5% Eye Drops contains 5mg of tropicamide in 1ml solution.
Drucamid® 1.0% Eye Drops contains 10mg of tropicamide in 1ml solution.
CLINICAL PHARMACOLOGY
Tropicamide in Drucamid® Eye Drops is an anticholinergic which blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). At higher concentrations (1%), tropicamide also paralyses accommodation. This preparation acts rapidly and has a relatively short duration of action.
INDICATIONS:
Tropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic.
It is used topically for:
-Diagnostic purposes for fundoscopy and cycloplegic refraction.
-Use in pre and post-operative states where a short acting mydriatic is required.
CONTRAINDICATIONS
Glaucoma or tendency towards glaucoma (e.g Narrow anterior chamber angle). Hypersensitivity to any component. This preparation contains benzalkonium chloride and should not be used where soft contact lenses are worn.
INTERACTIONS
The effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some antihistamine, butyrophenones, phenothiazines and tricyclic anti-depressants.
WARNINGS/PRECAUTIONS:
-Extreme caution is advised for use in children and individual susceptible to belladonna alkaloids because of the increased risk systemic toxicity.
-Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
-To reduce systemic absorption the lacrimal sac should be compressed at the medical canthus by digital pressure for at least one minute after instillation of the drops.
KEEP OUT OF THE REACH OF CHILDREN!
ADVERSE REACTIONS
Increased intraocular pressure, transient stinging and sensitivity to light secondary to papillary dilation. Prolong administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.
DOSAGE AND ADMINISTRATION:
Fundoscopy
One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.
Cycloplegic Refraction
One or two drops of 1% solution are required, repeated after 5 minutes; a further drop may be necessary to prolong the effect after 20 to 30 minutes.
The 0.5% is recommended where mydriasis only is desired. For cycloplegic effect in refractions, the 1.0% solution is necessary.
SYMPTOMS OF OVERDOSE AND ANTIDOTE
Systemic toxicity may occur following topical use, particularly in children, it is manifested by flushing and dryness of the skin, 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 supportive. In infants and small children the body surface must be kept moist. If accidentally ingested induce emesis or perform gastric lavage.
PRESENTATION
Drucamid® Eye Drops is supplied as 0.5% and 1% solution respectively in sterile lupolen bottles containing 10ml of the ophthalmic solution.
STORAGE CONDITION
Store below 30oC. Protect from light. Replace cap immediately after use> Discard after 28 days of opening the bottle.