Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Martindale Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, RM3 8UG
Atropine sulfate is an antimuscarinic agent used as a cycloplegic and mydriatic. The eye drops are used in the treatment of iritis and uveitis to immobilise the iris and ciliary muscle and to prevent or break down adhesions.
Since it is a powerful cycloplegic it is used in the determination of refraction in children below six years and children with convergent strabismus.
For topical ocular use.
The depth of the angle of the anterior chamber should be assessed before the product is used.
Refraction: One or two drops to be instilled into the eye(s) one hour before refracting.
Uveitis/iritis: One or two drops to be instilled into the eye(s) to a maximum of 4 times daily.
Mydriatics and cycloplegics should only be used with caution in the elderly and others who may have raised intra ocular pressure.
Refraction: One drop to be instilled into each eye twice daily for 1-3 days prior to the examination.
Uveitis/iritis: One drop to be instilled into each eye to a maximum of 3 times daily.
Systemic reactions to topical atropine are unlikely at normal doses. Symptoms which can occur following an overdose, however, include anticholinergic effects (as listed in section 4.8 above), cardiovascular changes (tachycardia, atrial arrhythmias, atrio-ventricular dissociation) and central nervous system effects (confusion, ataxia, restlessness, hallucination, convulsions).
Supportive therapy should be given as required.
Store bottle upright below 25°C in a dry place and protect from light.
Low density polythene 10ml bottle with polythene insert and high density polythene tamper-evident cap.
Not all pack sizes may be marketed.
None stated.
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