For mydriasis and cycloplegia for diagnostic procedures
Mydriatic and Cycloplegic agents
Tropicamide, which is to some extent structurally related to atropine, induces mydriasis and cycloplegia through paralysis of the parasympathetic system. Tropicamide is a parasympatholytic agent, which acts by blocking the action of the parasympathetic nervous system. As acetylcholine is the neurotransmitter at the receptor site of the parasympathetic nervous system, tropicamide competes with acetylcholine for uptake at the receptor sites, thereby blocking its action. The results are mydriasis, due to unopposed action of the dilator pupillae, and cycloplegia.
Tropicamide visibly dilates the pupil after 5 minutes. It reaches its maximum diameter after 20-25 minutes and returns to its normal size within approx. 6 hours. The onset of the effect is rapid, but it disappears 45-60 minutes after the last instillation. The best time for retinoscopy is therefore approximately 20 minutes after the instillation of the last drop.
For refraction,one or two drops of the 1% solution in the eye(s),repeated in five minutes. If patient is not seen within 20 to 30 minutes,an additional drop may be instilled to prolong mydriatic effect. For examination of fundus,one or two drops of the 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time,typically in 4 to 8 hours. However,in some cases, complete recovery may take up to 24 hours.
Atropine like substances, tricyclic antidepressants, numerous H1 antihistaminic substances, anti-cholinergic agents, anti-Parkinson drugs, phenothiazines and neuroleptic drugs are capable of reinforcing the effect of tropicamide when taken or used.
Contraindicated in persons showing hypersensitivity to any component of this preparation.
Ocular Transient stinging,blurred vision,photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular Dryness of the mouth,tachycardia,headache,allergic reactions,nausea,vomiting,pallor,central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions,behavioral disturbances,and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs
Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk,caution should be exercised when tropicamide is administered to a nursing woman.
Red face, accelerated pulse, dry mouth, reduced sweating and secretion as well as an increase in body temperature should be interpreted as a sign of overdosing, depending on the intensity of the symptoms. The emergency doctor should immediately be contacted in case of accidental ingestion. If required, the local effect can be counteracted or neutralized through the administration of a miotic agent (antidote).
Store at room temperature and protect from light. It is desirable that the contents should not be used more than one month after first opening of the bottle.
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