Tropicamide

The effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, antipsychotics, phenothiazines and tricyclic anti-depressants.

There is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.

It is unknown whether tropicamide/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tropicamide therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There is no adequate information on whether this drug may affect fertility in human males or females.

Tropicamide eye drops have a moderate influence on the ability to drive and use machines.

Tropicamide may cause drowsiness, blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.

The following adverse reactions have been reported following use of tropicamide topical ophthalmic preparations. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.

Nervous system disorders

Not known (cannot be estimated from the available data): dizziness, headache

Eye disorders

Not known (cannot be estimated from the available data): vision blurred, photophobia, eye pain, eye irritation, ocular hyperaemia

Vascular disorders

Not known (cannot be estimated from the available data): syncope, hypotension

Gastrointestinal disorders

Not known (cannot be estimated from the available data): nausea

Skin and subcutaneous issue disorders

Not known (cannot be estimated from the available data): rash

General disorders and administration site conditions

Not known (cannot be estimated from the available data): drug effect prolonged (mydriasis)

Cycloplegic drugs may increase intraocular pressure and can precipitate angle-closure glaucoma in predisposed patients.

Psychotic reactions, behavioural disturbances and cardio respiratory collapse have been reported with this class of drug, especially in children.

Other toxic manifestations of anticholinergic drugs include flushing of the skin, dryness of the mouth, dryness of mucous membranes, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrhythmias, decrease secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary urgency, difficulty and retention and decreased nasal, bronchial and lachrymal secretions.

Local: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.

Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.

Paediatric Population

Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children.

An increased risk for systemic toxicity has been observed in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage with cycloplegic drugs.