MYDRIATICUM

Tropicamide is an alkaloid atropine‐derived anticholinergic drug and a non‐selective antagonist of muscarinic acetylcholine (mACh) receptors.

Usually available in ophthalmic formulations, tropicamide is used to cause mydriasis and cycloplegia for eye exams or ocular procedures.

It is also used in combination with hydroxyamphetamine for the same indication.

Oral tropicamide has been investigated as a potential drug to relieve sialorrhea in patients with Parkinson's Disease.

Tropicamide is indicated to induce mydriasis (dilation of the pupil) for diagnostic procedures and in conditions where short-term pupil dilation is desired, either as monotherapy 9 or in combination with hydroxyamphetamine 10 or phenylephrine.

It provides clinically significant mydriasis with partial cycloplegia.

Tropicamide is an anticholinergic drug and that works by non‐selectively blocking muscarinic receptors to cause mydriasis and cycloplegia.

It relaxes the pupillary sphincter to dilate the pupil.

The onset of tropicamide‐induced mydriasis is about 10-15 minutes, 3 with optimal effect occurring 25-30 minutes post-administration.

Mydriasis caused by tropicamide wears off within four to eight hours, but it was seen up to 24 hours in some individuals.

Tropicamide hinders accommodation by causing the contraction of the ciliary muscle.

The cycloplegic effect occurs within to minutes following administration, with a duration of action of four to 10 hours.

Tropicamide can elevate intraocular pressure.

The ophthalmic use of tropicamide is not typically associated with serious systemic adverse events.

One randomized pilot study showed that oral tropicamide alleviated perceived symptoms of sialorrhea in patients with Parkinson's Disease: anticholinergics are believed to restore the dopaminergic to cholinergic activity imbalance in neurodegenerative diseases.

Similarly in one case report, tropicamide administered via ophthalmic solution relieved clozapine-induced sialorrhea.

Interestingly, in rodent models, tropicamide suppressed drug-induced tremulous jaw movements which are often used as a model of parkinsonian tremor: the significance of this finding requires further investigations.

Muscarinic acetylcholine receptor

M4 Antagonist Muscarinic acetylcholine receptor M1 Antagonist Muscarinic acetylcholine receptor M2 Antagonist + 1 more target.

Following ocular administration of 40 μL drops of 0.5% tropicamide in female subjects, tropicamide reached its mean peak concentration in plasma of 2.8 ± 1.7 ng/mL (mean ± SD) at five minutes.

No information can be found.

Tropicamide has a plasma half-life of 30 minutes.

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LD is 865 mg/kg in rats and 565 mg/kg in mice.

LD is 1210 mg/kg in rats and 695 mg/kg in mice.

LD is 872 mg/kg in rats and 665 mg/kg in mice.

There is limited information on tropicamide overdose.

Systemic adverse effects, such as tachycardia, central nervous system disturbances, and muscle rigidity have been reported with the use of tropicamide.

Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse have been reported with the use of anticholinergic in children.

For topical ophthalmic use only.

Not for injection.

This preparation may cause

CNS disturbances which may be dangerous in pediatric patients.

The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Remove contact lenses before using.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes.

If patient is not seen within to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.

For examination of fundus, instill one or two drops of 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 to 8 hours.

However, in some cases, complete recovery may take up to 24 hours.

To report SUSPECTED ADVERSE

REACTIONS, contact Sandoz Inc.fda.gov/medwatch.

3mL and 15mL in plastic dispensers. 1%.

• 3 mL: NDC 61314-355-01 1%.

• 15 mL: NDC 61314-355-02 STORAGE: Store at 8° to 27°C (46° to 80°F).

Do not refrigerate or store at high temperatures.

Keep container tightly closed.

Revised: 11-2021.