Data from FDA - Curated by EPG Health - Last updated 01 April 2018

Indication(s)

INDICATIONS AND USAGE: For mydriasis and cycloplegia for diagnostic procedures.

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Advisory information

contraindications
CONTRAINDICATIONS: Contraindicated in persons showing hypersensitivity to any component of this preparation.
Special warnings and precautions
PRECAUTIONS: General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to avoid excessive systemic absorption. Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Drug Interactions: Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential. 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. Pediatric Use: Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS). Keep this and all medications out of the reach of children.
Adverse reactions
ADVERSE REACTIONS: 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 mydri-atics. 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: For refraction, instill one or two drops of 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, instill one or two drops of 0.5% solution 15 to 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.
Pregnancy and lactation
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.

Interactions

Drug Interactions: Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

More information

Category Value
Authorisation number ANDA040315
Agency product number N0A3Z5XTC6
Orphan designation No
Product NDC 70518-0744
Date Last Revised 22-03-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 314238
Storage and handling STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or store at high temperatures. Keep container tightly closed. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 TC00N Rev. 10/16
Marketing authorisation holder REMEDYREPACK INC.