TROPICAMIDE: 750 Adverse Event Reports & Safety Profile

DESCRIPTION Tropicamide ophthalmic solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the following chemical structure: Chemical name: Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl)- Each mL contains: Active: tropicamide 5 mg (0.5%) or 10 mg (1%); Inactives: boric acid, hydrochloric acid, edetate disodium dihydrate, purified water. Sodium hydroxide and/or hydrochloric acid (to adjust pH) pH range 4.0 - 5.8. Preservative: benzalkonium chloride 0.01%. ChemStructure-Tropicamide.jpg

INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.

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 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. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

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 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

WARNINGS 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.

PRECAUTIONS General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce 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.

Geriatric

Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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