PEDIATRIC USE SECTION.

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.

PREGNANCY SECTION.

Pregnancy Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Tropicamide should be given to pregnant woman only if clearly needed.

WARNINGS SECTION.

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 reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.Mydriatics may produce transient elevation of intraocular pressure.Remove contact lenses before using.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Tropicamide Ophthalmic Solution, USP 1% is supplied in plastic bottle with red cap and controlled drop tip in the following sizes: NDC 24208-585-59: mL in 7.5 mL bottleNDC 24208-585-64: 15 mL in 15 mL bottleTropicamide Ophthalmic Solution, USP 0.5% is supplied in plastic bottle with red cap and controlled drop tip in the following sizes: NDC 24208-590-64: 15 mL in 15 mL bottle Storage: Store at 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. Keep container tightly closed.DO NOT USE IF IMPRINTED Protective Seal WITH YELLOW IS NOT INTACT.Keep out of reach of children.Distributed by:Bausch Lomb, division ofBausch Health US, LLCBridgewater, NJ 08807 USAManufactured by:Bausch Lomb IncorporatedTampa, FL 33637 USA(C) 2019 Bausch Lomb Incorporated or its affiliatesRevised: July 20199115806 (Folded)9115906 (Flat) symbol.

INDICATIONS & USAGE SECTION.

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

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Do not touch dropper tip to any surface, as this may contaminate the solution. Patients should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patients 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 childs mouth and wash their own hands and the childs hands following administration.

NURSING MOTHERS SECTION.

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 nursing woman.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. OcularTransient 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-OcularDryness 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 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil [mydriasis]. The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength (0.5%) may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION. Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the following chemical structure:Chemical name: Benzeneacetamide, N-ethyl--(hydroxymethyl)-N-(4-pyridinylmethyl)-Each mL contains:ACTIVE: Tropicamide 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 ADDED: Benzalkonium Chloride 0.01%.. ChemStructure-Tropicamide.jpg.

DOSAGE & ADMINISTRATION SECTION.

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

DRUG INTERACTIONS SECTION.

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

GENERAL PRECAUTIONS SECTION.

General. The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.

GERIATRIC USE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL (Mexico) 0.5. NDC 24208-590-64 TropicamideOphthalmicSolution, USP0.5% SterileFOR TOPICALOPHTHALMICUSE ONLYRx only 15 mLBAUSCH LOMB. Carton-Mexico 0.5 15mL.jpg.