ADVERSE REACTIONS SECTION.

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.

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 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. MYDRIACYL(R) (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:Each mL of MYDRIACYL(R) (tropicamide ophthalmic solution, USP) contains: Active: tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water; pH range 4.0-5.8.. chemical.

DOSAGE & ADMINISTRATION SECTION.

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 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. mL and 15 mL in plastic DROP-TAINER(R) dispensers.0.5% 15 mL: NDC 0998-0354-151% mL: NDC 0065-0355-0315 mL: NDC 0998-0355-15STORAGE: Store at 8C to 27C (46F-80F). Do not refrigerate or store at high temperatures. Keep container tightly closed.Rx Only.

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. 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 childs mouth and to wash their own hands and the childs hands following administration.

LACTATION 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0065-0355-03ALCON(R) DROP-TAINER(R) DISPENSER UNIT OF USE Mydriacyl(R) % (tropicamide ophthalmic solution, USP) mL Sterile INGREDIENTS: Each mL contains: Active: Tropicamide 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH range 4.0-5.8 Rx Only USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert. STORAGE: Store at 8-27C (46-80F). Do not refrigerate or store at high temperatures.Keep container tightly closed. (C) 2004, 2010 Alcon, Inc. Alcon(R) ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USAPrinted in USA 350544-0210 LOT: EXP.: NDC 0065-0355-03ALCON(R) Mydriacyl(R) (tropicamide ophthalmic solution USP)1 %3 mL SterileRx Only INGREDIENTS: Each mL contains: Active: Tropicamide 1%.USUAL DOSAGE: One or two drops topically in the eye(s). Read enclosed insert. STORAGE: Store at 8-27C (46-80F).Do not refrigerate or store at high temperatures.Keep container tightly closed. (C) 2000, 2004 Alcon, Inc. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USAPrinted in USA H13299-0214 LOT: EXP.:.

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.

PRECAUTIONS SECTION.

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 childs mouth and to wash their own hands and the childs 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. 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.. 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.. 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.

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.

SPL UNCLASSIFIED SECTION.

(C) 2004, 2018 NovartisDistributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134Alcon(R) Novartis companyT2018-39Revised: April 2018.

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