Label: MYDRIACYL - tropicamide solution/ drops

  • NDC Code(s): 0065-0355-03
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 28, 2019

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  • DESCRIPTION

    MYDRIACYL® (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure:

    
chemical

    Each mL of MYDRIACYL® (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.

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  • 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.

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  • INDICATIONS AND USAGE

    For mydriasis and cycloplegia for diagnostic procedures.

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  • CONTRAINDICATIONS

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

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  • 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.

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  • 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

    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.

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  • 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.

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  • 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.

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  • HOW SUPPLIED

    3 mL and 15 mL in plastic DROP-TAINER® dispensers.

    0.5%          15 mL: NDC 0998-0354-15

    1%          3 mL: NDC 0065-0355-03

    15 mL: NDC 0998-0355-15

    STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed.


    Rx Only

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  • SPL UNCLASSIFIED SECTION

    © 2004, 2018 Novartis


    Distributed by:

    ALCON LABORATORIES, INC.

    Fort Worth, Texas 76134


    Alcon®
    A Novartis company
    T2018-39


    Revised: April 2018

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  • PRINCIPAL DISPLAY PANEL

    NDC 0065-0355-03

    ALCON®

    DROP-TAINER® DISPENSER

    UNIT OF USE

    Mydriacyl® 1 %
    (tropicamide ophthalmic solution, USP)

    3 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°-27°C (46°-80°F).

    Do not refrigerate or store at high temperatures.
    Keep container tightly closed.

    © 2004, 2010 Alcon, Inc.

    Alcon®

    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    Printed in USA

    350544-0210

    LOT:

    EXP.:

    carton

    NDC 0065-0355-03

    ALCON®

    Mydriacyl®
    (tropicamide ophthalmic solution USP)

    1 %

    3 mL Sterile

    Rx 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°-27°C (46°-80°F).
    Do not refrigerate or store at high temperatures.
    Keep container tightly closed.

    © 2000, 2004 Alcon, Inc.

    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA
    Printed in USA

    H13299-0214

    LOT:

    EXP.:

    label
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  • INGREDIENTS AND APPEARANCE
    MYDRIACYL  
    tropicamide solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0355
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6) TROPICAMIDE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0065-0355-03 1 in 1 CARTON 04/01/1959
    1 3 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA084306 04/01/1959
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Research, Ltd. 007672236 manufacture(0065-0355)
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