TROPICAMIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]

TROPICAMIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]
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NDC 24208-585-59, 24208-585-64, 24208-590-64
Set ID 892b78c8-36bc-47d3-850e-502899b48fb9
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Bausch & Lomb Incorporated
Generic Name
Product Class Anticholinergic
Product Number
Application Number ANDA040064
  • SPL UNCLASSIFIED SECTION

    Rx only

  • 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:

    ChemStructure-Tropicamide.jpg

    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 ADDED: Benzalkonium Chloride 0.01%.

  • 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.

  • INDICATIONS AND USAGE

    For mydriasis and cycloplegia for diagnostic procedures.

  • CONTRAINDICATIONS

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

  • 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 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. 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 child’s mouth and 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.

  • 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 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

  • HOW SUPPLIED

    Tropicamide Ophthalmic Solution, USP 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:
    NDC 24208-585-59: 2 mL in a 7.5 mL bottle
    NDC 24208-585-64: 15 mL in a 15 mL bottle

    Tropicamide Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:
    NDC 24208-590-64: 15 mL in a 15 mL bottle

    Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)
    [see USP Controlled Room Temperature].
    Keep container tightly closed.

    DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW symbol IS NOT INTACT.

    Keep out of reach of children.

    Distributed by:
    Bausch + Lomb, a division of
    Bausch Health US, LLC
    Bridgewater, NJ 08807 USA

    Manufactured by:
    Bausch & Lomb Incorporated
    Tampa, FL 33637 USA

    © 2019 Bausch & Lomb Incorporated or its affiliates

    Revised: July 2019

    9115806 (Folded)
    9115906 (Flat)

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL (Mexico) - 0.5

    Carton-Mexico 0.5 15mL.jpg

    NDC 24208-590-64

    Tropicamide
    Ophthalmic
    Solution, USP
    0.5%
    Sterile

    FOR TOPICAL
    OPHTHALMIC
    USE ONLY

    Rx only

    15 mL

    BAUSCH + LOMB

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Japan – 0.5

    Carton-Japan 0.5 15mL.jpg

    NDC 24208-590-64

    Tropicamide
    Ophthalmic
    Solution, USP
    0.5%
    Sterile

    FOR TOPICAL
    OPHTHALMIC
    USE ONLY

    Rx only

    15 mL

    BAUSCH + LOMB

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Mexico 1

    NDC 24208-585-64

    Tropicamide
    Ophthalmic
    Solution, USP
    1%
    Sterile

    FOR TOPICAL
    OPHTHALMIC
    USE ONLY

    Rx only

    15 mL

    BAUSCH + LOMB

    Carton-Mexico 1.0 15mL.jpg
  • Package/Label Principal Display Panel Japan 1

    NDC 24208-585-64

    Tropicamide
    Ophthalmic
    Solution, USP
    1%
    Sterile

    FOR TOPICAL
    OPHTHALMIC
    USE ONLY

    Rx only

    15 mL

    BAUSCH + LOMB

    Carton-Japan 1.0 15mL.jpg
  • INGREDIENTS AND APPEARANCE
    TROPICAMIDE 
    tropicamide solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24208-590
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6) TROPICAMIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-590-641 in 1 CARTON07/27/1994
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04006707/27/1994
    TROPICAMIDE 
    tropicamide solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24208-585
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6) TROPICAMIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-585-591 in 1 CARTON07/27/1994
    12 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:24208-585-641 in 1 CARTON07/27/1994
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04006407/27/1994
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(24208-590, 24208-585)