TROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]

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TROPICAMIDE SOLUTION/ DROPS [AKORN, INC.]
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NDC 17478-101-12, 17478-102-12, 17478-102-20
Set ID 329a3382-3718-4311-890f-97c6b7e0077c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Akorn, Inc.
Generic Name
Product Class Anticholinergic
Product Number
Application Number ANDA040314
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  • 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 structural formula:

    Structural Formula

    C17H20N2O2         MW=284.36

    Established name: Tropicamide

    Chemical name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-.

    Each mL contains: Active: Tropicamide 0.5% (5 mg) or 1% (10 mg). Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Water for Injection. pH range 4.0 to 5.8. Preservative: 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 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 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 avoid 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.

  • 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 mydri-atics.

    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.

  • 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 to 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, 0.5% and 1% are supplied as sterile solutions in plastic dropper bottles.

     
    0.5%   NDC 17478-101-12 (15 mL)
     
    1%      NDC 17478-102-12 (15 mL)
     
    1%      NDC 17478-102-20 (2 mL)

    STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or store at high temperatures. Keep container tightly closed.

    Akorn

    Manufactured by: Akorn, Inc.
    Lake Forest, IL 60045
    TC00N Rev. 10/16

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-101-12

    Tropicamide

    Ophthalmic

    Solution, USP

    0.5%

    Sterile

    15 mL

    Rx only

    For Topical Ophthalmic Use Only

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-101-12

    Tropicamide

    Ophthalmic

    Solution, USP

    0.5%

    For Topical Ophthalmic

    Use only.

    Sterile

    15 mL

    Rx only [Akorn logo]

    Principal Display Panel Text for Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-102-12

    Tropicamide

    Ophthalmic

    Solution, USP

    1%

    Sterile

    15 mL

    Rx only

    For Topical Ophthalmic Use Only

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-102-12

    Tropicamide

    Ophthalmic

    Solution, USP

    1%

    For Topical Ophthalmic

    Use only.

    Sterile

    15 mL

    Rx only [Akorn logo]

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    TROPICAMIDE 
    tropicamide solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-102
    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)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium hydroxide (UNII: 55X04QC32I)  
    hydrochloric acid (UNII: QTT17582CB)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-102-121 in 1 CARTON09/29/2000
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:17478-102-201 in 1 CARTON09/29/2000
    22 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04031509/29/2000
    TROPICAMIDE 
    tropicamide solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-101
    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)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium hydroxide (UNII: 55X04QC32I)  
    hydrochloric acid (UNII: QTT17582CB)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-101-121 in 1 CARTON09/29/2000
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04031409/29/2000
    Labeler - Akorn, Inc. (117696770)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc.117696832MANUFACTURE(17478-102, 17478-101) , ANALYSIS(17478-102, 17478-101) , STERILIZE(17478-102, 17478-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc.117696790PACK(17478-102, 17478-101) , LABEL(17478-102, 17478-101)
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