Label: ATROPINE SULFATE- atropine sulfate solution

  • NDC Code(s): 24208-750-06, 24208-750-60
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 12/14

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  • DESCRIPTION

    Atropine Sulfate Ophthalmic Solution USP, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula:

    Structural Formula

    (C17H23NO3)2•H2SO4•H2O
    Mol. wt. 694.84

    Chemical name:

    Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-(3.2.1)oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate.

    Each mL Contains:

    Atropine Sulfate Ophthalmic Solution USP, 1%, contains in each mL of solution: ACTIVE: Atropine Sulfate USP, 1% (10mg); INACTIVES: Boric Acid, Hypromellose and Purified Water; Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

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  • CHEMICAL PHARMACOLOGY

    The anticholinergic effect of this product blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).

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  • INDICATIONS AND USAGE

    For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.

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  • CONTRAINDICATIONS

    This product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma. This product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. This product should not be used in those persons showing hypersensitivity to any component of this preparation.

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  • WARNINGS

    Not for injection into the eye. Do not touch dropper tip to any surface, as this may contaminate the solution. In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication, and use appropriate therapy as outlined in “OVERDOSAGE” section.

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  • PRECAUTIONS

    To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Administration of atropine in infants requires great caution.

    Patient Warning:

    Patients should be advised not to drive or engage in other 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 children’s mouth and to wash their own hands and the child’s hands following administration.

    Carcinogenesis, Mutagenesis, Impairment of Fertility:

    No studies have been conducted in animals or in humans to evaluate the potential of these effects.

    Pregnancy Category C:

    Animal reproduction studies have not been performed with atropine. It is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atropine should be given to pregnant women only if clearly needed.

    Pediatric Use:

    See "CONTRAINDICATIONS” and "WARNINGS” sections.

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  • ADVERSE REACTIONS

    Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young.

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  • OVERDOSAGE

    Systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in pediatric patients), blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination.


    Atropine poisoning, although distressing, is rarely fatal, even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication is discontinued. In severe intoxication, physostigmine salicylate may be administered parenterally to provide more prompt relief of the intoxication. Give physostigmine salicylate as 1-5 mL IV of dilution containing 1 mg in 5 mL of saline. The smaller dose is for pediatric patients, and injection should take not less than two minutes. EKG control is advisable. Dosage can be repeated every five minutes up to a total dose of 2 mg in pediatric patients and 6 mg in adults every 30 minutes. Physostigmine is contraindicated in hypotensive reactions. Atropine (1 mg) should be available for immediate injection if physostigmine causes bradycardia, convulsions or bronchoconstriction. In pediatric patients, the body surface must be kept moist.


    Use extreme caution when employing short-acting barbiturates to control excitement.

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  • DOSAGE AND ADMINISTRATION

    ATROPINE SULFATE SOLUTION: 1 or 2 drops in the eye(s) three times a day or as directed by a physician.


    FOR OPHTHALMIC USE ONLY.

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  • HOW SUPPLIED

    Atropine Sulfate Ophthalmic Solution USP, 1% is supplied in a plastic squeeze bottle with a controlled tip applicator in the following sizes:

    5 mL bottle – NDC 24208-750-60

    15 mL bottle – NDC 24208-750-06

    DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT

    STORAGE:

    Store between 15°-25°C (59°-77°F).

    KEEP OUT OF REACH OF CHILDREN.

    Revised: January 2013

    Bausch & Lomb Incorporated
    Tampa, FL 33637
    ©Bausch & Lomb Incorporated

    9114802 (Folded)

    9114902 (Flat)

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Atropine Sulfate Ophthalmic Solution carton label

    NDC 24208-750-06

    BAUSCH + LOMB

    Atropine Sulfate Ophthalmic Solution USP, 1% (Sterile)

    Rx only

    [icon-eye] [icon-1%] [icon-solution] [icon-15mL]

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  • INGREDIENTS AND APPEARANCE
    ATROPINE SULFATE 
    atropine sulfate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-750
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID  
    HYPROMELLOSES  
    WATER  
    SODIUM HYDROXIDE  
    HYDROCHLORIC ACID  
    BENZALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-750-60 1 in 1 CARTON
    1 5 mL in 1 BOTTLE, DROPPER
    2 NDC:24208-750-06 1 in 1 CARTON
    2 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 09/30/1990 12/31/2014
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 807927397 MANUFACTURE(24208-750)
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