Label: CARBASTAT- carbachol injection, solution 

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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
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Drug Label Information

Updated 09/06

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  • SPL UNCLASSIFIED SECTION

    Carbastat®

    (CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%

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  • DESCRIPTION

    CARBASTAT® (Carbachol Intraocular Solution, USP) 0.01% is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the structural formula:

    Image from Drug Label Content

    Established name: Carbachol

    Chemical name: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,N -trimethyl-, chloride.

    Each mL contains: Active: Carbachol 0.01%.

    Inactive: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid to adjust pH (5.0-7.5) and water for injection USP.

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  • CLINICAL PHARMACOLOGY

    Carbachol is a potent cholinergic (parasympathomimetic) agent which produces constriction of the iris and ciliary body resulting in reduction in intraocular pressure. The exact mechanism by which carbachol lowers intraocular pressure is not precisely known.

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  • INDICATIONS AND USAGE

    Intraocular use for obtaining miosis during surgery. In addition, Carbastat® (Carbachol Intraocular Solution USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery.

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  • CONTRAINDICATIONS

    Should not be used in those persons showing hypersensitivity to any of the components of this preparation.

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  • WARNINGS

    For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease.

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  • PRECAUTIONS

    Carcinogenesis

    Studies in animals to evaluate the carcinogenic potential have not been conducted.

    Pregnancy: Category C. 

    There are no adequate and well controlled studies in pregnant women. Carbastat® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mothers

    It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.

    Pediatric Use

    Safety and efficacy in pediatric patients have not been established.

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  • ADVERSE REACTIONS

    Ocular

    Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported.

    Systemic

    Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol.

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  • DOSAGE AND ADMINISTRATION

    Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray. Withdraw the contents into a dry sterile syringe, and replace the needle with an atraumatic cannula prior to intraocular irrigation. No more than one-half milliliter should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application.

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  • HOW SUPPLIED

    CARBASTAT (Carbachol Intraocular Solution, USP) 0.01%

    1.5 mL sterile glass vials in cartons of 12 (12 x 1.5 mL)

    NDC 58768-735-12

    Store at controlled room temperature 15°-30°C (59°-86°F).

    Rx only

     

    Manufactured by OMJ Pharmaceuticals, Inc.,

    San Germán, P.R. 00683

    for Novartis Ophthalmics

    Duluth, GA 30097

    5007-D

    March, 2001

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  • INGREDIENTS AND APPEARANCE
    CARBASTAT 
    carbachol injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58768-735
    Route of Administration INTRAOCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Carbachol (Carbachol) 0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    calcium chloride dihydrate 0.481 mg  in 1 mL
    hydrochloric acid  
    magnesium chloride hexahydrate 0.3 mg  in 1 mL
    potassium chloride 0.75 mg  in 1 mL
    sodium acetate trihydrate 3.9 mg  in 1 mL
    Sodium chloride 6.4 mg  in 1 mL
    sodium citrate dihydrate 1.7 mg  in 1 mL
    sodium hydroxide  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58768-735-12 12 in 1 CARTON
    1 1.5 mL in 1 VIAL, GLASS
    Labeler - Novartis Ophthalmics
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