Label: BEUTHANASIA-D SPECIAL- pentobarbital sodium and phenytoin sodium injection, solution

  • NDC Code(s): 0061-0473-05
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated September 17, 2015

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  • VETERINARY INDICATIONS

    FOR DOGS ONLY

    NADA #119-807

    PRODUCT
    INFORMATION

    CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • DESCRIPTION

    DESCRIPTION A nonsterile solution containing pentobarbital sodium and phenytoin sodium as the active ingredients. Rhodamine B, a bluish-red fluorescent dye, is included in the formulation to help distinguish it from parenteral drugs intended for therapeutic use. Although the solution is not sterile, benzyl alcohol, a bacteriostat, is included to retard the growth of microorganisms.

    Each mL contains: active ingredients: 390 mg pentobarbital sodium (barbituric acid derivative), 50 mg phenytoin sodium; inactive ingredients: 10% ethyl alcohol, 18% propylene glycol, 0.003688 mg rhodamine B, 2% benzyl alcohol (preservative), purified water qs. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

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  • MECHANISM OF ACTION

    ACTIONS BEUTHANASIA-D SPECIAL EUTHANASIA SOLUTION contains two active ingredients which are chemically compatible but pharmacologically different. Each ingredient acts in such a manner so as to cause humane, painless, and rapid euthanasia. Euthanasia is due to cerebral death in conjunction with respiratory arrest and circulatory collapse. Cerebral death occurs prior to cessation of cardiac activity.

    When administered intravenously, pentobarbital sodium produces rapid anesthetic action. There is a smooth and rapid onset of unconsciousness. At the lethal dose, there is depression of vital medullary respiratory and vasomotor centers.

    When administered intravenously, phenytoin sodium produces toxic signs of cardiovascular collapse and/or central nervous system depression. Hypotension occurs when the drug is administered rapidly.

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  • PHARMACODYNAMICS

    Pharmacodynamic Activity: The sequence of events leading to humane, painless, and rapid euthanasia following intravenous injection of BEUTHANASIA-D SPECIAL EUTHANASIA SOLUTION is similar to that following intravenous injection of pentobarbital sodium or other barbituric acid derivatives. Within seconds, unconsciousness is induced with simultaneous collapse of the dog. This stage rapidly progresses to deep anesthesia with concomitant reduction in the blood pressure. A few seconds later, breathing stops, due to depression of the medullary respiratory center; encephalographic activity becomes isoelectric, indicating cerebral death, and then cardiac activity ceases.

    Phenytoin sodium exerts its effect during the deep anesthesia stage caused by the pentobarbital sodium. This ingredient, due to its cardiotoxic properties, hastens the stoppage of electrical activity in the heart.

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  • VETERINARY INDICATIONS

    INDICATIONS For use in dogs for humane, painless, and rapid euthanasia.

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  • WARNINGS

    WARNING For canine euthanasia only. Must not be used for therapeutic purposes. Do not use in animals intended for food.

    ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.

    HUMAN WARNING Caution should be exercised to avoid contact of the drug with open wounds or accidental self-inflicted injections. Keep out of reach of children. If eye contact, flush eyes with water and seek medical attention.

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  • PRECAUTIONS

    PRECAUTIONS Euthanasia may sometimes be delayed in dogs with severe cardiac or circulatory deficiencies. This may be explained by the impaired movement of the drug to its site of action. An occasional dog may elicit reflex responses manifested by motor movement; however, an unconscious animal does not experience pain, because the cerebral cortex is not functioning.

    When restraint may cause the dog pain, injury, or anxiety, or danger to the person making the injection, prior use of tranquilizing or immobilizing drugs may be necessary.

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  • DOSAGE AND ADMINISTRATION

    Dosage: Dogs, 1 mL for each 10 pounds of body weight.

    Administration: Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection.

    The calculated dose should be given in a single bolus injection.

    For intravenous injection, a needle of sufficient gauge to ensure intravenous placement of the entire dose should be used. The use of a Luer-Lok® syringe is recommended to prevent accidental exposure due to needle/syringe separation.

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  • HOW SUPPLIED

    HOW SUPPLIED BEUTHANASIA-D SPECIAL EUTHANASIA SOLUTION is available in 100-mL multiple-dose vials, NDC 0061-0473-05.

    Manufactured by a nonsterilizing process.

    STORAGE Store between 15° and 30°C (59° and 86°F).

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  • SPL UNCLASSIFIED SECTION

    Made in Canada.

    Intervet Inc (d/b/a Merck Animal Health), Madison, NJ 07940

    Copyright © 1992, 1995, 1999, 2003, Intervet Inc., a subsidiary of Merck & Co., Inc. All rights reserved.

    Luer-Lok is a registered trademark of Becton, Dickinson and Company.

    81-482047
    Rev. 04/15

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  • PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

    NDC 0061-
    0473-05

    100 mL

    CIII

    Beuthanasia®-D
    Special

    (EUTHANASIA SOLUTION)

    FOR DOGS ONLY

    Caution: Federal law restricts
    this drug to use by or on the order
    of a licensed veterinarian.

    NADA #119-807

    MERCK
    Animal Health

    PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton
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  • INGREDIENTS AND APPEARANCE
    BEUTHANASIA-D SPECIAL 
    pentobarbital sodium and phenytoin sodium injection, solution
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0061-0473
    Route of Administration INTRACARDIAC, INTRAVENOUS DEA Schedule CIII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    pentobarbital sodium (UNII: NJJ0475N0S) (pentobarbital - UNII:I4744080IR) pentobarbital sodium 390 mg  in 1 mL
    phenytoin sodium (UNII: 4182431BJH) (phenytoin - UNII:6158TKW0C5) phenytoin sodium 50 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0061-0473-05 1 in 1 CARTON
    1 100 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA119807 04/24/1981
    Labeler - Merck Sharp & Dohme Corp. (001317601)
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