Label: EUTHANASIA- pentobarbital sodium and phenytoin sodium solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated October 18, 2019

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  • GENERAL PRECAUTIONS

    PRODUCT INFORMATION

    FOR DOGS ONLY

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

  • DESCRIPTION

    A non-sterile solution containing pentobarbital sodium and phenytoin sodium as the active ingredients. Rhodamine B, a bluishred
    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), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

  • ACTIONS

    EUTHANASIA SOLUTION (pentobarbital sodium and phenytoin sodium) 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.

  • Pharmacodynamic Activity

    The sequence of events leading to humane, painless, and rapid euthanasia following intravenous injection of 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.

  • INDICATIONS

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

  • 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 each of children. If eye contact, flush with water and seek medical advice/attention.

  • 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.

  • 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.

  • HOW SUPPLIED

    EUTHANASIA SOLUTION is available in 100 mL multiple dose vials.

    STORAGE

    Store at controlled room temperature of between 20˚ and 25˚C (68˚and 77˚F), with excursions permitted between 15° to 30°C (59° to 86°F). Manufactured by a nonsterilizing process.

  • SPL UNCLASSIFIED SECTION

    Manufactured for VEDCO, INC., St. Joseph, MO 64507
    For Technical Service, contact (800) 338-3659.

    09/17

  • PRINCIPAL DISPLAY PANEL - 100 mL Vial Bottle

    Non-Sterile Solution Multiple Dose Vial

    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 with water and seek medical advice/attention.
    Store at controlled room temperature 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86° F).

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  • INGREDIENTS AND APPEARANCE
    EUTHANASIA 
    pentobarbital sodium and phenytoin sodium solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-302
    Route of AdministrationINTRAVENOUS, INTRACARDIACDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pentobarbital sodium (UNII: NJJ0475N0S) (Pentobarbital - UNII:I4744080IR) pentobarbital sodium390 mg  in 1 mL
    phenytoin sodium (UNII: 4182431BJH) (Phenytoin - UNII:6158TKW0C5) phenytoin sodium50 mg  in 1 mL
    Product Characteristics
    ColorRED (bluish-red) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50989-302-121 in 1 CARTON
    1100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20007110/22/2012
    Labeler - Vedco, Inc. (021634266)