Pentobarbital and phenytoin

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This page reprints a manufacturer label. Everything below in quotation marks is copied from EUTHASOL® (pentobarbital sodium and phenytoin sodium) Euthanasia Solution, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for EUTHASOL® (pentobarbital sodium and phenytoin sodium) Euthanasia Solution by Virbac AH, Inc, a pentobarbital and phenytoin product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 4 other stored labels carry the same active ingredient and are listed at the end.

The label

Product: EUTHASOL® (pentobarbital sodium and phenytoin sodium) Euthanasia Solution. Manufacturer: Virbac AH, Inc. FDA Structured Product Label set id c885b1d9-db06-47fb-bdb0-4015e06ce08b. Label effective 2022-07-25. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

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

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. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Warnings

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.

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.

Description

A non-sterile 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), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. ACTIONS EUTHASOL® 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 EUTHASOL 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.

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. Manufactured for Virbac AH, Inc. , PO Box 162059, Fort Worth, TX 76161 © 2021 Virbac Corporation. All Rights Reserved. EUTHASOL is a registered trademark of Virbac AH, Inc. Luer-Lok is a registered trademark of Becton, Dickinson and Company. image description

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming pentobarbital and phenytoin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 877 reports

Reactions most often coded in dogs, 877 reports
VeDDRA reaction termReports
INEFFECTIVE, EUTHANASIA566
Lack of efficacy - NOS177
INEFFECTIVE, DELAYED EFFECT134
Death by euthanasia110
Overdose90
Vocalisation89
Unrelated death40
Injection site pain34
Accidental exposure29
Potency, Low21
Solution, Abnormal20
Abnormal breathing19
Hyperactivity18
Sedation13
Agonal breathing12

Outcome as recorded by the reporter: Died 407; Euthanized 351; Recovered/Normal 16; Outcome Unknown 7.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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