EUTHASOL® (pentobarbital sodium and phenytoin sodium) Euthanasia Solution

Manufacturer
Virbac AH, Inc.
Effective date
2022-07-25
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:41:32

Label at a glance#

ProductEuthasol
Active ingredientpentobarbital sodium, phenytoin sodium
Label structure11 sections

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, ...

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Approved by FDA under ANADA # 200-071

FOR DOGS ONLY

CAUTION

GENERAL PRECAUTIONS SECTION

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

DESCRIPTION

DESCRIPTION SECTION

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

MECHANISM OF ACTION SECTION

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

PHARMACODYNAMICS SECTION

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.

INDICATIONS

INDICATIONS & USAGE SECTION

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

WARNING

WARNINGS SECTION

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

ENVIRONMENTAL WARNING SECTION

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

USER SAFETY WARNINGS SECTION

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

PRECAUTIONS SECTION

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 & ADMINISTRATION SECTION

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 www.fda.gov/reportanimalae.

HOW SUPPLIED

HOW SUPPLIED SECTION

EUTHASOL Euthanasia Solution is available in 100 mL multiple dose vials.

STORAGE

STORAGE AND HANDLING SECTION

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).

SPL UNCLASSIFIED SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100449PENTobarbital sodium 390 MG/mL / phenytoin sodium 50 MG/mL Injectable SolutionPSN9
1100453pentobarbital sodium 390 MG/ML / phenytoin sodium 50 MG/ML Injectable Solution [Euthasol]SBD9
1100449pentobarbital sodium 390 MG/ML / phenytoin sodium 50 MG/ML Injectable SolutionSCD9
1100453Euthasol (pentobarbital sodium 390 MG/ML / phenytoin sodium 50 MG/ML) Injectable SolutionSY9
1100449Pentobarbital Sodium 390 MG/ML / DPH sodium 50 MG/ML Injectable SolutionSY9
1100453Pentobarbital Sodium 390 MG/ML / DPH sodium 50 MG/ML Injectable Solution [Euthasol]SY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYTOIN Pharmacologic Class Indexing4Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
a608f88c-baa8-0098-ce26-66cf9faa6b64Product name320180110
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51311-050-01Euthasol100 mL in 1 VIAL, MULTI-DOSESOLUTION1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51311-050EUTHASOL (PENTOBARBITAL SODIUM AND PHENYTOIN SODIUM) SOLUTION [VIRBAC AH, INC.]91 package rows20220726_c885b1d9-db06-47fb-bdb0-4015e06ce08b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
pentobarbital sodiumACTIVE INGREDIENTNJJ0475N0S2
phenytoin sodiumACTIVE INGREDIENT4182431BJH2
pentobarbitalACTIVE MOIETYI4744080IR2
phenytoinACTIVE MOIETY6158TKW0C52
alcoholINACTIVE INGREDIENT3K9958V90M2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH2
hydrochloric acidINACTIVE INGREDIENTQTT17582CB2
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
rhodamine BINACTIVE INGREDIENTK7G5SCF8IL2
sodium hydroxideINACTIVE INGREDIENT55X04QC32I2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51311-05051311-050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
pentobarbital sodiumNJJ0475N0SACTIB
phenytoin sodium4182431BJHACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 517 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
benzyl alcoholBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SOLUTION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSUSPENSION / INTRATYMPANIC1 mgExact identifier — unii candidate
148 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVESICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSUSPENSION / AURICULAR (OTIC)0.04 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS4.17 mgExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / SUBCUTANEOUS1037 mgExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSPRAY / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / PARENTERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ORAL125 mgExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / DENTALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSPONGE / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBOINTMENT / TOPICALNAExact identifier — unii candidate
148 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentobarbital SodiumPENTOBARBITAL SODIUMHikma Pharmaceuticals USA Inc.d375b92a-baa1-4d63-9ad1-1467dcfde7d52024-03-08Warnings, Adverse reactionsName fallback
generic name: PENTOBARBITAL SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.