PENTOBARBITAL SODIUM AND PHENYTOIN SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pentobarbital Sodium (UNII: NJJ0475N0S) (Pentobarbital - UNII:I4744080IR), Phenytoin Sodium (UNII: 4182431BJH) (Phenytoin - UNII:6158TKW0C5)

Available from:

Akorn

Administration route:

INTRACARDIAC

Prescription type:

PRESCRIPTION

Therapeutic indications:

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

Product summary:

Pentobarbital Sodium and Phenytoin Sodium is available in 100 mL multi-dose vials in package of one, NDC 59399-185-90. Manufactured by a nonsterilizing process. Store at controlled room temperature 20° to 25°C (68° to 77°F). Use contents within 60 days of first puncture. Approved by FDA under ANADA # 200-614 AKORN ANIMAL HEALTH Manufactured by: Akorn, Inc. Lake Forest, IL 60045 VPP00N         Rev. 12/19 Luer-Lok is a registered trademark of Becton, Dickinson and Company.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

PENTOBARBITAL SODIUM AND PHENYTOIN SODIUM- PENTOBARBITAL SODIUM
AND PHENYTOIN SODIUM INJECTION, SOLUTION
AKORN
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PENTOBARBITAL SODIUM AND PHENYTOIN SODIUM
EUTHANASIA SOLUTION
CIII
FOR DOGS ONLY
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
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.
ACTIONS:
Pentobarbital Sodium and Phenytoin Sodium 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.
PHARMACODYNAMIC ACTIVITY: The sequence of events leading to humane,
painless, and
rapid euthanasia following intravenous injection of Pentobarbital
Sodium and Phenytoin
Sod