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NEMBUTAL® Sodium Solution
(pentobarbital sodium) Injection, USP

DO NOT USE IF MATERIAL HAS PRECIPITATED

DESCRIPTION
The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act

The sodium salts of amobarbital, pentobarbital, phenobarbital, and secobarbital are available as sterile parenteral solutions.

Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring.

NEMBUTAL Sodium Solution (pentobarbital sodium injection) is a sterile solution for intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume. The pH is adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.

NEMBUTAL (pentobarbital) Sodium is a short-acting barbiturate, chemically designated as sodium 5-ethyl-5-(1-methylbutyl) barbiturate.
The sodium salt occurs as a white, slightly bitter powder which is freely soluble in water and alcohol but practically insoluble in benzene and ether.

INDICATIONS
Parenteral
Sedatives.
Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See "CLINICAL PHARMACOLOGY" section).
Preanesthetics.
Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.

HOW SUPPLIED
NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP)

Active Ingredients: PENTOBARBITAL SODIUM

Dosage Form:LIQUID and SOLUTION

Dosage Strength: 250MG/ML Available

Regulatory Information: Schedule G (CDSA IV)

Packaging Presentation:250ML

Each mL contains:

Pentobarbital Sodium, derivative of barbituric acid.......................................50 mg
Propylene glycol........................................................................................40% v/v
Alcohol ............................................................................................................10%
Water for Injection..............................................................................................qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.)

Vial stoppers are latex free.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20-25 C (68-77 F), however, brief excursions are permitted between 15-30 C (59-86 F).