PENTOBARBITAL SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pentobarbital sodium (UNII: NJJ0475N0S) (pentobarbital - UNII:I4744080IR)

Available from:

Sagent Pharmaceuticals

INN (International Name):

pentobarbital sodium

Composition:

pentobarbital sodium 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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. Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria. Pentobarbital sodium injection is subject to control by the Federal Controlled Substances Act under DEA schedule II. Barbiturates may be habit forming. Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. Daily administration in excess of 400 milligrams (mg) of pentobarbital or secobar

Product summary:

Pentobarbital Sodium Injection, USP is supplied as follows: Each mL contains: Pentobarbital Sodium, derivative of barbituric acid - 50 mg Propylene glycol - 40% v/v Alcohol - 10% v/v Water for Injection - qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from freezing. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTOBARBITAL SODIUM- PENTOBARBITAL SODIUM INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
PENTOBARBITAL SODIUM INJECTION, USP
VIALS
DO NOT USE IF MATERIAL HAS PRECIPITATED
CII
SAGENT
Rx only
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 (See "Drug Abuse and
Dependence" section).
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.
Pentobarbital Sodium Injection, USP 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% v/v and
water for injection, to volume. The pH is adjusted to approximately
9.5 with hydrochloric acid and/or
sodium hydroxide.
Pentobarbital Sodium Injection, USP is a short-acting barbiturate,
chemically designated as sodium 5-
ethyl-5-(1-methylbutyl) barbiturate. The structural formula for
Pentobarbital Sodium is:
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.
CLINICAL PHARMACOLOGY
Barbiturates are capable of producing all levels of CNS mood
alteration from excitation to mild
sedation, to hypnosis, and deep coma. Overdosage can produce death. In
high enough therapeutic doses,
barbiturates induce anesthesia.
Barbiturates depress the sensory cortex, decrease motor activity,
alter cerebellar function, and produce
drowsiness, sedation, and hypnosis.
Barbiturate-induced sleep differs from physiological