PENTOBARBITAL SODIUM injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

PENTOBARBITAL SODIUM (UNII: NJJ0475N0S) (PENTOBARBITAL - UNII:I4744080IR)

זמין מ:

Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

- 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 pentob

leaflet_short:

Pentobarbital Sodium Injection, USP is available in the following sizes: 20-mL multiple-dose vial, 1000 mg per vial (NDC 24201-010-20); and 50-mL multiple-dose vial, 2500 mg per vial (NDC 24201-010-50). 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.) The container closure is not made with natural rubber latex. 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). See USP controlled room temperature.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PENTOBARBITAL SODIUM- PENTOBARBITAL SODIUM INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC. (DBA LEUCADIA PHARMACEUTICALS)
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PENTOBARBITAL SODIUM INJECTION, USP
CII
RX ONLY
VIALS
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 (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 s