PENTOBARBITAL SODIUM injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Renaissance SSA, LLC

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

P a r e n t e r a l : - 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 pen

leaflet_short:

Pentobarbital Sodium Injection, USP is available in the following sizes: (NDC 70655-501-20) 1 x 20 mL Multiple-dose vial, 1 gram/20 mL (50 mg/mL) (NDC 70655-501-50) 1 x 50 mL Multiple-dose vial, 2.5 gram/50 mL (50 mg/mL) 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.) This container closure is not made with natural rubber latex. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Manufactured for:   Renaissance SSA, LLC Newtown, PA 18940 Rev. 12/17

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PENTOBARBITAL SODIUM- PENTOBARBITAL SODIUM INJECTION
RENAISSANCE SSA, LLC
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PENTOBARBITAL SODIUM INJECTION USP-50-MGML
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 sleep