AMYTAL SODIUM- amobarbital sodium injection, powder, lyophilized, for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

AMOBARBITAL SODIUM (UNII: G0313KNC7D) (AMOBARBITAL - UNII:GWH6IJ239E)

Saadav alates:

Bausch Health US, LLC

INN (Rahvusvaheline Nimetus):

AMOBARBITAL SODIUM

Koostis:

AMOBARBITAL SODIUM 0.5 g in 5 mL

Manustamisviis:

INTRAMUSCULAR

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Amobarbital sodium is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident. Amobarbital sodium is a Schedule II drug. 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 mg of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree of physical dependence. A dosage of 600 to 800 mg for at least 35 days is sufficient to produce withdrawal seizures. The average daily dose for the barbiturate addict is usually about 1.5 g. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than twofold. As this occurs, the margi

Toote kokkuvõte:

AMYTAL® SODIUM Vials 0.5 g (dry powder) are available as follows: NDC 0187-4303-05 Storage: Store at (15° to 30°C) (59° to 86°F) Lyophilized *Trademark of PDR Network, LLC Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Alcami Carolinas Corporation North Charleston, SC 29405 USA AMYTAL is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates Revised: July 2020 9476203 PC3328F

Volitamisolek:

unapproved drug other

Toote omadused

AMYTAL SODIUM- AMOBARBITAL SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
BAUSCH HEALTH US LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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AMYTAL SODIUM CII
(AMOBARBITAL SODIUM)
FOR INJECTION, USP
VIALS
CAUTION: THESE PRODUCTS ARE TO BE USED UNDER THE DIRECTION OF A
PHYSICIAN.
THE INTRAVENOUS ADMINISTRATION OF AMYTAL SODIUM
(AMOBARBITAL SODIUM) FOR INJECTION, USP CARRIES WITH IT THE POTENTIAL
DANGERS
INHERENT IN THE INTRAVENOUS USE OF ANY POTENT HYPNOTIC.
DESCRIPTION
The barbiturates are nonselective central nervous system (CNS)
depressants that are primarily used as
sedative hypnotics. In subhypnotic doses, they are also used as
anticonvulsants. The barbiturates and
their sodium salts are subject to control under the Federal Controlled
Substances Act.
Amobarbital sodium is a white, friable, granular powder that is
odorless, has a bitter taste, and is
hygroscopic. It is very soluble in water, soluble in alcohol, and
practically insoluble in ether and
chloroform. Amobarbital sodium is sodium
5-ethyl-5-isopentylbarbiturate and has the empirical formula
C
H N NaO Its molecular weight is 248.26.
It has the following structural formula:
Amobarbital sodium is a substituted pyrimidine derivative in which the
basic structure is barbituric acid,
a substance that has no CNS activity.
Vials of amobarbital sodium are for parenteral administration. The
vials contain 500 mg (2 mmol)
amobarbital sodium as a sterile lyophilized powder.
®
®
11
17
2
3.
CLINICAL PHARMACOLOGY
Barbiturates are capable of producing all levels of CNS mood
alteration, from excitation to mild
sedation, 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