PHENOBARBITAL tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Phenobarbital (UNII: YQE403BP4D) (Phenobarbital - UNII:YQE403BP4D)

Доступно од:

Proficient Rx LP

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Phenobarbital 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. Phenobarbital is a Schedule IV 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 taken 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 margin be

Резиме производа:

Phenobarbital Tablets, USP 16.2 mg are white, round, biconvex, scored tablets, debossed "162" on one side of the tablet, supplied in bottles of: NDC 71205-889-30 NDC 71205-889-60 NDC 71205-889-90 NDC 71205-889-00 NDC 71205-889-55 NDC 71205-889-11 Phenobarbital Tablets, USP 32.4 mg are white, round, biconvex, scored tablets, debossed "324" on one side of the tablet, supplied in bottles of: NDC 71205-891-30 NDC 71205-891-60 NDC 71205-891-90 NDC 71205-891-00 NDC 71205-891-55 NDC 71205-891-11 Phenobarbital Tablets, USP 64.8 mg are white, round, biconvex, scored tablets, debossed "648" on one side of the tablet, supplied in bottles of: NDC 71205-892-30 NDC 71205-892-60 NDC 71205-892-90 NDC 71205-892-00 NDC 71205-892-55 NDC 71205-892-11 Phenobarbital Tablets, USP 97.2 mg are white, round, biconvex, scored tablets, debossed "972" on one side of the tablet, supplied in bottles of: NDC 71205-893-30 NDC 71205-893-60 NDC 71205-893-90 NDC 71205-893-00 NDC 71205-893-55 NDC 71205-893-11

Статус ауторизације:

unapproved drug other

Карактеристике производа

PHENOBARBITAL- PHENOBARBITAL TABLET
PROFICIENT RX LP
_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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PHENOBARBITAL TABLETS, USP
CIV
RX ONLY
WARNING: MAY BE HABIT-FORMING
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.
Phenobarbital is a barbituric acid derivative and occurs as white,
odorless, small crystals
or crystalline powder that is very slightly soluble in water; soluble
in alcohol, in ether, and
in solutions of fixed alkali hydroxides and carbonates; sparingly
soluble in chloroform.
Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a
substituted pyrimidine
derivative in which the basic structure is barbituric acid, a
substance that has no CNS
activity. CNS activity is obtained by substituting alkyl, alkenyl, or
aryl groups on the
pyrimidine ring. It has the following structural formula:
C12H12N2O3 M.W. 232.24
Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2
mg of
phenobarbital.
In addition, each tablet contains: magnesium stearate,
microcrystalline cellulose, silicon
dioxide, and sodium starch glycolate.
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 physiologic sleep. Sleep
laboratory studies have
demonstrated that barbiturates reduce the amount of time spent in the
rapid eye
movement (REM) pha