PHENOBARBITAL TABLETS, USP

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D)

Доступно од:

Clinical Solutions Wholesale, LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

- Sedative - Anticonvulsant – For the treatment of generalized and partial seizures. 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 fata

Резиме производа:

Phenobarbital Tablets, USP 16.2 mg: White, round, tablets scored on one side and debossed “e5" above the score and "110” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-110-01, 1000 tablets, NDC 13517-110-10, 30 tablets in blister pack NDC 58118-1110-8 Phenobarbital Tablets, USP 32.4 mg: White, round, tablets scored on one side and debossed “e5" above the score and "111” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-111-01 and 1000 tablets, NDC 13517-111-10. Phenobarbital Tablets, USP 64.8 mg: White, round, tablets scored on one side and debossed “e5" above the score and "112” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-112-01 and 1000 tablets, NDC 13517-112-10. Phenobarbital Tablets, USP 97.2 mg: White, round, tablets scored on one side and debossed “e5" above the score and "113” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-113-01 and 1000 tablets, NDC 13517-113-10. Store at 20°- 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: e5 Pharma, LLC Boca Raton, FL 33432 Repackaged By: Clinical Solutions Wholesale Franklin, TN 37067

Статус ауторизације:

unapproved drug other

Карактеристике производа

PHENOBARBITAL- PHENOBARBITAL TABLET
CLINICAL SOLUTIONS WHOLESALE, 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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PHENOBARBITAL TABLETS, USP
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:
C
H
N
O
M.W. = 232.24
Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2
mg of phenobarbital, USP.
INACTIVE INGREDIENT
INACTIVE INGREDIENTS INCLUDE: colloidal silicon dioxide, lactose
anhydrous, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, and stearic acid.
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