PHENOBARBITAL tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

WINDER LABORATORIES, LLC

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant. Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates. In such patients, severe hepatic damage can occur from ordinary doses and is usually associated with dermatitis and involvement of parenchymatous organs. A personal or familial history of acute intermittent porphyria represents one of the few absolute contraindications to the use of barbiturates. Phenobarbital is also contraindicated in patients with marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. It should not be administered to persons with known previous addiction to the sedative/hypnotic group, since ordinary doses may be ineffectual and may contribute to further addiction. Phenobarbital is a Schedule IV drug. Prolonged, uninterrupted use of barbiturates (particularly the short-acting drugs), even in therapeutic doses, may result in psychic and physical dependence. Withdrawal symptoms d

Каталог на резюме:

Phenobarbital Tablets, USP 15 mg: White, Round Tablet; Debossed WL on one side and 136 on the other side. Phenobarbital Tablets, USP 16.2 mg (¼ grain): White, Round, Scored Tablet; Debossed WL on one side and 137 on the other side. Phenobarbital Tablets, USP 30 mg: White, Round, Scored Tablet; Debossed WL on one side and 138 on the other side. Phenobarbital Tablets, USP 32.4 mg (½ grain): White, Round, Scored Tablet; Debossed WL on one side and 139 on the other side. Phenobarbital Tablets, USP 60 mg: White, Round Tablet; Debossed WL on one side and 140 on the other side. Phenobarbital Tablets, USP 64.8 mg (1 grain): White, Round, Scored Tablet; Debossed WL on one side and 141 on the other side. Phenobarbital Tablets, USP 97.2 mg (1½ grain): White, Round, Scored Tablet; Debossed WL on one side and 142 on the other side. Phenobarbital Tablets, USP 100 mg: White, Round, Scored Tablet; Debossed WL on one side and 143 on the other side. Store at 20° to 25°C (68° to 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.

Статус Оторизация:

unapproved drug other

Данни за продукта

PHENOBARBITAL- PHENOBARBITAL TABLET
WINDER LABORATORIES, 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 CIV
RX ONLY
REV. JAN 2022
DESCRIPTION
The barbiturates are nonselective central nervous system (CNS)
depressants 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 for oral administration
and occurs as a white,
odorless, slightly bitter powder that is soluble in chloroform, freely
soluble in alcohol or
ether, and slightly soluble in water. Its saturated solution has a pH
of about 5.6.
Chemically, it is 5-ethyl-5-phenylbarbituric acid with the molecular
formula C
H
N
O
(232.24).
The structural formula is as follows:
Each Phenobarbital Tablet, USP contains 15 mg, 16.2 mg, 30 mg, 32.4
mg, 60 mg, 64.8
mg, 97.2 mg, or 100 mg of phenobarbital, USP.
Inactive ingredients are as follows:
Microcrystalline Cellulose; Lactose Monohydrate; Sodium Starch
Glycolate, Type-A;
Colloidal Silicon Dioxide; Magnesium Stearate
CLINICAL PHARMACOLOGY
12
12
2
3
Phenobarbital, a long-acting barbiturate, is a central nervous system
depressant. In
ordinary doses, the drug acts as a sedative and anticonvulsant. Its
onset of action
occurs within 30 minutes, and the duration of action ranges from 5 to
6 hours. It is
detoxified in the liver.
INDICATIONS AND USAGE
Phenobarbital Tablets, USP are indicated for use as a sedative or
anticonvulsant.
CONTRAINDICATIONS
Phenobarbital is contraindicated in patients who are hypersensitive to
barbiturates. In
such patients, severe hepatic damage can occur from ordinary doses and
is usually
associated with dermatitis and involvement of parenchymatous organs. A
personal or
familial history of acute intermittent porphyria represen