PHENOBARBITAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

PHENOBARBITAL

Composition:

PHENOBARBITAL 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Controlled Substance: 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 due to physical dependence following chronic use of large doses of barbiturates may include delirium, convulsions, and death.

Product summary:

Phenobarbital Tablets USP, 15 mg White, Round Tablet; Debossed “WW 445” on one side and plain on the other side.                              NDC 0143-1495-01: Bottle of 100 tablets                NDC 0143-1495-05: Bottle of 500 tablets   Phenobarbital Tablets USP, 30 mg White, Round, Scored Tablet; Debossed “WW 450” on one side and Scored on the other side.              NDC 0143-1500-01: Bottle of 100 tablets                 NDC 0143-1500-05: Bottle of 500 tablets   Phenobarbital Tablets USP, 60 mg White, Round Tablet; Debossed “WW 455” on one side and plain on the other side.              NDC 0143-1455-01: Bottle of 100 tablets               NDC 0143-1455-05: Bottle of 500 tablets Phenobarbital Tablets USP, 100 mg White, Round, Scored Tablet; Debossed “WW 458” on one side and Scored on the other side.              NDC 0143-1458-01: Bottle of 100 tablets                NDC 0143-1458-05: Bottle of 500 tablets 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. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights,  NJ 07922 C50000803/02      Revised August 2022

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL- PHENOBARBITAL TABLET
HIKMA PHARMACEUTICALS USA INC.
_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
CLINICAL PHARMACOLOGY
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 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.
WARNINGS
In small doses, the barbiturates may increase the reaction to painful
stimuli. Taken by
themselves, the barbiturates cannot be relied upon to relieve pain or
even to produce
sedation or sleep in the presence of severe pain.
PRECAUTIONS
GENERAL PRECAUTIONS
Barbiturates induce liver microsomal enzyme activity. This accelerates
the
biotransformation of various drugs and is probably part of the
mechanism of the
tolerance encountered with barbiturates. Phenobarbital, therefore,
should be used with
caution in patients with decreased liver function. This drug should
also be administere