PHENOBARBITAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

C.O. Truxton, Inc.

INN (International Name):

PHENOBARBITAL

Composition:

PHENOBARBITAL 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 do

Product summary:

Phenobarbital Tablets, USP 15 mg: White, Round Tablet; Debossed “West-ward 445” on one side and plain on the other side. Bottles of 100 and 1000 tablets Phenobarbital Tablets, USP 30 mg: White, Round, Scored Tablet; Debossed “West-ward 450” on one side and Scored on the other side. Bottles of 100 and 1000 tablets Phenobarbital Tablets, USP 60 mg: White, Round Tablet; Debossed “WW 455” on one side and plain on the other side. Bottles of 100 and 1000 tablets Phenobarbital Tablets, USP 100 mg: White, Round, Scored Tablet; Debossed “WW 458” on one side and Scored on the other side. Bottles of 100 and 1000 tablets 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 by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised March 2012

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL- PHENOBARBITAL TABLET
C.O. TRUXTON, 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
Rev. 10/12 C
R ONLY
DESCRIPTION
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, 30 mg, 60 mg or 100 mg
of phenobarbital, USP.
Inactive ingredients are as follows:
15 MG, 30 AND 60 MG: Calcium Stearate, Colloidal Silicon Dioxide, Corn
Starch, and Microcrystalline
Cellulose.
100 MG: Anhydrous Lactose, Colloidal Silicon Dioxide, Corn Starch,
Docusate Sodium, Lactose
Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, and
Sodium Starch Glycolate.
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.
INDICATION 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
IV
X
12
12
2
3
contraindicated in patients with marked impairment of liver function