PHENOBARBITAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

PHENOBARBITAL

Composition:

PHENOBARBITAL 64.8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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. Controlled Substance – Phenobarbital is a Schedule IV drug. Dependence – 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 intoxic

Product summary:

Phenobarbital Tablets, USP 16.2 mg are white, round, biconvex, scored tablets, debossed “5011” and “V” on one side and plain on the reverse side, and supplied as follows: Phenobarbital Tablets, USP 32.4 mg are white, round, biconvex, scored tablets, debossed “5012” and “V” on one side and plain on the reverse side, and supplied as follows: Phenobarbital Tablets, USP 64.8 mg are white, round, biconvex, scored tablets, debossed “5013” and “V” on one side and plain on the reverse side, and supplied as follows: Phenobarbital Tablets, USP 97.2 mg are white, round, biconvex, scored tablets, debossed “5014” and “V” on one side and plain on the reverse side, and supplied as follows:

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL- PHENOBARBITAL TABLET
DIRECT RX
_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
DESCRIPTION SECTION
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:
Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2
mg of phenobarbital.
In addition each tablet contains: colloidal silicon dioxide, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose and sodium starch glycolate.
CLINICAL PHARMACOLOGY SECTION
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) phase of sleep or the
dreaming stage. Also, S