PHENOBARBITAL liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Phenobarbital (UNII: YQE403BP4D) (Phenobarbital - UNII:YQE403BP4D)

Available from:

Rising Pharmaceuticals, Inc.

INN (International Name):

Phenobarbital

Composition:

Phenobarbital 20 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A. Sedative B. 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 administrations in excess of 400 mg of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree to 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 fa

Product summary:

Phenobarbital Oral Solution 20 mg/5 mL is supplied in 1 Pint (473mL) bottles NDC# 16571-330-16. Contains alcohol, 13.5% Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Keep tightly closed. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL- PHENOBARBITAL LIQUID
RISING PHARMACEUTICALS, 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 ORAL SOLUTION, USP
CIV
RX ONLY
DES CRIPTION
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
either, and in solutions of fixed
alkali hydroxides and carbonates; sparingly soluble in chloroform.
Phenobarbital is 5-ethyl-5-
phenylbarbituric acid and has the empirical formula C
H N O . Its molecular weight is 232.24. It has
the following structural formula:
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.
Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 13.5%.
The oral solution also contains
Glycerin, Sorbitol Solution, Sodium Saccharin, FD&C Red #40, Orange
Flavor and Purified Water.
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,
12
12
2
3
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