PHENOBARBITAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

e5 Pharma, LLC

INN (International Name):

PHENOBARBITAL

Composition:

PHENOBARBITAL 16.2 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. 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 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 intoxication increases; tolerance to a fata

Product summary:

Phenobarbital Tablets, USP 16.2 mg: White, round, tablets scored on one side and debossed “e5" above the score and "110” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-110-01 and 1000 tablets, NDC 13517-110-10. Phenobarbital Tablets, USP 32.4 mg: White, round, tablets scored on one side and debossed “e5" above the score and "111” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-111-01 and 1000 tablets, NDC 13517-111-10. Phenobarbital Tablets, USP 64.8 mg: White, round, tablets scored on one side and debossed “e5" above the score and "112” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-112-01 and 1000 tablets, NDC 13517-112-10. Phenobarbital Tablets, USP 97.2 mg: White, round, tablets scored on one side and debossed “e5" above the score and "113” below the score. The other side is plain. Available in bottles of 100 tablets, NDC 13517-113-01 and 1000 tablets, NDC 13517-113-10. 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 for: e5 Pharma, LLC Boca Raton, FL 33432

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL- PHENOBARBITAL TABLET
E5 PHARMA, 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
DESCRIPTION
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:
C
H
N
O M.W. = 232.24
Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2
mg of
phenobarbital, USP.
INACTIVE INGREDIENT
INACTIVE INGREDIENTS INCLUDE: colloidal silicon dioxide, lactose
anhydrous, magnesium
stearate, microcrystalline cellulose, sodium starch glycolate, and
stearic acid.
CLINICAL PHARMACOLOGY
Barbiturates are capable of producing all levels of CNS mood
alteration, from excitation
12
12
2
3
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