PHENOBARBITAL tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Chartwell RX, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

- Sedative Anticonvulsant – For the treatment of generalized and partial seizures. - 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 tole

Podsumowanie produktu:

Phenobarbital Tablets, USP, 15 mg are white, round, biconvex, scored tablets, debossed “691” below the score on one side and "ECI" on the reverse side. Supplied in bottles of 120 and 500: Phenobarbital Tablets, USP, 16.2 mg (1/4 grain) are white, round, biconvex, scored tablets, debossed “625” below the score on one side and "ECI" on the reverse side, supplied in bottles of 120: Phenobarbital Tablets, USP, 30 mg are white, round, biconvex, scored tablets, debossed “692” below the score on one side and "ECI" on the reverse side. Supplied in bottles of 60 and 500: Phenobarbital Tablets, USP, 32.4 mg (1/2 grain) are white, round, biconvex, scored tablets, debossed “626” below the score on one side and "ECI" on the reverse side, supplied in bottles of 60: Phenobarbital Tablets, USP, 60 mg are white, round, biconvex, scored tablets, debossed "693" below the score on one side and "ECI" on the reverse side. Supplied in bottles of 60 and 500: Phenobarbital Tablets, USP, 64.8 mg (1 grain) are white, round, flat face, bevel edge, scored tablets debossed “627” below the score on one side and "ECI" on the reverse side, supplied in bottles of 60: Phenobarbital Tablets, USP, 97.2 mg (1 1/2 grain) are white, round, flat face, bevel edge, scored tablets debossed “628” below the score on one side and "ECI" on the reverse side, supplied in bottles of 30: Phenobarbital Tablets, USP, 100 mg are white, round, biconvex, scored tablets, debossed “694” below the score on one side and "ECI" on the reverse side. Supplied in bottles of 90 and 500: Manufactured By: ECI Pharmaceuticals, LLC Fort Lauderdale, FL 33309 Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 08/2022-01 L71044

Status autoryzacji:

unapproved drug other

Charakterystyka produktu

PHENOBARBITAL- PHENOBARBITAL TABLET
CHARTWELL RX, 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
CIV
RX ONLY
WARNING: MAY BE HABIT-FORMING
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:
Each phenobarbital tablet contains 15 mg, 16.2 mg (1/4 grain), 30 mg,
32.4 mg (1/2
grain), 60 mg, 64.8 mg (1 grain) 97.2 mg (11/2 grain), or 100 mg of
phenobarbital.
In addition, each tablet contains: colloidal silicon dioxide, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose and sodium starch
glycolate.
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, 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 th