PHENOBARBITAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant. 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. Dependence: Prolonged, uninterrupted use of barbiturates (particularly the short-acting drugs), even in therapeutic doses, may result in psychic and phy

Product summary:

Phenobarbital Tablets, USP 15 mg: White to off-white round, biconvex tablets debossed “T35” on one side and plain on the other side. Available in bottles of 30 tablets, NDC 71205-845-30; 60 tablets, NDC 71205-845-60; 90 tablets, NDC 71205-845-90; 100 tablets, NDC 71205-845-00; 120 tablets, NDC 71205-845-72; 180 tablets, NDC 71205-845-78; 240 tablets, NDC 71205-845-64; 500 tablets, NDC 71205-845-55; and 1000 tablets, NDC 71205-845-11. Phenobarbital Tablets, USP 60 mg: White to off-white round, biconvex tablets debossed “T” above and “37” below the bisect on one side and plain on the other side. Available in bottles of 30 tablets, NDC 71205-848-30; 60 tablets, NDC 71205-848-60; 90 tablets, NDC 71205-848-90; 100 tablets, NDC 71205-848-00; 120 tablets, NDC 71205-848-72; 180 tablets, NDC 71205-848-78; 240 tablets, NDC 71205-848-64; 500 tablets, NDC 71205-848-55; and 1000 tablets, NDC 71205-848-11. Phenobarbital Tablets, USP 100 mg: White to off-white round, biconvex tablets debossed “T” above and “38” below the bisect on one side and plain on the other side. Available in bottles of 30 tablets, NDC 71205-851-30; 60 tablets, NDC 71205-851-60; 90 tablets, NDC 71205-851-90; 100 tablets, NDC 71205-851-00; 120 tablets, NDC 71205-851-72; 180 tablets, NDC 71205-851-78; 240 tablets, NDC 71205-851-64; 500 tablets, NDC 71205-851-55; and 1000 tablets, NDC 71205-851-11. Store at 20° to 25°C (68° to 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. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 52024 Rev. 07/20

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENOBARBITAL- PHENOBARBITAL TABLET
PROFICIENT RX LP
_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 C-IV
RX ONLY
WARNING: MAY BE HABIT-FORMING
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, 60 mg or 100 mg of
phenobarbital,
USP.
INACTIVE INGREDIENTS INCLUDE: colloidal silicon dioxide, lactose
monohydrate,
microcrystalline cellulose, sodium starch glycolate and magnesium
stearate.
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
12
12
2
3
detoxified in the liver.
INDICATIONS 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
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