PHENOBARBITAL tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

AvPAK

INN (Tarptautinis Pavadinimas):

PHENOBARBITAL

Sudėtis:

PHENOBARBITAL 15 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 physic

Produkto santrauka:

Phenobarbital Tablets, USP 15 mg: White, Round Tablet; Debossed “West-ward 445” on one side and plain on the other side. NDC 50268-653-15 (10 tablets per card, 5 cards per carton) Phenobarbital Tablets, USP 30 mg: White, Round, Scored Tablet; Debossed “West-ward 450” on one side and Scored on the other side. NDC 50268-654-15 (10 tablets per card, 5 cards per carton) Phenobarbital Tablets, USP 60 mg: White, Round Tablet; Debossed “WW 455” on one side and plain on the other side. NDC 50268-655-15 (10 tablets per card, 5 cards per carton) Phenobarbital Tablets, USP 100 mg: White, Round, Scored Tablet; Debossed “WW 458” on one side and Scored on the other side. Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Pharmacist: Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 09/15 AV 07/17 (P) AvPAK

Autorizacija statusas:

unapproved drug other

Prekės savybės

PHENOBARBITAL- PHENOBARBITAL TABLET
AVPAK
_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
PHENOBARBITAL TABLETS, USP
CIV
RX ONLY
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, 30 mg, 60 mg or 100 mg
of
phenobarbital, USP.
Inactive Ingredients are as follows:
15 MG, 30 MG AND 60 MG: Calcium Stearate, Colloidal Silicon Dioxide,
Corn Starch,
and Microcrystalline Cellulose.
100 MG: Anhydrous Lactose, Colloidal Silicon Dioxide, Corn Starch,
Docusate Sodium,
Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose,
and Sodium
Starch Glycolate.
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
detoxified in the liver.
12
12
2
3
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 fun