PHENOBARBITAL tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Rising Pharma Holdings, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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 100 tablets, NDC 16571-670-01; 500 tablets, NDC 16571-670-50; and 1000 tablets, NDC 16571-670-10. Phenobarbital Tablets, USP 30 mg: White to off-white round, biconvex tablets debossed “T” above and “36” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 16571-672-01; 500 tablets, NDC 16571-672-50; and 1000 tablets, NDC 16571-672-10. 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 100 tablets, NDC 16571-674-01; 500 tablets, NDC 16571-674-50; and 1000 tablets, NDC 16571-674-10. 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 100 tablets, NDC 16571-669-01; 500 tablets, NDC 16571-669-50; and 1000 tablets, NDC 16571-669-10. 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 52024 Rev. 07/20

অনুমোদন অবস্থা:

unapproved drug other

পণ্য বৈশিষ্ট্য

PHENOBARBITAL - PHENOBARBITAL TABLET
RISING PHARMA HOLDINGS, 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 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, 30 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 detoxified in the liver.
INDICATIONS AND USAGE
12
12
2
3
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