PHENOBARBITAL tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

McKesson Corporation dba SKY Packaging

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

- 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 fatal dosage, however, does not increase more than twofold. As this occurs, the margin between intoxicating dosage and fatal dosage becomes smaller. Symptoms of acute intoxication with barbiturates include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints. Symptoms of barbiturate dependence are similar to those of chronic alcoholism. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood, the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested. The symptoms of barbiturate withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of a barbiturate. These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of barbiturates. The intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Individuals susceptible to barbiturate abuse and dependence include alcoholics and opiate abusers as well as other sedative-hypnotic and amphetamine abusers. Drug dependence on barbiturates arises from repeated administration of a barbiturate or agent with barbiturate-like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence on barbiturates include: (a) a strong desire or need to continue taking the drug; (b) a tendency to increase the dose; (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation of those effects; and (d) a physical dependence on the effects of the drug, requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. In all cases, withdrawal requires an extended period of time. One method involves substituting a 30-mg dose of phenobarbital for each 100- to 200-mg dose of barbiturate that the patient has been taking. The total daily amount of phenobarbital is then administered in 3 or 4 divided doses, not to exceed 600 mg daily. If signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of phenobarbital may be administered IM in addition to the oral dose. After stabilization on phenobarbital, the total daily dose is decreased by 30 mg/day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patient’s regular dosage level and decreasing the daily dosage by 10% if tolerated by the patient. Infants who are physically dependent on barbiturates may be given phenobarbital, 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, and hyperreflexia) are relieved, the dosage of phenobarbital should be gradually decreased and completely withdrawn over a 2-week period.

Tóm tắt sản phẩm:

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: Boxes of 10x10 UD 100, NDC 63739-192-10 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: Boxes of 10x10 UD 100, NDC 63739-294-10 Storage and Handling 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 by: Sovereign Pharmaceutical 7590 Sand St Fort Worth, TX 76118 Distributed by: McKesson Corporation 4971 Southridge Blvd, Suite 101 Memphis, TN 38141 21458 November 2020

Tình trạng ủy quyền:

unapproved drug other

Đặc tính sản phẩm

PHENOBARBITAL- PHENOBARBITAL TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
_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 amou