seconal sodium- Secobarbital sodium capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

secobarbital sodium (UNII: XBP604F6UM) (secobarbital - UNII:1P7H87IN75)

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

Secobarbital sodium

Pharmaceutical form:

CAPSULE

Composition:

100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see Clinical Pharmacology). B. Preanesthetic Seconal Sodium is contraindicated in patients who are hypersensitive to barbiturates. It is also contraindicated in patients with a history of manifest or latent porphyria, marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a

Product summary:

Seconal Sodium capsules are (orange) and imprinted with RX679 on both the cap and the body: NDC 63304-679-01 100 mg Bottles of 100 Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Dispense in a tight container. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories, Inc. North Brunswick, NJ 08902 USA May 2007

Summary of Product characteristics

SECONAL SODIUM- SECOBARBITAL SODIUM CAPSULE
RANBAXY PHARMACEUTICALS INC.
----------
SECONAL SODIUM
SECOBARBITAL SODIUM CAPSULES
CII
RX ONLY
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.
Seconal Sodium (Secobarbital Sodium Capsules, USP) is a barbituric
acid derivative and occurs as a
white, odorless, bitter powder that is very soluble in water, soluble
in alcohol, and practically insoluble
in ether. Chemically, the drug is sodium 5-allyl-5-(1-methylbutyl)
barbiturate, with the molecular
formula C
H N NaO . Its molecular weight is 260.27. The structural formula is as
follows:
Each capsule contains 100 mg (0.38 mmol) of secobarbital sodium. It
also contains dimethicone, FD&C
Red No. 3, FD&C Yellow No. 10, gelatin, magnesium stearate,
pregelatinized starch, and titanium
dioxide.
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
that barbiturates reduce the amount of time spent in the rapid eye
movement (REM) phase, or dreaming
stage of sleep. Also, Stages III and IV sleep are decreased. Following
abrupt cessation of regularly
used barbiturates, patients may experience markedly increased
dreaming, nightmares, and/or insomnia.
Therefore, withdrawal of a single therapeutic dose over 5 or 6 days
has been recommended to lessen
the REM rebound and disturbed sleep that contribute to drug withdrawal
syndrome (for example,
decreasing the d