SECONAL Capsule (2007)

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1. 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 barbiturat...

2. 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, b...

3. Indications and Usage

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). Preanesthetic.

4. Contraindications

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 liv...

5. Warnings

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of th...

6.1. General

Barbiturates may be habit-forming. Tolerance and psychological and physical dependence may occur with continuing use (see Drug Abuse and Dependence). Barbiturates should be administered with cautio...

6.2. Information for Patients

"Sleep-Driving" and other complex behaviors: There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with...

6.3. Laboratory Tests

Prolonged therapy with barbiturates should be accompanied by periodic laboratory evaluation of organic systems, including hematopoietic, renal, and hepatic systems (see General under Precautions an...

6.4. Drug Interactions

Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal Data Phenobarbital sodium is carcinogenic in mice and rats after lifetime administration. In mice, it produced benign and malignant liver cell tumors. In rats, benign liver cell tumors were ...

6.7. Pregnancy

Teratogenic Effects Pregnancy Category D. See Usage in Pregnancy under Warnings. Nonteratogenic Effects Reports of infants suffering from long-term barbiturate exposure in utero included the acute ...

6.8. Labor and Delivery

Hypnotic doses of barbiturates do not appear to impair uterine activity significantly during labor. Full anesthetic doses of barbiturates decrease the force and frequency of uterine contractions. A...

6.9. Nursing Mothers

Caution should be exercised when Seconal Sodium is administered to a nursing woman, because small amounts of barbiturates are excreted in the milk.

7. Adverse Reactions

The following adverse reactions and their incidences were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of some...

8. Drug Abuse and Dependence

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 psychoac...

9. Overdosage

The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 g of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 g of ingested ba...

10. Dosage and Administration

Dosages of barbiturates must be individualized with full knowledge of their particular characteristics. Factors of consideration are the patient's age, weight, and condition. Adults As a hypno...

11. How Supplied

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)....