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 barbiturates and ...
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, barbiturates ...
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 liver function, ...
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 the patient. ...
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 caution, if ...
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 no memory of the ...
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 and Adverse ...
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 warrants ...
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 observed ...
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 withdrawal ...
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. Administration ...
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 of ...
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 psychoactive ...
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 barbiturate. ...
10. Dosage and Administration
Dosages of barbiturates must be individualized with full knowledge of their particular characteristics. Factors of consideration are the patients age, weight, and condition. Adults As a hypnotic, 100 mg ...
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). Dispense ...