AMYTAL SODIUM Powder for solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Bausch Health US LLC
Λέξεις κλειδιά
0187-4303
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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
Sedative Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (<em>see CLINICAL PHARMACOLOGY</em>). Preanesthetic ...
4. Contraindications
Amobarbital sodium 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 ...
5. Warnings
Habit Forming Amobarbital sodium may be habit forming. Tolerance, psychological and physical dependence may occur with continued use (<em>see CLINICAL PHARMACOLOGY, Pharmacokinetics and DRUG ABUSE AND ...
6.1. General
Barbiturates may be habit forming. Tolerance and psychological and physical dependence may occur with continuing use (<em>see DRUG ABUSE AND DEPENDENCE</em>). Barbiturates should be administered with caution, ...
6.2. Information for Patients
The following information should be given to patients receiving barbiturates: The use of barbiturates carries with it an associated risk of psychological and/or physical dependence. Barbiturates may impair ...
6.3. Laboratory Tests
Prolonged therapy with barbiturates should be accompanied by periodic evaluation of organ systems, including hematopoietic, renal, and hepatic systems (<em>see PRECAUTIONS, General and ADVERSE REACTIONS ...
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 (<em>See WARNINGS, Usage in Pregnancy</em>) Nonteratogenic Effects Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of ...
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 amobarbital sodium is administered to a nursing woman because small amounts of barbiturates are excreted in the milk.
6.10. Pediatric Use
Safety and effectiveness have not been established in children below the age of 6 years.
7. Adverse Reactions
The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of certain of ...
8. Drug Abuse and Dependence
Controlled Substance Amobarbital sodium is a Schedule II drug. Dependence Barbiturates may be habit-forming. Tolerance, psychological dependence, and physical dependence may occur, especially following ...
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. Toxic effects and fatalities have occurred following overdoses ...
10. Dosage and Administration
The dose of amobarbital sodium must be individualized with full knowledge of its particular characteristics and recommended rate of administration. Factors of consideration are the patients age, weight, ...
11. How Supplied
AMYTAL SODIUM Vials 0.5 g (dry powder) are available as follows: NDC 0187-4303-05 * Trademark of PDR Network, LLC Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Alcami ...
12. Storage and Handling
Store at (15° to 30°C) (59° to 86°F) Lyophilized Preparation of solution Solutions of amobarbital sodium should be made up aseptically with Sterile Water for Injection. The accompanying table will aid ...