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amobarbital sodium
Overview
What is Amytal Sodium?
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.
Amobarbital sodium is a white, friable, granular powder that is odorless, has a bitter taste, and is hygroscopic. It is very soluble in water, soluble in alcohol, and practically insoluble in ether and chloroform. Amobarbital sodium is sodium 5-ethyl-5-isopentylbarbiturate and has the empirical formula CHNNaOIts molecular weight is 248.26.
It has the following structural formula:
Amobarbital sodium is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity.
Vials of amobarbital sodium are for parenteral administration. The vials contain 500 mg (2 mmol) amobarbital sodium as a sterile lyophilized powder.
What does Amytal Sodium look like?
What are the available doses of Amytal Sodium?
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What should I talk to my health care provider before I take Amytal Sodium?
Sorry No records found
How should I use Amytal Sodium?
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 patient’s age, weight, and condition. The maximum single dose for an adult is 1 g.
What interacts with Amytal Sodium?
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 or respiratory disease in which dyspnea or obstruction is evident.
What are the warnings of Amytal Sodium?
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Intravenous Administration
Acute or Chronic Pain
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Synergistic Effects
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What are the precautions of Amytal Sodium?
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General
Barbiturates may be habit forming. Tolerance and psychological and physical dependence may occur with continuing use
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Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or have a history of drug abuse. Particular caution is also indicated before administering barbiturates to patients who have abused other classes of drugs (
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Elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion. In some persons, especially children, barbiturates repeatedly produce excitement rather than depression.
In patients with hepatic damage, barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma.
Parenteral solutions of barbiturates are highly alkaline. Therefore, extreme care should be taken to avoid perivascular extravasation or intra-arterial injection. Extravascular injection may cause local tissue damage with subsequent necrosis; consequences of intra-arterial injection may vary from transient pain to gangrene of the limb. Any complaint of pain in the limb warrants stopping the injection.
The systemic effects of exogenous and endogenous corticosteroids may be diminished by amobarbital sodium. Thus, this product should be administered with caution to patients with borderline hypoadrenal function, regardless of whether it is of pituitary or of primary adrenal origin.
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Information for Patients
The following information should be given to patients receiving barbiturates.
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Laboratory Tests
Prolonged therapy with barbiturates should be accompanied by periodic evaluation of organ systems, including hematopoietic, renal, and hepatic systems (and).
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Anticoagulants
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Corticosteroids
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Griseofulvin
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Doxycycline
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Phenytoin, Sodium Valproate, Valproic Acid
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CNS Depressants
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Monoamine Oxidase Inhibitors (MAOIs)
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Estradiol, Estrone, Progesterone, and Other Steroidal Hormones
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 serial blood level determinations of the relevant drugs when there are multiple therapies.
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Human Data
Carcinogenesis
Usage in Pregnancy
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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 of sedative-hypnotic barbiturates to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of barbiturates. If barbiturates are used during labor and delivery, resuscitation equipment should be available.
Data are not available to evaluate the effect of barbiturates when forceps delivery or other intervention is necessary or to determine the effect of barbiturates on the later growth, development, and functional maturation of the child.
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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.
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Usage in Children
Safety and effectiveness have not been established in children below the age of 6 years.
What are the side effects of Amytal Sodium?
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 the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
More than 1 in 100 Patients
The most common adverse reaction, estimated to occur at a rate of 1 to 3 patients per 100, is the following:
Somnolence
Less than 1 in 100 Patients
Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence:
Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormality in thinking
Hypoventilation, apnea, postoperative atelectasis
Bradycardia, hypotension, syncope
Nausea, vomiting, constipation
Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Amytal Sodium?
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 or respiratory disease in which dyspnea or obstruction is evident.
What might happen if I take too much Amytal Sodium?
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 of amobarbital sodium alone and in combination with other CNS depressants. Death commonly occurs after 2 to 10 g of ingested barbiturate. The sedated, therapeutic blood levels of amobarbital range between 2 to 10 mcg/mL; the usual lethal blood level ranges from 40 to 80 mcg/mL. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and various neurologic disorders. Potential tolerance must be considered when evaluating significance of dose and plasma concentration.
How should I store and handle Amytal Sodium?
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Keep bottles tightly closed.Dispense in a tight container.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Keep bottles tightly closed.Dispense in a tight container.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Keep bottles tightly closed.Dispense in a tight container.Amytal Sodium Vials 0.5 g (dry powder) are available as follows:NDC 0187-4303-05Storage: Store at 59° to 86°F (15° to 30°C).LyophilizedAmytal is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©Valeant Pharmaceuticals North America LLCManufactured for:Manufactured by:9476202 PC3328FAmytal Sodium Vials 0.5 g (dry powder) are available as follows:NDC 0187-4303-05Storage: Store at 59° to 86°F (15° to 30°C).LyophilizedAmytal is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©Valeant Pharmaceuticals North America LLCManufactured for:Manufactured by:9476202 PC3328FAmytal Sodium Vials 0.5 g (dry powder) are available as follows:NDC 0187-4303-05Storage: Store at 59° to 86°F (15° to 30°C).LyophilizedAmytal is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©Valeant Pharmaceuticals North America LLCManufactured for:Manufactured by:9476202 PC3328FAmytal Sodium Vials 0.5 g (dry powder) are available as follows:NDC 0187-4303-05Storage: Store at 59° to 86°F (15° to 30°C).LyophilizedAmytal is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©Valeant Pharmaceuticals North America LLCManufactured for:Manufactured by:9476202 PC3328FAmytal Sodium Vials 0.5 g (dry powder) are available as follows:NDC 0187-4303-05Storage: Store at 59° to 86°F (15° to 30°C).LyophilizedAmytal is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.©Valeant Pharmaceuticals North America LLCManufactured for:Manufactured by:9476202 PC3328F
Clinical Information
Chemical Structure
No Image foundClinical 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 of sleep or the dreaming stage. Also, Stages III and IV sleep are decreased. Following abrupt cessation of barbiturates used regularly, 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 the drug withdrawal syndrome (for example, the dose should be decreased from 3 to 2 doses/day for 1 week).
In studies, secobarbital sodium and pentobarbital sodium have been found to lose most of their effectiveness for both inducing and maintaining sleep by the end of 2 weeks of continued drug administration, even with the use of multiple doses. As with secobarbital sodium and pentobarbital sodium, other barbiturates (including amobarbital) might be expected to lose their effectiveness for inducing and maintaining sleep after about 2 weeks. The short-, intermediate-, and to a lesser degree, long-acting barbiturates have been widely prescribed for treating insomnia. Although the clinical literature abounds with claims that the short-acting barbiturates are superior for producing sleep whereas the intermediate-acting compounds are more effective in maintaining sleep, controlled studies have failed to demonstrate these differential effects. Therefore, as sleep medications, the barbiturates are of limited value beyond short-term use.
Barbiturates have little analgesic action at subanesthetic doses. Rather, in subanesthetic doses, these drugs may increase the reaction to painful stimuli. All barbiturates exhibit anticonvulsant activity in anesthetic doses. However, of the drugs in this class, only phenobarbital, mephobarbital, and metharbital are effective as oral anticonvulsants in subhypnotic doses.
Barbiturates are respiratory depressants, and the degree of respiratory depression is dependent upon the dose. With hypnotic doses, respiratory depression produced by barbiturates is similar to that which occurs during physiologic sleep and is accompanied by a slight decrease in blood pressure and heart rate.
Studies in laboratory animals have shown that barbiturates cause reduction in the tone and contractility of the uterus, ureters, and urinary bladder. However, concentrations of the drugs required to produce this effect in humans are not reached with sedative-hypnotic doses.
Barbiturates do not impair normal hepatic function but have been shown to induce liver microsomal enzymes, thus increasing and/or altering the metabolism of barbiturates and other drugs ().
Non-Clinical Toxicology
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 or respiratory disease in which dyspnea or obstruction is evident.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 serial blood level determinations of the relevant drugs when there are multiple therapies.
Barbiturates may be habit forming. Tolerance and psychological and physical dependence may occur with continuing use ).
Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or have a history of drug abuse. Particular caution is also indicated before administering barbiturates to patients who have abused other classes of drugs ( ).
Elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion. In some persons, especially children, barbiturates repeatedly produce excitement rather than depression.
In patients with hepatic damage, barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma.
Parenteral solutions of barbiturates are highly alkaline. Therefore, extreme care should be taken to avoid perivascular extravasation or intra-arterial injection. Extravascular injection may cause local tissue damage with subsequent necrosis; consequences of intra-arterial injection may vary from transient pain to gangrene of the limb. Any complaint of pain in the limb warrants stopping the injection.
The systemic effects of exogenous and endogenous corticosteroids may be diminished by amobarbital sodium. Thus, this product should be administered with caution to patients with borderline hypoadrenal function, regardless of whether it is of pituitary or of primary adrenal origin.
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 the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
More than 1 in 100 Patients
The most common adverse reaction, estimated to occur at a rate of 1 to 3 patients per 100, is the following: Somnolence
Less than 1 in 100 Patients
Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormality in thinking Hypoventilation, apnea, postoperative atelectasis Bradycardia, hypotension, syncope Nausea, vomiting, constipation Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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