Amytal Sodium
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Questions & Answers
Side Effects & Adverse Reactions
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Habit Forming — Amobarbital sodium may be habit forming. Tolerance, psychological and physical dependence may occur with continued use (see Drug Abuse and Dependenceand Pharmacokineticsunder Clinical Pharmacology). Patients who have psychological dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time (see Drug Abuse and Dependence).
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Intravenous Administration — Too rapid administration may cause respiratory depression, apnea, laryngo- spasm, or vasodilation with fall in blood pressure.
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Acute or Chronic Pain — Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established.
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Usage in Pregnancy — Barbiturates can cause fetal damage when administered to a pregnant woman. Retrospective, case-controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain. Fetal blood levels approach maternal blood levels following parenteral administration. Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy (see Drug Abuse and Dependence). If amobarbital sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
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Synergistic Effects — The concomitant use of alcohol or other CNS depressants may produce additive CNS- depressant effects.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- 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 (see Clinical Pharmacology).
- Preanesthetic
History
There is currently no drug history available for this drug.
Other Information
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 C11H17N2NaO3Its 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.
Sources
Amytal Sodium Manufacturers
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Marathon Pharmaceuticals, Llc
![Amytal Sodium (Amobarbital Sodium) Injection, Powder, Lyophilized, For Solution [Marathon Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amytal Sodium | Marathon Pharmaceuticals, Llc
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.
Intramuscular Use —Intramuscular injection of the sodium salts of barbiturates should be made deeply into a large muscle. The average intramuscular dose ranges from 65 mg to 0.5 g. A volume of 5 mL (irrespective of concentration) should not be exceeded at any one site because of possible tissue irritation. Twenty percent solutions may be used so that a small volume can contain a large dose. After IM injection of a hypnotic dose, the patient’s vital signs should be monitored. Superficial intramuscular or subcutaneous injections may be painful and may produce sterile abscesses or sloughs.
Intravenous Use —Intravenous injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia, or status epilepticus), because the patient resists (as in delirium), or because prompt action is imperative. Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded and equipment for resuscitation and artificial ventilation be available. The rate of IV injection for adults should not exceed 50 mg/min to prevent sleep or sudden respiratory depression. The final dosage is determined to a great extent by the patient’s reaction to the slow administration of the drug.
Adults:
Special Patient Population —
a. Sedative: 30 to 50 mg given 2 or 3 times daily.
b. Hypnotic: 65 to 200 mg at bedtime.Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease. Ordinarily, an intravenous dose of 65 mg to 0.5 g may be given to a child 6 to 12 years of age.
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Valeant Pharmaceuticals North America Llc
Amytal Sodium | Valeant Pharmaceuticals North America Llc
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.
Intramuscular Use —Intramuscular injection of the sodium salts of barbiturates should be made deeply into a large muscle. The average intramuscular dose ranges from 65 mg to 0.5 g. A volume of 5 mL (irrespective of concentration) should not be exceeded at any one site because of possible tissue irritation. Twenty percent solutions may be used so that a small volume can contain a large dose. After IM injection of a hypnotic dose, the patient’s vital signs should be monitored. Superficial intramuscular or subcutaneous injections may be painful and may produce sterile abscesses or sloughs.
Intravenous Use —Intravenous injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia, or status epilepticus), because the patient resists (as in delirium), or because prompt action is imperative. Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded and equipment for resuscitation and artificial ventilation be available. The rate of IV injection for adults should not exceed 50 mg/min to prevent sleep or sudden respiratory depression. The final dosage is determined to a great extent by the patient’s reaction to the slow administration of the drug.
Adults:
Special Patient Population —
a. Sedative: 30 to 50 mg given 2 or 3 times daily.
b. Hypnotic: 65 to 200 mg at bedtime.Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease. Ordinarily, an intravenous dose of 65 mg to 0.5 g may be given to a child 6 to 12 years of age.
![Amytal Sodium (Amobarbital Sodium) Injection, Powder, Lyophilized, For Solution [Valeant Pharmaceuticals North America Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2523317-e071-4e04-9d9f-9053286e0ce2&name=amytal-sodium-2.jpg)
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