Amobarbital sodium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
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Overview
Amobarbital sodium is a barbiturate that is FDA approved for the treatment of for the treatment of insomnia, also it is use as a sedative and for preanesthesic purpose.. Common adverse reactions include dizziness, headache, somnolence and confusion.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
Sedative
- 30 to 50 mg given 2 or 3 times daily.
Insomnia
- It is use as an Hypnotic for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks.
- 65 to 200 mg at bedtime.
Preanesthetic
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amobarbital sodium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Amobarbital sodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Amobarbital sodium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Amobarbital sodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Amobarbital sodium in pediatric patients.
Contraindications
- Hypersensitivity to barbiturates
- Patients with a history of manifest or latent porphyria
- Patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident
Warnings
Habit Forming
- Amobarbital sodium may be habit forming.
- Tolerance, psychological and physical dependence may occur with continued use *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.
====Intravenous Administration====Too rapid administration may cause respiratory depression, apnea, laryngo- spasm, or vasodilation with fall in blood pressure.
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.
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.
- 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.
Synergistic Effects
- The concomitant use of alcohol or other CNS depressants may produce additive CNS- depressant effects.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Amobarbital sodium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Amobarbital sodium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Amobarbital sodium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Amobarbital sodium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amobarbital sodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Amobarbital sodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Amobarbital sodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Amobarbital sodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Amobarbital sodium in geriatric settings.
Gender
There is no FDA guidance on the use of Amobarbital sodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Amobarbital sodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Amobarbital sodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Amobarbital sodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Amobarbital sodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Amobarbital sodium in patients who are immunocompromised.
Administration and Monitoring
Administration
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.
Monitoring
- After IM injection of a hypnotic dose, the patient’s vital signs should be monitored.
IV Compatibility
There is limited information regarding the compatibility of Amobarbital sodium and IV administrations.
Overdosage
There is limited information regarding Amobarbital sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Amobarbital sodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Amobarbital sodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Amobarbital sodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Amobarbital sodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Amobarbital sodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Amobarbital sodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Amobarbital sodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Amobarbital sodium How Supplied in the drug label.
Storage
There is limited information regarding Amobarbital sodium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Amobarbital sodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Amobarbital sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Amobarbital sodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Amobarbital sodium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.