Amobarbital sodium

Amobarbital sodium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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 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

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:

Nervous System

• 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:

Nervous System

• Agitation
• Confusion
• Hyperkinesia
• Ataxia
• CNS depression
• Nightmares
• Nervousness
• Psychiatric disturbance
• Hallucinations
• Insomnia
• Anxiety
• Dizziness
• Abnormality in thinking

Respiratory System

• Hypoventilation
• Apnea
• Postoperative atelectasis

Cardiovascular System

• Bradycardia
• Hypotension
• Syncope

Digestive System

• Nausea
• Vomiting
• Constipation

Other Reported Reactions

• Headache
• Injection site reactions
• Hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis) *Fever
• Liver damage
• Megaloblastic anemia following chronic phenobarbital use

Postmarketing Experience

There is limited information regarding Amobarbital sodium Postmarketing Experience in the drug label.

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.

Anticoagulants

• Phenobarbital lowers the plasma levels of dicumarol and causes a decrease in anticoagulant activity as measured by the prothrombin time.
• Barbiturates can induce hepatic microsomal enzymes, resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (eg, warfarin, acenocoumarol, dicumarol, and phenprocoumon).
• Patients stabilized on anticoagulant therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen.

Corticosteroids

• Barbiturates appear to enhance the metabolism of exogenous corticosteroids, probably through the induction of hepatic microsomal enzymes.
• Patients stabilized on corticosteroid therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen.

Griseofulvin

• Phenobarbital appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level.
• The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs.

Doxycycline

• Phenobarbital has been shown to shorten the half-life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued.
• This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic.
• If amobarbital sodium and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.

Phenytoin, Sodium Valproate, Valproic Acid

• The effect of barbiturates on the metabolism of phenytoin appears to be variable.
• Some investigators report an accelerating effect, whereas others report no effect. Because the effect of barbiturates on the metabolism of phenytoin is not predictable, phenytoin and barbiturate blood levels should be monitored more frequently if these drugs are given concurrently.
• Sodium valproate and valproic acid appear to increase the amobarbital sodium serum levels; therefore, amobarbital sodium blood levels should be closely monitored and appropriate dosage adjustments made as clinically indicated.

CNS Depressants

• The concomitant use of other CNS depressants, including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects.

Monoamine Oxidase Inhibitors (MAOIs)

• MAOIs prolong the effects of barbiturates, probably because metabolism of the barbiturate is inhibited.

Estradiol, Estrone, Progesterone, and Other Steroidal Hormones

• Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism.
• There have been reports of patients treated with antiepileptic drugs (eg, phenobarbital) who become pregnant while taking oral contraceptives.
• An alternate contraceptive method might be suggested to women taking barbiturates.

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

• 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.

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.

Pediatric Use

• Safety and effectiveness have not been established in children below the age of 6 years.

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

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 the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery.
• The patient should be cautioned accordingly.
• Alcohol should not be consumed while taking barbiturates.
• The concurrent use of the barbiturates with other CNS depressants (eg, alcohol, narcotics, tranquilizers, and antihistamines) may result in additional CNS-depressant effects.

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.