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Nembutal Sodium
Overview
What is Nembutal Sodium?
The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (See “” section).
The sodium salts of amobarbital, pentobarbital, phenobarbital, and secobarbital are available as sterile parenteral solutions.
Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring.
NEMBUTAL Sodium Solution (pentobarbital sodium injection) is a sterile solution for intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume. The pH is adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.
NEMBUTAL Sodium is a short-acting barbiturate, chemically designated as sodium 5-ethyl-5-(1-methylbutyl) barbiturate. The structural formula for pentobarbital sodium is:
The sodium salt occurs as a white, slightly bitter powder which is freely soluble in water and alcohol but practically insoluble in benzene and ether.
What does Nembutal Sodium look like?
What are the available doses of Nembutal Sodium?
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What should I talk to my health care provider before I take Nembutal Sodium?
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How should I use Nembutal Sodium?
Dosages of barbiturates must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical.
What interacts with Nembutal Sodium?
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What are the warnings of Nembutal Sodium?
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What are the precautions of Nembutal Sodium?
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What are the side effects of Nembutal Sodium?
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What should I look out for while using Nembutal Sodium?
Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.
What might happen if I take too much Nembutal Sodium?
The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and with various neurological disorders.
Acute overdosage with barbiturates is manifested by CNS and respiratory depression which may progress to Cheyne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may show paralytic dilation), oliguria, tachycardia, hypotension, lowered body temperature, and coma. Typical shock syndrome (apnea, circulatory collapse, respiratory arrest, and death) may occur.
In extreme overdose, all electrical activity in the brain may cease, in which case a “flat” EEG normally equated with clinical death cannot be accepted. This effect is fully reversible unless hypoxic damage occurs. Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to involve trauma.
Complications such as pneumonia, pulmonary edema, cardiac arrhythmias, congestive heart failure, and renal failure may occur. Uremia may increase CNS sensitivity to barbiturates. Differential diagnosis should include hypoglycemia, head trauma, cerebrovascular accidents, convulsive states, and diabetic coma. Blood levels from acute overdosage for some barbiturates are listed in .
Treatment of overdosage is mainly supportive and consists of the following:
How should I store and handle Nembutal Sodium?
NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. NEMBUTAL Sodium Solution (pentobarbital sodium injection, USP) is available in the following sizes: 20-mL multiple-dose vial, 1 g per vial (NDC 76478-501-20); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 76478-501-50). Each mL contains: Pentobarbital Sodium, derivative of barbituric acid ……………….. 50 mgPropylene glycol ………………………………………………… 40% v/vAlcohol ………………………………………………………….. 10%Water for Injection ………………………………………………. qs (pH adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide.) Vial stoppers are latex free. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Barbiturates are capable of producing all levels of CNS mood alteration from excitation to mild sedation, to 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 physiological sleep. Sleep laboratory studies have demonstrated that barbiturates reduce the amount of time spent in the rapid eye movement (REM) phase of sleep or 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 which contribute to drug withdrawal syndrome (for example, decrease the dose from 3 to 2 doses a 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 at fixed doses. 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 while 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 have been clinically demonstrated to be effective as oral anticonvulsants in subhypnotic doses.
Barbiturates are respiratory depressants. The degree of respiratory depression is dependent upon dose. With hypnotic doses, respiratory depression produced by barbiturates is similar to that which occurs during physiologic sleep with 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. (See “” section).
Non-Clinical Toxicology
Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.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. (See “” section.) Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse.
Elderly or debilitated patients may react to barbiturates with marked excitement, depression, and confusion. In some persons, 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 following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients. 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.
Nervous System:
Less than 1 in 100 patients.
Nervous system:
Respiratory system:
Cardiovascular system:
Digestive system:
Other reported reactions:
To report SUSPECTED ADVERSE REACTIONS, contact Oak Pharmaceuticals, Inc. at 1-800-932-5676 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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