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Frequently Asked Questions

What is NEMBUTAL?

NEMBUTAL Sodium Solution CII (pentobarbital sodium injection, USP) is a sterile solution for intravenous or intramuscular injection. Each milliliter 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..

What are the features and benefits of NEMBUTAL?

NEMBUTAL Sodium Solution CII (pentobarbital sodium injection, USP) is indicated for parenteral:
Sedatives.
Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See "Clinical Pharmacology" section).
Preanesthetics.
Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Barbiturates are contraindicated in patients with known barbiturate sensitivity.
Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria

What is the indication for NEMBUTAL?

NEMBUTAL Sodium Solution CII (pentobarbital sodium injection, USP) is indicated for parenteral:
Sedatives.
Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See "Clinical Pharmacology" section).
Preanesthetics.
Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Barbiturates are contraindicated in patients with known barbiturate sensitivity.
Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria

How is NEMBUTAL dosed and administered?

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.
Intramuscular Administration: IM injection of the sodium salts of barbiturates should be made deeply into a large muscle, and a volume of 5 mL should not be exceeded at any one site because of possible tissue irritation. After IM injection of a hypnotic dose, the patient's vital signs should be monitored. The usual adult dosage of NEMBUTAL Sodium Solution CII is 150 to 200 mg as a single IM injection; the recommended pediatric dosage ranges from 2 to 6 mg/kg as a single IM injection not to exceed 100 mg.
Intravenous Administration: NEMBUTAL Sodium Solution should not bead mixed with any other medication or solution. IV 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), or 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 should not exceed 50 mg/min for pentobarbital sodium. There is no average intravenous dose of NEMBUTAL Sodium Solution CII (pentobarbital sodium injection) that can be relied on to produce similar effects in different patients. The possibility of overdose and respiratory depression is remote when the drug is injected slowly in fractional doses. A commonly used initial dose for the 70 kg adult is 100 mg. Proportional reduction in dosage should be made for pediatric or debilitated patients. At least one minute is necessary to determine the full effect of intravenous pentobarbital. If necessary, additional small increments of the drug may be given up to a total of from 200 to 500 mg for normal adults.
Anticonvulsant use: In convulsive states, dosage of NEMBUTAL Sodium Solution CII should be kept to a minimum to avoid compounding the depression which may follow convulsions. The injection must be made slowly with due regard to the time required for the drug to penetrate the blood-brain barrier.
Special patient population: 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.

What are the ingredients of NEMBUTAL?

Actives: Pentobarbital Sodium, derivative of Barbituric Acid 50 mg;
Preservative: None;
Inactives: Propylene Glycol 40%, Alcohol 10% and Water for Injection (pH adjusted to approximately 9.5 with Hydrochloric Acid and/or Sodium Hydroxide).

How is NEMBUTAL packaged?

NEMBUTAL Sodium Solution CII NDC 76478-501-20 in 20-mL multiple-dose vial, 1 g per vial,
NEMBUTAL Sodium Solution CII NDC 76478-501-20 in 50-mL multiple-dose vial, 2.5 g per vial,
Sold in an eaches (1)

NEMBUTAL use in specific populations.

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.

What important safety information should I know about NEMBUTAL?

NEMBUTAL Sodium Solution CII (pentobarbital sodium injection, USP) is contraindicated in patients with a known hypersensitivity to any barbiturate, manifest or latent porphyria. Barbiturates including NEMBUTAL may be habit forming. Abrupt discontinuation may result in withdrawal symptoms, including delirium, convulsions and possibly death. Too rapid of an intravenous administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with fall in blood pressure.
Concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects. Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, chronic or acute pain. Barbiturates can cause fetal damage and infants may have withdrawal symptoms if mothers receive barbiturates. Withdrawal symptoms occur in infants born to mothers who receive barbiturates during the last trimester of pregnancy. Prolonged treatment with barbiturates should be monitored. The most commonly reported adverse event (>1 in 100 patients) is somnolence.

What is the shelf life of NEMBUTAL?

24 months

How should NEMBUTAL be stored?

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20-25°C (68-77°F), however, brief excursions are permitted between 15-30°C (59-86°F). See USP controlled room temperature.
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