Nembutal Sodium (Page 4 of 4)

DOSAGE AND ADMINISTRATION

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 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 be admixed 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 (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 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.

Inspection: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution containers permit. Solutions for injection showing evidence of precipitation should not be used.

HOW SUPPLIED

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 mg
Propylene glycol ………………………………………………… 40% v/v
Alcohol ………………………………………………………….. 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), however, brief excursions are permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans.

In primates, exposure to 3 hours of exposure to an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data (see “Warnings-Pediatric Neurotoxicity” and “Precautions-Pregnancy and Pediatric Use”).

AKORN
Distributed by: Akorn, Inc.
Lake Forest, IL 60045

OAK
Manufactured for: Oak Pharmaceuticals, Inc.
® Trademark of Oak Pharmaceuticals, Inc.

OPNM00N Rev. 04/19

Principal Display Panel Text for Container Label:

NDC 76478-501-20 20 mL Sterile Solution

Nembutal®

Sodium Solution

(pentobarbital sodium injection, USP)

50 mg/mL CII

For Intravenous or Intramuscular Use.

Multiple-dose Vial. LATEX-FREE

Rx only Oak Logo

Principal Display Panel Text for Container Label
(click image for full-size original)

Principal Display Panel Text for Carton Label:

NDC 76478-501-20 20 mL

Sterile Solution

Nembutal®

Sodium Solution

(pentobarbital sodium

injection, USP)

50 mg/mL CII

For Intravenous or Intramuscular Use.

Multiple-dose Vial. LATEX-FREE.

Caution: This solution is not suitable

for subcutaneous administration.

Rx only Oak Logo

Principal Display Panel Text for Carton Label
(click image for full-size original)
NEMBUTAL SODIUM
pentobarbital sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76478-501
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pentobarbital sodium (pentobarbital) pentobarbital sodium 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Propylene Glycol
Alcohol
Water
Hydrochloric Acid
Sodium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76478-501-20 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (76478-501-20)
2 NDC:76478-501-50 1 VIAL in 1 CARTON contains a VIAL
2 50 mL in 1 VIAL This package is contained within the CARTON (76478-501-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083246 09/19/1973
Labeler — Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719)
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 063434679 PACK (76478-501), LABEL (76478-501)
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 155135783 MANUFACTURE (76478-501), ANALYSIS (76478-501), STERILIZE (76478-501)

Revised: 12/2016 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)

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