Dilution Pentobarbital ( Nembutal ®)

Pentobarbital ( Nembutal ®)

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Usual Diluents

NS, D5W

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Maximum rate: 50 mg/min
[100 mg] [50 ml]
[500 – 2000 mg] [250 ml](Concentrations from 0.5 to 8 mg/ml appear to be stable)
Infusion rate: As directed.

Stability / Miscellaneous

EXP: 12 to 24 hrs (RT) variable (Review specialized reference for additional info).
Label: Do not refrigerate.Onset: 15-60 min
Duration:
(Oral): 1-4 hrs (IV): 15 min

May be given deep IM (max 250mg per site) or by slow IV injection. Note: can be given IV undiluted.

Dosing:
Hypnotic (Adult):
Oral: 100-200mg qhs.
IM: 150-200mg.
IV: Initially 100mg, may repeat q1-3min up to 200-500mg total dose. Rectal: 120-200mg at bedtime.

Preoperative sedation: IM: 150-200 mg.

Barbiturate coma in head injury patients: IV loading dose of 5-10 mg/kg over 1 to 2 hours. Maintenance: Initial: 1 mg/kg/hr; may increase to 2-3 mg/kg/hr. Monitor for dose-dependent cardiovascular and respiratory depression. Maintain serum concentration at 2-4 mg/dl.

Supplied: 50mg/ml-1ml, 2 ml, 20ml, 50ml. (C-II)

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 67386- 501-52); and 50-mL multiple-dose vial, 2.5 g per vial (NDC 67386-501-55).

Manufactured by
Hospira, Inc.
Lake Forest, Illinois 60045 U.S.A.
For:
OVATION Pharmaceuticals, Inc.
Deerfield, Illinois, U.S.A. 60015

Source: [package insert]