PENTOBARBITAL SODIUM (Generic for NEMBUTAL SODIUM) Pediatric Monographs

 

 General Administration Information

For storage information, see the specific product information within the How Supplied section.

Extemporaneous Compounding

-Although details regarding stability are not available, the parenteral solution has been mixed in a 3:1 ratio with cherry syrup and given orally. In both of these studies, oral pentobarbital was better tolerated and as effective as the comparator (IV pentobarbital or chloral hydrate).

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Injectable Administration

-IV administration is restricted to conditions in which other routes are not feasible (unconscious or noncooperative patients; conditions may include cerebral hemorrhage, status epilepticus, and delirium) or because prompt action is imperative.

-Parenteral solutions are very alkaline (pH = 9.5); avoid intra-arterial injection and extravasation.

-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous Administration

Intermittent IV Injection

-Do not admix with any other medication or solution; administer undiluted.

-Slow IV injection is essential; do not exceed a rate of 50 mg/min. Rapid IV injection may cause respiratory depression, apnea, laryngospasm, and hypotension.

-At least 1 minute is necessary to determine the full effect of intravenous pentobarbital.

-Monitor patients carefully during administration; monitor vital signs and take measures to maintain blood pressure, respiration, and cardiac function as needed. Equipment necessary for resuscitation and artificial ventilation should be readily available.

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Continuous IV Infusion

-Administer the pentobarbital bolus over a minimum of 30-60 minutes. Increase administration time to reduce the risk of hypotension; larger doses may be given over 2-3 hours. Adjust infusion rate based on clinical response (e.g., seizure activity, intracranial pressure, cerebral perfusion pressure, blood pressure).

-Pentobarbital 0.6 mg/ml or 1.25 mg/ml in either NS or D5W was stable for 12 hours, and use of a 0.45 micron filter did not affect the amount of pentobarbital that was delivered to a patient. In another compatibility study, pentobarbital concentrations less than 8 mg/ml in either NS or D5W were stable for 24 hours; precipitation was noted at higher pentobarbital concentrations.

Intramuscular Administration

-Inject deeply into a large muscle mass.

-Administer undiluted. While a maximum volume in pediatric patients has not been specified, the manufacturer states that a volume of 5 ml at a single injection site not be exceeded in adults.

Pentobarbital is a CNS-depressant. It is used therapeutically as a sedative-hypnotic and in high doses to induce therapeutic coma in status epilepticus or traumatic brain injury. Reported CNS adverse effects and general CNS-depressant effects of pentobarbital include ataxia, confusion, drowsiness, dizziness, lethargy, headache, hallucinations, impaired cognition (abnormal thinking), vertigo, anxiety, weakness, and irritability. Hypnotic doses produce residual sedation, emotional lability, and motor skill impairment that can last for several hours. Children may experience more CNS reactions than other populations. Some children respond with paradoxical CNS stimulation (e.g., agitation, hyperactivity, nightmares, insomnia). Other CNS effects include hyperkinesis, nervousness, and psychiatric disturbances.