Nembutal

Frequency Not Defined

Angioedema (rare)

Bradycardia

Hypotension

Agitation

Ataxia

CNS depression

Confusion

Dizziness

Fever

Headache

Hyperkinesia

Nightmares

Nervousness

Somnolence (frequent)

Syncope

Rash

Stevens-Johnson syndrome

Constipation

Nausea

Vomiting

Agranulocytosis (rare)

Megaloblastic anemia with prolonged use (rare)

Injury of liver with prolonged use (rare)

SLE

Apnea

Hypoventilation

Contraindications

Barbiturate sensitivity, porphyria liver disease, severe respiratory disease

Cautions

General anesthetics and sedation drugs in young children and pregnant women

• Brain development
  • Prolonged or repeated exposure may result in negative effects on fetal or young children’s brain development
  • Caution with use during surgeries or procedures in children younger than 3 yr or in pregnant women during their third trimester
  • Assess the risk:benefit ratio in these populations, especially for prolonged procedures (ie, >3 hr) or multiple procedures

IV Incompatibilities

Additive: chlorpheniramine, ephedrine, hydrocortisone, hydroxyzine, insulin (regular), levorphanol, norepinephrine, penicillin G potassium, pentazocine, phenytoin, promazine, promethazine, Na bicarb, streptomycin, succinylcholine, thiopental, triflupromazine, vancomycin

Syringe: butorphanol, chlorpromazine, cimetidine, dimenhydrinate, diphenhydramine, droperidol, fentanyl, glycopyrrolate, hydroxyzine, meperidine, midazolam, morphine, nalbuphine, pentazocine, prochlorperazine, promazine, promethazine, ranitdine

Y-site: amphotericin B cholSO4, fenoldopam

Not spec: cefazolin, clindamycin, diazepam, tetracycline

IV Compatibilities

Additive: amikacin, aminophylline, CaCl2, chloramphenicol, erythromycin, lidocaine, thiopental, verapamil

Syringe: aminophylline, atropine (<15 min), ephedrine, hyaluronidase, hydromorphone, neostigmine, scopolamine, Na-bicarb, thiopental

Y-site: acyclovir, gatifloxacin, insulin, linezolid, propofol

IV Preparation

Solution: no further prep needed (available form: 50 mg/mL)

IV/IM Administration

IV: slow push; NMT 50 mg/min

• only when other routes not available

IM: NMT 5 mL per site; deep into large muscle

Vials are for multiple use (contains 20 mL=1 g)

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Potential for pentobarbital to impair mental alertness or physical coordination; do not drive or operate machinery until effects on individual are known.a e

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.a Importance of avoiding alcohol while taking the drug.a

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

• Importance of informing patients of other important precautionary information.a (See Cautions.)

• It is used to treat sleep problems.
• It is used to calm you before care.
• It is used to treat seizures.
• It is used to put you to sleep for surgery.
• It may be given to you for other reasons. Talk with the doctor.

Use Nembutal as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Parenteral:

1. Sedatives.
2. 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.)
3. Preanesthetics.
4. 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.

Pentobarbital sodium injection is subject to control by the Federal Controlled Substances Act under DEA schedule II.

Barbiturates may be habit forming. Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. Daily administration in excess of 400 milligrams (mg) of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree of physical dependence. A dosage of from 600 to 800 mg taken for at least 35 days is sufficient to produce withdrawal seizures. The average daily dose for the barbiturate addict is usually about 1.5 grams. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxicating dosage and fatal dosage becomes smaller.

Symptoms of acute intoxication with barbiturates include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.

Symptoms of barbiturate dependence are similar to those of chronic alcoholism. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested.

The symptoms of barbiturate withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of a barbiturate. These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Individuals susceptible to barbiturate abuse and dependence include alcoholics and opiate abusers, as well as other sedative-hypnotic and amphetamine abusers.

Drug dependence to barbiturates arises from repeated administration of a barbiturate or agent with barbiturate-like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence to barbiturates include: (a) a strong desire or need to continue taking the drug; (b) a tendency to increase the dose; (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation of those effects; and (d) a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn.

Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate dependent patients can be withdrawn by using a number of different withdrawal regimens. In all cases withdrawal takes an extended period of time. One method involves substituting a 30 mg dose of phenobarbital for each 100 to 200 mg dose of barbiturate that the patient has been taking. The total daily amount of phenobarbital is then administered in 3 to 4 divided doses, not to exceed 600 mg daily. Should signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of phenobarbital may be administered IM in addition to the oral dose. After stabilization on phenobarbital, the total daily dose is decreased by 30 mg a day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patient's regular dosage level and decreasing the daily dosage by 10 percent if tolerated by the patient.

Infants physically dependent on barbiturates may be given phenobarbital 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of phenobarbital should be gradually decreased and completely withdrawn over a 2-week period.

Summary of Use during Lactation

Because there is little published experience with pentobarbital during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. A mother who was 4 days postpartum had taken pentobarbital 100 mg daily for 3 days. A milk level of 170 mcg/L was measured 19 hours after the previous dose.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Zaleplon, Zolpidem

References

1. Horning MG, Stillwell WG, Nowlin J et al. Identification and quantification of drugs and drug metabolites in human breast milk using GC-MS-COM methods. Mod Probl Paediatr. 1975;15:73-9.

LactMed Record Number

503

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.