Butabarbital

You should not use butabarbital if you have porphyria.

You should not use butabarbital if you are allergic to it, or if you have:

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

To make sure butabarbital is safe for you, tell your doctor if you have:

• a chronic pain condition, such as fibromyalgia;

• new or sudden pain that is not already being treated with medication;

• liver disease;

• any type of breathing problem;

• a history of depression, mental illness, or suicide attempt; or

• an allergy to aspirin, or any kind of yellow dye (coloring in food or medicines).

Do not use butabarbital if you are pregnant. It could harm the unborn baby. Butabarbital may cause withdrawal symptoms or seizures in your newborn if you take the medication during pregnancy. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Butabarbital can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with butabarbital.

Butabarbital may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

45 to 60 minutes

Refer to adult dosing.

Note: Butisol sodium elixir has been discontinued in the US for more than 1 year.

Preoperative sedation: Children and Adolescents: Oral: 2 to 6 mg/kg 60 to 90 minutes before surgery; maximum: 100 mg

Studies in pregnant women have demonstrated a risk to the fetus. Barbiturates cross the placenta and can be found in fetal tissues. Acute withdrawal symptoms may occur in the neonate following in utero exposure near term. Withdrawal symptoms may include seizures and hyperirritability and may be delayed for up to 14 days after birth.

Use of butabarbital is contraindicated in patients with porphyria and in patients with a hypersensitivity to barbiturates.

Butabarbital should be administered with caution in patients with a history of substance abuse, depression, or suicidal ideation. In addition, butabarbital should be used with caution in patients with borderline hypoadrenal function, regardless of origin.

Butabarbital should not be administered to patients with premonitory signs of hepatic coma.

In patients receiving prolonged therapy, periodic monitoring of the hematopoietic system and renal and liver function is recommended.

Butabarbital has been assigned to pregnancy category D by the FDA. Use of barbiturates during pregnancy has been associated with a higher incidence of fetal abnormalities. Neonatal barbiturate withdrawal symptoms have been reported in infants whose mothers took barbiturates during pregnancy. In addition, administration of sedative-hypnotic barbiturates during labor may cause respiratory depression in the newborn. There are no controlled data in human pregnancy. Patients who receive butabarbital during pregnancy should be advised of the potential hazard to the fetus.

Summary of Use during Lactation

Because there is little published experience with butabarbital 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 butabarbital 8 mg twice daily for 3.5 days. A milk level of 370 mcg/L was measured 1.5 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

Lorazepam, Oxazepam, 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.