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Butabarbital Pregnancy and Breastfeeding Warnings

Butabarbital is also known as: Busodium, Butisol Sodium

Butabarbital Pregnancy Warnings

Human studies suggest that barbiturate use is connected to a higher than expected incidence of fetal abnormalities. This drug crosses the placental barrier and distributes in fetal tissues, including the placenta, liver, and brain. Use during the first and third trimesters may be associated with an increased risk of teratogenicity and withdrawal symptoms in the newborn, respectively. This drug decreases the force and frequency of uterine contractions when used at full anesthetic doses.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Case-controlled, retrospective studies with barbiturates have suggested a connection between maternal consumption and an increased incidence of fetal abnormalities.

-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Use of adequate non-hormonal methods of contraception should be encouraged.
-If used during labor, the newborn should be monitored for respiratory depression and resuscitation equipment should be available.
-If used during pregnancy, the newborn should be monitored for acute withdrawal syndrome symptoms for up to 14 days after birth.

See references

Butabarbital Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

-The effects in the nursing infant are unknown.
-Some experts recommend using alternative agents (e.g., lorazepam, oxazepam, zaleplon, zolpidem), especially when breastfeeding a preterm or newborn infant.

A lactating patient given 8 mg orally 2 times a day for 3.5 days had a milk level of 370 mcg/L at 1.5 hours post-dose.

See references

References for pregnancy information

  1. "Product Information. Butisol Sodium (butabarbital)." Wallace Laboratories (2001):
  2. "Product Information. Butisol Sodium (butabarbital)." Meda Pharmaceuticals (2010):

References for breastfeeding information

  1. "Product Information. Butisol Sodium (butabarbital)." Wallace Laboratories (2001):
  2. "Product Information. Butisol Sodium (butabarbital)." Meda Pharmaceuticals (2010):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.