Butalbital and acetaminophen
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
HEPATOTOXICITY ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
Barbiturate
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Drug interactions
Check butalbital and acetaminophen against a medication listLabel text (1 paragraph)
Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. Butalbital and acetaminophen may enhance the effects of:other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Contraindications
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product. Patients with porphyria.
Pregnancy and lactation
Pregnancy
Pregnancy Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed. Nonteratogenic Effects: Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum.
The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
Lactation
Nursing Mothers Barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.