Classes
DEA Class; Rx
Common Brand Names; Fioricet, Orbivan, Alagesic LQ, Dolgic Plus, Esgic Plus, Margesic, Zebutal
- Analgesics, Barbiturate Combos
Description
Barbiturate (butalbital), acetaminophen, and caffeine analgesic combination
Used to treat tension headaches in adult and pediatric patients 12 years and older; prolonged use not advisable
Associated with concerns of abuse, medication-overuse headache, and withdrawal; boxed warning for acetaminophen hepatotoxicity risk
Indications
Contraindications
Hypersensitivity
Adverse Effects
Butalbital
Dizziness, drowsiness, feeling of intoxication, lightheadedness, sedation
Abdominal pain, nausea, vomiting
Shortness of breath
Acetaminophen
Angioedema, laryngeal edema
Pruritic maculopapular rash, urticaria
Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
Hepatotoxicity
Anaphylactoid reaction
Caffeine
Tachycardia, palpitations (dose dependent)
Insomnia, irritability, nervousness, restlessness, tinnitus, tremor
Diarrhea, nausea, vomiting
Diuresis
Warnings
Use caution in hepatitis or severe hepatic/renal impairment
Use caution in repeated administration to patients with anemia, or with cardiovascular, pulmonary, or renal disease porphyria
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)
Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash
Patients with G6PD deficiency
Butalbital may cause sedation; avoid driving a car, operating machinery, or administering with other CNS depressants (eg, alcohol)
Caution with special-risk patients (eg, elderly or debilitated or those with severe renal or hepatic dysfunction or with acute abdominal conditions)
Pregnancy and Lactation
Pregnancy
Case reports of withdrawal seizures in newborns whose mothers had taken butalbital-containing drug during pregnancy
Lactation
Excreted in breast milk in small amounts; not recommended
Maximum Dosage
Butalbital 300 mg per day PO, acetaminophen 4 grams per day PO, and caffeine 240 mg per day PO.
Butalbital 300 mg per day PO, acetaminophen 4 grams per day PO, and caffeine 240 mg per day PO.
Butalbital 300 mg per day PO, acetaminophen 4 grams per day PO, and caffeine 240 mg per day PO.
12 years: Butalbital 300 mg per day PO, acetaminophen 4 grams per day PO, and caffeine 240 mg per day PO.
Less than 12 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.