Classes
DEA Class; Rx
Common Brand Names; Phrenilin Forte, Phrenilin, Bupap, Orbivan CF
- Analgesics, Barbiturate Combos
Description
Acetaminophen and barbiturate (butalbital) 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
For the treatment of the symptom complex of tension (muscle contraction) headache.
Contraindications
Hypersensitivity
Hepatitis or severe hepatic/renal impairment
Repeated administration in patients w/ anemia, cardiovascular, pulmonary, or renal disease
Porphyria
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
Warnings
Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and 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
G6PD deficiency
Avoid driving car or operating machinery
Pregnancy and Lactation
Pregnancy category: C
Lactation: excreted in breast milk; caution advised
Maximum Dosage
Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.
Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.
Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.
12 years: Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.
1 to 11 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.