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Butalbital/Paracetamol

    DEA Class;  Rx

    Common Brand Names; Phrenilin Forte, Phrenilin, Bupap, Orbivan CF

    • Analgesics, Barbiturate Combos

    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

    For the treatment of the symptom complex of tension (muscle contraction) headache.

    Hypersensitivity

    Hepatitis or severe hepatic/renal impairment

    Repeated administration in patients w/ anemia, cardiovascular, pulmonary, or renal disease

    Porphyria

    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

    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 category: C

    Lactation: excreted in breast milk; caution advised

    Adults

    Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.

    Geriatric

    Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.

    Adolescents

    Butalbital 300 mg per day PO and acetaminophen 3,900 mg per day PO.

    Children

    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.

    Infants

    Safety and efficacy have not been established.

    FDA is asking manufacturers to limit acetaminophen in prescription products to 325 mg/dosage unit; manufacturers have until January 14, 2014 to comply

    butalbital/acetaminophen

    tablet

    • 50mg/300mg (Orbivan CF)
    • 50mg/325mg (Phrenilin)
    • 50mg/650mg (Bupap)

    capsule

    • 50mg/650mg (Phrenilin Forte)