butalbital/acetaminophen (Rx)

Brand and Other Names:Phrenilin Forte, Phrenilin, more...Bupap, Orbivan CF
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

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)
more...

Tension Headache

1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day

Not to exceed 4 g acetaminophen/24 hr

Renal Impairment

Mild-to-moderate: Administer lower dose

Severe: Use caution

Hepatic Impairment

Mild-to-moderate: Administer lower dose

Severe: Use caution

Dosage Forms & Strengths

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)
more...

Tension Headache

<12 years: Safety and efficacy not established

≥12 years: As adults; 1-2 tab or cap PO q4hr; not to exceed 6 tab or cap per day

Not to exceed 4 g acetaminophen/24 hr

Tension headache

1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day

Not to exceed 4 g acetaminophen/24 hr

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Interactions

Interaction Checker

and butalbital/acetaminophen

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            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
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            Warnings

            Black Box Warnings

            Contains acetaminophen

            Hepatotoxicity may occur with acetaminophen doses that exceed 4 grams/day (ie, 4,000 mg/day)

            Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and death

            Most cases of liver injury are associated with the use of acetaminophen at doses that exceed 4 grams/day, and often involve more than 1 acetaminophen-containing product

            New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen

            Healthcare professionals can direct patients to take 1 or 2 tablets, capsules or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times a day (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4000 mg/day)

            Contraindications

            Hypersensitivity

            Hepatitis or severe hepatic/renal impairment

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

            Porphyria

            Cautions

            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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: excreted in breast milk; caution advised

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Butalbital: Barbiturate; elicits generalized CNS depressant effects

            Acts on hypothalamus to produce antipyresis; may work peripherally to pain impulse generation; may also inhibit prostaglandin synthesis in CNS

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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