butalbital/acetaminophen/caffeine (Rx)Brand and Other Names:Fioricet, Orbivan, more...Alagesic LQ, Dolgic Plus, Esgic Plus, Margesic, Zebutal

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • butalbital/acetaminophen/caffeine
  • 50mg/325mg/40mg (Fioricet, Esgic)
  • 50mg/500mg/40mg (Esgic-Plus)
  • 50mg/750mg/40mg (Dolgic Plus)

capsule

  • butalbital/acetaminophen/caffeine
  • 50mg/300mg/40mg (Orbivan)
  • 50mg/325mg/40mg (Esgic, Margesic)
  • 50mg/500mg/40mg (Esgic-Plus, Zebutal)

liquid, oral

  • butalbital/acetaminophen/caffeine
  • (50mg/325mg/40mg)15mL (Alagesic LQ)
more...

Tension Headache

50 mg/300-325 mg/40 mg: 2 tablets or capsules PO q4hr; not to exceed 6 tablets or capsules/day

50 mg/500 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 6 tablets or capsules/day

50 mg/750 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 5 tablets or capsules/day

15-30 mL solution PO q4hr; not to exceed 180 mL solution/day

Not to exceed 4 g/day of acetaminophen for any dosage form or regimen

Dosing Modifications

Renal impairment: Not studied; use caution and reduce dosing if necessary in severe renal impairment

Hepatic impairment: Not studied; use caution and reduce dosing if necessary in severe hepatic impairment

Dosage Forms & Strengths

tablet

  • butalbital/acetaminophen/caffeine
  • 50mg/325mg/40mg (Fioricet, Esgic)
  • 50mg/500mg/40mg (Esgic-Plus)
  • 50mg/750mg/40mg (Dolgic Plus)

capsule

  • butalbital/acetaminophen/caffeine
  • 50mg/300mg/40mg (Orbivan)
  • 50mg/325mg/40mg (Esgic, Margesic)
  • 50mg/500mg/40mg (Esgic-Plus, Zebutal)

liquid, oral

  • butalbital/acetaminophen/caffeine
  • (50mg/325mg/40mg)15mL (Alagesic LQ)
more...

Tension Headache

<12 years: Safety and efficacy not established

≥12 years

  • 50 mg/300-325 mg/40 mg: 2 tablets or capsules PO q4hr; not to exceed 6 tablets or capsules/day
  • 50 mg/500 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 6 tablets or capsules/day
  • 50 mg/750 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 5 tablets or capsules/day
  • 15-30 mL solution PO q4hr; not to exceed 90 mL solution/day
  • Not to exceed 4 g/day of acetaminophen for any dosage form or regimen

Dosing Modifications

Renal impairment: Not studied; use caution and reduce dosing if necessary in severe renal impairment

Hepatic impairment: Not studied; use caution and reduce dosing if necessary in severe hepatic impairment

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Interactions

Interaction Checker

butalbital/acetaminophen/caffeine and

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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

            Caffeine

            • Tachycardia, palpitations (dose dependent)
            • Insomnia, irritability, nervousness, restlessness, tinnitus, tremor
            • Diarrhea, nausea, vomiting
            • Diuresis
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            Warnings

            Black Box Warnings

            Contains acetaminophen

            Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day; take into account all acetaminophen-containing products the patient is taking, including PRN doses and OTC products

            Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death

            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 daily (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4 g/day)

            Contraindications

            Hypersensitivity

            Cautions

            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)

            Butalbital may be habit-forming; for short-term use only

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            Pregnancy & Lactation

            Pregnancy category: C; 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

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Butalbital: Barbiturate; elicits generalized CNS depressant effects; depresses sensory cortex; decreases motor activity

            Acetaminophen: Nonopioid, nonsalicylate analgesic; acts on hypothalamus to produce analgesia and antipyresis

            Caffeine: Vasoconstrictive properties of cerebral blood vessels may be helpful when treating headaches; improves skeletal muscle contraction and medullary respiratory center sensitivity; stimulates central inspiratory drive

            Absorption

            Butalbital and caffeine: Well absorbed

            Bioavailability: 100% acetaminophen

            Distribution

            Protein bound: Butalbital (45%); acetaminophen (20-50%)

            Metabolism

            Butalbital

            • Metabolized in liver by CYP450 enzyme system
            • Induces hepatic enzymes, but to lesser degree than phenobarbital

            Acetaminophen

            • Metabolized in liver by microsomal enzyme systems
            • 80-85% conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine
            • 4% metabolized by CYP450 to toxic metabolite (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone [NAPQI]), which is detoxified by conjugation with glutathione; high doses may deplete fixed amount of glutathione in body, causing NAPQI accumulation

            Caffeine

            • Metabolized in liver via CYP1A2 to paraxanthine, theobromine, and theophylline

            Elimination

            Half-life: 35 hr butalbital; 2-4 hr acetaminophen; 3-7 hr caffeine

            Excretion: Butalbital (59-88% in urine); acetaminophen (90-100% in urine, principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate); caffeine (principally in urine)

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            Formulary

            FormularyPatient Discounts

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

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            • View the formulary and any restrictions for each plan.
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            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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