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codeine/acetaminophen/butalbital/caffeine (Rx)Brand and Other Names:Fioricet with Codeine

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

codeine/acetaminophen/butalbital/caffeine

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

capsule: Schedule III

  • 30mg/325mg/50mg/40mg
more...

Tension Headache

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

Dosage Forms & Strengths

codeine/acetaminophen/butalbital/caffeine

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

capsule: Schedule III

  • 30mg/325mg/50mg/40mg
more...

Tension Headache

<12 years: Safety and efficacy not established

≥12 years: 1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day (not to exceed acetaminophen 4 g/day)

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Interactions

Interaction Checker

codeine/acetaminophen/butalbital/caffeine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Codeine

            • Drowsiness
            • Constipation

            1-10%

            Codeine

            • Bradycardia, hypotension, tachycardia
            • Confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, weakness
            • Rash, urticaria
            • Anorexia, nausea, vomiting, xerostomia
            • LFT's increased
            • Ureteral spasm, urination decreased
            • Dyspnea
            • Burning at injection site, blurred vision, histamine release

            Frequency Not Defined

            Acetaminophen

            • Angioedema, laryngeal edema
            • Pruritic maculopapular rash, urticaria
            • Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
            • Hepatotoxicity
            • Anaphylactoid reaction

            Butalbital

            • Drowsiness, dizziness, intoxicated feeling, lightheadedness, sedation
            • Abdominal pain, nausea, vomiting
            • Shortness of breath

            Caffeine

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

            Postoperative pain in children

            • Deaths have occurred in children with obstructive sleep apnea who receive codeine for postoperative pain following tonsillectomy and/or adenoidectomy
            • Codeine is converted to morphine by the liver; these children had evidence of being ultra-rapid metabolizers (via CYP2D6) of codeine, which is an inherited (genetic) ability that causes codeine to be converted rapidly into life-threatening or fatal amounts of morphine (see Pharmacology)

            Contraindications

            Hypersensitivity

            Hepatitis or severe hepatic/renal impairment

            Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease

            Porphyria

            Postoperative use in children following tonsillectomy and/or adenoidectomy (see Black Box Warnings)

            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 may cause rare serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), which can be fatal; discontinued at the first appearance of skin rash

            G6PD deficiency

            Avoid driving car or operating machinery

            May increase respiratory depressant effects; caution with head injury, COPD, or other conditions with decreased respiratory drive

            Codeine may cause tolerance/dependency

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            Pregnancy & Lactation

            Pregnancy category: C; may prolong delivery and cause respiratory depression/withdrawal symptoms in newborn

            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

            Codeine: Opioid agonist; analgesia

            Acetaminophen: Acts on hypothalamus to produce analgesia and antipyresis

            Butalbital: Barbiturate; elicits generalized CNS depressant effects

            Caffeine: Vasoconstrictive properties of cerebral blood vessels may be helpful when treating headaches

            Pharmacogenomics

            10% of codeine is metabolized to morphine by CYP2D6; the active morphine metabolite has a higher affinity for opioid receptors

            CYP2D6 poor metabolizers may not achieve adequate analgesia

            Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

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            Images

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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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            • 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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