acetaminophen/caffeine (OTC)

Brand and Other Names:Excedrin Tension Headache, Excedrin Aspirin Free, more...APAP-Plus
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/caffeine

gel tab

  • 500mg/65mg

tablet

  • 500mg/65mg

caplet

  • 500mg/65mg
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Analgesia

1 capsule/tablet/geltab PO q4-6hr PRN

Safety & efficacy not established

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Interactions

Interaction Checker

and acetaminophen/caffeine

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Acetaminophen

            Pruritic maculopapular rash

            Urticaria

            Laryngeal edema

            Angioedema

            Anaphylactoid reaction

            Thrombocytopenia

            Leukopenia

            Pancytopenia

            Neutropenia

            Thrombocytopenic purpura

            Agranulocytosis

            Hepatotoxicity

            May increase uric acid, chloride, glucose

            May decrease sodium, calcium, bicarbonate  

            Caffeine

            Insomnia

            Restlessness

            Nervousness

            Tremor

            Tinnitus

            Irritability

            Nausea

            Vomiting

            Diarrhea

            Tachycardia

            Diuresis

            Palpitations (dose dependent)

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            Warnings

            Contraindications

            Hypersensitivity

            Hepatitis or severe hepatic/renal impairment

            Cautions

            Hepatic impairment or consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen)

            Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose

            Caution in G6PD deficiency

            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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Excreted in breast milk

            Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

            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

            Acetaminophen: Acetaminophen: Inhibitis prostaglandin sythesis in CNS and may block peripheral pain impulse generation; acts on hypothalamus to antipyresis

            Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

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