acetaminophen/caffeine/pyrilamine (OTC)

Brand and Other Names:Midol Complete
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/caffeine/pyrilamine

caplet

  • 500mg/60mg/15mg
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Menstrual Symptoms

Indicated for temporary relief of symptoms associated with menstrual periods

2 caplets PO q6hr prn; not to exceed 8 caplets/day

Dosage Forms & Strengths

acetaminophen/caffeine/pyrilamine

caplet

  • 500mg/60mg/15mg
more...

Menstrual Symptoms

Indicated for temporary relief of symptoms associated with menstrual periods

<12 years: Safety and efficacy not established

12 years or older: 2 caplets PO q6hr prn; not to exceed 8 caplets/day

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Interactions

Interaction Checker

and acetaminophen/caffeine/pyrilamine

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined (acetaminophen)

            Pruritic maculopapular rash

            Urticaria

            Laryngeal edema

            Angioedema

            Anaphylactoid reaction

            Thrombocytopenia

            Leukopenia

            Pancytopenia

            Neutropenia

            Thrombocytopenic purpura

            Agranulocytosis

            Hepatotoxicity

            Frequency Not Defined (caffeine)

            Insomnia

            Restlessness

            Nervousness

            Tremor

            Tinnitus

            Irritability

            Nausea

            Vomiting

            Diarrhea

            Tachycardia

            Diuresis

            Palpitations (dose dependent)

            Frequency Not Defined (pyrilamine)

            Sedation

            Xerostomia

            Blurred vision

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            Warnings

            Contraindications

            Hypersensitivity

            Hepatitis or severe hepatic/renal impairment

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

            Cautions

            Risk of hepatotoxicity; risk is higher in alcoholics or with use of more than one acetaminophen-containing product

            Caution regarding daily acetaminophen consumption; do not exceed 3-4 g/day and do not take for prolonged duration G6PD deficiency

            Caution with glaucoma, difficulty in urination caused by prostate gland enlargement, and emphysema or chronic bronchitis

            Additive sedation may occur if used with alcohol or sedative drugs

            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: Acts on hypothalamus to produce analgesia

            Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

            Pyrilamine: Elicits mild diuretic properties

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