naproxen/pseudoephedrine (OTC)

Brand and Other Names:Aleve-D Sinus & Headache
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

caplet

  • 200mg/120mg (220mg naproxen sodium equivalent to 200mg naproxen)
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Sinus Headache/Cold/Flu

1 caplet PO q12hr

Administration

Swallow whole; do not chew or crush

Take each dose with full glass of water

Dosage Forms & Strengths

caplet

  • 200mg/120mg (220mg naproxen sodium equivalent to 200mg naproxen)
more...

Sinus Headache/Cold/Flu

<12 years: Safety and efficacy not established

12 years or older: 1 caplet PO q12hr

Administration

Swallow whole; do not chew or crush

Take each dose with full glass of water

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Interactions

Interaction Checker

and naproxen/pseudoephedrine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Naproxen

            • Abdominal pain, constipation, nausea, diarrhea
            • GI bleeding, perforation, ulcers
            • Dizziness, headache

            Pseudoephedrine

            • Tremor, restlessness, insomnia
            • Nausea, vomiting
            • Hypertension
            • Atrial fibrillation, premature ventricular beats
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            Warnings

            Contraindications

            Hypersensitivity

            Do not coadministration pseudoephedrine with MAOIs or within 2 weeks after discontinuing MAOIs

            Cautions

            NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal

            Naproxen may cause hypersensitivity, particularly in individuals allergic to aspirin

            Pseudoephedrine may increase blood pressure

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            Pregnancy & Lactation

            Pregnancy Category: B; D if used for prolonged periods, or near term (naproxen)

            Lactation: Naproxen and pseudoephedrine are both excreted in breast milk

            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

            Naproxen: Inhibits cyclooxygenase; [at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2)], thereby inhibiting prostaglandin synthesis

            Pseudoephedrine: Alpha adrenergic agonist

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