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naproxen/pseudoephedrine (Aleve-D Sinus and Headache)

 

Classes: Cough/Cold, Other Combos; Analgesic/Decongestant Combos

Dosing and uses of Aleve-D Sinus and Headache (naproxen/pseudoephedrine)

 

Adult dosage forms and strengths

caplet

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

 

Sinus Headache/Cold/Flu

1 caplet PO q12hr

 

Administration

Swallow whole; do not chew or crush

Take each dose with full glass of water

 

Pediatric dosage forms and strengths

caplet

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

 

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

 

Aleve-D Sinus and Headache (naproxen/pseudoephedrine) adverse (side) 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

 

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

 

Pregnancy and 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.

 

Pharmacology of Aleve-D Sinus and Headache (naproxen/pseudoephedrine)

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