naproxen/pseudoephedrine (OTC)

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

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 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.

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