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
