Comparative Pharmacology
Head-to-head clinical analysis: ALEVE D SINUS COLD versus ALEVE PM.
Head-to-head clinical analysis: ALEVE D SINUS COLD versus ALEVE PM.
ALEVE-D SINUS & COLD vs ALEVE PM
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis. Pseudoephedrine is a sympathomimetic amine that acts as a decongestant via alpha-adrenergic receptor agonism in the nasal mucosa.
Diphenhydramine is a histamine H1 receptor antagonist that competes with histamine for binding at H1 receptor sites, reducing symptoms of allergic reactions and causing sedation. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, decreasing synthesis of prostaglandins, which reduces pain and inflammation.
Naproxen 220 mg (as naproxen sodium) and pseudoephedrine HCl 120 mg orally every 12 hours; maximum 2 doses per 24 hours.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
None Documented
None Documented
Naproxen: 12-17 hours (clinical: twice daily dosing); pseudoephedrine: 4-6 hours (clinical: every 4-6 hours).
Naproxen: 12-17 hours (mean 13.6 hours); sufficient for twice-daily dosing; prolonged in renal impairment. Diphenhydramine: 2.4-9.3 hours (mean 5.5 hours); longer in elderly, hepatic impairment.
Renal elimination: naproxen ~95% (mostly as unconjugated naproxen and 6-O-desmethyl naproxen), pseudoephedrine ~70-90% unchanged. Biliary/fecal: minor (<5% for each).
Naproxen: renal (95% as unchanged drug and metabolites, primarily as naproxen and 6-O-desmethyl naproxen). Diphenhydramine: renal (50-60% as unchanged drug and metabolites, primarily as diphenhydramine and nor diphenhydramine); small amounts in feces.
Category C
Category C
NSAID/Decongestant Combination
NSAID/Antihistamine Combination