Comparative Pharmacology
Head-to-head clinical analysis: ALEVE PM versus TAB PROFEN.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ALEVE PM versus TAB PROFEN.
ALEVE PM vs TAB-PROFEN
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
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.
Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor; reduces prostaglandin synthesis.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
400-800 mg orally every 6-8 hours as needed; maximum 3200 mg/day.
None Documented
None Documented
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.
The terminal elimination half-life is 2-4 hours in adults with normal renal function. In elderly patients or those with renal impairment, half-life may be prolonged up to 8-12 hours, requiring dose adjustment.
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.
Renal excretion of unchanged drug accounts for approximately 70-90% of the administered dose, with the remainder eliminated as glucuronide conjugates in urine. Biliary/fecal elimination is minimal (<5%).
Category C
Category C
NSAID/Antihistamine Combination
NSAID