Comparative Pharmacology
Head-to-head clinical analysis: ALEVE PM versus TOLECTIN 600.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ALEVE PM versus TOLECTIN 600.
ALEVE PM vs TOLECTIN 600
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.
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
600 mg orally three times daily; maximum 1800 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.
Terminal elimination half-life is approximately 5 hours (range 4-6 hours) in healthy adults; prolonged in renal impairment.
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: approximately 90% as metabolites and conjugates; biliary/fecal: minor (less than 10%)
Category C
Category C
NSAID/Antihistamine Combination
NSAID