Comparative Pharmacology
Head-to-head clinical analysis: ALEVE PM versus INDICLOR.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ALEVE PM versus INDICLOR.
ALEVE PM vs INDICLOR
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.
Alkylating agent that crosslinks DNA, inhibiting DNA replication and transcription.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
INDICLOR is not a recognized drug; no standard dosing available.
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 12 hours (range 10-15 hours) in patients with normal renal function; prolonged in renal impairment (up to 25 hours in severe cases).
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.
Primarily renal excretion (approximately 70% unchanged drug); biliary/fecal excretion accounts for about 10-15% as metabolites.
Category C
Category C
NSAID/Antihistamine Combination
NSAID