Comparative Pharmacology
Head-to-head clinical analysis: ALEVE PM versus INDOCIN.
Head-to-head clinical analysis: ALEVE PM versus INDOCIN.
ALEVE PM vs INDOCIN
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.
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis, which mediates inflammation, pain, and fever. It also decreases renal blood flow and may cause ductus arteriosus closure.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
25 mg orally 2-3 times daily; maximum 200 mg/day. Intravenous: 0.5-1 mg/kg as single dose for ductus arteriosus closure.
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 approximately 4.5 hours (range 2.6–11.2 hours); prolonged in elderly and patients with hepatic 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 (60% as unchanged drug and glucuronide conjugates), biliary/fecal (33% via enterohepatic circulation).
Category C
Category C
NSAID/Antihistamine Combination
NSAID