Comparative Pharmacology
Head-to-head clinical analysis: ALEVE D SINUS COLD versus HISTAFED.
Head-to-head clinical analysis: ALEVE D SINUS COLD versus HISTAFED.
ALEVE-D SINUS & COLD vs HISTAFED
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.
HISTAFED is a combination of pseudoephedrine, a sympathomimetic amine that acts as a decongestant by stimulating alpha-adrenergic receptors in the nasal mucosa causing vasoconstriction, and triprolidine, a first-generation antihistamine that competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract, thereby preventing histamine-mediated effects.
Naproxen 220 mg (as naproxen sodium) and pseudoephedrine HCl 120 mg orally every 12 hours; maximum 2 doses per 24 hours.
60 mg orally every 4 to 6 hours as needed; maximum 360 mg per day.
None Documented
None Documented
Naproxen: 12-17 hours (clinical: twice daily dosing); pseudoephedrine: 4-6 hours (clinical: every 4-6 hours).
3-4 hours for pseudoephedrine component; shorter in children (2-3 h), prolonged in renal impairment
Renal elimination: naproxen ~95% (mostly as unconjugated naproxen and 6-O-desmethyl naproxen), pseudoephedrine ~70-90% unchanged. Biliary/fecal: minor (<5% for each).
Renal (approximately 65% as unchanged drug and metabolites), biliary/fecal (35%)
Category C
Category C
NSAID/Decongestant Combination
Antihistamine/Decongestant Combination