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Naproxen Sodium & Pseudoephedrine HCl
Naproxen sodium reduces pain and inflammation via COX inhibition, while pseudoephedrine HCl constricts nasal blood vessels to relieve congestion.
Naproxen sodium reduces pain and inflammation via COX inhibition, while pseudoephedrine HCl constricts nasal blood vessels to relieve congestion. Used for Pain and inflammation associated with cold, flu, or sinus congestion, Nasal and sinus congestion relief.
At a glance
| Generic name | Naproxen Sodium & Pseudoephedrine HCl |
|---|---|
| Also known as | Aleve Cold and Sinus |
| Sponsor | Dr. Reddy's Laboratories Limited |
| Drug class | NSAID + sympathomimetic decongestant combination |
| Target | COX-1/COX-2 (naproxen); alpha-1 adrenergic receptor (pseudoephedrine) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Respiratory / Cold & Allergy |
| Phase | FDA-approved |
Mechanism of action
Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thereby decreasing pain, fever, and inflammation. Pseudoephedrine HCl is a sympathomimetic amine that acts as an alpha-adrenergic agonist on nasal blood vessels, causing vasoconstriction to relieve nasal and sinus congestion. This combination addresses both pain/inflammation and congestion symptoms commonly associated with cold and sinus conditions.
Approved indications
- Temporary relief of minor aches and pains due to the common cold, headache, muscular aches, backache, minor pain of arthritis, menstrual cramps, and toothache with nasal congestion
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Headache
- Dizziness
- Nervousness or insomnia
- Tachycardia
Key clinical trials
- Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions (PHASE1)
- Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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