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Naproxen Sodium Codeine
Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain, while codeine acts as an opioid agonist to provide additional analgesic and antitussive effects.
Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain, while codeine acts as an opioid agonist to enhance analgesia through central nervous system depression. Used for Moderate pain relief, Pain associated with inflammation.
At a glance
| Generic name | Naproxen Sodium Codeine |
|---|---|
| Also known as | Apranax Plus |
| Sponsor | Istanbul Medeniyet University |
| Drug class | NSAID + opioid combination analgesic |
| Target | COX-1/COX-2 enzymes; mu opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation, pain, and fever. Codeine is an opioid analgesic and antitussive that binds to mu opioid receptors in the central nervous system. The combination provides synergistic pain relief for moderate pain conditions.
Approved indications
- Moderate pain relief
- Pain with inflammatory component
Common side effects
- Gastrointestinal upset (nausea, dyspepsia)
- Dizziness or drowsiness
- Constipation
- Headache
- Respiratory depression
Key clinical trials
- Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain (PHASE4)
- Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial (NA)
- Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure (PHASE2)
- Pain Control After Lumbar Spine Fusion (PHASE4)
- Are Opioids Needed After ACL Reconstruction (PHASE4)
- Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study (PHASE2)
- Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction (PHASE3)
- Pain Management After Surgery (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Naproxen Sodium Codeine CI brief — competitive landscape report
- Naproxen Sodium Codeine updates RSS · CI watch RSS
- Istanbul Medeniyet University portfolio CI