MedPath

Naproxen

Generic Name
Naproxen
Brand Names
Aleve, Aleve PM, Aleve-D, Anaprox, Naprelan, Naprosyn, Sallus, Sudafed Sinus & Pain, Treximet, Vimovo
Drug Type
Small Molecule
Chemical Formula
C14H14O3
CAS Number
22204-53-1
Unique Ingredient Identifier
57Y76R9ATQ

Overview

Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.

Background

Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.

Indication

Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain. Further, it is first-line therapy for osteoarthritis, acute gouty arthritis, dysmenorrhea, and musculoskeletal inflammation and pain.

Associated Conditions

  • Acute Gouty Arthritis
  • Acute Migraine
  • Ankylosing Spondylitis (AS)
  • Back pain
  • Bursitis
  • Extra-Articular Rheumatism
  • Fever
  • Flu caused by Influenza
  • Headache
  • Juvenile Idiopathic Arthritis (JIA)
  • Menstrual Distress (Dysmenorrhea)
  • Migraine
  • Muscle Spasms
  • Nasal Congestion
  • Osteoarthritis (OA)
  • Pain
  • Post Traumatic Pain
  • Postoperative pain
  • Primary Dysmenorrhoea
  • Rheumatoid Arthritis
  • Rheumatoid Arthritis, Juvenile
  • Seasonal Allergic Rhinitis
  • Sinusitis
  • Tendinitis
  • Toothache
  • Articular inflammation

FDA Approved Products

Naproxen
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/01/30
NDC:50090-3055
Naproxen
Manufacturer:RPK Pharmaceuticals, Inc.
Route:ORAL
Strength:375 mg in 1 1
Approved: 2023/01/07
NDC:53002-3102
NAPROXEN
Manufacturer:DIRECT RX
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/04/13
NDC:61919-204
Naproxen
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:375 mg in 1 1
Approved: 2024/03/20
NDC:70518-3486
Naproxen
Manufacturer:REMEDYREPACK INC.
Route:ORAL
Strength:250 mg in 1 1
Approved: 2024/02/16
NDC:70518-1450

Singapore Approved Products

No Singapore products found for this drug

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