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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 sodium
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:550 mg in 1 1
Approved: 2021/05/28
NDC:50090-5238
Naproxen
Manufacturer:Aphena Pharma Solutions - Tennessee, LLC
Route:ORAL
Strength:500 mg in 1 1
Approved: 2021/06/24
NDC:71610-560
Naproxen
Manufacturer:Advanced Rx Pharmacy of Tennessee, LLC
Route:ORAL
Strength:500 mg in 1 1
Approved: 2024/03/21
NDC:80425-0378
Naproxen
Manufacturer:Amneal Pharmaceuticals of New York LLC
Route:ORAL
Strength:500 mg in 1 1
Approved: 2021/10/20
NDC:53746-190
Naproxen
Manufacturer:Zydus Lifesciences Limited
Route:ORAL
Strength:250 mg in 1 1
Approved: 2023/09/27
NDC:65841-676

Singapore Approved Products

SUNPROX 550 TABLET 550 mg
Manufacturer:SUNWARD PHARMACEUTICAL PRIVATE LIMITED
Form:TABLET, FILM COATED
Strength:550 mg
Online:Yes
Approved: 1998/08/22
Approval:SIN09953P
ZYNAL TABLET 275 mg
Manufacturer:KOREAN DRUG CO LTD
Form:TABLET, FILM COATED
Strength:275 mg
Online:Yes
Approved: 1996/04/04
Approval:SIN08637P
APO-NAPROXEN TABLET 500 mg
Manufacturer:APOTEX INC
Form:TABLET
Strength:500 mg
Online:Yes
Approved: 1991/01/08
Approval:SIN05294P
ALEVE TABLET 220 mg (OTC Pack)
Manufacturer:BAYER BITTERFELD GmbH
Form:TABLET, FILM COATED
Strength:220 mg
Online:Yes
Approved: 2003/10/09
Approval:SIN12440P
SOPROXEN TABLET 250 mg
Manufacturer:BERLIN PHARMACEUTICAL INDUSTRY CO LTD
Form:TABLET, FILM COATED
Strength:250 mg
Online:Yes
Approved: 1998/06/04
Approval:SIN09804P

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