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Diclofenac

Generic Name
Diclofenac
Brand Names
Aleve Arthritis Pain, Arthrotec, Cambia, Cataflam, Flector, Licart, Lofena, Pennsaid, Previdolrx Analgesic Pak, Salonpas Pain Relieving Patch, Solaraze, Voltaren, Voltaren Emulgel, Xrylix, Zipsor, Zorvolex
Drug Type
Small Molecule
Chemical Formula
C14H11Cl2NO2
CAS Number
15307-86-5
Unique Ingredient Identifier
144O8QL0L1

Overview

Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID). NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of phenylbutazone, mefenamic acid, and indomethacin. The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with misoprostol to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).

Background

Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID). NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of phenylbutazone, mefenamic acid, and indomethacin. The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with misoprostol to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).

Indication

Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma. It is often used in combination with misoprostol as a gastro-protective agent in patients with high risk of developing NSAID-induced ulcers.

Associated Conditions

  • Actinic Keratosis (AK)
  • Acute Arthritis
  • Acute Gouty Arthritis
  • Acute Migraine
  • Acute Musculoskeletal Pain
  • Ankylosing Spondylitis (AS)
  • Common Cold
  • Fever
  • Gout
  • Inflammation
  • Inflammatory Disease of the Oral Cavity
  • Inflammatory Disease of the throat
  • Inflammatory Reaction of the Nerve
  • Joint Pain
  • Juvenile Idiopathic Arthritis (JIA)
  • Menstrual Distress (Dysmenorrhea)
  • Muscle Inflammation
  • Myalgia
  • Neuropathic Pain
  • Ocular Inflammation
  • Osteoarthritis (OA)
  • Osteoarthritis of the Knee
  • Pain
  • Pain caused by Rheumatism
  • Pericarditis
  • Photophobia
  • Postoperative Inflammatory Response
  • Postoperative pain
  • Primary Dysmenorrhoea
  • Radicular Pain
  • Rheumatism
  • Rheumatoid Arthritis
  • Seasonal Allergic Conjunctivitis
  • Spinal pain
  • Tendon pain
  • Vertebral column pain
  • Acute Musculoskeletal injury
  • Acute, moderate, severe Pain, Inflammatory
  • Localized soft tissue rheumatism
  • Mild to moderate joint pain
  • Mild to moderate pain
  • Minor pain
  • Perioperative miosis

FDA Approved Products

Diclofenac Sodium
Manufacturer:Alembic Pharmaceuticals Inc.
Route:TOPICAL
Strength:30 mg in 1 g
Approved: 2023/03/01
NDC:62332-581
Diclofenac Potassium
Manufacturer:Leading Pharma, LLC
Route:ORAL
Strength:25 mg in 1 1
Approved: 2022/03/22
NDC:69315-275
Diclofenac Sodium
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2021/04/16
NDC:68071-2045
diclofenac sodium
Manufacturer:Proficient Rx LP
Route:TOPICAL
Strength:30 mg in 1 g
Approved: 2022/08/01
NDC:71205-692
Diclofenac Sodium
Manufacturer:Preferred Pharmaceuticals, Inc.
Route:TOPICAL
Strength:10 mg in 1 g
Approved: 2023/05/04
NDC:68788-7772

Singapore Approved Products

DICLORAN TABLET 50 mg
Manufacturer:UNIQUE PHARMACEUTICALS LABORATORIES (A DIV OF J B CHEMICALS & PHARM LTD)
Form:TABLET, ENTERIC COATED
Strength:50 mg
Online:Yes
Approved: 2005/04/14
Approval:SIN12653P
ANALPAN INJECTION 25 mg/ml
Manufacturer:DUOPHARMA (M) SDN BHD
Form:INJECTION
Strength:25 mg/ml
Online:Yes
Approved: 1998/06/16
Approval:SIN09829P
Voltfast Powder for Oral Solution 50mg/sachet
Manufacturer:Mipharm S.p.A.
Form:POWDER, FOR SOLUTION
Strength:50.0 mg
Online:Yes
Approved: 2011/01/25
Approval:SIN13913P

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