Diclofenac Sodium

Therapeutic Group

Anti-inflammatory And Anti-rheumatic Products

Indication Dosage

Pain And Inflammation In Rheumatic Disease Including Juvenile Idiopathic Arthritis: 

Oral: 

  • Adult: 75-150 Mg Daily In 2-3 Divided Doses 
  • Children 6 Months -18 Yrs: 1.5-2.5 Mg/kg (max 75 Mg) Twice Daily; Total Daily Dose May Alternatively Be Given In 3 Divided Doses 

By Rectum: 

  • Adult: 75-150 Mg Suppositories Daily In Divided Doses; 
  • Children 6 Months-18 Yr: Body-weight 8-12 Kg: 12.5 Mg Suppositories Twice Daily For Max 4 Days; Body-weight Over 12 Kg: 1 Mg/kg Suppositories (max 50 Mg) 3 Times Daily For Max 4 Days. 

By IV Infusion Or Deep IM Inj: 

  • Children 2-18 Yr: 0.3-1 Mg/kg Once Or Twice Daily Iv Infusion Or Deep IM Injection Into Gluteal Muscle, For Max 2 Days (max 150 Mg Daily). 

Pain And Inflammation In Musculoskeletal Disorders, Acute Goutrheumatoid Arthritis, Osteoarthrosis, Ankylosing Spondylitis, Acute Gout: 

Oral: 

  • Adult: 75-150 Mg Daily In 2-3 Divided Doses 

By Rectum: 

  • Adult: 75-150 Mg Suppositories Daily In Divided Doses 
  • Children 2-18 Yrs: Body-weight 8-12 Kg: 12.5 Mg Suppositories Twice Daily For Max 4 Days; Body-weight Over 12 Kg: 1 Mg/kg Suppositories (max 50 Mg) 3 Times Daily For Max 4 Days. 

By IM Inj: 

  • Adult: 75 Mg Once Or Twice Daily By Deep Intragluteal Inj For Max 2 Days. Continue If Necessary With Tab. 

Acute Postoperative Pain, Acute Back Pain, Pain In Acute Trauma And Fractures, Renal Colic: 

Oral: 

  • Adult: 75-150 Mg Daily In 2-3 Divided Doses 
  • Children 6 Months -18 Yrs: 1.5-2.5 Mg/kg (max 75 Mg) Twice Daily; Total Daily Dose May Alternatively Be Given In 3 Divided Doses 

By Rectum: 

  • Adult: 75-150 Mg Suppositories Daily In Divided Doses; 
  • Children 2-18 Yrs: Body-weight 8-12 Kg: 12.5 Mg Suppositories Twice Daily For Max 4 Days; Body-weight Over 12 Kg: 1 Mg/kg Suppositories (max 50 Mg) 3 Times Daily For Max 4 Days. 

By IV Inj: 

  • Adult: 75 Mg Repeated Every 4-6 Hr If Necessary, Max 150 Mg In 24 Hr. Prevention Of Postoperative Pain: A Loading Dose Of 25-50 Mg Should Be Infused After Surgery Over 15 Min To 1 Hour, Followed By Continuous Infusion Of About 5 Mg Per Hour Up To a Maximum of 150 Mg In 24 Hours. 

Moderate To Severe Postoperative Pain, 75 Mg Infused Continuously Over A Period Of 30 Min To 2 Hours. 

By IV Infusion Or Deep IM Inj: 

  • Children 2-18 Yr: 0.3-1 Mg/kg Once Or Twice Daily Iv Infusion Or Deep IM Injection Into Gluteal Muscle, For Max 2 Days (max 150 Mg Daily). 

By IM Inj: 

  • Adult: 75 Mg Once Or Twice Daily By Deep Intragluteal Inj For Max 2 Days. Continue If Necessary With Tab.

Content

  • Tab /Cap 25mg /50mg /75mg /100mg: Diclofenac Sodium 25mg /50mg /75mg / 100mg.
  • Inj 75mg: Per ml: Diclofenac Sodium 25mg; 3 ml (75mg) Amp.
  • Suppositories 12.5mg /25mg /50mg /100mg: Diclofenac Sodium.

Pregnancy

Contraindicated In Pregnancy.

Stability

  • Phenylacetic Acid

Contra Indications

  • Active Or Recurrent GI bleeding Or Ulceration, Cerebrovascular Disease, History Of GI bleeding Or GI perforation Related To Previous Nsaid Therapy, History Of Recurrent GI haemorrhage, Ischaemic Heart Disease, Heart Failure, Peripheral Arterial Disease, Moderate To Severe Renal Impairment, Aspirin/anti-inflammatory Induced Allergy.
  • With Intravenous Use: Dehydration, History Of Asthma, History Of Confirmed Or Suspected Cerebrovascular Bleeding,.

Precautions

  • Active Or Recurrent GI bleeding Or Ulceration, Cerebrovascular Disease, History Of GI bleeding Or GI perforation Related To Previous Nsaid Therapy, History Of Recurrent GI haemorrhage, Ischaemic Heart Disease, Heart Failure, Peripheral Arterial Disease, Moderate To Severe Renal Impairment, Aspirin/anti-inflammatory Induced Allergy.
  • With Intravenous Use: Dehydration, History Of Asthma, History Of Confirmed Or Suspected Cerebrovascular Bleeding,.

Lactation

  • Contraindicated or Not Recommended.

Side Effects

  • Angioedema
  • Blood Disorders
  • Bronchospasm
  • Colitis
  • Crohn's Disease
  • Depression
  • Diarrhoea
  • Dizziness
  • Drowsiness
  • Fluid Retention
  • Gi Bleeding And Ulceration
  • Gi Disturbances
  • Haematuria
  • Headache
  • Hearing Disturbances
  • Hypersensitivity Reactions
  • Insomnia
  • Nausea
  • Nervousness
  • Photosensitivity
  • Raised Blood Pressure
  • Rashes
  • Renal Failure (especially In Patients With Preexisting Renal Impairment)
  • tinnitus
  • Vertigo.
  • Rare: Hepatic Damage
  • Interstitial Fibrosis Associated With Nsaids
  • Stevens-johnson Syndrome
  • Toxic Epidermal Necrolysis
  • Visual Disturbances
  • Local Irritation With Use Of Rectal Suppositories

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