Diclogesic(Diclofenac Sod.) by Dar Al Dawa

Diclogesic (diclofenac sodium) is a non-steroidal anti-inflammatory agent with marked anti-rheumatic, analgesic antipyretic properties.

PRESENTATION

  • Diclogesic 25 Enteric Coated Tablets:Each tablet contains 25mg  diclofenac sodium. 
  • Diclogesic 50 Enteric Coated Tablets: Each tablet contains 50mg diclofenac sodium.
  • Diclogesic Retard 100 Film Coated Tablets: Each tablet contains 100mg of diclofenac sodium.
  • Diclogesic Retard 100 Capsules: Each capsule contains 100mg diclofenac sodium.
  • Diclogesic 50 Suppositories: Each suppository contains 50mg diclofenac sodium. 
  • Diclogesic 100 Suppositories: Each suppository contains 100mg diclofenac sodium. 
  • Diclogesic is also available as gel.
  • Diclogesic 75mg ampoules
  • Diclogesic 12.5mg suppositories for children.
  • Diclogesic eye drops.
ديكلوجيسيك by pharmacia1
ديكلوجيسيك by pharmacia1

PHARMACOLOGY

  • Diclofenac is rapidly absorbed when given orally or as a rectal suppository. It is absorbed more slowly when given as an enteric coated tablet, especially when this dosage form is given with food.
  • Although orally administered diclofenac is almost completely absorbed; it is subject to first-pass metabolism so that about 50% of the drug reaches the systemic circulation in the unchanged form.
  • At therapeutic concentrations, more than 99% of diclofenac is bound to plasma proteins.
  • Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of glucuronide and sulfate conjugates of the metabolites. The terminal plasma half-life is about 1 to 2 hours. 

INDICATIONS

Diclogesic is used in the treatment of the following:

  • Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondyloarthritis, painful syndromes of the vertebral column, non-articular rheumatism.
  • Inflammation and swelling following dental and orthopaedic surgery.
  • Acute attacks of gout.
  • Post-traumatic and post-operative pain.
  • Painful inflammatory. conditions in gynecology and primary dysmenorrhea.

DOSAGE AND ADMINISTRATION

  • The recommended initial daily dosage is 100 to 150 mg. 
  • rng In milder cases, as well as for long term therapy 75 to 100mg daily is usually sufficient.
  • The total daily dosage should be divided into 2 to 3 doses. 
  • The dosage of Diclogesic should be individualized to the lowest effective dose to minimize adverse effects.
  • Rheumatoid arthritis: The recommended dosage is 100 to 200mg/ day. In rare cases where 100mg diclofenac is unsatisfactory, the dose may be increased to 100 mg twice daily. Dosage above 200rng is not recommended.
  • Osteoarthritis: The recommended dosage is 100 to 150 mg/day in 2 or 3 divided doses. More than 200mg are not recommended for patients with osteoarthritis.
  • Ankylosing spondylitis: The recommended dosage is 100 to 125 mg /day, Diclogesic 25mg 4 times daily with an extra 25mg at bedtime if necessary.
  • In primary dysmenorrhea: The recommended dosage is 50 mg 3 times daily. In some patients, an initial dose of 100mg followed by 50 mg dose will provide better relief.
  • Other indications such as post-traumatic pain. post-operative pain, dental surgery, inflammation and swelling or orthopedic surgery: The recommended dose should not exceed 150 mg in 3 divided doses daily. 

CONTRAINDICATIONS

Diclofenac sodium is contraindicated in: 

  • Patients with known hypersensitivity to the drug.
  • Patients with peptic ulcer.
  • Patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin. or other NSAIDs.

SIDE EFFECTS

  • Gastrointestinal tract: occasional epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia and very rare gastrointestinal bleeding or gastric or intestinal ulcer.
  • Central nervous system: occasional headache dizziness, vertigo and rare drowsiness. 
  • Skin: occasional rashes and rare urticaria.
  • Kidney: rare oedema, isolated cases of acute renal failure and urinary abnormality. 
  • Blood: isolated cases of thrombocytopenia, leucopenia, hemolytic anaemia, aplastic anaemia and agranulocytosis.
  • Liver: occasional elevation of serum aminotransferase enzymes and rare hepatitis. 
  • Hypersensitivity: hypersensitivity reaction such as asthma, systemic anaphylactic/anaphylactoid reactions including hypotension. 
  • Special senses: disturbances of vision, impaired hearing, tinnitus and taste disturbances.

PRECAUTIONS

Gastrointestinal bleeding or ulceration can occur at any time during treatment with or without warning symptoms or a previous history, they generally have more serious consequences in the elderly, however, in these rare cases where gastrointestinal bleeding or ulceration occur in patients receiving Diclogesic the drug should be discontinued. 

As with other NSAIDs, allergic reactions including anaphylactic./ anaphylactoid reactions could also occur in rare cases without earlier exposure to the drug.

As with other NSAIDs, values of one or more liver enzymes may increase during prolonged treatment with Diclogesic monitoring of hepatic function is indicated as precautionary measure. If abnormal liver function tests persist or worsen, Diclogesic• should be withdrawn.

Caution is indicated in the elderly on basic medical grounds, in particular, it is recommended that the lowest effective dosage be used in frail elderly patients or those with low body weight.

Pregnancy: Diclogesic should be employed only for compelling reasons and only in the lowest effective doses.

Nursing mothers: The active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected. 

Diclogesic 12.5 supp
Diclogesic 12.5 supp

Patient Information Leaflet

ENG - Patient Information Leaflet
Diclogesic – Patient Information Leaflet
Patient_Information_Leaflet
ديكلوجيسيك- النشرة الداخلية

Categories and tags: M01AB05, Diclofenac, Acetic acid derivatives and related substances, ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, MUSCULO-SKELETAL SYSTEM, M02AA15 , S01BC03.

For Arabic Information
Diclogesic- Arabic Information

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