Divon Gel (Diclofenac diethylamine)

• Composition :
  Diclofenac Diethylamine 1.16%w/w (Eq. to Diclofenac Sodium 1%w/w) + Linseed Oil 3.00% w/w + Methyl Salicylate IP 10%w/w + Menthol IP 5%w/w + Benzyl Alcohol IP 1%w/w.
• Indications :
  for the relief of the painamenable to topical treatment, such as osteoarthritis of joints such as the knees, those of thehands and other muscle pain
• Pharmacodynamics :
  Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin.
• Dosage and administration :
  Lower extremities: Apply the gel (4 g) to the affected area 4 times daily. Do not apply more than 16 g daily to any one affected joint of the lower extremities. Upper extremities: Apply the gel (2 g) to the affected area 4 times daily. Do not apply more than 8 g daily to any one affected joint of the upper extremities. Total dose should not exceed 32 g per day, over all affected joints.
• Contraindications :
  Hypersensitivity to the active substance(s) or to any of the excipients, history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs and in the setting of CABG surgery. Diclofenac is contraindicated during third trimester of pregnancy.
• Precautions and warnings :
  Caution should be exercise in patients with: Hepatotoxicity, hypertension, heart-failure and edema, renal toxicity and aspirin sensitive asthma. Diclofenac gel should be applied only to intact skin, and not on broken or irritated skin or open wounds. The preparation should not come into contact with the eyes or mucous membranes. Diclofenac gel should not be co-administered with other products containing diclofenac. Discontinue the treatment if anaphylactic reactions occur.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestationThere are no adequate and well-controlled studies of diclofenac gel in pregnant women.Based on available data, diclofenac may be present in human milk. Hence avoid use during lactation.Safety and effectiveness in pediatric patients have not been established.
• Drug interactions :
  Increased risk of bleeding in patients who are concomitantly using diclofenac gel with drugs that interfere with hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs). Concomitant use of ACE Inhibitors, angiotensin receptor blockers (ARB), or beta-blockers with diclofenac gel may diminish the antihypertensive effect of these drugs.
• Adverse reactions :
  Application site reactions, including dermatitis.
• Therapy Area :
  Anti-Inflammatories