Tolpa-D Enteric Coated Tablets (Diclofenac Sodium + Serratiopeptidase )

• Composition :
  EachTablet contains Diclofenac Sodium 50mg + Serratiopeptidase 10mg.
• Indications :
  It is indicated for the treatment of acute pain in adults.
• Pharmacodynamics :
  Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Diclofenac has shown anti-inflammatory, analgesic, and antipyretic activity. Its inhibits prostaglandin synthesis. Serratiopeptidase binds to alpha-2-macroglobulin in the blood, which helps to mask its antigenicity, but retain its enzymatic activity. Levels of serratiopeptidase are slowly transferred to the exudate at the site of inflammation and gradually, the blood level declines. By hydrolysing bradykinin, histamine and serotonin, it indirectly reduces dilatation of blood capillaries and controls permeability. Serratiopeptidase blocks plasmin inhibitors, thus helping the fibrinolytic activity of plasmin.
• Dosage and administration :
  Two tablets a day. Morning and evening preferably after food.
• Contraindications :
  Tolpa-D is contraindicated in patients with known hypersensitivity to diclofenac/serratiopeptidase, active peptic ulcer or GI bleeding, pregnant women, history of anaphylactic reactions to NSAIDs, treatment of peri-operative pain in the setting of CABG surgery and in patients with renal and hepatic failure.
• Precautions and warnings :
  Caution is required in respiratory disorders, cardiovascular and cerebrovascular effects, renal and hepatic impairment, GI bleeding and pre-existing asthma. Anemia is sometimes seen in patients receiving NSAIDs, including Diclofenac.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women, appear in breast milk caution should be exercised. Should be avoided in pregnancy. Safety and effectiveness in pediatrics have not been established.
• Drug interactions :
  Concomitant administration of Diclofenac with aspirin reduces its protein binding. Diclofenac may diminish the antihypertensive effect of ACE inhibitors,and affect renal prostaglandins, Diclofenac can reduce the natriuretic effect of furosemide, observe carefully for signs of lithium toxicity with diclofenac. Concomitant use of diclofenac and warfarin have a risk of serious GI bleeding, CYP2C9 Inhibitors or Inducers may enhance the exposure and toxicity of diclofenac. Serratiopeptidase interact with anticoagulant/antiplatelet drugs and might slow blood clotting.
• Adverse reactions :
  Most common adverse reactions are GI ulceration, GI bleeding, renal papillary necrosis, raised hepatic enzymes, dizziness, drowsiness, dyspepsia abdominal pain, nausea and diarrhoea.
• Therapy Area :
  Anti-Inflammatories