Indications

Diclofenac Sodium: Analgesic/antipyreticSerratiopeptidase: Bony and joint pain (osteoarthritis, rheumatoid arthritis, osteoporosis, fibromyalgia), Headache (migraine, tension headache), Inflammation of sinuses, pharynx and sinuses, Ear infections (otitis

Contraindication

Diclofenac: Hypersensitivity. Patients in whom asthma, urticaria, or other sensitivity reactions are precipitated by aspirin or other NSAIDs. Active or suspected peptic ulcer or GI bleeding, ulcerative or acute inflammatory conditions of the anus, rectum (proctitis) and sigmoid colon. Treatment of perioperative pain in CABG surgery. High dose of systemic diclofenac (150 mg/day) for >4 wk in patients w/ established CV disease or uncontrolled HTN. IV diclofenac should not be given in patients w/ hypovolaemia, dehydration, history of haemorrhagic diathesis, cerebrovascular bleeding (including suspected), undergoing surgery w/ a high risk of haemorrhage. Pregnancy (3rd trimester). Serratiopeptidase: Bleeding disorders, Liver disorders, Kidney damage, Swelling due to the absces

Special Precautions

Patients w/ known CV disease or risk factors for CV disease, fluid retention or heart failure, SLE, HTN, history of GI disease. Patients who may be adversely affected by prolongation of bleeding time. Hepatic and renal impairment. Elderly. Lactation. Patient Counselling Patients should not wear soft contact lenses while using the ophth drops. Patch should not be worn while bathing or showering. When topical gel is used, minimise or avoid exposure of treated areas to natural or artificial sunlight. Topical form must not be applied on damaged skin. May impair ability to drive or operate machinery. Monitoring Parameters Periodically monitor serum transaminase values, CBC and chemistry profile in patients receiving long-term therapy. BP should be closely monitored during initiation and throughout the therapy.

Side Effects

Oedema, CHF, HTN, tachycardia, and syncope. Nausea, diarrhoea, constipation, abdominal pain or cramps, flatulence, vomiting, dyspepsia, oesophagitis, gastritis, glossitis, stomatitis, aphthous stomatitis, changes in appetite, dry mouth and mucous membranes, pancreatitis (w/ or w/o hepatitis), thirst, colitis, colon ulcer and distress. Headache, dizziness, anxiety, asthenia, confusion, depression, abnormal dreams, drowsiness, insomnia, malaise, nervousness, paraesthesia, somnolence, tremors, irritability, and vertigo. Interstitial nephritis, acute renal failure, nephrotic syndrome, renal papillary necrosis, liver function abnormalities, rash, pruritus, alopecia photosensitivity, excessive perspiration. Tinnitus, blurred vision, conjunctivitis, hearing impairment. Anaemia, leucopenia, thrombocytopenia, purpura, ecchymosis, eosinophilia, melaena, rectal bleeding, asthma, dyspnoea, fever, sepsis, infection. Increased BUN and serum creatinine concentrations, may inhibit platelet aggregation and prolong bleeding time.

Drug Interactions

Diclofenac: May increase serum levels of methotrexate. Concomitant use w/ other NSAIDs or anticoagulants (e.g. warfarin) is associated w/ higher risk of GI bleeding. Increased risk of nephrotoxicity w/ ciclosporin or triamterene. May increase the risk of developing corneal complications in patients w/ significant pre-existing corneal inflammation when use concomitantly w/ ophth preparation containing corticosteroids. Colestyramine and colestipol reduce the bioavailability of diclofenac. Decreased plasma concentration when administered after sucralfate. Ophth application of diclofenac may reduce the efficacy of ophth acetylcholine and carbachol. May increase serum levels of lithium and digoxin.Serratiopeptidase: Aspirin, Clopidogrel, Dalteparin, Diclofenac, Enoxaparin or Heparin, Warfarin

Route of Administration

Oral

Dosage

As directed by the physician