Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
HOVID BERHAD
DICLOFENAC SODIUM
100 Tablets
HOVID BERHAD
VICLO26-var (MY) CLOFENAC 50 TABLET 809 DESCRIPTION Round, yellowish brown enteric coated tablet with shallow convex faces and bevel-edged. COMPOSITION Diclofenac sodium 50 mg per tablet PHARMACODYNAMICS Diclofenac sodium has analgesic, anti-inflammatory and anti- pyretic properties. It is an inhibitor of prostaglandin synthetase (cyclo-oxygenase). PHARMACOKINETICS • ABSORPTION: Diclofenac is absorbed form the gastro-intestinal tract but is subject to first-pass metabolism. • PROTEIN BINDING: At the therapeutic concentration, diclofenac is more than 99% bound to plasma proteins. • EXCRETION: Diclofenac is excreted primarily in the form of metabolites, mainly in the urine but also in the bile. INDICATIONS Diclofenac sodium is used for relief of pain and inflammation in conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout and following some surgical procedures. CONTRAINDICATIONS • Diclofenac sodium was considered unsafe in patients with acute porphyria because it has been shown to be porphyrinogenic in animals or _in vitro_ system. • Avoid giving to patients who are sensitive to aspirin. • Use in pregnant women should be avoided. • Severe cardiac failure (see section WARNING and PRECAUTIONS) WARNING CARDIOVASCULAR EFFECTS Treatment with NSAIDs including diclofenac, particularly at high dose and in long term, may be associated with an increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke). Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated with diclofenac only after careful consideration and only at doses ≤ 100mg d Διαβάστε το πλήρες έγγραφο