Unique Pharma Lab


Concise Prescribing Info
Diclofenac Na
Acute & chronic symptomatic treatment of RA, OA & ankylosing spondylitis.
Dosage/Direction for Use
Adult Initially 100-150 mg daily in 2-3 divided doses. Milder cases & long-term therapy 100 mg daily. Primary dysmenorrhoea 50-150 mg daily, may be increased up to max: 200 mg daily. Childn ≥1 yr & adolescent 0.5-2 mg/kg daily in 2-3 divided doses. Juvenile RA May be increased up to max: 3 mg/kg daily in divided doses. Max: Not to exceed 150 mg daily.
Should be taken on an empty stomach: Swallow whole, do not divide/chew.
Hypersensitivity to diclofenac, aspirin or other NSAIDs-induced asthma, urticaria or other allergic type reaction. Rhinitis. Severe cardiac failure.
Special Precautions
Hypersensitivity. Discontinue use if rash, GI bleeding or ulceration occur. GI disorders, history of gastric or intestinaI ulceration, ulcerative colitis or Crohn's disease; history of serious GI events & other risk factors associated w/ PUD eg, smoking, alcoholism. Not recommended in patients w/ established CV disease (eg, CHF, established ischemic heart disease, peripheral arterial disease) or uncontrolled HTN, or significant risk factors eg, hyperlipidaemia, DM, smoking. Patients w/ CV disease or risk of CV event; serious arteriothrombotic events eg, chest pain, shortness of breath, weakness, slurring of speech; HTN; fluid retention or heart failure. Stevens-Johnson syndrome & toxic epidermal necrolysis. May mask signs & symptoms of infections. High-dose & long-term use. Patients on antihypertensive & corticosteroid therapy. Severe hepatic impairment. Avoid use during late pregnancy. Not recommended during lactation. Not recommended in childn & adolescents <14 yr. Elderly.
Adverse Reactions
Peptic ulcers, perforation & GI bleeding; nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis & Crohn's disease.
Drug Interactions
Increased plasma conc & decreased elimination of lithium. Exacerbated cardiac failure, reduced GFR & increased plasma glycoside levels w/ cardiac glycosides. Enhanced effects of anticoagulant eg, warfarin. Hyperglycaemic & hypoglycaemic effects w/ oral antidiabetic agents. Increased nephrotoxicity w/ ciclosporin & tacrolimus. Reduced mifepristone effect. Increased toxicity of methotrexate. Increased risk of convulsions associated w/ quinolone antibiotics. Increased frequency of side effects w/ other systemic NSAIDs (eg, aspirin). Increased risk of GI bleeding w/ corticosteroids. Increased risk of nephrotoxicity by diuretics. Reduced effect of antihypertensives.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Dicloran DR tab 50 mg
10 × 10 × 10's;10 × 10's
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