Category : NSAIDS, ANTIPYRETICS, ANALGESICS

Name : DICLOKIM®     Type & Dosage : S.R. Tab. ; 100mg Package : 30

Pharmacologic Category Nonsteroidal Anti- inflammatory Drug (NSAID) Mechanism Of Action Diclokim® ( diclofenac ) inhibits prostaglandin synthesis by decreasing the activity of enzyme cyclooxygenase , which results in decreased formation of prostaglandin precursors from arachidonic acid. Indications Diclokim® is used for chronic treatment of rheumatoid arthritis and osteoarthritis. Side Adverse Effects Abdominal cramps and pain ; Constipation ; Diarrhea ; Flatulence ; Indigestion ; Nausea ; Peptic ulcer / GI bleeding ; Pancreatitis ; Vomiting ; Increased ALT / AST ; Cirrhosis ; Hepatic necrosis ; Headache ; Dizziness ; Pruritus ; Rash ; Alopecia ; Photosensitivity ; Fluid retention ; Acute renal failure ; Aseptic meningitis ; Agranulocytosis ; Aplastic anemia ; Thrombocytopenia ; Leukopenia ; Anaphylaxis ; Asthma ; Angioedema ; Eosinophilia ; Erythema multiforme major ; Hearing loss ; Visual changes ; Nephrotic syndrome . Contraindications Hypersensitivity to diclofenac , any component of the formulation , aspirin or other NSAIDs ; Porphyria ; Pregnancy ( 3 rd trimester ). Warnings Precautions Use with caution in patients with CHF , dehydration , hypertension , decreased renal or hepatic function , history of GI disease , active GI ulceration or bleeding , pre – existing asthma , or those receiving anticoagulants . Elderly are at a high risk for adverse effects from NSAIDs ; therefore use lowest effective dose for shortest period possible . Withhold for at least 4 – 6 half – lives prior to surgical or dental procedures. Pregnancy Exposure late in pregnancy may lead to premature closure of the ductus arteriosus and may inhibit uterine contractions . Therefore , diclokim® is contraindicated in 3rd trimester of pregnancy. Breast Feeding Diclokim® enters breast milk / use with caution. Drug Interactions Concurrent use with diclokim® may decrease the antihypertensive effects of ACE inhibitors , angiotensin II antagonists , loop diuretics , thiazides and hydralazine . Anticoagulants and antiplatelet drugs can cause an increased risk of bleeding . Cholestyramine and colestipol reduce the bioavailability of diclokim . Corticosteroids may increase the risk of GI ulceration ; avoid concurrent use . NSAIDs may increase serum creatinine and cyclosporine levels ; monitor cyclosporine level and renal function . Lithium levels can be increased ; avoid concurrent use or monitor lithium levels . Avoid use during moderate or high – dose methotrexate ( increased and prolonged methotrexate levels ) . Verapamil plasma concentration is decreased ; avoid concurrent use . Sucralfate decreases the plasma concentration of diclofenac. Monitoring Parameters Monitor CBC , liver enzymes , urine output and serum BUN / creatinine , occult blood loss , hemoglobin , hematocrit. Dietary Considerations Diclokim® may be taken with food to decrease GI distress. Administration And Dosage Usual adult dose: Rheumatoid arthritis – Oral , 100 mg once a day , in the morning or evening . Osteoarthitis – Oral , 100 – 200 mg once a day , in morning or evening . Diclokim® is not intended as initial therapy ; the daily maintenance dose should be determined using an immediate or delayed – release formulation of diclofenac . Then , diclokim® dosage may be used . Diclokim® tablets are to be swallowed whole , not crushed or chewed . Usual pediatric dose: Safety and efficacy have not been established. How Supplied Tablet, 100 mg Storage Store below 40° C (104° F), preferably between 15 and 30°C (59 and 86 °F). Protect from light and moisture. References USP DI, 2005 Up To Date, Vol. 13.3 (2005) Martindale, The Complete Drug Reference, 34 rd edition 2005