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| Diclokim® (DICLOFENAC) |
| :: Anti-inflammatory, Nonsteroidal :: |
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S.R. Tab. 100 mg |
Pellet S.R. Cap. 100 mg |
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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
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
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