Each capsule contains: 100 mg Diclofenac Sodium as follow :
Diclofenac Sodium B.P. 25 mg. (In EC form)
Diclofenac Sodium B.P. 75 mg. (In SR form)
Each 50 ml DT dispersable tablets contains : 100 mg Diclofenac Free Acid 46.5 mg equivalent to 50 mg Diclofenac Sodium.
Diclosan (Diclofenac Sodium) is a non-steroidal anti-inflammatory compound with antirheumatic, analgesic, and antipyretic properties. Diclofenac Sodium acts mainly by inhibiting prostaglandin synthesis, which plays a major role in inflammation, pain and fever. Diclosan is an ideal dual release Diclofenac formulation which is containing part of dose in enteric coated pellets form that provides immediate action after consumption while the rest of the dose is in the form of controlled release pellets that prolongs the action sufficiently to prevent pain at night and early morning stiffness. The former component of the formulation ensures that the drug is not released in the stomach thus preventing gastric irritation and ulcer producing tendency of the drug. Diclofenac Sodium is well absorbed after oral administration .Its peak plasma concentrations are achieved rapidly and the plasma concentration is remained above the effective level for longer period of time. It is more than 99% bound to plasma proteins. It penetrates the synovial fluid where the concentration may persist for a long time (half life of elimination 3 - 6 hours).
Diclosan is indicated in :
- Inflammatory and degenerative forms of rheumatism : Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis.
- painful syndromes of the vertebral column.
- Non-articular rheumatism.
- Post - traumatic and postoperative pain, inflammation and swelling .
- Painful and/or inflammatory conditions in gynaecology (e.g primary dysmenorrhea).
DOSAGE & ADMINISTRATION :
Diclosan DRS : should be taken with liquid preferably with meals as a single daily dose (one capsule) in milder case as well as for long term therapy.
Diclosan DT : Drop of Diclosan DT tablet into aglass of water and stirred to aid dispersion before swallow 2-3 dispersible tablet daily.
RESTRICTIONS ON USE :
- Diclosan is contraindicated in patients with gastric or intestinal ulcer and known hypersensitivity to the active substance .
- It is also contraindicated in patients in whom urticaria , attacks of asthma or acute rhinitis are precipitated by any agent with
prostaglandin - synthetase
- Diclosan should be taken with caution in patients suffering from impaired hepatic function and in patients with symptoms
indicative of gastro-intestinal disorders or history of gastric or intestinal ulceration. Also in patients with ulcerative colitis or crohn's
- As with other NSAIDs , hepatic function and blood count should be monitored regularly during long term treatment with Diclosan .
- Particular caution should be taken in patients with impaired cardiac or renal function , the elderly, patients being treated with diuretics.
Use in Pregnancy and lactation
Not recommended unless strictly recommended by physician.
DRUG INTERACTIONS :
- Diclofenac Sodium may enhance the anticoagulant effect of cumarins.
- Concomitant therapy with cyclosporine may increase cyclosporine's nephrotoxicity.
- Diclofenac Sodium may raise plasma concentrations of lithium and digoxin when given concomitantly.
- Diclofenac Sodium may increase blood concentration of methotrexate and its toxicity if it's administered less than 24 hours
before or after treatment with methotrexate.
- Concomitant use of probenecid with Diclofenac Sodium increases elimination rate of Diclofenac Sodium.
- Concomitant use of furosemide can reduce the natriuretic effect of furosemide and thiazides.
ADVERSE EFFECTS :
Diclosan is well tolerated .
- The main adverse effects include: epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence and anorexia .
- Rare adverse effects : gastro-intestinal bleeding, gastric or intestinal ulcer.
- The drug should be discontinued if GIT bleeding occurs.
STORAGE INSTRUCTIONS :
Store below 30oC , in a dry place.
Diclosan DRS : Pack of 10 capsules and hospital packs of different sizes.
Diclosan DT : Pack of 20 Tablets and hospital packs of different sizes.