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Avorek (Diclofenac potassium)

Information for medical Professionals

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Each Avorek 50mg film coated tablet contains 50 mg of diclofenac potassium.

Diclofenac potassium is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory and anti-pyretic properties. The mechanism of action of diclofenac potassium, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthesis inhibition.

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Diclofenac is rapidly and completely absorbed after oral administration. Food intake does not affect absorption. However, there is delay in onset of absorption. Diclofenac undergoes first-pass metabolism and is extensively metabolised. Only about 50% of the absorbed dose is systemically available. Peak plasma concentration after one 50 mg tablet was 3.9 µmol/l after 20-60 minutes.

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Diclofenac is highly bound to plasma proteins (99.7%), chiefly albumin (99.4%).

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The terminal half-life in plasma is 1-2 hours. Approx. 60% of the dose administered is excreted in the urine in the form of metabolites, and less than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

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Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric use
As with any NSAIDs, caution should be exercised in treating the elderly (65 and older).

Hepatic Insufficiency
Hepatic metabolism accounts for almost 100% of diclofenac potassium elimination. Dose adjustment is required in patients with hepatic disease.

Renal Insufficiency
Diclofenac pharmacokinetics has been investigated in subjects with renal insufficiency. No differences in the pharmacokinetics of diclofenac have been detected in studies of patients with renal impairment. In patients with renal impairment AUC values and elimination rate were comparable to those in healthy subjects.

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