Difen-Guyenne B12 Diclofenac Potassiumbetamethasone Sodium
Model No.: OV-16051804
Diclofenac Potassium - Clinical Pharmacology
Diclofenac Potassium is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Diclofenac Potassium, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.
Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). In some fasting volunteers, measurable plasma levels are observed within 10 minutes of dosing with Diclofenac Potassium. Peak plasma levels are achieved approximately one hour in fasting normal volunteers, with a range of .33 to 2 hours. Food has no significant effect on the extent of diclofenac absorption. However, there is usually a delay in the onset of absorption and a reduction in peak plasma levels of approximately 30%.
The pharmacokinetics of Diclofenac Potassium has not been investigated in pediatric patients.
Pharmacokinetic differences due to race have not been identified.
Hepatic metabolism accounts for almost 100% of Diclofenac Potassium elimination, so patients with hepatic disease may require reduced doses of Diclofenac Potassium compared to patients with normal hepatic function.
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 (inulin clearance 60 to 90, 30 to 60, and < 30 mL/min; N = 6 in each group), AUC values and elimination rate were comparable to those in healthy subjects.
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