A colourless transparent gel, free from grittiness and undispersed particles having characteristic smell.
Each gram contains Diclofenac Diethylamine 11.6 mg (1.16%) equivalent to Diclofenac Sodium B.P. 10 mg (1%).
Pharmacology: Diclofenac Diethylamine (Diclogen) is a multi-action topical gel for quick relief from pain, swelling & inflammation.
Pharmacokinetics: When Diclofenac Diethylamine (Diclogen) is applied locally, the active substance is absorbed through the skin. In healthy volunteers approximately 6% of the dose applied is absorbed when determined by urinary excretion of diclofenac and its hydroxylated metabolites. Findings in patients confirm that diclofenac penetrates inflamed areas following local application of Diclofenac Diethylamine (Diclogen).
Synovial fluid and tissue levels of diclofenac are higher than those detected in plasma.
Diclofenac Diethylamine (Diclogen) is used topically for the local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles and joints, e.g., due to sprains, strains and bruises, localized forms of soft tissue rheumatism.
Adults: Diclofenac Diethylamine (Diclogen) should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4 g it should be applied 3-4 times a day and rubbed in lightly. After application, the hands should be washed unless they are the site being treated.
Use in the elderly: The usual adult dosage may be used.
Children: Diclogen gel is not recommended for use in children as dosage recommendations and indications for use in this group of patients have not been established.
Route of Administration: Topical.
Or as prescribed by the physician.
An overdose of topical Diclofenac Diethylamine (Diclogen) is extremely unlikely due to the low systemic absorption of this dosage form. To decrease absorption: Induction of emesis and/or gastric lavage should be initiated.
Hypersensitivity to any of the components of the formulation.
Diclofenac Diethylamine (Diclogen) should not be taken by mouth and should not be used under occlusive, airtight dressings. It should be applied only to intact skin surfaces and not to skin wounds or open injuries. It should not come in contact with eyes or mucous membranes.
FOR EXTERNAL USE ONLY.
No effects have been reported.
Occasionally local side effects such as skin rash, itching and reddening may be observed.
Since systemic absorption of diclofenac from topical application is very low, interactions are very unlikely.
Perforate the closed opening of the tube with special spike found on the cap.
After each use, close the tube carefully and tightly with cap and store it in carton pack until complete use of the contents.
Incompatibilities: Not applicable.
Store at temperatures not exceeding 30°C.
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Diclogen topical gel 11.6 mg/g
20 g x 1's;30 g x 1's
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