Diclofenac Gel 3%, 50G

General Characteristics Composition:

International and chemical names: diclofenac; sodium salt of 2 – [(2,6-dichlorophenyl) amino] phenylacetic acid;
basic physical and chemical properties: gel of white color, homogeneous consistency, with a specific odour;
composition: 1 g of gel contains diclofenac sodium in terms of 100% substance – 30 mg;
auxiliary substances: methyl para-hydroxybenzoate (nipagin), mint oil (mint oil either), Carbomer, glycerin or glycerol, macrogol 400, ethanol (96%), dimethylsulfoxide, 15% ammonia solution, purified water.

Pharmacological Properties:

Diclofenac Gel 3%: Pharmacodynamics. Anti-inflammatory, analgesic, antirheumatic. The mechanism of action is due to the inhibition of biosynthesis of prostaglandins by inhibition of cyclooxygenase, a decrease in the formation of kinins and other mediators of inflammation and pain, and a stabilizing effect on lysosomal membranes. With rheumatic diseases reduces swelling, flushing, and pain in rest and motion, morning stiffness and swelling of the joints, improving their functional capacity. With postoperative and traumatic injuries, it quickly reduces pain and inflammation in the area of application, promotes resorption of post-traumatic hematoma. Dimethyl sulfoxide and mint oil increase the anti-inflammatory and analgesic effect of the drug.

[hide] Diclofenac Gel 3% [/hide]Pharmacokinetics. Diclofenac with the skin application of the drug penetrates well through the skin barrier, mainly concentrating in the focus of inflammation and synovial fluid. Binding to plasma proteins is 99%. Metabolised in the liver. It is excreted by the kidneys (about 65%) and bile (about 35%) in the form of inactive compounds with glucuronic and sulfuric acids; less than 1% is excreted unchanged.

Diclofenac Gel 3% Indications For Use:

Rheumatoid arthritis , ankylosing spondylitis, acute gouty, infectious, psoriatic and traumatic arthritis, osteoarthritis, bursitis, tendovaginitis, radiculitis, thrombophlebitis, neuralgia , myalgia , posttraumatic inflammation of muscles, joints, tendons and ligaments (sprains, bruises ), postoperative edema and pain syndrome , and also as a symptomatic therapy of other diseases accompanied by inflammation and pain.

Diclofenac Gel 3% Dosing And Administration:

The Diclofenac gel in the amount of 2-3 g (1-3 cm) is applied a thin layer on the skin in the area of inflammation (joints or other areas of the body with inflammation and pain) 2-4 times a day, easily rubbed into the skin. The average daily dose for adults and children over 14 years is 6 grams of gel.
The duration of treatment is determined individually depending on the effectiveness and sensitivity to therapy and, as a rule, does not exceed 14 days. [hide] Diclofenac Gel 3% [/hide]

Features Of Application:

The gel should be applied only to undamaged skin areas, avoiding contact with open wounds, eyes, and mucous membranes. After applying the drug, you should wash your hands if this area is not being treated.
The use of the gel can be combined with the use of diclofenac in tablets, the daily dose of which should not exceed 75 mg. [hide] Diclofenac Gel 3% [/hide] Before use, patients with gastric ulcer and duodenal ulcer, bronchial asthma, rhinitis, polyps of the nasal mucosa, impaired liver, kidney or hematopoiesis, as well as with the use of other non-steroidal anti-inflammatory drugs should consult a doctor.
Be wary appoint patients who have a history of data on allergic reactions to non-steroidal anti-inflammatory drugs and dimethyl sulfoxide, peptic ulcer. [hide] Diclofenac Gel 3% [/hide]

Diclofenac Gel Dosage and Route of Administration

Diclofenac Gel 3% Side Effects:

The phenomena of local skin irritation: itching, hyperemia, burning, rash.

Interaction With Other Drugs:

With the dermal application of the drug, its interaction with other drugs has not been established.
However, it must be borne in mind that diclofenac sodium can potentiate the effects and ulcerogenic effects of corticosteroids, increase the concentration of digoxin and lithium in the blood, and weaken the effect of diuretics and saluretics of the thiazide and furosemide groups. Therapeutic efficacy, when used with salicylates, is reduced, while the ulcerogenic effect on the gastric mucosa is enhanced. When used simultaneously with anticoagulants, the condition of the blood coagulation system should be monitored. [hide] Diclofenac Gel 3% [/hide]


Erosive-ulcerative lesions of the gastrointestinal tract, bronchial asthma, hematopoiesis disorders, individual sensitivity to the drug components, pregnancy, the period of breastfeeding, children under 14 years. [hide] Diclofenac Gel 3% [/hide]

Diclofenac Gel 3% Overdose:

When applying the gel to large areas of the skin or when exceeding the recommended doses, systemic side effects, characteristic of diclofenac sodium and other non-steroidal anti-inflammatory drugs are possible: dyspepsia, nausea, epigastric pain, headache, dizziness, drowsiness, bronchospasm. Treatment: dose reduction or withdrawal of the drug, symptomatic therapy. [hide] Diclofenac Gel 3% [/hide]

Diclofenac Gel 3% Storage Conditions:

Keep out of the reach of children at temperatures between 15 ° C and 25 ° C.

Shelf life – 2 years.

[hide] Diclofenac Gel 3% [/hide]


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