Diclofenac, gel 5% 30 g

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID)

ATX Code

S01BC03

Pharmacodynamics: The active ingredient is diclofenac, a nonsteroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Pharmacokinetics:

In external application diclofenac penetrates well through the skin and is mainly concentrated in the center of inflammation and synovial fluid. The quantity of diclofenac which is absorbed through skin is proportional to the time of gel contact with skin and to the application surface area depends on the total dose of the preparation and on the degree of skin hydration. With the recommended method of application of the drug no more than 6% of diclofenac is absorbed. Application of the occlusive dressing for 10 hours leads to a 3-fold increase in resorption of diclofenac.

Indications

Active ingredient

Composition

How to take, the dosage

Interaction

Special Instructions

Contraindications

Hepatic porphyria (exacerbation) gastrointestinal erosive-ulcerative lesions severe liver and renal function disorders chronic heart failure blood clotting disorders (including hemophilia).including hemophilia prolongation of bleeding time susceptibility to bleeding) elderly age pregnancy I and II trimester.

Side effects

The incidence of side effects is classified according to the World Health Organization recommendations: very frequently – at least 10%; frequently – at least 1% but less than 10%; infrequently – not less than 0.1% but less than 1%; rarely – not less than 001% but less than < 0.1%; very rarely including single reports – less than 0.01%.

Local reactions: infrequent – erythema multiforme exudative (including Stevens-Johnson syndrome) eczema very rare – contact dermatitis (itching hyperemia swelling of the treated skin area papulosis-vesicular rash peeling).

If the gel is applied to large surfaces of the skin over a long period of time, systemic side effects of diclofenac may develop.

Systemic reactions: rare – generalized skin rash allergic reactions (urticaria angioedema bronchospastic reactions) rare – photosensitization. very rare – anaphylactic reactions (including shock).

Overdose

Because of the low systemic absorption by application of the gel, overdose is unlikely. In case of accidental ingestion systemic adverse reactions are possible.

Symptoms: nausea and vomiting.

Treatment: gastric lavage induction of vomiting activated charcoal forced diuresis symptomatic therapy.

Hemodialysis is not effective due to the high degree of binding to diclofenac proteins (about 99%).

Pregnancy use

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