Olfen-gel

General characteristics. Structure:

Gel of 1% opalescent, from colourless till light yellow color, with an isopropanol smell.

Active ingredient: diclofenac of sodium of 10 mg

Excipients: lactic acid, diisopropyl adipate, isopropanol (isopropyl alcohol), sodium metabisulphite, the hydroxyethylcellulose, hydroxypropyl cellulose, water purified.

Pharmacological properties:

NPVS for external use. The main mechanism of action is suppression of synthesis of prostaglandins. Besides, possesses local analgeziruyushchy action. At topical administration of Olfen™ gel gets through skin and collects in the subject fabrics. At rheumatic and posttraumatic inflammations of Olfen™ gel, rendering analgeziruyushchy and antiinflammatory effect, accelerates recovery of motive function.

Pharmacokinetics. Absorption

Cmax in plasma at transdermal absorption is 10% less, than at parenteral use.

Distribution

When drawing Olfen™ of gel diclofenac concentrates on skin of knee joints and joints of hands in synovial fluid and fabrics more than in plasma. Linkng of diclofenac with proteins of plasma (preferential albumine) makes 99.7%.

Metabolism

Part of diclofenac biotransformirutsya by a glyukuronization of an intact molecule, but the most part biotransformirutsya by a hydroxylation with formation of several derivatives, two of these metabolites are biologically active, but in much smaller degree, than diclofenac.

Removal

Diclofenac and its metabolites, generally in the form of glucuronides, are removed preferential with urine. The general system plasma clearance of diclofenac averages 263 ml/min., and final T1/2 - 1-2 h.

Pharmacokinetics in special clinical cases

The plasma clearance of diclofenac does not depend on a liver or renal failure, but the clearance of metabolites in this case can be reduced.

Indications to use:

— the pseudorheumatism ankylosing a spondylarthritis as a part of complex therapy;

— tendovaginitis, bursitis, periartropatiya;

— osteoarthrosis;

— posttraumatic inflammation of soft tissues and musculoskeletal system (stretchings and bruises).

Route of administration and doses:

Depending on the size of an affected area of 2-4 g of gel put and distribute on skin, without rubbing, 3-4 Maximum daily dose - 15 g. The maximum single dose - 4 g. Duration of a course of treatment should not exceed 14 days without consultation of the doctor.

Features of use:

Олфен™ gel should be applied only on the unimpaired skin. It is necessary to avoid contact of drug with the injured skin, open wounds, eyes and mucous membranes.

It is not necessary to apply occlusive dressings those sites of skin where Olfen™ gel was put.

It is necessary to avoid action of direct sunshine.

It is necessary to avoid long use of gel in high doses and on big sites of skin.

Influence on ability to driving of motor transport and to control of mechanisms

Does not influence.

Side effects:

Local reactions: seldom - allergic dermatitis, an itch, a hyperemia, papulation, bubbles, a skin peeling.

System reactions: are possible - separate cases of an enanthesis, a photosensitization, generalized hypersensitivity reactions (for example, attacks of bronchial asthma, a Quincke's edema).

Probability of emergence of system side effects after external use of gel small, but if gel is applied on big sites of skin throughout a long time, it is impossible to exclude possibility of system side reactions.

Interaction with other medicines:

So far there were no messages on any reactions of interaction during use of Olfen™ of gel.

Contraindications:

— eczema;

— disturbance of integrity of integuments;

— pregnancy;

— lactation period;

— children's and teenage age up to 12 years;

— hypersensitivity to other anti-inflammatory drugs, such as acetylsalicylic acid;

— hypersensitivity to diclofenac or other components of drug.

 

Use of the drug OLFEN™ GEL at pregnancy and feeding by a breast

Drug is contraindicated at pregnancy and in the period of a lactation.

Overdose:

Typical clinical symptoms of overdose of the drug Olfen™ gel are unknown.

Treatment: special therapy, such as an artificial diuresis, dialysis or hemoperfusion helps slightly because of high extent of linkng of NPVS with proteins of plasma and extensive metabolism. Carry out a symptomatic and maintenance therapy.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature from 2 °C to 25 °C. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

20 g - aluminum (1) - boxes cardboard.