Диклак®гель

General characteristics. Structure:

Gel for external use of 5% 1 g
active agent:  diclofenac of sodium of 50 mg
excipients: isopropyl alcohol; makrogol-7-glitserolkokoat; gipromelloza; fragrant oil; the purified water.

Pharmacological properties:

Diklak Gel — NPVP for external use of group of derivatives of phenylacetic acid. Diklak Gel has the properties expressed local antirheumatic, analgetic and antiinflammatory caused by oppression of synthesis of prostaglandins — mediators of pain and an inflammation. Use Diklak Gelya reduces expressiveness of pain at rest and at the movement, promotes increase in volume of movements in the affected joints.
Diclofenac of sodium is slowly and partially absorbed on the surface of skin. Cmax in a blood plasma note in 6–9 h. After use in Cmax in a blood plasma it is reached approximately in 1–2 h. The average time of deduction of active ingredient in system circulation — about 9 h that much longer in comparison with 1–2 h after internal use. Metabolism and removal of drug after drawing on skin are similar to that after system use. Diclofenac contacts proteins of a blood plasma for 99%. After bystry metabolism in a liver (a hydroxylation and linkng with glucuronic acid) ⅔ substances are emitted with kidneys and 1/3 — with bile.

Indications to use:

Symptomatic treatment of pain, inflammation and hypostasis at:
• damages of soft tissues: injuries of sinews, sheaves, muscles and joints (for example owing to dislocation, stretching, a hematoma); sports injuries;
• the localized forms of rheumatic diseases of soft tissues: tendinitis (including "a tennis elbow"), bursitis, syndrome "shoulder brush" and periartropatiya;
• the localized forms of degenerative rheumatism (an osteoarthritis of peripheral joints and a backbone).

Route of administration and doses:

At adults and children Diklak Gel is aged more senior than 12 years apply 2–3 times a day. The amount of drug which is used depends on the size of the struck zone (for example 2–4 g of gel which on volume are similar to the size of cherry or walnut, are enough for drawing on the site of 400-800 cm2). Gel put with a thin layer and slightly rub.
After application of drug it is necessary to wash up hands, except those cases when the site of hands is subject to treatment.
Diklak Gel it is possible to apply in combination with an ionophoresis. This form of an electrotherapy allows to raise extent of penetration of drug through skin. Diklak Gel it is necessary to put under a negative pole (cathode).
Duration of therapy depends on indications and efficiency of treatment and makes 10–14 days. Indications concerning duration of treatment need to be revised in 2 weeks.
It is longer not necessary to use drug 14 days in a row at defeat of soft tissues or at rheumatic diseases of soft tissues or longer than 21 days in case of the pain caused by arthritis in those cases if the doctor did not appoint other therapy.
In case of drug use not on doctor's orders it is necessary to address for consultation if after 7 days of treatment the condition of the patient did not improve or worsened.

Features of use:

With care it is necessary to use drug with peroral NPVP.
The probability of development of system side effects at topical administration of diclofenac is insignificant in comparison with use of its peroral forms, but it is not excluded at use of drug on rather big sites of skin for a long time.
Diklak Gel is recommended to apply only on intact sites of skin, avoiding hit on the inflamed, wound surface or infected skin. It is necessary to avoid contact of drug with a mucous membrane of eyes and other mucous membranes. Not to use drug inside.
At emergence of any skin rash treatment by drug should be stopped. Use of a hermetic bandage is not recommended. In case of sprain the affected area can be tied up bandage. Not to apply on open wounds or the infected skin, and also on the sites of skin affected with eczema or on mucous membranes.
Use during pregnancy and feeding by a breast. Clinical experience concerning use of drug during pregnancy is limited. Its use during pregnancy, especially in the III trimester, and also during feeding is not recommended by a breast. Drug use Diklak Gel in the I-II trimester of pregnancy and during feeding by a breast perhaps in the presence of strong reasons when, according to the doctor, the expected advantage for mother exceeds potential risk for a fruit or the child. Drug should not be applied on area of a breast or big sites of skin and it is not necessary to apply throughout a long time.
Ability to influence speed of response at control of vehicles or work with other mechanisms. Does not influence.
Children. Due to the lack of sufficient experience of use of diclofenac, children aged up to 12 years are not recommended to appoint drug.

Side effects:

Assessment of side reactions is given on the frequency of manifestations: very often (≥1/10), it is frequent (≥1/100, <1/10), infrequently (≥1/1000, <1/100), is rare (≥1/10 000, <1/1000), is very rare (<1/10 000).
From skin: infrequently — an itch, an erythema, a dieback, burning, emergence of hypostases and vesicles, papules, pustules, a peeling and a xeroderma, dermatitis (including contact dermatitis); seldom — violent dermatitis; very seldom — reactions of a photosensitivity, generalized skin rashes, eczema.
From immune system: very seldom — hypersensitivity reactions (a Quincke's disease of the person), an asthma.
From respiratory system: very seldom — OH.
From a GIT side reactions arise very seldom after topical administration of the drugs containing diclofenac.
At use of gel in high doses or its drawing on big sites of skin it is impossible to exclude possibility of system side reactions, and also reactions of hypersensitivity in the form of an angioedema, диспноэ.

Interaction with other medicines:

As system absorption of diclofenac owing to topical administration of drug very low, emergence of interactions is improbable.

Contraindications:

Hypersensitivity to diclofenac or other NPVP, isopropyl alcohol, propylene glycol or other components of drug. Existence in the anamnesis of attacks OH, a small tortoiseshell or acute rhinitis, nasal polyps, an angioedema, especially at patients with hypersensitivity to all types of analgetics and antirheumatic means. III trimester of pregnancy.

Overdose:

Owing to low system absorption of diclofenac intoxication after topical administration is improbable. In case of an accidental proglatyvaniye of drug it is necessary to wash out a stomach and to accept a sorbent. A symptomatic treatment using the therapeutic measures used at NPVP poisoning.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity of the drug Диклак® 3 of year.

Issue conditions:

According to the recipe

Packaging:

Gel of 5% of a tube of 50 g. Gel of 5% of a tube of 100 g.