Диклак® липогель

General characteristics. Structure:

Active ingredient: diclofenac of sodium of 10 mg/g

Other ingredients: rRR-tocopherol (коферол F1300), carbomer, decyloleate, 2 octyllauryl alcohol, lecithin, solution of ammonia of 10%, dinatrium эдетат, Vert de Creme fragrance, isopropanol, the water purified.

Pharmacological properties:

Pharmacodynamics. Diklak Lipogel — NPVP for external use, derivative phenylacetic acid. Diklak Lipogel renders the expressed local antirheumatic, analgetic and antiinflammatory action caused by oppression of synthesis of prostaglandins — mediators of pain and an inflammation. Use of diclofenac reduces expressiveness of pain, an inflammation and hypostasis at rheumatic, degenerative diseases, injuries without open wounds, and also leads to reduction of the period of recovery of functions of the injured bodies.
Lipophilic emulsion gel has also local anesthetizing and cooling effect; it is quickly and completely absorbed by skin, leaving it smooth and soft.

Pharmacokinetics. The amount of the diclofenac absorbed through skin in proportion to duration of contact with skin and the size of the site of the skin covered with the gel containing diclofenac also depends on a local general dose, and also on hydration of skin.
The level of hypodermic absorption (bioavailability) of diclofenac established in comparative researches (orally/locally) makes about 5%. Diclofenac contacts proteins of a blood plasma, is preferential with albumine (99,4%), for 99,7%.
Cmax of diclofenac in a blood plasma is about 100 times lower after topical administration of gel which contains 1% of diclofenac, than after treatment using diclofenac inside. After drawing within several days of the gel containing 1% of diclofenac on the inflamed wrists at patients with polyarthritis, its concentration in synovial tissue of joints which were exposed to treatment are about 20-70 times higher, than in a blood plasma. The measured concentration of diclofenac in the studied synovial fabric made 0,41–8,62 µmol/kg of body weight that is much higher, than in a blood plasma.
After metabolism in a liver (a hydroxylation, a glyukuronidation) pharmacological inactive metabolites are completely removed, mainly, by kidneys (about 70%), and also with bile. T½ makes about 2 h and almost does not depend on function of a liver and kidneys.

Indications to use:

For elimination of pain, an inflammation and hypostasis at:
• degenerative diseases of joints of extremities and in the field of a rachis;
• the localized forms of rheumatic diseases of soft tissues (the tendinitis also tendosinovit, a bursitis, neuropathy of a brachial plexus, an inflammation in muscular and capsular sites);
• posttraumatic inflammations of sinews, sheaves, muscles and joints (stretching, overload, injuries).

Route of administration and doses:

The amount of the used drug depends on the size of an affected area. Diklak Lipogel apply 3 times a day. It is necessary to squeeze out about 11 cm of gel that corresponds to 3 g (30 mg of diclofenac of sodium) and to apply on the painful site with a thin layer, rubbing the easy movements. Gel has to dry for several minutes before imposing of a bandage.
The hermetic bandage is not recommended.
The maximum general daily dose of gel — 9 g (90 mg of diclofenac of sodium).
Diklak Lipogel it is possible to use in the form of additional treatment along with other dosage forms containing diclofenac.
Duration of treatment depends on indications and efficiency of therapy. Indications concerning continuation of treatment need to be revised in 2 weeks.

Features of use:

To patients with attacks OH, skin allergic reactions, allergic rhinitis in the anamnesis which emergence is connected with the previous local use of NPVP or analgetics use of drug is allowed after careful studying of probable risk of emergence of complications and the expected effect. It is necessary to exclude contact of children with the applied medicine.
Period of pregnancy and feeding by a breast. Sufficient experience of rather safe use of drug during pregnancy is absent. Because influence of inhibition of synthesis of prostaglandins on the course of pregnancy is unknown, Diklak Lipogel it is possible to apply in I and II trimesters of pregnancy only after careful assessment of a sotnosheniye advantage/risk. In the III trimester drug should not be used throughout the long period and on big sites of skin.
Diclofenac of sodium gets into breast milk in a small amount. To avoid any direct contact of the child with gel, drug should not be applied on a breast during feeding with a breast.
Children. Sufficient experience of use of drug for children is absent.
Ability to influence speed of response at control of vehicles or work with other mechanisms. There are no data.

Side effects:

Local side reactions: sometimes note reactions from skin (an itch, a hyperemia, a dieback, a burning sensation, a xeroderma, a small tortoiseshell).
System side effects: can arise at use of gel in high doses or its drawing on big sites of skin. There were messages on separate cases of emergence of gastrointestinal disturbances, a generalized dieback, reactions of hypersensitivity in the form of a face edema (Quincke's disease) and диспноэ, photosensitivity.

Interaction with other medicines:

Interactions at topical administration are not revealed now.

Contraindications:

Hypersensitivity to any of components of drug or other NPVP. A peptic ulcer of a stomach and duodenum in an aggravation stage. Not to apply on open wounds, the inflamed or infected skin, and also on the sites of skin affected with eczema or on mucous membranes. Children's age up to 15 years.

Overdose:

Owing to low system absorption of diclofenac of sodium intoxication after topical administration is improbable.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Drug period of validity 3 years.

Issue conditions:

According to the recipe

Packaging:

Gel of 1% of a tube of 50 g.