Dolobene gel, 45 g

• Swelling, bruising and inflammation of soft tissues, muscles, tendons, tendon sheaths,

• closed injuries, bruises,

• joint injuries with sprains of ligaments and tendons,

• epicondylitis of the shoulder ('tennis elbow'), tendinitis (inflammation of the tendons), tendovaginitis (inflammation of the tendon sheaths), bursitis (inflammation of the mucous membrane of the joint bag),

• periarthritis of the shoulder joint,

• acute neuralgia.

Dolobene should be applied with a surface layer on the skin over the affected skin area 2-4 times a day.

When using a gel under the dressing, apply the gel and wait a few minutes for it to be absorbed by the skin and the isopropanol to evaporate. Then you can apply an airtight bandage.

Dolobene can be used for iontophoresis. The drug is applied under the cathode. Dolobene as a contact gel can be used in ultrasound therapy (phonophoresis). The active substances of the gel complement the therapeutic effect of the ultrasonic waves. The duration of treatment depends on the severity of the symptoms and the severity of the disease.

100 g of gel contains:
Active substances:
Sodium
heparin 50,000 IU Dexpanthenol 2,500 g
Dimethyl sulfoxide 90% 16,660 g
(dry basis) (15,000 g)
Excipients:
Polyacrylic acid 1,000 - 1,400 g, trometamol 0.200 - 0.300 g, macrogol glyceryl hydroxystearate ( cremophor SO 455) 1,000 g, isopropanol 35,000 g, rosemary oil 0.200 g, mountain pine oil 0.250 g, citronella oil 0.050 g, purified water 42.023 - 42.913 g.

• Hypersensitivity to one of the components of the gel (active / excipient),

• bronchial asthma,

• severe dysfunction of the liver, kidneys,

• severe disorders of the cardiovascular system,

• pregnancy and lactation,

• age up to 5 years,

• open wounds at the site of application.

Pharmacodynamics:

Dimethyl sulfoxide (DMSO).
DMSO has anti-inflammatory, decongestant and local analgesic effects.

Anti-inflammatory activity is associated with several pharmacological effects, the most significant of which is the inactivation of hydroxyl radicals, which are produced in large quantities during the inflammation process and have a destructive effect on tissues.

DMSO has a local analgesic effect by reducing the rate of conduction of nociceptive (pain) impulses in peripheral neurons. The anti-edematous effect is provided by the inactivation of hydroxyl radicals and the improvement of the subcutaneous metabolic reaction at the site of application of the drug. To a certain extent, the hygroscopic properties of DMSO are also responsible for its anti-edema effect. DMSO (50% or more) penetrates through biological membranes, including through the skin, facilitating better and deeper penetration into tissues of other drugs used simultaneously with it.

Heparin.
Heparin has an anti-inflammatory effect, promotes the regeneration of connective tissue by inhibiting the activity of hyaluronidase. Heparin exhibits a dose-dependent antithrombotic effect, enhancing the inhibitory activity of antithrombin III on the activation of prothrombin and thrombin. The penetration of heparin through healthy skin is dose dependent and is confirmed for dosages starting at 300 IU / g.

Dexpanthenol.
When applied topically, dexpanthenol is transformed in the skin into pantothenic acid (a B vitamin). The effectiveness of dexpanthenol is comparable to that of pantothenic acid. Pantothenic acid as a component of coenzyme A is involved in various catabolic and anabolic processes in tissues, by improving the processes of granulation and epithelialization, it contributes to the regeneration of damaged skin areas.

Pharmacokinetics:

Dimethyl sulfoxide (DMSO).
The physiological concentration of DMSO in normal blood plasma is 40 ng / ml. 6 hours after application of the drug, the maximum concentration in blood plasma reaches 120 ng / ml and lasts up to 12 hours after application. After 60 hours after application, the concentration of DMSO in the blood plasma reaches a physiological level of 40 ng / ml. 12-25% of absorbed DMSO is excreted within the first 24 hours and 37-48% is excreted within 7 days unchanged via the kidneys or as a metabolite (dimethylsulfone). 3.5-6% of the total DMSO is excreted through the lungs in the form of dimethyl sulfide 6-12 hours after drug administration.

When using 1 g of dimethyl sulfoxide 3 times a day for 5 days, its average content at the site of application to the skin is 3 mg / g, the average content in the underlying muscle tissues and synovial membrane at the site of the synovial junction is 7-10 ?g / ml, in the synovial liquids - 0.8 ?g / g. The concentration of dimethyl sulfoxide in blood plasma is 0.5 ?g / g. The half-life of DMSO is 11-14 hours.

Heparin.
When applied externally, heparin is absorbed slightly.

Dexpanthenol.
When applied externally, dexpanthenol is transformed into pantothenic acid in the skin. Good absorption of dexpanthenol has been confirmed experimentally.

Application during pregnancy and lactation:

Application during pregnancy.
Since there are no data from studies on the use of the drug in pregnant women, its use during pregnancy is contraindicated.

Application during lactation.
Dimethyl sulfoxide passes into breast milk, therefore, while using the drug, you should stop breastfeeding the baby.

Side effect:

Local skin reactions (redness, itching, burning sensation at the site of application of the gel) are possible, which usually disappear during further treatment. Due to the content of DMSO or other components of the drug, an allergic skin reaction is sometimes possible.

In rare cases, during the use of the drug in some patients, the smell of garlic from the mouth may appear. The smell is caused by DMSO, which is a metabolic product of DMSO. It is possible to change the taste sensations, which disappear a few minutes after the application of the gel.

In isolated cases, immediate allergic reactions (urticaria, Quincke's edema) may occur. It is extremely rare that when the drug is applied to large areas of the body, nausea, diarrhea, difficulty breathing, headache, and chills may occur.

Overdose:

There are no data on drug overdose.

Interaction with other medicinal products:

The application of another drug at the same time as Dolobene can increase their permeability through the skin. With the simultaneous use of the drug Dolobene and the nonsteroidal anti-inflammatory drug Sulindac, the development of peripheral neuropathy is possible.

Special instructions:

The place of application of the gel should be free of other medicines, cosmetics or any chemicals. Dolobene should not be applied to the mucous membranes of the eyes, nose, mouth, open wounds or damaged skin areas (due to radiation, severe sunburn, postoperative scars).

During treatment with the drug, the photosensitivity of the skin may increase, therefore, during the period of its use, intense sunbathing and visits to the solarium should be limited. In case of skin reactions, treatment should be discontinued. Due to the high absorption of dimethyl sulfoxide, Dolobene should not be used in combination with other ointments and gels.