Pharmacodynamics.
Dimethyl sulfoxide (DMSO). DMSO has anti-inflammatory, local anesthetic and decongestant effects. The anti-inflammatory effect is based on several pharmacological effects, the main one of which is the inactivation of hydroxyl radicals, which are formed in large quantities during inflammation and lead to tissue destruction.
DMSO has a local analgesic effect, reducing the rate of conduction of excitatory impulses in peripheral neurons. The anti-edema effect is explained by the inactivation of hydroxyl radicals and, as a result, the improvement of metabolic processes in the focus of inflammation. The hygroscopic properties of DMSO are also partly responsible for this.
Heparin. Heparin competitively inhibits hyaluronidase activity, which in turn prevents excessive degeneration of connective tissue during inflammation. Thus, heparin has an anti-inflammatory effect and promotes healing. In addition, heparin has a dose-dependent antithrombotic effect, significantly increasing the inhibitory effect of antithrombin III on the activation of prothrombin and thrombin.
Dexpanthenol. When applied topically, dexpanthenol is converted in the skin to pantothenic acid, a B vitamin. Dexpanthenol has the same biological effectiveness as pantothenic acid. Pantothenic acid, which is a part of coenzyme A, enters various reactions of formation and decay in all tissues and promotes the passage of regeneration processes during wound healing and epithelialization.
Dimethyl sulfoxide (DMSO). DMSO is present in human blood plasma as a natural substance at a concentration of about 40 ng / ml. After a single application of 1.5 g of Dolobene gel on a skin surface with an area of 400 cm2, DMSO is absorbed with a half-life of 3-4 hours. 6 hours after application, the concentration in blood plasma reaches a plateau (about 120 ng / ml), and remains at this level until 12 hours after application. T1 / 2 of DMSO from blood plasma is 11-14 hours. Endogenous plasma concentration is again reached 60 hours after application.
12–25% of DMSO is excreted within the first 24 hours and 37–48% within 7 days in the urine unchanged as DMSO or as the main metabolite, dimethylsulfone (DMSO2). 3.5–6% of the total dose of DMSO is exhaled by the lungs within 6–12 hours after application in the form of dimethyl sulfide (DMS).
Heparin. Penetration of heparin through healthy skin is dose dependent and has been confirmed for dosages of 300 IU / h or more.
There are no data on the pharmacokinetics of heparin after application to the skin.
Dexpanthenol. Dexpanthenol is absorbed faster than pantothenic acid. The rapid absorption of dexpanthenol has been confirmed experimentally.
Injuries (including sports), hematomas, damage to muscles, periarticular structures or joints (without skin lesions); tendinitis, tendovaginitis, bursitis, periarthritis and epicondylitis of the shoulder (pathological basis of the clinical syndrome "tennis elbow"); acute neuralgia.
The gel is applied in a thin layer (for example, a column of gel 3 cm long is applied to an area the size of which corresponds to the projection of the knee joint) to the affected areas and / or around them (in case of abrasions), evenly spread over the skin surface with light rubbing movements 2–4 times a day. when applying dressings with dolobene gel, an air-permeable dressing is used only after most of the gel has penetrated into the skin and the alcohol contained in the preparation has evaporated (a few minutes). when using iontophoresis, the gel is applied under the cathode, taking into account the anionic properties of heparin, which is part of dolobene. with phonophoresis, the drug, due to its good contact properties and the content of active substances, complements the physiotherapeutic effect of ultrasonic waves. the duration of the course of treatment for dolobene is individual and depends on the severity of the course of the disease, as well as on the effectiveness of therapy.
Hypersensitivity to the components of the drug; severe violations of liver and kidney function; ba; unstable hemodynamics; severe disorders of the cardiovascular system (severe angina pectoris, myocardial infarction, stroke, severe general atherosclerosis); trophic leg ulcers that bleed, open and / or infected wounds, hemorrhagic diathesis, purpura, thrombocytopenia, hemophilia, bleeding tendency; coma, glaucoma, cataract.
On the part of the immune system: allergic skin reactions, in some cases allergic reactions of an immediate type are possible, such as urticaria and angioedema.
From the side of the cardiovascular system: in some cases, when applied to large areas of the skin, violations of the heart are possible (a cause-and-effect relationship has not been established).
On the part of the respiratory system: in some cases, when applied to large areas of the skin, violations of the respiratory system are possible (the cause-and-effect relationship has not been determined).
On the part of the digestive system: temporary odor of garlic from the mouth (due to the action of dimethyl sulfide, a metabolite of dimethyl sulfoxide); a change in taste that disappears within a few minutes; in some cases, when applied to large areas of the skin - abnormalities from the stomach, nausea, diarrhea (cause-and-effect relationship has not been determined).
On the part of the skin: hypersensitivity reactions to the action of light.
General disorders: erythema, itching, burning, blistering, urticaria at the site of application. These reactions usually disappear with treatment. Otherwise, the drug should be discontinued. In some cases, when applied to large areas of the skin, increased fatigue, headache, chills are possible (the cause-and-effect relationship has not been determined).
Due to the action of dimethyl sulfoxide: dizziness, insomnia, weakness, dermatitis, bronchospasm, vomiting.
Due to the action of dexpanthenol: contact dermatitis, allergic dermatitis, eczema, rash, skin irritation.
Due to the action of heparin: swelling of the skin, skin rash, hemorrhages, sometimes - the appearance of small pustules, vesicles or blisters, which quickly disappear after the drug is discontinued.
The drug contains isopropyl alcohol, therefore, in order to avoid painful reactions, it should not be applied to mucous membranes, an open wound surface or damaged skin (for example, after radiation, with dermatitis, dermatoses, postoperative scars, burns).
Other medicines should not be applied to the treated areas of the skin for several hours before and after the application of Dolobene gel.
In order to prevent the appearance of undesirable effects, the drug must be applied to the skin cleared of other drugs, cosmetics and impurities.
Contact with eyes should be avoided.
The application of dimethyl sulfoxide can lead to the development of photosensitization. In this regard, when using Dolobene gel, one should refrain from sunburn and visiting a solarium. If hypersensitivity reactions occur, the drug should be discontinued.
Application during pregnancy or lactation. The experience of using dimethyl sulfoxide in pregnant women is still insufficient, therefore, the use of the drug during pregnancy and lactation is contraindicated. Potential teratogenic effects of DMSO have been reported in animals.
Dimethyl sulfoxide passes into breast milk, therefore, the use of the gel during breastfeeding is contraindicated.
The ability to influence the reaction rate when driving vehicles or other mechanisms. Does not affect.
Children. The drug is not prescribed to children due to limited experience of use.
The simultaneous use of other topical drugs may be accompanied by an increase in their absorption.
Due to the ability of dimethyl sulfoxide to enhance both the specific activity and toxicity of some drugs, the simultaneous application of other drugs for topical use should be avoided.
The drug Dolobene containing dimethyl sulfoxide should not be used with sulindac (NSAIDs) due to the possibility of severe toxic reactions (peripheral neuropathy).
The use of heparin can lead to an increase in prothrombin time in patients taking oral anticoagulants. Dimethyl sulfoxide enhances the effect of ethanol (alcohol inhibits the elimination of the drug) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin, etc.), the body is sensitized to drugs for anesthesia.
When using dolobene, no cases of overdose were observed.
An increase in the manifestations of hematoma and an increase in the risk of bleeding have been reported with external use of heparin at a dose of more than 180,000 IU. Intestinal absorption of heparin is negligible, so the appearance of signs of overdose if accidentally swallowed is unlikely.
At a temperature not exceeding 25 ° c.
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