Dolonite-MosPharma (Dolonite-MosPharma)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHeparin sodium + Dexpanthenol + Dimethyl sulfoxideHeparin sodium + Dexpanthenol + Dimethyl sulfoxide
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  • Hepatrombin C
    gel externally 
    Hemofarm AD     Serbia
  • Dolonite-MosPharma
    gel externally 
    MOSCOW PHARMACEUTICAL FACTORY, CJSC     Russia
    • Dosage form: & nbspGefor external use.
    Composition:

    Per 100 g:

    Active substances:

    Heparin sodium (heparin sodium salt) (in terms of dry matter)

    50,000 ME

    Dexpanthenol (D-Panthenol) (in terms of 100% dry matter)

    2.50 g

    Dimethyl sulfoxide (dimexide) (in terms of 100% substance)

    15.00 g

    Excipients:

    Carbomer homopolymer type C

    1.00 g

    Trometamol

    0.20 g

    Macrogol glycerol hydroxy stearate

    0.90 g

    Ethanol (ethyl alcohol) 95%

    38.06 g

    Rosemary oil

    0.20 g

    Common pine needles oil

    0.25 g

    Lemon oil

    0.05 g

    Purified water

    up to 100.00 g
    Description:

    Colorless, transparent or slightly opalescent homogeneous gel with a characteristic odor.

    Pharmacotherapeutic group:anticoagulant direct action for topical application + other drugs
    ATX: & nbsp

    C.05.B.A.53   Heparin in combination with other drugs

    C.05.B.A   Heparin-containing preparations for topical application

    Pharmacodynamics:

    The action of the drug is due to its active ingredients: dimethylsulfoxide, sodium heparin and dexpanthenol.

    Dimethylsulfoxide (DMSO)

    DMSO has anti-inflammatory, anti-edematous and local analgesic effect.

    Anti-inflammatory activity is associated with some 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 the tissue.

    DMSO has a local analgesic effect due to a decrease in the rate of nociceptive (pain) impulses in peripheral neurons.

    Anti-void action is provided by inactivation of hydroxyl radicals and improvement of subcutaneous metabolic reaction at the place of application of the drug. To a certain extent, the hygroscopic properties of DMSO are also responsible for its anti-edema effects.

    DMSO (from 50% and more) penetrates through biological membranes, including through the skin, promoting better and deeper penetration into the tissues of other medicines used simultaneously.

    Sodium Heparin

    Heparin sodium, which is part of the drug, is an anticoagulant of direct action; thanks to the inactivation of biogenic amines in the tissue, shows a clear anti-inflammatory effect, improves local blood circulation. Sodium Heparin inhibits the action of hyaluronidase and, thereby, effectively promotes the regeneration of connective tissue.

    Heparin sodium exhibits a dose-dependent antithrombotic effect, enhancing the inhibitory activity of antithrombin III on the activation of prothrombin and thrombin. Penetration of sodium heparin through healthy skin is dose-dependent and is confirmed for dosage starting at 300 IU / g.

    Dexpanthenol

    Dexpanthenol shows anti-inflammatory and dermatoprotective action, stimulates regeneration processes. After absorption, it turns into pantothenic acid, which participates in numerous metabolic processes, being an integral part of coenzyme A; by improving the processes of granulation and epithelization promotes the regeneration of damaged skin areas.

    Pharmacokinetics:

    Dimethylsulfoxide (DMSO)

    DMSO enters the systemic circulation, the half-absorption period is 3-4 hours, the half-life from the blood plasma is 11-14 hours. DMSO penetrates into breast milk. Eliminated mainly with urine.

    After 6 hours after application, the maximum concentration in the blood plasma reaches 120 ng / ml and remains up to 12 hours after use.After 60 hours after application, the concentration of DMSO in blood plasma reaches a physiological level of 40 ng / ml.

    12-25% absorbed DMSO is excreted within the first 24 hours and 37-48% is excreted for 7 days unchanged via the kidneys or in the form of a metabolite (dimethylsulfone).

    3.5-6.0% of total DMSO is excreted through the lungs in the form of dimethyl sulfide, 6-12 hours after application of the drug.

    When applied to 1 g of DMSO 3 times a day for 5 days, its average content at the site of application on the skin is 3 mg / g, the average content in the underlying muscular tissues and synovial membrane at the site of the synovial joint 7-10 μg / ml, in the synovial fluid - 0.8 μg / g. The concentration of DMSO in blood plasma is 0.5 μg / g.

    The half-life of DMSO is 11-14 hours.

    Sodium Heparin

    Heparin sodium quickly penetrates the skin; already within the first hour after application of the gel, the concentration in the underlying tissues corresponds to the concentrations that are reached after intravenous administration of 5000 ME heparin. Sodium Heparin It does not penetrate the placental barrier and does not enter the breast milk.

    Dexpanthenol

    With external application dexpanthenol is transformed in the skin into pantothenic acid, in which the rate and degree of transdermal penetration is less than that of dexpanthenol.

    Indications:

    - Edema, hematoma and inflammation of soft tissues, muscles, tendons, tendon sheaths and ligaments after bruises, squeezing, trauma;

    - closed injuries, bruises;

    - injuries of joints with ligament damage;

    - humeropyritis and epicondylitis of the shoulder ("tennis elbow"), tendinitis (tendon inflammation), tendovaginitis (inflammation of the tendon sheaths), bursitis (inflammation of the mucous bag of joints);

    - acute neuralgia.

    Contraindications:

    - Hypersensitivity to one of the gel components (active / excipients);

    - severe dysfunction of the liver and / or kidney;

    - bronchial asthma;

    - marked violations of the cardiovascular system (IV functional class of angina pectoris according to the classification of the Canadian Cardiology Society, myocardial infarction, stroke, severe generalized atherosclerosis);

    - pregnancy, the period of breastfeeding;

    - children under 5 years.

    Do not apply the drug to the mucous membranes (eyes, nose, mouth), open wounds or damaged skin (for example,condition after irradiation or severe sunburn, fresh postoperative scars).

    Pregnancy and lactation:

    Application during pregnancy

    Since the research data on the use of the drug in pregnant women are not available, its use during pregnancy is contraindicated.

    Application in the period of breastfeeding

    Dimethyl sulfoxide penetrates into breast milk, so during breast-feeding should stop breastfeeding.

    Dosing and Administration:

    The drug is applied by a thin surface layer over the skin over the area of ​​soft tissues, joints or tendons (edema, hematoma, inflammation, trauma) and evenly distributed with light rubbing movements.

    In order to cover the entire surface of the bruised knee, it is usually sufficient to squeeze out 3-4 cm of gel from the tube.

    The procedure is repeated 2-4 times a day for 7 days or until the disappearance of such symptoms as pain, swelling, swelling, inflammation.

    If there is no clear improvement within 7 days of treatment, it is necessary to consult a doctor.

    When applying bandages with gel, the breathable dressing is applied only after the majority of the gel has penetrated the skin and the alcohol evaporates (several minutes).

    Dolonite-MosPharma and iontophoresis

    This drug can be used for iontophoresis. Contained in the preparation heparin sodium in solution is an anion. Application of the drug under the cathode promotes increased penetration of sodium heparin into the affected area, and dimethylsulfoxide shows a synergistic effect with the effect of electric current (anesthesia, reduction of local edema).

    Precautionary measures

    It must be remembered that self-treatment with electric current can cause local reactions of skin irritation. Therefore, it is necessary to carefully follow the manufacturers' instructions that the use of the drug does not enhance these local reactions.

    Always pay attention to the adequacy of coating the electrodes with a damp sponge.

    Dolonite-MosPharma and ultrasound (phonophoresis)

    This drug is a good contact gel for ultrasound therapy (phonophoresis). Active substances of gel (dimethylsulfoxide and heparin sodium) supplements the therapeutic effect of ultrasonic waves.

    Side effects:

    The drug is usually well tolerated, but in some cases local skin reactions (redness, itching and burning sensation at the site of application) are possible, which usually disappear gradually during the treatment.

    Sometimes, due to the content of DMSO or other components of the drug, there may be a general skin allergic reaction with hives and Quinck's edema.

    In rare cases, during the use of this drug in some patients may smell of garlic from the mouth, which is due to the presence of dimethyl sulfide, a metabolite of dimethyl sulfoxide. This smell indicates a good absorption of dimethyl sulfoxide.

    In some patients, after the application of the gel, a change in taste sensations may appear, which disappears after a few minutes.

    It is extremely rare when applying the drug to large areas of the body may cause nausea, diarrhea, difficulty breathing, headache, chills.

    Overdose:

    Cases of overdose and poisoning with the drug are not described.

    Interaction:

    Local application of other drugs simultaneously with the drug Dolonite-MosPharma contributes to a sharp increase in their permeability through the skin.

    When used simultaneously with the nonsteroidal anti-inflammatory drug sulindac, the development of peripheral neuropathy is possible (due to the presence of dimethylsulfoxide in the composition of the Dolonite-Mospharm preparation).

    Special instructions:

    The drug is consumed sparingly, quickly penetrates the skin and leaves no fat layer on the skin and stains on the laundry.

    Thanks to the contained alcohol (ethanol), which evaporates after the application of the gel, there is pleasant cooling at the site of application. A pleasant cooling effect is enhanced if the gel is stored in the refrigerator, and also if the drug is used in hot weather (by increasing the evaporation of alcohol).

    The area of ​​skin on which the drug is applied should be cleaned of dirt, cosmetics, other medicines and chemicals.

    When using dressings, after the application of the gel, wait a few minutes for the bulk of the gel to absorb and ethyl alcohol (ethanol) has evaporated. This is especially important in cases where a bandage that is poorly permeable to air is used.

    During the treatment, the photosensitivity of the skin can be intensified, therefore, during the period of application, intensive sunbathing and visiting the solarium should be limited.

    In case of skin reactions, treatment should be stopped.

    Due to the high absorption of dimethylsulfoxide, Dolonite-MosPharma should not be used in combination with other ointments and gels.

    It should be remembered that getting the drug on open wounds causes pain reaction, since the gel contains ethyl alcohol (ethanol).

    Effect on the ability to drive transp. cf. and fur:

    The drug for dermal application does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Gel for external use.

    Packaging:

    For 30 g or 50 g in tubes of aluminum.

    Each tube together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003592
    Date of registration:26.04.2016
    Expiration Date:26.04.2021
    The owner of the registration certificate:MOSCOW PHARMACEUTICAL FACTORY, CJSC MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspMOSCOW PHARMACEUTICAL FACTORY MOSCOW PHARMACEUTICAL FACTORY Russia
    Information update date: & nbsp08.07.2016
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