Dolobieni (Dolobene)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspgel for external use
Composition:

100 g of gel contain:

Active substances:

Heparin sodium 50000 IU

Dexpanthenol 2.500 g

Dimethylsulfoxide 90% 16.660 g

(in terms of dry matter) (15,000 g)

Excipients:

Polyacrylic acid 1,000-1,400 g, trometamol 0,200-0,300, macrogol glyceryl hydroxy stearate (cremfor CO 455) 1,000 g, isopropanol 35,000 g, rosemary oil 0.200 g, pine mountain oil 0.250 g, citronella oil 0.050 g, purified water 42.023-42.913 g.

Description:

From clear to slightly cloudy and from colorless to slightly yellowish color gel.

Pharmacotherapeutic group:anticoagulant direct action for topical use + other drugs.
ATX: & nbsp
  • Heparin in combination with other drugs
    • Pharmacodynamics:

    Dimethylsulfoxide (DMSO).

    DMSO has anti-inflammatory, anti-edematous and local anesthetic 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 by reducing the rate of nociceptive (pain) impulses in peripheral neurons.Anti-edematous 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-edematous effect.

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

    Heparin.

    Heparin has an anti-inflammatory effect, promotes the regeneration of connective tissue due to inhibition of hyaluronidase activity.

    Heparin exhibits a dose-dependent antithrombotic effect, enhancing the inhibitory activity of antithrombin III on the activation of prothrombin and thrombin.

    Penetration of heparin through healthy skin is dose-dependent and is confirmed for dosage starting at 300 IU / g.

    Dexpanthenol.

    With topical application dexpanthenol is transformed in the skin into pantothenic acid (vitamin B). The efficacy of dexpanthenol is comparable to that of pantothenic acid.Pantothenic acid as a component of coenzyme A participates in various catabolic and anabolic processes in tissues, due to the improvement of granulation and epithelization processes promotes the regeneration of damaged skin areas.

    Pharmacokinetics:

    Dimethylsulfoxide (DMSO).

    The physiological concentration of DMSO in normal blood plasma is 40 ng / ml. 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% of the absorbed DMSO is excreted within the first 24 hours and 37-48 % is excreted for 7 days unchanged through the kidneys or in the form of a metabolite (dimethylsulfone).

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

    When 1 g of dimethyl sulfoxide is used 3 times a day for 5 days, the average content at the site of application on the skin is 3 mg / g, the average content in the underlying muscle tissue and synovial membrane at the site of the synovial compound is 7-10 μg / ml, of the liquid is 0.8 μg / g. The concentration of dimethyl sulfoxide in blood plasma is 0.5 μg / g.The half-life of DMSO is 11-14 hours.
    Heparin.
    With external application, heparin is absorbed only slightly.
    Dexpanthenol.
    With external application dexpanthenol is transformed in the skin into pantothenic acid. Good absorption of dexpanthenol has been confirmed experimentally.
    Indications:

    - swelling, bruising and inflammation of soft tissues, muscles, tendons, tendon sheaths,

    - closed injuries, bruises,

    - injuries of joints with sprains of ligaments and tendons,

    - epicondylitis of the shoulder ("elbow tennis player"), tendinitis (tendon inflammation), tendovaginitis (inflammation of the tendon sheaths), bursitis (inflammation of the mucous bag of the joint),

    - periarthritis of the shoulder joint

    acute neuralgia.

    Contraindications:

    - hypersensitivity to one of the components of the gel (active / auxiliary substances),

    - bronchial asthma,

    - severe violations of the liver, kidneys,

    - expressed violations of the cardiovascular system,

    - pregnancy and lactation,

    - age up to 5 years,

    - open wounds at the site of application.

    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 during lactation.

    Dimethyl sulfoxide penetrates into breast milk, so during the use of the drug should stop breastfeeding.

    Dosing and Administration:

    Dolobien should be applied on the skin over the affected area of ​​the skin 2-4 times a day.

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

    Dolobene can be used for iontophoresis. The drug is applied to 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 ultrasonic waves. The duration of treatment depends on the severity of the symptoms and the severity of the disease.

    Side effects:

    Possible local skin reactions (redness, itching, burning sensation at the site of application of the gel), which usually disappear during further treatment.

    Due to the content of DMSO or other components of the drug, it is sometimes possible to develop a skin allergic reaction.

    In rare cases, during the use of the drug in some patients may smell of garlic from the mouth.The smell is caused by dimethyl sulphide, which is a product of the metabolism of dimethylsulfoxide.

    Perhaps a change in taste, disappearing a few minutes after applying the gel.

    In isolated cases, the occurrence of allergic reactions of an immediate type (urticaria, Quincke's edema) is possible.

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

    Overdose:

    Data on drug overdose are absent.

    Interaction:

    The application of another drug simultaneously with the drug Dolobene can enhance their permeability through the skin. With the simultaneous use of the drug Dolobene and a non-steroidal anti-inflammatory drug sulindac, the development of peripheral neuropathy is possible.

    Special instructions:Place the application of the gel should be free of other medicines, cosmetics or any chemical agents. Doloben can not be applied to the mucous membranes of the eyes, nose, mouth, open wounds or to damaged areas of the skin (due to irradiation, severe sunburn, post-operative scars).

    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, do not use Dolobene in combination with other ointments and gels.

    Form release / dosage:

    Gel for external use.

    Packaging:

    For 50 g or 100 g of the drug in aluminum tubes, tightened with aluminum foil to control the first opening, with a screwed polymer cover.

    1 tube together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013758 / 01
    Date of registration:08.07.2008 / 28.10.2014
    The owner of the registration certificate:ratiofarm GmbHratiofarm GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp05.01.16
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