Instructions for Dolobene gel tube 50 g
Composition
active ingredients: heparin sodium, dimethyl sulfoxide, dexpanthenol;
100 g of gel contains heparin sodium 50,000 IU, dimethyl sulfoxide 15 g, dexpanthenol
2.5 g;
Excipients: polyacrylic acid, trometamol, macrogol glyceryl hydroxystearate, isopropyl alcohol, rosemary oil, mountain pine oil, citronella oil, purified water.
Dosage form
Gel.
Main physicochemical properties: transparent or cloudy, homogeneous, colorless or yellowish gel with a characteristic odor.
Pharmacotherapeutic group
Topical preparations for joint and muscle pain. ATX code M02A X.
Pharmacological properties
Pharmacodynamics
Dimethyl sulfoxide (DMSO)
DMSO has anti-inflammatory, local analgesic and anti-edematous effects. The anti-inflammatory effect is based on several pharmacological effects, the main 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 speed of conduction of excitatory impulses in peripheral neurons. The anti-edematous effect is explained by the inactivation of hydroxyl radicals and the resulting improvement of metabolic processes in the focus of inflammation. The hygroscopic properties of DMSO are also partly responsible for this.
Heparin
Heparin competitively inhibits the activity of hyaluronidase, which in turn prevents excessive degeneration of connective tissue during inflammation. Thus, heparin exerts an anti-inflammatory effect and promotes healing. In addition, heparin exerts 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 vitamin of group B. Dexpanthenol has the same biological efficacy as pantothenic acid. Pantothenic acid, which is a component of coenzyme A, enters into various formation and decomposition reactions in all tissues and promotes regeneration processes during wound healing and epithelialization.
Pharmacokinetics
Dimethyl sulfoxide (DMSO)
DMSO is present in human blood plasma as a natural substance at a concentration of approximately 40 ng/ml. After a single application of 1.5 g of Dolobene gel to a skin surface area of 400 cm², DMSO is absorbed with a half-life of 3-4 hours. 6 hours after application, the plasma concentration reaches a plateau (approximately 120 ng/ml) and remains at this level for up to 12 hours after application. The half-life of DMSO from blood plasma is 11-14 hours. 60 hours after application, the endogenous plasma concentration is again reached.
12-25% of DMSO is excreted in the urine within the first 24 hours and 37-48% within 7 days as unchanged DMSO or as the main metabolite, dimethylsulfone (DMSO2). 3.5-6% of the total DMSO dose is exhaled through the lungs within 6-12 hours after administration as dimethylsulfide (DMS).
Heparin
Penetration of heparin through healthy skin is dose-dependent and has been confirmed for doses of 300 IU/g and above. Data on the pharmacokinetics of heparin after application to the skin are not available.
Dexpanthenol
Dexpanthenol is absorbed faster than pantothenic acid. The rapid absorption of dexpanthenol has been confirmed experimentally.
Indication
Dolobene, gel, is used to treat:
– injuries (including sports), hematomas, injuries to muscles, periarticular structures or joints (without skin damage);
– tendinitis and tendovaginitis, bursitis, shoulder scapular periarthritis and epicondylitis of the shoulder (pathological basis of the clinical syndrome “tennis elbow”);
– acute neuralgia.
Contraindication
Hypersensitivity to any of the components of the drug; severe liver and/or kidney dysfunction; bronchial asthma; unstable hemodynamics, severe disorders of the cardiovascular system (severe angina, myocardial infarction, stroke, severe general atherosclerosis); bleeding trophic leg ulcers, open and/or infected wounds, hemorrhagic diathesis, purpura, thrombocytopenia, hemophilia, bleeding tendency; comatose states, glaucoma, cataracts; concomitant use with drugs containing sulindac; pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
Concomitant use of other topical medications may increase their absorption. Due to the ability of dimethyl sulfoxide to enhance both the specific activity and toxicity of some medications, simultaneous application of other topical medications should be avoided.
The use of heparin can contribute to the prolongation of prothrombin time in patients taking oral anticoagulants. Dimethyl sulfoxide enhances the effect of ethanol (alcohol inhibits the excretion of the drug) and insulin, acetylsalicylic acid, butadione; digitalis preparations, quinidine, nitroglycerin, antibiotics (streptomycin, monomycin, etc.), sensitizes the body to anesthetics.
Application features
Dolobene should not be used in patients who may be allergic to dimethyl sulfoxide and/or heparin (history of allergy).
The drug contains isopropyl alcohol, so to avoid painful reactions, it should not be applied to mucous membranes, open wound surfaces or damaged skin (for example, after irradiation, dermatitis, dermatoses, postoperative scars, burns).
Other medications should not be applied to the treated skin areas for several hours before and after application of Dolobene gel. In order to prevent undesirable effects, the drug should be applied to skin that has been cleansed of other medications, cosmetics and dirt. Avoid contact with the eyes.
Application of dimethyl sulfoxide may cause photosensitivity. Therefore, when using Dolobene gel, one should refrain from sunbathing and visiting a solarium. If hypersensitivity reactions occur, the use of the drug should be discontinued. The drug should not be used in patients with systemic lupus erythematosus.
Use during pregnancy or breastfeeding
The potential teratogenic effects of DMSO in animals have been reported.
There is currently insufficient experience with the use of dimethyl sulfoxide in pregnant women, therefore the use of Dolobene during pregnancy or breastfeeding is contraindicated.
Dimethyl sulfoxide passes into breast milk, so the use of Dolobene during breastfeeding is contraindicated.
Ability to influence reaction speed when driving vehicles or other mechanisms
No specific studies have been conducted on the effect of Dolobene on the ability to drive and use machines. However, it is known that Dolobene generally does not affect the ability to drive and use machines.
Method of administration and doses
Apply the gel in a thin layer (for example, a strip of gel 3 cm long is used for an area the size of which corresponds to the projection of the knee joint) on the affected areas and/or around them (for abrasions). The gel does not need to be rubbed in, it should be applied carefully and evenly distributed over the entire affected area. Repeat the procedure 1-2 times a day.
When applying Dolobene dressings, use breathable dressing material. The dressing is applied after most of the gel has penetrated the skin and the alcohol contained in the preparation has evaporated (i.e. after a few minutes).
When administering the drug by iontophoresis, the gel should be applied under the cathode, taking into account the anionic properties of heparin, which is part of Dolobene.
During phonophoresis, the drug, due to its good contact properties and content of active substances, complements the physiotherapeutic effect of ultrasonic waves.
The duration of treatment with Dolobene gel is determined by the doctor individually, depending on the severity and course of the disease, as well as the effectiveness of the therapy.
Children
The drug should not be prescribed to children due to limited experience with its use.
Overdose
No cases of overdose have been observed when using Dolobene.
Increased hematoma and increased risk of bleeding have been reported with topical heparin doses exceeding 180,000 IU. Intestinal absorption of heparin is negligible, so signs of overdose are unlikely if it is accidentally swallowed.
Adverse reactions
On the part of the immune system: allergic skin reactions, in some cases immediate allergic reactions such as urticaria and angioedema are possible.
Cardiovascular system: in some cases, when applied to large areas of skin, cardiac disorders are possible (causal relationship not determined).
Respiratory system: in some cases, when applied to large areas of skin, respiratory system disorders are possible (causal relationship not determined).
Gastrointestinal: temporary garlic odor from the mouth (due to the action of dimethyl sulfide - a metabolite of dimethyl sulfoxide); change in taste sensations, which passes within a few minutes; in some cases, when applied to large areas of the skin - stomach upset, nausea, vomiting, diarrhea, constipation or anorexia (causal relationship not determined).
Skin: photosensitivity reactions.
General disorders: erythema, itching, burning, blisters, urticaria at the site of application. These reactions usually disappear during treatment. Otherwise, the use of the drug should be discontinued. In some cases, when applied to large areas of the skin, increased fatigue, headache, chills are possible (causal relationship not determined).
Caused by the action of dimethyl sulfoxide: dizziness, insomnia, adynamia, dermatitis, bronchospasm, vomiting.
Caused by the action of heparin: skin swelling, skin rash, hemorrhages, sometimes the appearance of small pustules, blisters or blisters, which quickly disappear after discontinuation of the drug.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
20 g or 50 g or 100 g of gel in a tube. 1 tube in a box.
Vacation category
Without a prescription.
Producer
Merkle GmbH.
Location of the manufacturer and address of its place of business
Ludwig-Merkle-Strasse 3, 89143 Blaubeuren, Germany.
