Dolonit-MosPharma gel for external approx. 30g tube No. 1


Dolonit-MosPharma

Drug website: dolonit.ru

Trade name of the drug: Dolonit-MosPharma

Group name: sodium heparin + dexpanthenol + dimethyl sulfoxide

Dosage form: gel for external use

Composition per 100 g Active substances: Heparin sodium (heparin sodium salt) – 50,000 IU (in terms of dry matter) Dexpanthenol (D-Panthenol) – 2.50 g (in terms of 100% dry matter) Dimethyl sulfoxide (dimexide) – 15.00 g (based on 100% substance)

Excipients: Carbomer homopolymer type C – 1.00 g Trometamol – 0.20 g Macrogol glyceryl hydroxystearate – 0.90 g Ethanol (ethyl alcohol) 95% – 38.06 g Rosemary oil – 0.20 g Scots pine 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.

ATX code: S05BA53

Pharmacotherapeutic group: Direct action anticoagulant for local use + other drugs.

pharmachologic effect

Pharmacodynamics: The effect of the drug is due to the active substances included in its composition: dimethyl sulfoxide, sodium heparin and dexpanthenol. 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 tissue. DMSO has a local analgesic effect by reducing the speed of nociceptive (pain) impulses in peripheral neurons. The anti-edema effect is ensured 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-edematous effect. DMSO (50% or more) penetrates biological membranes, including the skin, facilitating better and deeper penetration into tissues of other drugs used simultaneously. Heparin sodium. Heparin sodium, which is part of the drug, is a direct anticoagulant; Due to the inactivation of biogenic amines in tissue, it exhibits a distinct anti-inflammatory effect and 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. The penetration of heparin sodium through healthy skin is dose-dependent and has been confirmed for dosages starting at 300 IU/g. Dexpanthenol. Dexpanthenol exhibits anti-inflammatory and dermatoprotective effects, stimulates regeneration processes. After absorption, it turns into pantothenic acid, which participates in numerous metabolic processes, being an integral part of co-enzyme A; by improving the processes of granulation and epithelization, it promotes the regeneration of damaged skin areas.

Pharmacokinetics: Dimethyl sulfoxide (DMSO). DMSO enters the systemic circulation, the half-life of absorption is 3 - 4 hours, the half-life of elimination from blood plasma is 11 - 14 hours. DMSO passes into breast milk. Eliminated primarily in urine. 6 hours after application of the drug, the maximum concentration in the blood plasma reaches 120 ng/ml and persists for up to 12 hours after application. 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 through the kidneys or as a metabolite (dimethyl sulfone). 3.5 - 6.0% of total DMSO is excreted through the lungs in the form of dimethyl sulfide, 6 - 12 hours after using the drug. When using 1 g of DMSO 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 tissue and synovial membrane at the site of the synovial junction is 7 - 10 μg/ml, in the synovial liquid – 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. Heparin sodium. Heparin sodium penetrates quickly into the skin; already within the first hour after applying the gel, the concentration in the underlying tissues corresponds to the concentrations that are achieved after intravenous administration of 5000 IU of heparin. Heparin sodium does not cross the placental barrier and does not enter breast milk. Dexpanthenol. When applied externally, dexpanthenol is transformed in the skin into pantothenic acid, whose rate and degree of transdermal penetration is less than that of dexpanthenol.

Indications for use: - swelling, hematomas and inflammation of soft tissues, muscles, tendons, tendon sheaths and ligaments after bruises, compression, injuries; - closed injuries, bruises; — joint injuries with ligament damage; — humeroscapular periarthritis and epicondylitis of the shoulder (“tennis elbow”), tendonitis (inflammation of the tendons), tendovaginitis (inflammation of the tendon sheaths), bursitis (inflammation of the mucous membrane of the joints); - acute neuralgia.

Contraindications: - hypersensitivity to one of the components of the gel (active/excipients); - severe dysfunction of the liver and/or kidneys; - bronchial asthma; - severe disorders of the cardiovascular system (IV functional class of angina pectoris according to the classification of the Canadian Society of Cardiology, myocardial infarction, stroke, severe generalized atherosclerosis); — pregnancy, breastfeeding period; - children under 5 years of age. Do not apply the drug to mucous membranes (eyes, nose, mouth), open wounds or damaged skin (for example, conditions after radiation or severe sunburn, fresh post-operative scars). Use during pregnancy and breastfeeding Use during pregnancy Since there are no research data on the use of the drug in pregnant women, its use during pregnancy is contraindicated. Use during breastfeeding Dimethyl sulfoxide passes into breast milk, so breastfeeding should be stopped while taking the drug.

Method of administration and dosage: The drug is applied in a thin surface layer to the skin over the area of ​​damage to soft tissues, joints or tendons (swelling, hematoma, inflammation, injury) and evenly distributed with light rubbing movements. In order to cover the entire surface of the bruised knee, it is usually enough 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 symptoms of the disease such as pain, swelling, edema, and inflammation disappear. If there is no clear improvement within 7 days of treatment, you should consult a doctor. When applying dressings with gel, a breathable dressing material is applied only after most of the gel has penetrated the skin and the alcohol has evaporated (several minutes). Dolonit-MosPharma and iontophoresis. This drug can be used for iontophoresis. The sodium heparin contained in the drug in solution is an anion. Application of the drug under the cathode promotes increased penetration of sodium heparin into the affected area, and dimethyl sulfoxide exhibits a synergistic effect with the effect of electric current (pain relief, reduction of local edema). Precautionary measures. It must be remembered that electric current treatment itself can cause local skin irritation reactions. Therefore, it is necessary to carefully follow the instructions of the device manufacturers so that the use of the drug does not intensify these local reactions. Always ensure that the electrodes are sufficiently covered with a damp sponge. Dolonit-MosPharma and ultrasound (phonophoresis). This drug is a good contact gel for ultrasound therapy (phonophoresis). The active ingredients of the gel (dimethyl sulfoxide and sodium heparin) complement the therapeutic effect of ultrasonic waves. Overdose Cases of overdose and poisoning by the drug have not been described.

Side effects: The drug is usually well tolerated, however, in isolated cases, local skin reactions (redness, itching and burning sensation at the application site) are possible, which usually gradually disappear during treatment. Sometimes, due to the content of DMSO or other components of the drug, a general allergic skin reaction with urticaria and Quincke's edema may occur. In rare cases, some patients may experience a garlic breath odor while using this drug due to the presence of dimethyl sulfide, a metabolite of dimethyl sulfoxide. This smell indicates good absorption of dimethyl sulfoxide. Some patients may experience a change in taste after applying the gel, which disappears after a few minutes. It is extremely rare that when applying the drug to large areas of the body, nausea, diarrhea, difficulty breathing, headache, and chills may occur.

Interaction with other drugs: Local use of other drugs simultaneously with the drug Dolonit-MosPharma contributes to a sharp increase in their permeability through the skin. When used simultaneously with the non-steroidal anti-inflammatory drug sulindac, the development of peripheral neuropathy is possible (due to the presence of dimethyl sulfoxide in the composition of the drug Dolonit-MosPharma). Effect on the ability to drive vehicles and engage in other potentially hazardous activities. When administered cutaneously, the drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Special instructions: The drug is used sparingly, quickly penetrates the skin and does not leave a greasy layer on the skin or stains on the laundry. Thanks to the alcohol contained (ethanol), which evaporates after applying the gel, a pleasant cooling sensation is felt at the site of application of the drug. The pleasant cooling effect is enhanced if the gel is stored in the refrigerator, as well as if the drug is used in hot weather (due to increased evaporation of alcohol). The area of ​​skin to which the drug is applied must be cleaned of dirt, cosmetics, other medications and chemicals. When using dressings, it is necessary to wait a few minutes after applying the gel so that the bulk of the gel is absorbed and the ethyl alcohol (ethanol) evaporates. This is especially important in cases where a bandage that is poorly permeable to air is used. During treatment with the drug, the photosensitivity of the skin may increase, so during its use you should limit intense sunbathing and visits to the solarium. If skin reactions occur, treatment should be discontinued. Due to the high absorption of dimethyl sulfoxide, Dolonit-MosPharma should not be used in combination with other ointments and gels. It should be remembered that contact of the drug on open wounds causes a painful reaction, since the gel contains ethyl alcohol (ethanol).

Release form: Gel for external use. 30 g or 50 g in aluminum tubes. Each tube, along with instructions for use, is placed in a cardboard pack.

Shelf life: 3 years. Do not use the drug after the expiration date.

Storage conditions: Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Conditions of release: Dispensed without a prescription.

Dolonit-MosPharma gel 30g

Drug website: dolonit.ru

Trade name of the drug: Dolonit-MosPharma

Group name: sodium heparin + dexpanthenol + dimethyl sulfoxide

Dosage form: gel for external use

Composition per 100 g Active substances: Heparin sodium (heparin sodium salt) – 50,000 IU (in terms of dry matter) Dexpanthenol (D-Panthenol) – 2.50 g (in terms of 100% dry matter) Dimethyl sulfoxide (dimexide) – 15.00 g (based on 100% substance)

Excipients: Carbomer homopolymer type C – 1.00 g Trometamol – 0.20 g Macrogol glyceryl hydroxystearate – 0.90 g Ethanol (ethyl alcohol) 95% – 38.06 g Rosemary oil – 0.20 g Scots pine 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.

ATX code: S05BA53

Pharmacotherapeutic group: Direct action anticoagulant for local use + other drugs.

pharmachologic effect

Pharmacodynamics: The effect of the drug is due to the active substances included in its composition: dimethyl sulfoxide, sodium heparin and dexpanthenol. 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 tissue. DMSO has a local analgesic effect by reducing the speed of nociceptive (pain) impulses in peripheral neurons. The anti-edema effect is ensured 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-edematous effect. DMSO (50% or more) penetrates biological membranes, including the skin, facilitating better and deeper penetration into tissues of other drugs used simultaneously. Heparin sodium. Heparin sodium, which is part of the drug, is a direct anticoagulant; Due to the inactivation of biogenic amines in tissue, it exhibits a distinct anti-inflammatory effect and 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. The penetration of heparin sodium through healthy skin is dose-dependent and has been confirmed for dosages starting at 300 IU/g. Dexpanthenol. Dexpanthenol exhibits anti-inflammatory and dermatoprotective effects, stimulates regeneration processes. After absorption, it turns into pantothenic acid, which participates in numerous metabolic processes, being an integral part of co-enzyme A; by improving the processes of granulation and epithelization, it promotes the regeneration of damaged skin areas.

Pharmacokinetics: Dimethyl sulfoxide (DMSO). DMSO enters the systemic circulation, the half-life of absorption is 3 - 4 hours, the half-life of elimination from blood plasma is 11 - 14 hours. DMSO passes into breast milk. Eliminated primarily in urine. 6 hours after application of the drug, the maximum concentration in the blood plasma reaches 120 ng/ml and persists for up to 12 hours after application. 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 through the kidneys or as a metabolite (dimethyl sulfone). 3.5 - 6.0% of total DMSO is excreted through the lungs in the form of dimethyl sulfide, 6 - 12 hours after using the drug. When using 1 g of DMSO 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 tissue and synovial membrane at the site of the synovial junction is 7 - 10 μg/ml, in the synovial liquid – 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. Heparin sodium. Heparin sodium penetrates quickly into the skin; already within the first hour after applying the gel, the concentration in the underlying tissues corresponds to the concentrations that are achieved after intravenous administration of 5000 IU of heparin. Heparin sodium does not cross the placental barrier and does not enter breast milk. Dexpanthenol. When applied externally, dexpanthenol is transformed in the skin into pantothenic acid, whose rate and degree of transdermal penetration is less than that of dexpanthenol.

Indications for use: - swelling, hematomas and inflammation of soft tissues, muscles, tendons, tendon sheaths and ligaments after bruises, compression, injuries; - closed injuries, bruises; — joint injuries with ligament damage; — humeroscapular periarthritis and epicondylitis of the shoulder (“tennis elbow”), tendonitis (inflammation of the tendons), tendovaginitis (inflammation of the tendon sheaths), bursitis (inflammation of the mucous membrane of the joints); - acute neuralgia.

Contraindications: - hypersensitivity to one of the components of the gel (active/excipients); - severe dysfunction of the liver and/or kidneys; - bronchial asthma; - severe disorders of the cardiovascular system (IV functional class of angina pectoris according to the classification of the Canadian Society of Cardiology, myocardial infarction, stroke, severe generalized atherosclerosis); — pregnancy, breastfeeding period; - children under 5 years of age. Do not apply the drug to mucous membranes (eyes, nose, mouth), open wounds or damaged skin (for example, conditions after radiation or severe sunburn, fresh post-operative scars). Use during pregnancy and breastfeeding Use during pregnancy Since there are no research data on the use of the drug in pregnant women, its use during pregnancy is contraindicated. Use during breastfeeding Dimethyl sulfoxide passes into breast milk, so breastfeeding should be stopped while taking the drug.

Method of administration and dosage: The drug is applied in a thin surface layer to the skin over the area of ​​damage to soft tissues, joints or tendons (swelling, hematoma, inflammation, injury) and evenly distributed with light rubbing movements. In order to cover the entire surface of the bruised knee, it is usually enough 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 symptoms of the disease such as pain, swelling, edema, and inflammation disappear. If there is no clear improvement within 7 days of treatment, you should consult a doctor. When applying dressings with gel, a breathable dressing material is applied only after most of the gel has penetrated the skin and the alcohol has evaporated (several minutes). Dolonit-MosPharma and iontophoresis. This drug can be used for iontophoresis. The sodium heparin contained in the drug in solution is an anion. Application of the drug under the cathode promotes increased penetration of sodium heparin into the affected area, and dimethyl sulfoxide exhibits a synergistic effect with the effect of electric current (pain relief, reduction of local edema). Precautionary measures. It must be remembered that electric current treatment itself can cause local skin irritation reactions. Therefore, it is necessary to carefully follow the instructions of the device manufacturers so that the use of the drug does not intensify these local reactions. Always ensure that the electrodes are sufficiently covered with a damp sponge. Dolonit-MosPharma and ultrasound (phonophoresis). This drug is a good contact gel for ultrasound therapy (phonophoresis). The active ingredients of the gel (dimethyl sulfoxide and sodium heparin) complement the therapeutic effect of ultrasonic waves. Overdose Cases of overdose and poisoning by the drug have not been described.

Side effects: The drug is usually well tolerated, however, in isolated cases, local skin reactions (redness, itching and burning sensation at the application site) are possible, which usually gradually disappear during treatment. Sometimes, due to the content of DMSO or other components of the drug, a general allergic skin reaction with urticaria and Quincke's edema may occur. In rare cases, some patients may experience a garlic breath odor while using this drug due to the presence of dimethyl sulfide, a metabolite of dimethyl sulfoxide. This smell indicates good absorption of dimethyl sulfoxide. Some patients may experience a change in taste after applying the gel, which disappears after a few minutes. It is extremely rare that when applying the drug to large areas of the body, nausea, diarrhea, difficulty breathing, headache, and chills may occur.

Interaction with other drugs: Local use of other drugs simultaneously with the drug Dolonit-MosPharma contributes to a sharp increase in their permeability through the skin. When used simultaneously with the non-steroidal anti-inflammatory drug sulindac, the development of peripheral neuropathy is possible (due to the presence of dimethyl sulfoxide in the composition of the drug Dolonit-MosPharma). Effect on the ability to drive vehicles and engage in other potentially hazardous activities. When administered cutaneously, the drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Special instructions: The drug is used sparingly, quickly penetrates the skin and does not leave a greasy layer on the skin or stains on the laundry. Thanks to the alcohol contained (ethanol), which evaporates after applying the gel, a pleasant cooling sensation is felt at the site of application of the drug. The pleasant cooling effect is enhanced if the gel is stored in the refrigerator, as well as if the drug is used in hot weather (due to increased evaporation of alcohol). The area of ​​skin to which the drug is applied must be cleaned of dirt, cosmetics, other medications and chemicals. When using dressings, it is necessary to wait a few minutes after applying the gel so that the bulk of the gel is absorbed and the ethyl alcohol (ethanol) evaporates. This is especially important in cases where a bandage that is poorly permeable to air is used. During treatment with the drug, the photosensitivity of the skin may increase, so during its use you should limit intense sunbathing and visits to the solarium. If skin reactions occur, treatment should be discontinued. Due to the high absorption of dimethyl sulfoxide, Dolonit-MosPharma should not be used in combination with other ointments and gels. It should be remembered that contact of the drug on open wounds causes a painful reaction, since the gel contains ethyl alcohol (ethanol).

Release form: Gel for external use. 30 g or 50 g in aluminum tubes. Each tube, along with instructions for use, is placed in a cardboard pack.

Shelf life: 3 years. Do not use the drug after the expiration date.

Storage conditions: Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Conditions of release: Dispensed without a prescription.

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