Sodium Heparin, Dexpanthenol, Dimethyl Sulfoxide
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2019-09-19
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Clinical Pharmacology
Dimethyl sulfoxide (DMSO).
DMSO has anti-inflammatory, anti-edematous and local anesthetic action.
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 process of inflammation 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 provided by the inactivation of hydroxyl radicals and the improvement of the subcutaneous metabolic reaction at the site of use of the drug. To a certain extent, the hygroscopic properties of DMSO are also responsible for its anti-edema action. DMSO (from 50% or more) penetrates through biological membranes, including through the skin, contributing to a better and deeper penetration into the tissue of other drugs used simultaneously with it.
Heparin.
Heparin has an anti-inflammatory effect, promotes the regeneration of connective tissue by inhibiting the activity of hyaluronidase. Heparin exhibits a dose-dependent antithrombotic effect, enhancing the inhibitory activity of antithrombin III on the activation of prothrombin and thrombin. The penetration of heparin through healthy skin is dose-dependent and is confirmed for dosage starting at 300 IU / g.
Dexpanthenol.
When applied topically, dexpanthenol is transformed into pantothenic acid (vitamin B) in the skin. The effectiveness of dexpanthenol is comparable to the effectiveness of pantothenic acid. Pantothenic acid as a component of coenzyme A is involved in various catabolic and anabolic processes in tissues; by improving the processes of granulation and epithelization, it promotes the regeneration of damaged skin.
Pharmacokinetics:
Dimethyl sulfoxide (DMSO).
The physiological concentration of DMSO in normal blood plasma is 40 ng / ml. After 6 hours after application of the drug, the maximum plasma concentration reaches 120 ng / ml and lasts up to 12 hours after application. After 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% of total DMSO is excreted through the lungs in the form of dimethyl sulfide 6-12 hours after the use of the drug.
When using 1 g of dimethyl sulfoxide 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 tissues and the synovial membrane at the site of the synovial compound is 7-10 μg / ml, in the synovial liquids - 0.8 mcg / g. The concentration of dimethyl sulfoxide in the blood plasma is 0.5 μg / g. The half-life of DMSO is 11-14 hours.
Heparin.
When applied externally, heparin is absorbed slightly.
Dexpanthenol.
When applied externally, dexpanthenol is transformed into pantothenic acid in the skin. Good absorption of dexpanthenol is confirmed experimentally.
DMSO has anti-inflammatory, anti-edematous and local anesthetic action.
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 process of inflammation 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 provided by the inactivation of hydroxyl radicals and the improvement of the subcutaneous metabolic reaction at the site of use of the drug. To a certain extent, the hygroscopic properties of DMSO are also responsible for its anti-edema action. DMSO (from 50% or more) penetrates through biological membranes, including through the skin, contributing to a better and deeper penetration into the tissue of other drugs used simultaneously with it.
Heparin.
Heparin has an anti-inflammatory effect, promotes the regeneration of connective tissue by inhibiting the activity of hyaluronidase. Heparin exhibits a dose-dependent antithrombotic effect, enhancing the inhibitory activity of antithrombin III on the activation of prothrombin and thrombin. The penetration of heparin through healthy skin is dose-dependent and is confirmed for dosage starting at 300 IU / g.
Dexpanthenol.
When applied topically, dexpanthenol is transformed into pantothenic acid (vitamin B) in the skin. The effectiveness of dexpanthenol is comparable to the effectiveness of pantothenic acid. Pantothenic acid as a component of coenzyme A is involved in various catabolic and anabolic processes in tissues; by improving the processes of granulation and epithelization, it promotes the regeneration of damaged skin.
Pharmacokinetics:
Dimethyl sulfoxide (DMSO).
The physiological concentration of DMSO in normal blood plasma is 40 ng / ml. After 6 hours after application of the drug, the maximum plasma concentration reaches 120 ng / ml and lasts up to 12 hours after application. After 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% of total DMSO is excreted through the lungs in the form of dimethyl sulfide 6-12 hours after the use of the drug.
When using 1 g of dimethyl sulfoxide 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 tissues and the synovial membrane at the site of the synovial compound is 7-10 μg / ml, in the synovial liquids - 0.8 mcg / g. The concentration of dimethyl sulfoxide in the blood plasma is 0.5 μg / g. The half-life of DMSO is 11-14 hours.
Heparin.
When applied externally, heparin is absorbed slightly.
Dexpanthenol.
When applied externally, dexpanthenol is transformed into pantothenic acid in the skin. Good absorption of dexpanthenol is confirmed experimentally.
Indications
- Swelling, hematomas and inflammation of the soft tissues, muscles, tendons, tendon sheaths,
- closed injuries, bruises,
- joint injuries with sprains and tendons,
- shoulder epicondylitis ("tennis player's elbow"), tendinitis (tendon inflammation), tendovaginitis (tendon sheath inflammation), bursitis (inflammation of the mucosa of the joint bag),
- periarthritis of the shoulder joint,
- acute neuralgia.
Composition
100 g of gel contain:
Active substances:
Sodium Heparin 50000 ME
Dexpanthenol 2,500 g
Dimethyl sulfoxide 90% 16.660 g
(in terms of dry substance) (15,000 g)
Excipients:
Polyacrylic acid 1,000 - 1,400 g, trometamol 0,200 - 0,300 g, macrogol glyceryl hydroxystearate (Cremophor 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
Sodium Heparin, Dexpanthenol, Dimethyl Sulfoxide is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| gel | |||
| Dolobene | Merkle GmbH | Germany | gel |
| Hepatrombin | Hemofarm | Serbia | gel |
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Dosage and Administration
The drug is applied in a thin layer on the affected skin or on the skin over the painful area, trying to avoid applying the gel directly on wounds and abrasions.
In order to cover the entire surface of the injured knee, it is usually sufficient to squeeze out a 3-4 cm long gel strip from the tube.
The procedure is repeated 2-4 times / day for 7-10 days or until the disappearance of symptoms of the disease (pain, swelling, inflammation).
The patient should be warned that if within 10 days of application Dolobene does not occur a distinct improvement, you should consult a doctor.
Adverse reactions
Local reactions: most often - redness, itching, burning sensation (gradually passing through the treatment process).
Allergic reactions: sometimes - skin reactions; in rare cases - immediate allergic reactions (urticaria, angioedema).
Systemic reactions: in rare cases - the smell of garlic from the mouth, a change in taste (disappearing after a few minutes).
Contraindications
- severe abnormal liver function;
- Severe renal dysfunction;
- bronchial asthma;
- pronounced disorders of the cardiovascular system (including severe angina, myocardial infarction, stroke, severe atherosclerosis);
- pregnancy;
- lactation period;
- children's age up to 5 years;
- Hypersensitivity to the drug.
The drug should not be applied to the mucous membranes (eyes, nose, mouth), open wounds or damaged skin (including the state after irradiation, severe sunburn, fresh postoperative scars).
Drug interactions
With joint external use Dolobene significantly enhances the penetration of other drugs through the skin.
With the simultaneous use of drugs containing sulindak (NSAIDs), with the drug Dolobene may develop severe toxic reactions (peripheral neuropathy).
Pregnancy and Lactation
The use of the drug Dolobene contraindicated in pregnancy due to the lack of clinical data confirming the safety of dimethyl sulfoxide (which is part of the gel) during this period.
In experimental animal studies it was found that dimethyl sulfoxide has a teratogenic effect.
The use of Dolobene during lactation is contraindicated, since dimethyl sulfoxide is excreted in breast milk.
Special instructions
Before applying Dolobene should thoroughly clean the skin from dirt, cosmetics, other drugs and chemicals.
When using the dressing, after applying Dolobene it is necessary to wait a few minutes so that the gel is mainly absorbed into the skin, and the alcohol (isopropanol) evaporates. This is especially important in cases when the applied bandage does not allow air to pass through.
Contact with the drug on areas with violation of the integrity of the skin can cause a painful reaction due to the content in the gel isopropanol.
The drug is consumed sparingly, absorbs quickly and leaves no greasy marks on the skin or clothing.
When using Dolobene, the isopropanol in the gel evaporates and has a cooling effect. This effect is enhanced when using the gel stored in the refrigerator, or in the hot season (due to increased evaporation of alcohol).
Dolobene can be used in iontophoresis. Heparin, which is part of the gel, in relation to the pH of the skin is an anion. The application of the drug under the cathode improves the penetration of heparin through the skin, while dimethyl sulfoxide exhibits synergy with the action of electric current (anesthesia, reduction of local edema). When conducting iontophoresis, it should be borne in mind that electric current treatment may cause local skin irritation. It is necessary to carefully follow the instructions for use of devices and always pay attention to the adequacy of the electrode coating with a wet sponge.
Dolobene is a good contact gel during phonophoresis.Dimethyl sulfoxide and heparin complement the therapeutic effect of ultrasound.
Overdosage
To date, cases of drug overdose Dolobene not described.
- Brand name: Dolobene
- Active ingredient: Sodium Heparin, Dexpanthenol, Dimethyl Sulfoxide
- Dosage form: Gel for external use.
- Manufacturer: Diode
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