Dolobene

Dolobene gel is a combined local preparation containing several active components:

1. Sodium Heparin: Heparin is an anticoagulant that prevents blood clots and improves blood circulation. It is often used in topical preparations to relieve inflammation and swelling, as well as to treat thrombophlebitis, varicose veins, and other vascular diseases.
2. Dexpanthenol: Dexpanthenol, or provitamin B5, is a component that stimulates the regeneration of the skin and mucous membranes, moisturizes and softens the skin. It is often used in cosmetics and medical products to treat wounds, burns, dry and irritated skin.
3. Dimethyl sulfoxide (DMSO): DMSO has anti-inflammatory and analgesic effects. It promotes the penetration of other components of the drug into the skin and enhances their effectiveness. DMSO also has the ability to reduce swelling and improve blood circulation.
4. 10% H2O: The water contained in the product serves as the basis for creating the gel and provides hydration and cooling to the skin.

Dolobene gel is commonly used to treat various conditions associated with muscle pain, joint inflammation, sprains, rheumatic diseases, as well as for the treatment of carpal tunnel syndrome and other neurological disorders.

Indications Dolobene

1. Varicose Veins: Sodium heparin in the gel helps improve blood circulation and reduce swelling, which can relieve symptoms of varicose veins such as fatigue and heaviness in the legs.
2. Thrombophlebitis: Heparin is an anticoagulant and can be used to treat thrombophlebitis, an inflammation of the vein walls that causes blood clots.
3. Injuries and strains: Dexpanthenol helps stimulate the wound healing process and accelerates tissue regeneration, so the gel can be useful for treating injuries, strains, bruises and other soft tissue damage.
4. Rheumatic diseases: The gel can be used to relieve pain and inflammation in various rheumatic diseases such as arthritis and arthrosis.
5. Muscle pain: Dimethyl sulfoxide has anti-inflammatory and analgesic properties, so the gel can be used to relieve pain and inflammation in muscles and joints.
6. Neurological disorders: The gel can be used to treat neurological disorders such as tunnel syndrome, neuritis and neuralgia due to its analgesic effect.

Release form

Gel for external use: This is the most common form of Dolobene. The gel is applied directly to the skin in the area of inflammation or pain. Due to its components, the gel helps reduce swelling, has an anti-inflammatory and analgesic effect. The gel is easily absorbed and does not leave greasy marks on clothing.

Pharmacodynamics

1. Sodium heparin:

   • Mechanism of action: Heparin is an anticoagulant that acts by inhibiting clotting factors such as thrombin and Howell factors. It also stimulates the action of antithrombin III, which inactivates clotting factors.
   • Pharmacological effects: Heparin prevents the formation of blood clots and helps break down existing blood clots, making it effective in the prevention and treatment of thrombosis and embolism.

2. Dexpanthenol:

   • Mechanism of action: Dexpanthenol (provitamin B5) is converted into pantothenic acid in the body, which is an important component in the process of tissue regeneration and healing.
   • Pharmacological effects: Dexpanthenol has anti-inflammatory and wound-healing properties. It promotes wound healing, accelerates cell growth and repair of damaged tissue.

3. Dimethyl sulfoxide (DMSO):

   • Mechanism of action: DMSO has anti-inflammatory and analgesic properties. It improves the penetration of other substances through the skin, making it useful as a carrier for other active ingredients.
   • Pharmacological effects: DMSO reduces inflammation, relieves pain and promotes the resorption of hematomas and reduction of swelling.

4. 10% water solution: Water in this case is used as a solvent for other components of the drug.

Pharmacokinetics

1. Sodium heparin:

   • Absorption: Sodium heparin is not generally absorbed through the skin when applied topically.
   • Distribution: Because sodium heparin is a large molecule, it does not usually penetrate the skin in significant quantities and therefore is not distributed into the organs and tissues of the body.
   • Metabolism: Sodium heparin is not metabolized in the body.
   • Elimination: Sodium heparin is usually eliminated from the body via the kidneys.

2. Dexpanthenol:

   • Absorption: Dexpanthenol has good ability to penetrate the skin.
   • Distribution: After absorption, dexpanthenol can be evenly distributed in the body tissues, including the skin and mucous membranes.
   • Metabolism: Dexpanthenol is metabolized in the liver to pantothenic acid, which is the active form of vitamin B5.
   • Elimination: Dexpanthenol is excreted from the body mainly through the kidneys in the form of metabolites.

3. Dimethyl sulfoxide (DMSO):

   • Absorption: DMSO has a high ability to penetrate the skin.
   • Distribution: After absorption, DMSO can be distributed evenly throughout various tissues and organs.
   • Metabolism: DMSO is metabolized in the body to compounds such as dimethyl sulfone and dimethyl sulfide, and then excreted from the body through the kidneys and lungs.
   • Elimination: DMSO is eliminated from the body primarily through the kidneys.

4. Aqueous solution:

   • Absorption: Water can also be absorbed through the skin in small amounts.
   • Distribution: Water is distributed throughout the tissues and cells of the body.
   • Metabolism and Elimination: Water is not metabolized and is eliminated from the body primarily through the kidneys and to a lesser extent through the lungs.

Dosing and administration

Directions for use:

1. Clean skin: Before applying the gel, make sure the skin is clean and dry.
2. Application: Apply a thin layer of gel to the affected area. No need to rub hard, just a gentle rub to ensure coverage.
3. Frequency of application: The gel is usually applied 2-4 times daily, depending on the instructions and the severity of symptoms.
4. Duration of use: The duration of treatment depends on the symptoms and response to treatment, but without consulting a doctor, it is not recommended to use the gel for more than 10-14 days in a row.

Dosage:

• The amount of gel depends on the size of the area being treated. Usually, a strip of gel about 3-5 cm long is enough to treat a small area, such as a wrist or elbow. Larger areas, such as the back or leg, will require more gel.

Special instructions:

• Avoid contact of the gel with mucous membranes, eyes or open wounds.
• Do not apply occlusive (closed) dressings to the area where the gel is applied.
• If there is no improvement within a few days or symptoms worsen, you should consult a doctor.
• Before using Dolobene during pregnancy or breastfeeding, you should consult your doctor.

Use Dolobene during pregnancy

Dolobene should be used with caution during pregnancy.

1. Sodium heparin:

   • Heparin, including low molecular weight forms, is generally considered safe for use during pregnancy as it does not cross the placenta. This makes it the preferred choice for anticoagulant therapy during pregnancy, particularly for the prevention or treatment of venous thromboembolism (Clark et al., 2009).

2. Dexpanthenol:

   • Dexpanthenol (provitamin B5) is commonly used in medical and cosmetic products to promote skin healing and maintain skin health. Available studies do not indicate direct contraindications for its use during pregnancy, but data are limited.

3. Dimethyl sulfoxide (DMSO):

   • DMSO is used in medicine as a carrier of other medicinal substances through the skin and as an anti-inflammatory agent. However, its safety during pregnancy has not been fully studied and its use requires caution. Potential risks must be taken into account, especially regarding the possible penetration of other components through the placenta.

Contraindications

1. Allergy or hypersensitivity to any of the components of the drug, such as sodium heparin, dexpanthenol, dimethyl sulfoxide or other substances in the composition.
2. Skin integrity disorders. Do not apply to open wounds or damaged skin areas, including infected areas, ulcers or burns.
3. Severe forms of liver and kidney failure. These conditions can affect the metabolism and excretion of the drug components, increasing the risk of adverse reactions.
4. Hemophilia or other conditions associated with blood clotting disorders. Sodium heparin in the composition may increase the tendency to bleeding.
5. First trimester of pregnancy. Caution is needed when used during pregnancy, especially in the first three months, although topical application usually minimizes risks.
6. Breastfeeding period. Since it is not known whether the components of the drug penetrate into breast milk, its use during breastfeeding should be agreed with the doctor.

Side effects Dolobene

1. Skin reactions: Some people may develop skin irritation, redness, itching or rashes at the site of application of the gel. This is usually due to individual sensitivity to the components of the drug.
2. Allergic reactions: In rare cases, more serious allergic reactions may occur, such as angioedema (swelling of the skin, mucous membranes, and sometimes subcutaneous tissue), urticaria, or anaphylactic shock. If signs of allergy occur, stop using the drug and seek medical help.
3. Local reactions: A slight burning or tingling sensation may occur at the site of application of the gel. This is usually temporary and easily tolerated.
4. Systemic side effects: In case of topical application of Dolobene gel, systemic side effects are unlikely, since the active components mainly remain on the skin surface. However, when applying large volumes of gel to large areas of skin, some of the active substances may be absorbed and cause systemic reactions.
5. Interaction with other drugs: In case of simultaneous use of Dolobene gel with other topical drugs or medications for internal use, interaction of active components is possible, which can lead to strengthening or weakening of effects.

Overdose

1. Sodium heparin:

   • Hemorrhagic complications: Excessive use of heparin can cause bleeding, which may be serious and require medical intervention.
   • Thrombocytopenia: Long-term use of heparin may lead to the development of thrombocytopenia, which increases the risk of thrombosis.

2. Dexpanthenol:

   • Complications associated with overactivation of the potassium ion activation pathway are possible: including the development of hyperkalemia, especially in individuals with impaired renal function.

3. Dimethyl sulfoxide (DMSO):

   • When taken orally, dimethyl sulfoxide may cause digestive problems, nausea, vomiting, dizziness, headache, and other adverse reactions.
   • When applied to the skin, excess amounts of DMSO may cause skin irritation, rashes, or allergic reactions.

Interactions with other drugs

1. Drugs that enhance anticoagulation: Sodium heparin is an anticoagulant, and its concomitant use with other anticoagulants such as warfarin or heparin may result in increased anticoagulant effect and increased risk of bleeding.
2. Medicines affecting blood formation: Using Dolobene with medicines that affect platelet function or the blood clotting system may increase the risk of bleeding or impair blood clot formation.
3. Topical preparations: When used in combination with other topical preparations, especially those containing antiseptics, antimicrobials or steroids, interactions with the components of Dolobene may occur, leading to changes in their absorption or effectiveness.
4. Medicines affecting kidney function: Since sodium heparin is eliminated from the body via the kidneys, concomitant use of Dolobene with other medicines affecting kidney function may increase the risk of negative effects on the kidneys.
5. Medicines affecting the liver: Paracetamol contained in Doloben is metabolized in the liver. Concomitant use with other medicines affecting the liver or having hepatotoxic properties may lead to increased negative impact on the liver.
6. Drugs that cause allergic reactions: Any component of Dolobene may cause an allergic reaction in sensitive patients. Taking with other drugs may increase the risk of allergic reactions.

Storage conditions

1. Storage Temperature: The drug should generally be stored at room temperature, i.e. between 15°C and 25°C. This means that it should be protected from extreme temperatures, both cold and heat.
2. Storage conditions: The drug should be stored in a dry place, protected from direct sunlight and moisture. This may mean that the drug should be stored in packaging that provides protection from light and moisture.
3. Special Instructions: Some medications may have special storage instructions, such as a requirement to refrigerate or not to freeze. It is important to read and follow these instructions carefully.
4. Additional instructions: If the drug has special requirements or storage restrictions, they are usually indicated on the packaging or in the official information about the drug.