Dolobene

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

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 preparations 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 preparation serves as a base for the creation of 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 to treat 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 help 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 with the formation of blood clots.
3. Injuries and sprains: Dexpanthenol helps stimulate the wound healing process and speeds up tissue regeneration, so the gel can be useful for treating injuries, sprains, bruises and other soft tissue injuries.
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 release of Dolobene. The gel is applied directly to the skin in areas of inflammation or pain. Thanks to its components, the gel helps reduce swelling and has an anti-inflammatory and analgesic effect. The gel is easily absorbed and does not leave greasy marks on clothes.

Pharmacodynamics

1. Heparin sodium:

   • Mechanism of Action: Heparin is an anticoagulant that acts by inhibiting blood clotting factors such as thrombin and Howell's factors. It also stimulates the action of antithrombin III, which inactivates blood clotting factors.
   • Pharmacological effects: Heparin prevents the formation of blood clots and helps destroy existing blood clots, which makes it effective for 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 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. Heparin sodium:

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

2. Dexpanthenol:

   • Absorption: Dexpanthenol has good ability to penetrate the skin.
   • Distribution: After absorption, dexpanthenol can be evenly distributed in body tissues, including skin and mucous membranes.
   • Metabolism: Dexpanthenol is metabolized in the liver to panthenic 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 evenly distributed in various tissues and organs.
   • Metabolism: DMSO is metabolized in the body into 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 quantities.
   • Distribution: Water is distributed in 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

Method of application:

1. Skin cleanliness: Make sure your skin is clean and dry before applying the gel.
2. Application: Apply a thin layer of gel to the affected area. You don't need to rub in too hard, just a light rub is enough to provide coverage.
3. Frequency of application: The gel is usually applied 2-4 times a day, depending on the instructions and 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 treated area. Typically, a strip of gel about 3-5 cm long is sufficient to treat a small area such as the wrist or elbow. Larger areas such as the back or leg will require more gel.

Special instructions:

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

Use Dolobene during pregnancy

The drug Dolobene requires caution when used during pregnancy.

1. Heparin sodium:

   • Heparin, including low molecular weight forms, is generally considered safe for use during pregnancy because it does not cross the placenta. This makes it a preferred choice for anticoagulant therapy during pregnancy, especially 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 improve skin healing and maintain skin health. Available studies do not indicate any direct contraindications to its use during pregnancy, but data are limited.

3. Dimethyl sulfoxide (DMSO):

   • DMSO is used in medicine as a carrier of other drugs 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 considered, especially with regard to the possible passage 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. Violations of skin integrity. Do not use on open wounds or damaged areas of skin, including infected areas, ulcers or burns.
3. Severe forms of liver and kidney failure. These conditions may affect the metabolism and elimination of drug components, increasing the risk of adverse reactions.
4. Haemophilia or other bleeding disorders. Heparin sodium in the composition may increase the tendency to bleeding.
5. First trimester of pregnancy. Caution is advised 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 pass into breast milk, its use during breastfeeding should be discussed with a doctor.

Side effects Dolobene

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

Overdose

1. Heparin sodium:

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

2. Dexpanthenol:

   • Possible complications associated with reactivation of the potassium ion activation pathway: including the development of hyperkalemia, especially in individuals with impaired renal function.

3. Dimethyl sulfoxide (DMSO):

   • When taking dimethyl sulfoxide orally, digestive problems, nausea, vomiting, dizziness, headache and other undesirable reactions may occur.
   • If applied to the skin, excessive amounts of DMSO may cause skin irritation, skin rashes, or allergic reactions.

Interactions with other drugs

1. Drugs that enhance anticoagulation: Heparin sodium is an anticoagulant, and its combined use with other anticoagulants such as warfarin or heparin may result in increased anticoagulant effects and an increased risk of bleeding.
2. Drugs affecting hematopoiesis: Using Dolobene with drugs that affect platelet function or the blood clotting system may increase the risk of bleeding or interfere with the formation of blood clots.
3. Topical preparations: When used together with other external preparations, especially those containing antiseptics, antimicrobials or steroids, interaction with the components of Dolobene may occur, resulting in a change in their absorption or effectiveness.
4. Drugs that affect kidney function: Since heparin sodium is excreted from the body through the kidneys, concomitant use of Dolobene with other drugs that affect kidney function may increase the risk of negative effects on the kidneys.
5. Drugs affecting the liver: Paracetamol contained in Doloben is metabolized in the liver. Concomitant use with other drugs that affect the liver or have hepatotoxic properties may lead to increased negative effects on the liver.
6. Drugs that cause allergic reactions: Any component of Dolobene may cause an allergic reaction in sensitive patients. Taking with other medications may increase the risk of allergic reactions.

Storage conditions

1. Storage temperature: The drug should usually be stored at room temperature, i.e. From 15°C to 25°C. This means that it must 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 drugs may have special storage instructions, such as requiring refrigeration or not freezing. It is important to read and follow these instructions carefully.
4. Additional instructions: If a drug has special storage requirements or restrictions, they are usually indicated on the packaging or in the official information about the drug.