Hepatrombin C (Gel) Instructions for Use

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

ATC Code

C05BA53 (Heparin in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Heparin sodium (Rec.INN registered by WHO)

Dimethyl sulfoxide (Rec.INN registered by WHO)

Dosage Form

Hepatrombin C

Gel for external use 500 IU+150 mg+25 mg/g: tube 40 g

Dosage Form, Packaging, and Composition

Gel for external use white transparent homogeneous with a characteristic odor.

Excipients: isopropanol 353.3 mg, carbomer 940 10 mg, macrogol glycerol hydroxystearate 10 mg, trolamine 5 mg, mountain pine oil 2.5 mg, rosemary oil 2 mg, lemon oil 0.5 mg, purified water 438.6 mg.

40 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antithrombotic and tissue regeneration-improving action for topical use

Pharmacotherapeutic Group

Direct-acting anticoagulant for topical use + other drugs

Pharmacological Action

A combined drug for external use. The action of the drug is due to the active substances included in its composition.

Heparin sodium is a direct-acting anticoagulant; due to the inactivation of biogenic amines and blocking of lysosomal enzymes in tissues, it exhibits an anti-inflammatory effect; accelerates the dissolution of microthrombi in the area of subcutaneous capillaries; improves local blood flow; promotes the regeneration of connective tissue by inhibiting the activity of hyaluronidase. When applied topically, it also has an anti-edema effect.

Dexpanthenol (provitamin B₅) exhibits anti-inflammatory and dermatoprotective effects; by improving metabolic processes, it stimulates regeneration processes. By improving the processes of epithelialization and granulation, it promotes the regeneration of damaged tissues.

Dimethyl sulfoxide has anti-inflammatory, local anesthetic, analgesic, and antimicrobial effects; has moderate fibrinolytic activity. It penetrates through the skin, mucous membranes, and biological membranes, and promotes deeper penetration of other components of the drug into the tissues.

Pharmacokinetics

Heparin sodium, when applied externally, quickly penetrates the skin: 1 hour after applying the gel to the skin, the concentration in the underlying tissues is comparable to the concentration observed after IV administration of 5000 IU of heparin. Heparin does not cross the placental barrier and is not excreted in breast milk.

Dexpanthenol – after resorption into the skin, it is converted into pantothenic acid (vitamin B5), which, being a component of coenzyme A, is involved in numerous metabolic processes.

Dimethyl sulfoxide quickly penetrates through the skin, mucous membranes, and biological membranes (including through the membranes of microbial cells). After application to the skin, C_max in plasma is reached after 4-8 hours. It is evenly distributed in the body, except for the brain, where its concentration is minimal. It is excreted mainly in the urine (30% of the dose as unchanged drug and dimethyl sulfone); to a small extent – through the lungs and intestines. The metabolite dimethyl sulfide causes a characteristic garlic odor from the mouth in some patients.

Indications

• Hematomas, inflammation of soft tissues, muscles, tendons, tendon sheaths, ligaments after bruises, compressions, injuries (including sports injuries);
• Scapulohumeral periarthritis;
• Humeral epicondylitis (“tennis elbow”);
• Tendinitis, tenosynovitis;
• Bursitis;
• Deforming osteoarthritis (in the presence of damage to periarticular tissues);
• Neuralgia.

ICD codes

Dosage Regimen

Externally.

The gel is applied in a thin layer to the affected areas of the skin or the skin over the painful area, trying to avoid applying the drug directly to wounds and abrasions. After applying the gel, a bandage should not be applied. Before application, the skin should be clean and dry.

The procedure is repeated 1-2 times a day for 7-10 days or until the symptoms of the disease disappear (pain, swelling, inflammation). If no distinct improvement occurs within 10 days of using the gel, it is recommended to consult a doctor.

Adverse Reactions

Redness, itching and burning of the skin in the application area; allergic reactions (urticaria, angioedema); garlic odor from the mouth; change in taste sensations.

Contraindications

• Hypersensitivity to heparin, dimethyl sulfoxide, dexpanthenol and other components of the drug;
• Bronchial asthma;
• Pregnancy;
• Lactation period;
• Severe hepatic and/or renal failure;
• Severe disorders of the cardiovascular system (including severe angina pectoris, myocardial infarction, stroke, severe general atherosclerosis);
• Lupus erythematosus;
• Open wounds at the site of drug application;
• Children under 5 years of age.

Use in Pregnancy and Lactation

Hepatrombin C gel is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

Contraindication: severe hepatic failure.

Use in Renal Impairment

Contraindication: severe renal failure.

Pediatric Use

Contraindication: children under 5 years of age.

Special Precautions

It is not recommended to apply the gel to open wounds.

If skin allergic reactions occur, treatment should be discontinued.

Overdose

To date, no cases of overdose with Hepatrombin C have been reported. With proper use of the gel, overdose is unlikely.

Drug Interactions

The Dimethyl sulfoxide included in the gel significantly enhances the penetration of other drugs through the skin. To prevent undesirable effects of these substances, other drugs should not be applied to the skin before or after applying Hepatrombin C.

Storage Conditions

The drug should be stored out of the reach of children at a temperature of 15 to 25°C (77°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.