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Heparin (Gel) Instructions for Use

ATC Code

C05BA03 (Heparin sodium)

Active Substance

Heparin sodium (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antithrombotic action for topical use

Pharmacotherapeutic Group

Direct-acting anticoagulant for topical use

Pharmacological Action

A direct anticoagulant for external use. When applied externally, it exerts a local antithrombotic, anti-exudative, and moderate anti-inflammatory effect.

It blocks the formation of thrombin, inhibits the activity of hyaluronidase, and activates the fibrinolytic properties of blood.

Heparin penetrating the skin reduces the inflammatory process and exerts an antithrombotic effect, improves microcirculation, and activates tissue metabolism, thereby accelerating the processes of resorption of hematomas and thrombi and reducing tissue swelling.

Pharmacokinetics

A small amount of heparin is absorbed from the skin surface into the systemic circulation.

The Cmax of the active substance in the blood is observed 8 hours after application.

Heparin sodium is excreted mainly by the kidneys, T1/2 is 12 hours. It does not cross the placental barrier.

Indications

Diseases of superficial veins: varicose veins, chronic venous insufficiency and its associated complications (superficial thrombophlebitis, superficial periphlebitis); blunt trauma and contusions of soft tissues; subcutaneous hematomas (including hematomas after phlebectomy); localized infiltrates and edema of soft tissues.

ICD codes

ICD-10 code Indication
I80 Phlebitis and thrombophlebitis
I83 Varicose veins of lower extremities
I87.2 Venous insufficiency (chronic) (peripheral)
R60 Edema, not elsewhere classified
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T81.0 Haemorrhage and haematoma complicating a procedure, not elsewhere classified
ICD-11 code Indication
BD70.0 Superficial thrombophlebitis of lower extremities
BD70.Z Superficial thrombophlebitis, unspecified
BD71.4 Deep vein thrombosis of lower extremity
BD74.1Z Varicose veins of lower extremities, unspecified
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
BD7Z Diseases of veins, unspecified
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
MG29.Z Edema, unspecified
ND56.0 Superficial injury of unspecified body region
NE81.0Z Hemorrhage or hematoma of other or unspecified sites complicating a procedure, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the gel externally to intact skin over the affected area.

Use a thin layer of gel, applying it 1 to 3 times daily.

Gently rub the gel into the skin until fully absorbed.

Continue application daily until inflammatory symptoms resolve, typically for a duration of 3 to 7 days.

Do not apply to open wounds, mucous membranes, or areas with ulcerative or necrotic skin changes.

Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

Wash hands before and after application unless the hands are the treatment area.

Do not cover the application site with occlusive dressings unless directed by a physician.

If no improvement is observed after one week of use, discontinue the product and consult a physician.

For extensive or prolonged use, especially with concurrent oral anticoagulants, monitor coagulation parameters.

Adverse Reactions

In some cases: hypersensitivity reactions, which may be due to the active substance, as well as excipients included in the drug used – skin redness, skin itching, which usually disappear after discontinuation of the drug.

Contraindications

Hypersensitivity to heparin sodium, ulcerative-necrotic skin changes at the sites of intended application of the drug, traumatic violation of the integrity of the skin, increased tendency to bleeding, thrombocytopenia, age under 18 years.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible if the intended benefit to the mother outweighs the potential risk to the fetus.

Heparin sodium does not cross the placental barrier and into breast milk.

Due to insignificant absorption of heparin during external use, it does not have a systemic effect on the body.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

No special precautions.

Special Precautions

It is not recommended to use for bleeding, in the presence of local purulent processes, and also to apply to open wounds, mucous membranes.

Use with particular caution in cases of increased vascular permeability.

Not recommended for deep vein thrombosis.

With prolonged use of the drug on large areas of the skin and simultaneous use of indirect anticoagulants (including warfarin, acenocoumarol), prothrombin time and blood clotting time should be monitored.

Drug Interactions

A drug for external use containing Heparin sodium is not recommended to be mixed with other topical agents.

Simultaneous application with NSAIDs, tetracyclines, and antihistamines is not recommended.

Concomitant use with oral anticoagulants may cause prolongation of prothrombin time.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Heparin 1000 Gel for external use 1000 IU/g: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or with a slightly yellowish tint, almost transparent gel with a characteristic odor.

100 g
Heparin sodium 100000 IU

Excipients : methylparahydroxybenzoate – 0.15 g, ethanol 95% – 24 g, carbomer – 1 g, trometamol – 0.5 g, orange flower oil – 0.025 g, lavender oil – 0.025 g, water – up to 100 g.

30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Heparin-Akrikhin 1000 Gel for external use 1000 IU/1 g: tubes 30 g, 50 g or 100 g

Dosage Form, Packaging, and Composition

Gel for external use transparent or almost transparent, colorless or with a slightly yellowish tint, with a specific odor.

1 g
Heparin sodium (calculated on dry substance) 0.0083 g (1000 IU)

Excipients : methylparahydroxybenzoate, ethanol 96%, carbomer 940, trometamol, lavender oil, orange flower oil (neroli oil), purified water.

30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
100 g – aluminum tubes (1) – cardboard boxes.

Marketing Authorization Holder

Danson-BG (Bulgaria)

Manufactured By

Vetprom, AD (Bulgaria)

Dosage Form

Bottle OTC Icon Heparin DS Gel for external use 1000 IU/1 g: tubes 30 g, 40 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or with a slightly yellowish tint, almost transparent, viscous consistency, with a characteristic odor.

100 g
Heparin sodium 0.83 g

Excipients : carbomer 940 – 1.25 g, ethanol 96% – 24.22 g, trolamine – 0.85 g, methylparahydroxybenzoate – 0.12 g, propylparahydroxybenzoate – 0.03 g, lavender oil – 0.05 g, purified water – up to 100 g.

30 g – aluminum tubes (1) – cardboard boxes.
40 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.

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