Lioton^® 1000 (Gel) Instructions for Use

Marketing Authorization Holder

A.Menarini Industrie Farmaceutiche Riunite, S.r.l. (Italy)

Manufactured By

A.Menarini Manufacturing Logistics and Services, S.r.l. (Italy)

ATC Code

C05BA03 (Heparin sodium)

Active Substance

Heparin sodium (Rec.INN registered by WHO)

Dosage Form

Lioton® 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 colorless or with a slightly yellowish tint, almost transparent, of viscous consistency, with a pleasant odor.

Excipients: carbomer 940 – 1.25 g, methylparahydroxybenzoate – 0.12 g, propylparahydroxybenzoate – 0.03 g, ethanol 96% – 30 ml, neroli oil – 0.05 g, lavender oil – 0.05 g, trolamine (triethanolamine) – 0.85 g, purified water – up to 100 g.

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

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 through 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 bloodstream.

The C_max of the active substance in the blood is noted 8 hours after application.

Heparin sodium is excreted mainly by the kidneys, T_1/2 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 injuries and contusions of soft tissues; subcutaneous hematomas (including hematomas after phlebectomy); localized infiltrates and edema of soft tissues.

ICD codes

Dosage Regimen

Apply the gel externally to the affected skin area.

Use a column of gel 3 to 5 centimeters long for an area approximately the size of a palm.

Apply the product 1 to 3 times per day.

Gently rub the gel into the skin until fully absorbed.

Continue treatment daily until inflammatory symptoms resolve.

The typical treatment course is 3 to 7 days.

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

Wash hands thoroughly after each application.

Avoid contact with eyes.

Do not cover the treated area with an occlusive dressing.

Discontinue use if signs of hypersensitivity, such as skin redness or itching, occur.

Adverse Reactions

In some cases: hypersensitivity reactions, which may be due to the active substance, as well as the 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 impairment of skin integrity, 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 for use in cases of bleeding, in the presence of local purulent processes, and also for application to open wounds or 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 2°C (36°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.