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Heparin ointment (Ointment) Instructions for Use

ATC Code

C05BA53 (Heparin in combination with other drugs)

Active Substances

Heparin sodium (Rec.INN registered by WHO)

Benzocaine (Rec.INN registered by WHO)

Benzylnicotinat (DAB German Pharmacopoeia)

Clinical-Pharmacological Group

A drug with antithrombotic action for topical use

Pharmacotherapeutic Group

Angioprotectors; preparations for the treatment of varicose veins; heparins or heparinoids for topical application

Pharmacological Action

A combined medicinal product for external use.

Heparin is a direct-acting anticoagulant belonging to the group of medium molecular weight heparins. When applied externally, it exerts a local anticoagulant, anti-exudative, and moderate anti-inflammatory effect. It blocks the formation of thrombin. Heparin reduces the inflammatory process and exerts an anticoagulant effect, indirectly improves microcirculation, which promotes the process of resorption of hematomas and thrombi and reduces tissue swelling.

Benzocaine is a local anesthetic for superficial anesthesia. By reducing the permeability of the cell membrane to sodium ions, it blocks the conduction of nerve impulses. It prevents the occurrence of pain impulses in the endings of sensory nerves and their conduction along nerve fibers.

Benzyl nicotinate dilates superficial vessels, promoting the absorption of heparin.

Pharmacokinetics

Heparin. It is absorbed insignificantly. Plasma protein binding is up to 95%, Vd is 0.06 L/kg. It does not cross the placental barrier and into breast milk. It is intensively captured by endothelial cells and cells of the mononuclear-macrophage system, concentrated in the liver and spleen. It is metabolized in the liver by N-desulfamidase and platelet heparinase, which is involved in the metabolism of heparin at later stages. Desulfated molecules are converted into low molecular weight fragments under the influence of renal endoglycosidase. T1/2 is 1-6 hours (on average – 1.5 hours); it increases with obesity, hepatic and/or renal insufficiency; it decreases with pulmonary embolism, infections, malignant tumors.

It is excreted by the kidneys mainly as inactive metabolites, and only when used in high doses is excretion (up to 50%) in unchanged form possible. It is not excreted by hemodialysis.

Benzocaine is practically not absorbed when applied externally. It is hydrolyzed by plasma and hepatic cholinesterase to metabolites of para-aminobenzoic acid and is excreted in the urine.

Indications

Superficial thrombophlebitis (prevention and treatment); post-injection and post-infusion phlebitis; external hemorrhoids; inflammation of postpartum hemorrhoids; trophic ulcers of the leg; elephantiasis; superficial periphlebitis; lymphangitis; superficial mastitis; localized infiltrates and edema; injuries and bruises (including those of muscle tissue, tendons, joints), subcutaneous hematoma.

ICD codes

ICD-10 code Indication
I80 Phlebitis and thrombophlebitis
I80.0 Phlebitis and thrombophlebitis of superficial vessels of lower extremities
I83.2 Varicose veins of lower extremities with ulcer and inflammation
I89.0 Lymphedema, not elsewhere classified
I89.1 Lymphangitis
K64 Hemorrhoids and perianal venous thrombosis
L98.4 Chronic skin ulcer, not elsewhere classified
N61 Inflammatory diseases of the breast
R60.0 Localized edema
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
ICD-11 code Indication
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
BD70.0 Superficial thrombophlebitis of lower extremities
BD70.Z Superficial thrombophlebitis, unspecified
BD71.4 Deep vein thrombosis of lower extremity
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
BD7Z Diseases of veins, unspecified
BD91 Lymphangitis
BD93.Z Lymphedema, unspecified
DB6Z Hemorrhoids or perianal venous diseases, unspecified
EA40 Tropical phagedenic ulcer
EF60 Ischemic ulceration of the skin
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
EM0Z Unspecified skin disorder
GB21.Z Inflammatory diseases of the breast, unspecified
ME60.2 Ulcerative skin lesion of unspecified nature
MG29.0 Localized edema
ND56.0 Superficial injury of unspecified body region
ND56.3 Dislocation, sprain or strain of unspecified body region

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.

Ointment

For external use. Apply a thin layer of the ointment to the affected area (at the rate of 0.5-1 g (2-4 cm of ointment) on an area with a diameter of 3-5 cm) and gently rub the ointment into the skin. The ointment is used 2-3 times a day daily until the inflammatory phenomena disappear, on average from 3 to 7 days. The possibility of a longer course of treatment is determined by the doctor.

For thrombosis of external hemorrhoids, the ointment is applied to a cotton or linen pad, which is applied directly to the thrombosed nodes and fixed. The ointment should be used daily until symptoms disappear, on average from 3 to 14 days; for the same purpose, a tampon soaked in heparin ointment can be used, which is inserted into the anus.

Adverse Reactions

Local reactions skin hyperemia, allergic reactions.

Contraindications

Hypersensitivity; ulcerative-necrotic processes; impaired integrity of the skin, children under 2 years of age.

With caution

Thrombocytopenia, increased bleeding tendency.

Use in Pregnancy and Lactation

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

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

Do not apply to open wounds, to mucous membranes, in the presence of purulent processes.

Avoid contact with eyes due to possible irritation. If the ointment accidentally gets into the eyes, rinse immediately with running water.

Drug Interactions

Do not use externally simultaneously with NSAIDs, tetracyclines, antihistamines.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°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

Altayvitamins, JSC (Russia)

Dosage Form

Bottle OTC Icon Heparin ointment Ointment for external use 100 IU+40 mg+800 mcg/1 g: 10 g or 25 g tubes

Dosage Form, Packaging, and Composition

Ointment for external use 1 g
Heparin sodium 100 IU
Benzocaine 40 mg
Benzyl nicotinate 800 mcg

10 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Belmedpreparaty, JSC (Republic of Belarus)

Dosage Form

Bottle OTC Icon Heparin ointment Ointment for external use 100 IU+40 mg+800 mcg/1 g: 25 g tube

Dosage Form, Packaging, and Composition

Ointment for external use 1 g
Heparin sodium 100 IU
Benzocaine 40 mg
Benzyl nicotinate 800 mcg

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

Marketing Authorization Holder

Zelenaya Dubrava, CJSC (Russia)

Dosage Form

Bottle OTC Icon Heparin ointment Ointment for external use 10000 IU+4 g+0.08 g/100 g: 10 g or 25 g tubes

Dosage Form, Packaging, and Composition

Ointment for external use white with a yellowish tint.

100 g
Heparin sodium 0.0833 g (10000 IU*)
Benzocaine 4 g
Benzyl nicotinate 0.08 g

* at a sodium heparin activity of 120 IU/mg.

Excipients: glycerol (glycerin, distilled glycerin) – 15 g, petrolatum (medical petrolatum) – 6 g, stearin (stearic acid, cosmetic stearin) – 5 g, corn oil (corn oil) – 5 g, emulsifier No. 1 (lanett®SX, neovax®SX) – 8 g, methylparahydroxybenzoate (methylparaben, nipagin) – 0.148 g, propylparahydroxybenzoate (propylparaben, nipasol) – 0.048 g, purified water – up to 100 g.

10 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Dosage Form

Bottle OTC Icon Heparin ointment Ointment for external use 100 IU/1 g+40 mg/1 g+0.8 mg/1 g: 25 g tubes

Dosage Form, Packaging, and Composition

Ointment for external use from white to white with a yellowish tint.

1 g
Heparin sodium 100 IU (0.833 mg*)
Benzocaine 40 mg
Benzyl nicotinate 0.8 mg

* at a sodium heparin activity of 120 IU/mg

Excipients: glycerol, petrolatum, stearic acid 50, peach oil, emulsifier No. 1, methylparahydroxybenzoate, propylparahydroxybenzoate, purified water.

25 g – tubes (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Heparin ointment Ointment for external use: 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g tubes

Dosage Form, Packaging, and Composition

Ointment for external use from white to white with a yellowish tint, homogeneous.

1 g
Heparin sodium 100 IU (0.833 mg*)
Benzocaine 40 mg
Benzyl nicotinate 0.8 mg

* at a sodium heparin activity of 120 IU/mg

Excipients: glycerol – 150 mg, petrolatum – 60 mg, stearic acid – 50 mg, peach oil – 50 mg, emulsifier No. 1 (Lanette SX) – 50 mg, methylparahydroxybenzoate – 1.5 mg, propylparahydroxybenzoate – 0.5 mg, purified water – up to 1 g.

20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.

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