Heparin gel 1000 IU/g
Gelum Heparini
International Non-proprietary Name
Heparin.
Heparin
Pharmacotherapeutic group
Anticoagulants. Heparin.
Composition
Active substances – heparin. – 1000 IU/g; excipients – carbopol 980 NF, menthol, nipagin, nipasol, ethyl alcohol rectified 96%, trolamine, purified water.
Pharmacological action
Pharmacodynamics
Heparin gel when applied on the skin prevents thrombus formation, exhibits moderate anti-inflammatory, antiexudative action and has a local analgesic effect. It blocks the formation of thrombin, inhibits hyaluronidase activity, activates fibrinolytic blood properties.
Heparin gradually released from the gel exhibits antithrombotic activity and decreases inflammatory process, enhances microcirculation and activates tissue exchange, due to this it accelerates the process of hematoma and thrombus resolution and reduces tissue puffiness.
Pharmacokinetics
Heparin poorly penetrates through intact skin and mucosa, due to this the preparation virtually does not exhibit systemic resorptive action.
After absorption heparin is metabolized in the liver (partially by hepatic heparinase enzyme) and in reticulo-endothelial system. Plasma elimination half-life is 30-60 min.
Indications
Heparin gel is used in thrombophlebitis of extremities (predominantly superficial), hemorrhoidal veins thrombosis, phlebitis after repeated intravenous injection, elephantiasis, superficial periphlebitis, lymphangitis, superficial mastitis, localized infiltrates and edemas, traumas and injuries (including muscular tissue, tendons, joints), subcutaneous hematoma.
Administration and dosing regimen
Thrombophlebitis of extremities, phlebitis after repeated intravenous injections. The gel is applied in thin layer (0.5-1 g on a surface of 3-5 cm in diameter) on the effected area and rubbed into the skin with caution.
Hemorrhoidal veins thrombosis. The gel is applied on a cotton or linen padding, which is applied directly onto piles and fixed with bandage. Swab impregnated with heparin gel, which is introduced into anus also can be used. The duration of treatment is 3-4 days.
The gel is applied 2-3 times daily till the disappearance of inflammatory events, on average for 3 - 14 days. The possibility of more prolonged course of treatment should be determined by the doctor.
Special indications
Application during pregnancy is possible only according to indication, under medical control. Application during lactation is possible - according to the indications.
Side effects
In isolated cases local allergic reactions and skin flushing can occur.
When used in recommended doses toxic effects are not reported.
Contraindications
Application of heparin gel is contraindicated in ulcerous-necrotic processes in thrombophlebitis area, traumatic lesions of skin integrity, as well as in case of decreased coagulation, thrombocytopenia. Hypersensitivity to gel components.
Precautions
Do not apply on open wounds, on mucosa, should not be used in the presence of pyogenic processes.
Drug interactions
Anticoagulative activity of heparin is enhanced with concomitant use of anticoagulants, antiaggregants and NSAIDs. Ergot alkaloids, thyroxine, tetracycline, antihistamines and nicotine decrease the effect of heparin.
Overdosage
Due to low systemic absorption overdose is unlikely. There are no reports about overdosage during treatment with heparin gel.
Prolonged application on large areas can cause hemorrhagic complications.
Treatment: withdrawal of treatment. Heparin antagonist — protamine sulphate (1% solution) can be used if necessary.
Presentation
30g in aluminium tubes. Each tube is packed into a carton with a package-insert.
