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  • Heparin EP Lock Flush Solution
    / Kamada


    Active Ingredient
    Heparin Sodium 10 IU/ml, 100 IU/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 ml X 10 IU/ml

    not in the basket chart 80940 8360

    Vial

    10 ml X 100 IU/ml

    full basket chart 28952 8029

    Dosage

    See prescribing information for full details.


    Indications

    For maintenance of patency of indwelling intravenous catheter designed for intermittent injection therapy or blood sampling. Should not be used for anticoagulant therapy.


    Contra-Indications

    Hypersensitivity to heparin, severe thrombocytopenia. Should not be used in patients with an uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation.


    Special Precautions

    Infants with disease states in which there is an increased danger of hemorrhage. An overly prolonged clotting time or minor bleeding can usually be controlled by withdrawing the drug.
    Use with extreme caution in disease states in which there is increased danger of hemorrhage. See prescribing information for full details.
    Neonatologists do not advise the use of the 100 unit/ml concentration because of the risk of bleeding, especially in low birth weight infants. Not intended for intramuscular use.
    Patients may develop new thrombus formation in association with thrombocytopenia, the so-called “hite clot syndrome”. Therefore, administration should be promptly discontinued if a patient develops a new thrombosis in association with thrombocytopenia.
    Increased resistance to the drug is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, MI, cancer and postoperative states.
    A higher incidence of bleeding has been reported in women over 60 years of age. Periodic platelet count, hematocrit, and tests for occult blood in stool are recommended during the entire course of heparin therapy. Precautions must be exercised with drugs which are incompatible with heparin or administered through an indwelling intravenous catheter containing the solution.


    Side Effects

    Hemorrhage: See prescribing information for full details. Local reactions: Avoid IM. Hypersensitivity. Osteoporosis and function suppression after long-term high doses; cutaneous necrosis, suppressed aldosterone synthesis, delayed transient alopecia, priapism and rebound hyperlipemia after discontinuation. Significant elevation of aminotransferase SGOT and SGPT.


    Drug interactions

    Drugs that interfer with platelet aggregation reactions. Digitalis, tetracyclines, nicotine or antihistamines.


    Pregnancy and Lactation

    Pregnancy: Should be given to a pregnant woman only if clearly needed.
    Lactation: Not excreted in human milk.


    Overdose

    Symptoms: Bleeding is the chief sign of heparin overdose. Nosebleeds blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.
    Treatment: Neutralization of heparin effect.
    When clinical circumstances (bleeding) require reversal of heparinization protamine sulfate by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly, in any 10 minute period.
    Each mg of protamine sulfate neutralizes approximately 100 International units of heparin. The amount of protamine required decreases over time, as heparin is metabolized.
    Although the metabolism of heparin is complex it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about ½ hour after intravenous injection. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and dose administered.
    It is important to avoid overdose of protamine sulphate because protamin sulphate itself has anticoagulant properties.
    Administration of protamine sulfate can cause severe hypotensive and
    anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readil available.
    For additional information consult the labeling of Protamine Sulfate Injection products.


    Manufacturer
    Kamada Ltd.
    Licence holder
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