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Heparin Sodium Injection

FDA Drug Information • Also known as: Heparin Sodium

Brand Names
Heparin Sodium
Route
INTRAVENOUS, SUBCUTANEOUS
Dosage Form
INJECTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of heparin sodium, USP (representative subunits): Heparin Sodium Injection, USP is a sterile solution of heparin sodium, USP derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with benzyl alcohol is available in the following concentrations/mL: pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. Formula1.jpg Image5.jpg

What Is Heparin Sodium Injection Used For?

INDICATIONS AND USAGE Heparin Sodium Injection is indicated for:

  • Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
  • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;
  • Atrial fibrillation with embolization;
  • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
  • Prevention of clotting in arterial and cardiac surgery;
  • Prophylaxis and treatment of peripheral arterial embolism.
  • Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. Heparin Sodium Injection is an anticoagulant indicated for (1)
  • Prophylaxis and treatment of venous thrombosis and pulmonary embolism
  • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
  • Atrial fibrillation with embolization
  • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
  • Prevention of clotting in arterial and cardiac surgery
  • Prophylaxis and treatment of peripheral arterial embolism
  • Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures

    • Dosage and Administration

    Dosage and Administration 2.1 Preparation for Administration Confirm the choice of the correct heparin sodium injection vial to ensure that the 1 mL vial is not confused with a “catheter lock flush” vial or other 1 mL vial of incorrect strength [see WARNINGS AND PRECAUTIONS (5.1)].Confirm the selection of the correct formulation and strength prior to administration of the drug. To lessen this risk, the 1 mL vial includes a red cautionary label that extends above the main label. Read the cautionary statement and confirm that you have selected the correct medication and strength. Then locate the “Tear Here” point on the label, and remove this red cautionary label prior to removing the flip-off cap. When heparin is added to an infusion solution for continuous intravenous administration, invert the container repeatedly to ensure adequate mixing and prevent pooling of the heparin in the solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and the seal is intact. Do not use if solution is discolored or contains a precipitate. Administer heparin sodium injection by intermittent intravenous injection, intravenous infusion, or deep subcutaneous (intrafat, i.e., above the iliac crest or abdominal fat layer) injection. Do not administer heparin sodium injection by intramuscular injection because of the risk of hematoma at the injection site [see ADVERSE REACTIONS (6)]. 2.2 Laboratory Monitoring for Efficacy and Safety Adjust the dosage of heparin sodium injection according to the patient’s coagulation test results. Dosage is considered adequate when the activated partial thromboplastin time (aPTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value. When initiating treatment with heparin sodium injection by continuous intravenous infusion, determine the coagulation status (aPTT, INR, platelet count) at baseline and continue to follow aPTT approximately every 4 hours and then at appropriate intervals thereafter. When the drug is administered intermittently by intravenous injection, perform coagulation tests before each injection during the initiation of treatment and at appropriate intervals thereafter. After deep subcutaneous (intrafat) injections, tests for adequacy of dosage are best performed on samples drawn 4 to 6 hours after the injection. Periodic platelet counts and hematocrits are recommended during the entire course of heparin therapy, regardless of the route of administration. 2.3 Therapeutic Anticoagulant Effect with Full-Dose Heparin The dosing recommendations in Table 1 are based on clinical experience. Although dosages must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines: Table 1: Recommended Adult Full-Dose Heparin Regimens for...

    Side Effects (Adverse Reactions)

    ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hemorrhage [see WARNINGS AND PRECAUTIONS (5.2)]
  • Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see WARNINGS AND PRECAUTIONS (5.3)]
  • Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [see WARNINGS AND PRECAUTIONS (5.4)]
  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS (5.5)]
  • Heparin Resistance [see WARNINGS AND PRECAUTIONS (5.7)]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS (5.8)] 6.1 Postmarketing Experience The following adverse reactions have been identified during post approval use of heparin sodium injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Hemorrhage is the chief complication that may result from heparin therapy [see WARNINGS AND PRECAUTIONS (5.2)]. Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect:
  • Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases.
  • Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term heparin therapy.
  • Retroperitoneal hemorrhage
  • HIT and HITT, including delayed onset cases [see WARNINGS AND PRECAUTIONS (5.3)].
  • Local Irritation – Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium. Because these complications are much more common after intramuscular use, the intramuscular route is not recommended.
  • Histamine-like reactions – Such reactions have been observed at the site of injections. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin, occasionally requiring skin grafting [see WARNINGS AND PRECAUTIONS (5.3)].
  • Hypersensitivity – Generalized hypersensitivity reactions have been reported, with chills, fever and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring less frequently. Itching and burning, especially on the plantar side of the feet, may occur. [see WARNINGS AND PRECAUTIONS (5.8)]
  • Elevations of aminotransferases – Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin [see DRUG INTERACTIONS (7)].
  • Miscellaneous - Osteoporosis following long-term administration of high doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported. Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

    • Contraindications

    CONTRAINDICATIONS The use of heparin sodium injection is contraindicated in patients with the following conditions:

  • History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see WARNINGS AND PRECAUTIONS (5.3)];
  • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see ADVERSE REACTIONS (6.1)]
  • In whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);
  • An uncontrolled active bleeding state [see WARNINGS AND PRECAUTIONS (5.4)], except when this is due to disseminated intravascular coagulation.
  • Severe thrombocytopenia (4)
  • When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (4)
  • An uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation (4)

    • Overdosage

    OVERDOSAGE Bleeding is the chief sign of heparin overdosage. Neutralization of Heparin Effect When clinical circumstances (bleeding) require reversal of the heparin effect, protamine sulfate (1% solution) 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 USP heparin units. 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 1/2 hour after intravenous injection. Because fatal reactions often resembling anaphylaxis have been reported with protamine, it should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. For additional information consult the labeling of protamine sulfate injection.

    How Supplied

    HOW SUPPLIED/STORAGE AND HANDLING Heparin Sodium Injection, USP preserved with benzyl alcohol is available in the following strengths and in single-dose vials as a package of 25s carton: *Discard unused portion Heparin Sodium Injection, USP preserved with benzyl alcohol is available in the following strengths and in multiple-dose vials as a package of 25s carton: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 67457-602-99 Package of 25 NDC 0404-9873-01 1 single-dose vial in a bag (Vial bears NDC 67457-602-02) 10,000 USP units per mL (1 mL-fill) Image6.jpg Image7.jpg

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.