Heparin

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.

Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin does not have fibrinolytic activity, therefore, it will not lyse existing clots.

Recommended Adult Dosages: • Therapeutic Anticoagulant Effect with Full-Dose Heparin†. Deep Subcutaneous (Intrafat) Injection Use a different site for each injection Initial Dose 5,000 units by intravenous injection followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously Every 8 hours or Every 12 hours 8,000 to 10,000 units of a concentrated solution 15,000 to 20,000 units of a concentrated solution Intermittent Intravenous Injection Initial Dose 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Every 4 to 6 hours 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Intravenous Infusion Initial Dose 5,000 units by intravenous injection Continuous 20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion † Based on 150 lb (68 kg) patient.

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, • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions), • 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, except when this is due to disseminated intravascular coagulation.

• Fatal Medication Errors: Confirm choice of correct strength prior to administration. • Hemorrhage: Hemorrhage, including fatal events, has occurred in patients receiving heparin. Use caution in conditions with increased risk of hemorrhage. • HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS. • Benzyl Alcohol Toxicity: Use preservative-free formulation in neonates and infants • Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Periodically monitor platelet count, hematocrit, and occult blood in stool in all patients receiving heparin

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hemorrhage • Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis • Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative • Thrombocytopenia • Heparin Resistance • Hypersensitivity Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels.

Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding Oral Anticoagulants Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn, if a valid prothrombin time is to be obtained.

Store at 20° to 25°C (68° to 77°F).