Dextrose and Heparin

Heparin Sodium in 5% Dextrose Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation Treatment of acute and chronic consumption 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 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 closing 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*. Intermittent Intravenous Injection Initial Dose 10,000 Units Subsequent Doses 5,000 to 10,000 Units every 4 to 6 hours Continuous Intravenous Infusion Initial Dose 5,000 Units by intravenous injection Continuous 20,000 to 40,000 Units every 24 hours * Based on 150 lb. (68 kg) patient. Cardiovascular Surgery. Intravascular via Total Body Perfusion Initial Dose Greater than or equal to 150 units/kg, adjust for longer procedures Extracorporeal Dialysis. Intravascular via Extracorporeal Dialysis Follow equipment manufacturer's operating directions carefully. For pediatric dosing see section 2.4 of full prescribing information.

The use of HEPARIN SODIUM in 5% Dextrose Injection is contraindicated in patients with the following conditions: History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) 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) Uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT).

Fatal Medication Errors: Confirm choice of correct strength prior to administration. Hemorrhage: Fatal cases have occurred. Monitor for signs of bleeding and manage promptly. HIT or HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. SCARs: Fatal cases have occurred. Interrupt if symptoms occur and permanently discontinue therapy if concluded to be SCAR. Thrombocytopenia: Monitor platelet count during therapy, discontinue heparin in HIT or HITT is suspected. Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin. Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.

The following serious adverse reactions are described elsewhere in the labeling: Hemorrhage Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis Severe Cutaneous Adverse Reactions (SCARs) Thrombocytopenia Heparin Resistance Hypersensitivity Hyperkalemia Elevations of Serum Aminotransferases Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, heparin resistance, hypersensitivity reactions, hyperkalemia, 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°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F).