HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use HEPARIN SODIUM IN 5% DEXTROSE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN 5% DEXTROSE INJECTION.
HEPARIN SODIUM IN 5% DEXTROSE INJECTION, for intravenous use
Initial U.S. Approval: 1939 RECENT MAJOR CHANGES Contraindications (4) | 12/2023 | Warnings and Precautions, Hemorrhage (5.2) | 12/2023 | Warnings and Precautions, Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) (5.3) | 12/2023 | Warnings and Precautions, Hypersensitivity Reactions (5.7) | 12/2023 | Warnings and Precautions, Hyperkalemia (5.8) | 12/2023 | Warnings and Precautions, Elevations of Serum Aminotransferases (5.9) | 12/2023 |
INDICATIONS AND USAGEHeparin Sodium in 5% Dextrose Injection is indicated for: (1) - •
- Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
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- Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation.
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- Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation).
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- Prevention of clotting in arterial and cardiac surgery.
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- Prophylaxis and treatment of peripheral arterial embolism.
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- Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
DOSAGE AND ADMINISTRATIONRecommended Adult Dosages: - •
- Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
Intermittent Intravenous Injection | Initial Dose | 10,000 Units, either undiluted or in 50 to 100 mL of 5% Dextrose Injection | Subsequent Doses | 5,000 to 10,000 Units every 4 to 6 hours, either undiluted or in 50 to 100 mL of 5% Dextrose Injection | Continuous Intravenous Infusion | Initial Dose | 5,000 Units by intravenous injection | Continuous | 20,000 to 40,000 Units every 24 hours in 1000 mL of 5% Dextrose Injection |
*Based on 150 lb. (68 kg) patient. - •
- Cardiovascular Surgery (2.5)
Intravascular via Total Body Perfusion | Initial Dose | Greater than or equal to 150 units/kg; adjust for longer procedures |
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- Extracorporeal Dialysis (2.8)
| For pediatric dosing see section 2.4 of full prescribing information. | Intravascular via Extracorporeal Dialysis | Follow equipment manufacturer's operating directions carefully. |
DOSAGE FORMS AND STRENGTHS- •
- Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection. (3)
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- Heparin Sodium 10,000 USP units per 100 mL (100 USP units per mL) in 5% Dextrose Injection. (3)
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- Heparin Sodium 12,500 USP units per 250 mL (50 USP units per mL) in 5% Dextrose Injection. (3)
CONTRAINDICATIONS- •
- History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT). (4)
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- Known hypersensitivity to heparin or pork products. (4)
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- In whom suitable blood coagulation tests cannot be performed at appropriate intervals. (4)
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- Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation. (4)
WARNINGS AND PRECAUTIONS- •
- Fatal Medication Errors: Confirm choice of correct strength prior to administration. (5.1)
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- Hemorrhage: Fatal cases have occurred. Monitor for signs of bleeding and manage promptly. (5.2)
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- HIT or HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. (5.3)
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- Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. (5.4)
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- Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin. (5.5)
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- Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. (5.6)
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- Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. (5.7)
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- Hyperkalemia: Measure plasma potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients. (5.8)
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- Elevations of Serum Aminotransferases: Interpret elevation of these enzymes with caution. (5.9)
ADVERSE REACTIONSMost common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, heparin resistance, hypersensitivity reactions, hyperkalemia, and elevations of aminotransferase levels. (6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSDrugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. (7) See 17 for PATIENT COUNSELING INFORMATION. Revised: 12/2023 |