HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION.
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, for intravenous use
Initial U.S. Approval: 1939 INDICATIONS AND USAGEHEPARIN SODIUM IN SODIUM CHLORIDE 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 | Every 4 to 6 hours | 5,000 Units to 10,000 Units | Continuous Intravenous Infusion | Initial Dose | 5,000 Units | Continuous | 20,000 Units to 40,000 Units/24 hours | *Based on 150 lb (68 kg) patient. |
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- Cardiovascular Surgery (2.5)
Intravascular via Total Body Perfusion | Initial Dose | Not less than 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 STRENGTHSHeparin sodium is available as: (3) - •
- Injection: 100 USP Units/mL in Sodium Chloride clear solution (25,000 USP Units/250 mL) in single-dose flexible plastic container
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- Injection: 50 USP Units/mL in Sodium Chloride clear solution (12,500 USP Units/250 mL) in single-dose flexible plastic container
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- Injection: 50 USP Units/mL in Sodium Chloride clear solution (25,000 USP Units/500 mL) in single-dose flexible plastic container
CONTRAINDICATIONS- •
- History of Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) (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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- With an uncontrollable active bleeding state, except when treating 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. Use caution in conditions with increased risk of hemorrhage (5.2)
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- HIT (With or Without Thrombosis): Monitor for signs and symptoms and discontinue if indicative of HIT (With or Without Thrombosis) (5.3)
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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)
ADVERSE REACTIONSMost common adverse reactions are hemorrhage, thrombocytopenia, HIT (With or Without Thrombosis), local irritation, hypersensitivity reactions, and elevations of aminotransferase levels. (6.1) 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: 3/2022 |