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heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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

INDICATIONS AND USAGE

HEPARIN SODIUM IN 5% DEXTROSE INJECTION is indicated for: (1)

  • 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

DOSAGE AND ADMINISTRATION

Recommended Adult Dosages:

  • Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
Intermittent Intravenous InjectionInitial Dose10,000 Units, either undiluted or in 50 to 100 mL of 5% Dextrose Injection
Every 4 to 6 hours5,000 to 10,000 Units, either undiluted or in 50 to 100 mL of 5% Dextrose Injection
Continuous Intravenous InfusionInitial Dose5,000 Units by intravenous injection
Continuous20,000 to 40,000 Units/24 hours in 1000 mL of 5% Dextrose Injection

*Based on 150 lb. (68 kg) patient.

  • Cardiovascular Surgery (2.5)
Intravascular via Total Body PerfusionInitial Dose≥150 units/kg; adjust for longer procedures
  • Extracorporeal Dialysis (2.8)
Intravascular via Extracorporeal DialysisFollow equipment manufacturer's operating directions carefully.

For pediatric dosing see section 2.4 of full prescribing information.

DOSAGE FORMS AND STRENGTHS

  • Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection (3)
  • Heparin Sodium 10,000 USP units per 100 mL (100 USP units per mL) in 5% Dextrose Injection (3)
  • 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) (With or Without Thrombosis) (4)
  • Known hypersensitivity to heparin or pork products (4)
  • In whom suitable blood coagulation tests cannot be performed at appropriate intervals (4)
  • With an uncontrollable active bleeding state, except when treating disseminated intravascular coagulation (4)
  • Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products (4)

WARNINGS AND PRECAUTIONS

  • Fatal Medication Errors: Confirm choice of correct strength prior to administration. (5.1)
  • Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage. (5.2)
  • HIT (With or Without Thrombosis): Monitor for signs and symptoms and discontinue if indicative of HIT (With or Without Thrombosis). (5.3)
  • Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin. (5.5)

ADVERSE REACTIONS

Most 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 INTERACTIONS

Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2018

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