heparin sodium injection CARPUJECT Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION.

HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use
Initial U.S. Approval: 1984

INDICATIONS AND USAGE

Heparin Sodium Injection is an anticoagulant indicated for (1):

  • Prophylaxis and treatment of venous thrombosis and pulmonary embolism
  • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic 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
  • Use as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures

DOSAGE AND ADMINISTRATION

Recommended Adult Dosages:

  • Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
* Based on 150 lb (68 kg) patient. Adjust dose based on laboratory monitoring.
Deep, Subcutaneous (Intrafat) InjectionInitial dose5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously
Use a different site for each injection.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 InjectionInitial dose10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP
Every 4 to 6 hours5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP
Intravenous InfusionInitial dose5,000 units by intravenous injection
Continuous20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion

DOSAGE FORMS AND STRENGTHS

  • Heparin Sodium: 5,000 USP Units/0.5 mL, Preservative free (3)
  • Heparin Sodium: 5,000 USP Units/1 mL (3)

CONTRAINDICATIONS

  • Severe thrombocytopenia (4)
  • When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (4)
  • An uncontrolled 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)
  • Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage (5.2)
  • HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS (5.3)
  • Benzyl Alcohol Toxicity: Do not use this product in neonates and infants (5.4)
  • Monitoring: Blood coagulation tests guide therapy for full-dose heparin (5.6)
  • Monitor platelet count and hematocrit in all patients receiving heparin (5.5, 5.6)

ADVERSE REACTIONS

Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITTS, local irritation, hypersensitivity reactions, and elevations of aminotransferase levels. (6.2)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Drugs that interfere with platelet aggregation: May induce bleeding. (7.2)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Preservative-free formulation recommended. Limited human data in pregnant women (8.1)
  • Lactation: Advise females not to breastfeed (8.2)
  • Pediatric Use: Use preservative-free formulation in neonates and infants (8.4)
  • Geriatric Use: A higher incidence of bleeding reported in patients, particularly women, over 60 years of age (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2021

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION.

HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use
Initial U.S. Approval: 1984

INDICATIONS AND USAGE

Heparin Sodium Injection is an anticoagulant indicated for (1):

  • Prophylaxis and treatment of venous thrombosis and pulmonary embolism
  • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic 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
  • Use as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures

DOSAGE AND ADMINISTRATION

Recommended Adult Dosages:

  • Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
* Based on 150 lb (68 kg) patient. Adjust dose based on laboratory monitoring.
Deep, Subcutaneous (Intrafat) InjectionInitial dose5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously
Use a different site for each injection.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 InjectionInitial dose10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP
Every 4 to 6 hours5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP
Intravenous InfusionInitial dose5,000 units by intravenous injection
Continuous20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion

DOSAGE FORMS AND STRENGTHS

  • Heparin Sodium: 5,000 USP Units/0.5 mL, Preservative free (3)
  • Heparin Sodium: 5,000 USP Units/1 mL (3)

CONTRAINDICATIONS

  • Severe thrombocytopenia (4)
  • When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (4)
  • An uncontrolled 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)
  • Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage (5.2)
  • HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS (5.3)
  • Benzyl Alcohol Toxicity: Do not use this product in neonates and infants (5.4)
  • Monitoring: Blood coagulation tests guide therapy for full-dose heparin (5.6)
  • Monitor platelet count and hematocrit in all patients receiving heparin (5.5, 5.6)

ADVERSE REACTIONS

Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITTS, local irritation, hypersensitivity reactions, and elevations of aminotransferase levels. (6.2)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Drugs that interfere with platelet aggregation: May induce bleeding. (7.2)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Preservative-free formulation recommended. Limited human data in pregnant women (8.1)
  • Lactation: Advise females not to breastfeed (8.2)
  • Pediatric Use: Use preservative-free formulation in neonates and infants (8.4)
  • Geriatric Use: A higher incidence of bleeding reported in patients, particularly women, over 60 years of age (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2021
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