HEPARIN SODIUM- heparin sodium injection, solution
Hepalink USA Inc.
Heparin sodium injection is indicated for:
- Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
- Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic 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.
- Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
Confirm the choice of the correct heparin sodium injection vial to ensure that the 1 mL vial is not confused with a “catheter lock flush” vial or other 1 mL vial of incorrect strength [see Warnings and Precautions ( 5.1)] . Confirm the selection of the correct formulation and strength prior to administration of the drug.
Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and the seal is intact. Do not use if solution is discolored or contains a precipitate.
When heparin is added to an infusion solution for continuous intravenous (IV) administration, invert the container at least six times to ensure adequate mixing and prevent pooling of the heparin in the solution. Storage of prepared infusion solution should not exceed 4 hours at room temperature or 24 hours at 2°C to 8°C (36° to 46°F).
Administer heparin sodium injection by intermittent intravenous injection, intravenous infusion, or deep subcutaneous (intrafat, i.e., above the iliac crest or abdominal fat layer) injection. The intramuscular route of administration should be avoided because of the frequent occurrence of hematoma at the injection site [see Adverse Reactions ( 6.1)] .
Adjust the dosage of heparin sodium injection according to the patient’s coagulation test results. Dosage is considered adequate when the activated partial thromboplastin time (aPTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value. When initiating treatment with heparin sodium injection by continuous intravenous infusion, determine the coagulation status (aPTT, INR, platelet count) at baseline and continue to follow aPTT approximately every 4 hours and then at appropriate intervals thereafter. When the drug is administered intermittently by intravenous injection, perform coagulation tests before each injection during the initiation of treatment and at appropriate intervals thereafter. After deep subcutaneous (intrafat) injections, tests for adequacy of dosage are best performed on samples drawn 4 to 6 hours after the injection.
Periodically monitor platelet counts, hematocrit, and occult blood in stool during the entire course of heparin therapy, regardless of the route of administration.
The dosing recommendations in Table 1 are based on clinical experience. Although dosages must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines:
|Method of Administration||Frequency||Recommended Dose|
Deep Subcutaneous (Intrafat) Injection
Use a different site for each injection to prevent the development of hematoma
|Initial dose||5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously|
Every 8 hours
|8,000 to 10,000 units of a concentrated solution|
|Every 12 hours||15,000 to 20,000 units of a concentrated solution|
|Intermittent Intravenous Injection||Initial Dose||10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP|
|Every 4 to 6 hours||5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP|
|Continuous Intravenous Infusion||Initial Dose|| |
5,000 units by intravenous injection
|Continuous||20,000 to 40,000 units/24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion|
*Based on 68 kg patient
Use preservative-free heparin sodium injection in neonates and infants [see Warnings and Precautions ( 5.4)].
There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience. In general, the following dosage schedule may be used as a guideline in pediatric patients:
|Recommended Pediatric Use|
|Initial Dose||75 to 100 units/kg (IV bolus over 10 minutes)|
|Maintenance Dose|| |
Infants: 25 to 30 units/kg/hour;
Infants < 2 months have the highest requirements (average 28 units/kg/hour)
Children > 1 year of age: 18 to 20 units/kg/hour;
|Monitoring||Adjust heparin to maintain aPTT of 60 to 85 seconds, assuming this reflects an anti-Factor Xa level of 0.35 to 0.70|
Patients undergoing total body perfusion for open-heart surgery should receive an initial dose of not less than 150 units of heparin sodium per kilogram of body weight. Frequently, a dose of 300 units per kilogram is used for procedures estimated to last less than 60 minutes, or 400 units per kilogram for those estimated to last longer than 60 minutes.
The most widely used dosage has been 5,000 units 2 hours before surgery and 5,000 units every 8 to 12 hours thereafter for 7 days or until the patient is fully ambulatory, whichever is longer. Administer the heparin by deep subcutaneous (intrafat, i.e., above the iliac crest or abdominal fat layer, arm, or thigh) injection with a fine (25 to 26-gauge) needle to minimize tissue trauma.
To ensure continuous anticoagulation when converting from Heparin Sodium Injection to warfarin, continue full heparin therapy for several days until the INR (prothrombin time) has reached a stable therapeutic range. Heparin therapy may then be discontinued without tapering [see Drug Interactions ( 7.1)] .
For patients currently receiving intravenous heparin, stop intravenous infusion of heparin sodium immediately after administering the first dose of oral anticoagulant; or for intermittent intravenous administration of heparin sodium, start oral anticoagulant 0 to 2 hours before the time that the next dose of heparin was to have been administered.
Follow equipment manufacturers’ operating directions carefully. A dose of 25 to 30 units/kg followed by an infusion rate of 1,500 to 2,000 units/hour is suggested based on pharmacodynamic data if specific manufacturers’ recommendations are not available.
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