HEPARIN SODIUM INJECTION USP
DESCRIPTION
Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties.
Heparin Sodium Injection, USP (porcine) is available as follows:
Each 1,000 Units/mL contains: 1,000 USP Heparin Units (porcine); 9 mg sodium chloride; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0-7.5).
CLINICAL PHARMACOLOGY
Heparin sodium inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin sodium in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin sodium can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin sodium also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.
INDICATIONS
Heparin Sodium Injection is indicated for:
· Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension.
· In a low-dose regimen for prevention of post-operative 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.
· Prophylaxis and treatment of pulmonary embolism.
· Atrial fibrillation with embolization.
· Diagnosis and 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.
· As an anticoagulant in blood transfusions, extracorporeal circulation, dialysis procedures and in blood samples for laboratory purposes.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Slight discoloration does not alter potency.
When heparin sodium is added to an infusion solution for continuous intravenous administration, the container should be inverted at least six times to insure adequate mixing and prevent pooling of the heparin sodium in the solution.
Heparin sodium is not effective by oral administration and should be given 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.
The dosage of heparin sodium should be adjusted according to the patient's coagulation test results.
Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.
THERAPEUTIC ANTICOAGULANT EFFECT WITH FULL-DOSE HEPARIN
Although dosage must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines:
|
PRIVATEmethod of administration |
frequency |
recommended dose* |
|
Deep Subcutaneous (Intrafat) Injection |
Initial Dose |
5,000 Units by IV injection followed by 10,000 to 20,000 Units of a concentrated solution, subcutaneously |
|
A different site should be used for each injection to prevent the development of massive hematoma |
Every 8 hours |
8,000 to 10,000 Units of a concentrated solution |
|
|
or |
|
|
|
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 IV 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
Pediatric Use
Follow recommendations of appropriate pediatric reference texts. In general, the following dosage schedule may be used as a guideline:
Initial Dose: 50 Units/kg (IV, IV infusion)
Maintenance Dose: 100 Units/kg (IV, IV infusion) every four hours or 20,000
Units/m2/24 hours continuously.
Surgery of the Heart and Blood Vessels
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.
Extracorporal Dialysis
Follow equipment manufacturers' operating directions carefully.
Blood Transfusion
Addition of 400 to 600 USP Units per 100 mL of whole blood is usually employed to prevent coagulation. Usually, 7,500 USP Units of heparin sodium are added to 100 mL of 0.9% Sodium Chloride Injection, USP (or 75,000 USP Units/1000 mL of 0.9% Sodium Chloride Injection, USP) and mixed; from this sterile solution, 6 to 8 mL is added per 100 mL of whole blood.
HOW SUPPLIED
Heparin Sodium Injection, USP (porcine), preservative free, is available as follows:
1,000 USP Heparin Units/mL in a 2 mL single dose, flip-top vial, in packages of 25.
Preservative Free. Discard Unused Portion.
Use only if solution is clear and seal intact.
Store at controlled room temperature 15°-
CAUTION: Federal law prohibits dispensing without prescription.
