Heparin Preservative Free
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Heparin Preservative Free
Heparin Sodium (heparin sodium injection preservative free) Injection is indicated for:
Low dose regimen for 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 (see DOSAGE AND ADMINISTRATION);
Prophylaxis and treatment of pulmonary embolism;
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism.
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.
Confirm the choice of the correct Heparin Sodium (heparin sodium injection preservative free) Injection vial prior to administration of the drug to a patient (see WARNINGS, Fatal Medication Errors). The 1 mL vial must not be confused with a "catheter lock flush" vial or other 1 mL vial of inappropriate strength. Confirm that you have selected the correct medication and strength prior to administration of the drug.
When heparin is added to an infusion solution for continuous intravenous administration, the container should be inverted at least six times to ensure adequate mixing and prevent pooling of the heparin in the solution.
Heparin sodium (heparin sodium injection preservative free) 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 (heparin sodium injection preservative free) should be adjusted according to the patient's coagulation test results. When heparin is given by continuous intravenous infusion, the coagulation time should be determined approximately every four hours in the early stages of treatment. When the drug is administered intermittently by intravenous injection, coagulation tests should be performed before each injection during the early stages of treatment and at appropriate intervals thereafter. 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. After deep subcutaneous (intrafat) injections, tests for adequacy of dosage are best performed on samples drawn four to six hours after the injection.
Converting to Oral Anticoagulant
When an oral anticoagulant of the coumarin or similar type is to be begun in patients already receiving heparin sodium (heparin sodium injection preservative free) , baseline and subsequent tests of prothrombin activity must be determined at a time when heparin activity is too low to affect the prothrombin time. This is about five hours after the last IV bolus and 24 hours after the last subcutaneous dose. If continuous IV heparin infusion is used, prothrombin time can usually be measured at any time. In converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant should be the usual initial amount and thereafter prothrombin time should be determined at the usual intervals. To ensure continuous anticoagulation, it is advisable to continue full heparin therapy for several days after the prothrombin time has reached the therapeutic range. Heparin therapy may then be discontinued without tapering.
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:
|METHOD OF ADMINISTRATION||FREQUENCY||RECOMMENDED DOSE
(based on 150 lb [68 kg] patient)
|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 or||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|
|Intravenous Infusion||Initial Dose||5,000 units by IV injection|
|Continuous||20,000 to 40,000 units in 1,000 mL of 0.9% Sodium Chloride|
|Injection, USP (or in any compatible solution) for infusion|
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, infusion)|
|Maintenance Dose:||100 units/kg (IV, infusion) every four hours, or 20,000 units/m2/24 hours continuously|
Patients over 60 years of age may require lower doses of heparin.
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 (heparin sodium injection preservative free) per kilogram of body weight. Frequently, a dose of 300 units of heparin sodium (heparin sodium injection preservative free) per kilogram of body weight 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.
Low-Dose Prophylaxis of Postoperative Thromboembolism
A number of well-controlled clinical trials have demonstrated that low-dose heparin prophylaxis, given just prior to and after surgery, will reduce the incidence of postoperative deep vein thrombosis in the legs (as measured by the I-125 fibrinogen technique and venography) and of clinical pulmonary embolism. The most widely used dosage has been 5,000 units two hours before surgery and 5,000 units every 8 to 12 hours thereafter for seven days or until the patient is fully ambulatory, whichever is longer. The heparin is given by deep subcutaneous injection in the arm or abdomen with a fine needle (25 to 26 gauge) to minimize tissue trauma. A concentrated solution of heparin sodium (heparin sodium injection preservative free) is recommended. Such prophylaxis should be reserved for patients over the age of 40 who are undergoing major surgery. Patients with bleeding disorders and those having neurosurgery, spinal anesthesia, eye surgery or potentially sanguineous operations should be excluded, as well as patients receiving oral anticoagulants or platelet-active drugs (see WARNINGS). The value of such prophylaxis in hip surgery has not been established. The possibility of increased bleeding during surgery or postoperatively should be borne in mind. If such bleeding occurs, discontinuance of heparin and neutralization with protamine sulfate are advisable. If clinical evidence of thromboembolism develops despite low-dose prophylaxis, full therapeutic doses of anticoagulants should be given unless contraindicated. All patients should be screened prior to heparinization to rule out bleeding disorders, and monitoring should be performed with appropriate coagulation tests just prior to surgery. Coagulation test values should be normal or only slightly elevated. There is usually no need for daily monitoring of the effect of low -dose heparin in patients with normal coagulation parameters.
Follow equipment manufacturers operating directions carefully.
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/1,000 mL of 0.9% Sodium Chloride Injection, USP) and mixed; and from this sterile solution, 6 to 8 mL are added per 100 mL of whole blood.
Addition of 70 to 150 units of heparin sodium per 10 to 20 mL sample of whole blood is usually employed to prevent coagulation of the sample. Leukocyte counts should be performed on heparinized blood within two hours after addition of the heparin. Heparinized blood should not be used for isoagglutinin, complement or erythrocyte fragility tests or platelet counts.
Heparin Sodium Injection, USP (porcine), preservative free, is available as follows:
|Product No.||NDC No.|
|27602||63323-276-02||1,000 USP Heparin Units/mL in a 2 mL single dose, flip-top vial, in packages of 25.|
Discard Unused Portion.
Do not use if solution is discolored or contains a precipitate.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room temperature].
1. Tahata T, Shigehito M, Kusuhara K, Ueda Y, et al. Delayed-Onset of Heparin Induced Thrombocytopenia-A Case Report- J Jpn Assn Torca Surg. 1992; 40 (3): 110-111.
2. Warkentin T, Kelton J. Delayed-Onset Heparin-Induced Thrombocytopenia and Thrombosis. Annals of Internal Medicine. 2001;135:502-506.
3. Rice L, Attisha W, Drexler A, Francis J. Delayed-Onset Heparin Induced Thrombocytopenia. Annals of Internal Medicine, 2002; 136:210-215.
4. Dieck J., C. Rizo-Patron, et al. (1990). "A New Manifestation and Treatment Alternative for Haparin-Induced Thrombosis." Chest 98(1524-26).
5. Smythe M, Stephens J, Mattson. Delayed-Onset Heparin Induced Thrombocytopenia, Annals of Emergency Medicine, 2005;45(4):417-419.
6. Divgi A. (Reprint), Thumma S., Hari P., Friedman K., Delayed Onset Heparin-Induced Thrombocytopenia (HIT) Presenting After Undocumented Drug Exposure as Post-Angiography pulmonary Embolism. Blood. 2003; 102(11): 127b.
APP Pharmaceuticals, LLC Schaumburg, IL 60173. For Product Inquiry: 1-800-551-7176. Revised: August 2008. FDA Rev date: 9/23/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/29/2008
Additional Heparin Preservative Free Information
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