Heparin Sodium

HEPARIN SODIUM- heparin sodium injection
Pfizer Laboratories Div Pfizer Inc

1 INDICATIONS AND USAGE

HEPARIN SODIUM INJECTION is indicated for:

  • 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.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

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 [se e 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 SODIUM INJECTION 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° to 8°C (36° to 46°F). HEPARIN SODIUM INJECTION is incompatible with certain substances in solution (e.g., alteplase, amikacin sulfate, atracurium besylate, ciprofloxacin, cytarabine, daunorubicin, droperidol, erythromycin lactobionate, gentamicin sulfate, idarubicin, kanamycin sulfate, mitoxantrone HCl, polymyxin B sulfate, promethazine HCl, streptomycin sulfate, tobramycin sulfate). Consult specialized references to verify with which substances incompatibilities have been noted, as compatibility may depend on concentration, temperature, time, and other variables.

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. HEPARIN SODIUM INJECTION is not intended for intramuscular (IM) use [see Adverse Reactions (6.1)].

2.2 Laboratory Monitoring for Efficacy and Safety

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 initiation of treatment and at appropriate intervals thereafter. After deep subcutaneous injections, tests for adequacy of dosage are best performed on samples drawn 4 to 6 hours after the injections.

Periodically monitor platelet counts, hematocrit, and occult blood in stool during the entire course of HEPARIN SODIUM INJECTION therapy, regardless of the route of administration.

2.3 Therapeutic Anticoagulant Effect with Full-Dose Heparin

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:

Table 1: Recommended Adult Full-Dose Heparin Regimens for Therapeutic Anticoagulant Effect
METHOD OF ADMINISTRATION FREQUENCY RECOMMENDED DOSE *
*
Based on 68 kg patient
Deep Subcutaneous (Intrafat) InjectionUse a different site for each injection to prevent the development of hematoma Initial Dose 333 units/kg subcutaneously
Every 12 hours 250 units/kg subcutaneously
Intermittent Intravenous Injection Initial Dose 10,000 units, either undiluted or in 50 mL to 100 mL of 0.9% Sodium Chloride Injection, USP
Every 4 to 6 hours 5,000 units to 10,000 units, either undiluted or in 50 mL to 100 mL of 0.9% Sodium Chloride Injection, USP
Continuous Intravenous Infusion Initial Dose 5,000 units by intravenous injection
Continuous 20,000 units to 40,000 units per 24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion

2.4 Pediatric Use

Use preservative-free HEPARIN SODIUM INJECTION in neonates and infants.

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:

Initial Dose 75 units/kg to 100 units/kg ( intravenous bolus over 10 minutes)
Maintenance Dose Infants: 25 units/kg/hour to 30 units/kg/hour; Infants less than 2 months have the highest requirements (average 28 units/kg/hour)
Children greater than 1 year of age: 18 units/kg/hour to 20 units/kg/hour;Older children may require less heparin, similar to weight-adjusted adult dosage
Monitoring Adjust heparin to maintain aPTT of 60 seconds to 85 seconds, assuming this reflects an anti-Factor Xa level of 0.35 to 0.70.

2.5 Cardiovascular Surgery

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.

2.6 Low-Dose Prophylaxis of Postoperative Thromboembolism

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.

2.7 Converting to Warfarin

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)].

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