Heparin Sodium

HEPARIN SODIUM — heparin sodium injection
Gland Pharma Limited

1 INDICATIONS & USAGE

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

2 DOSAGE & 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 [see Warnings and Precautions (5.1)]. Confirm the selection of the correct formulation and strength prior to administration of the drug.

When heparin is added to an infusion solution for continuous intravenous administration, invert the container repeatedly to ensure adequate mixing and prevent pooling of the heparin in the solution.

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.

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. Do not administer heparin sodium injection by intramuscular injection because of the risk of hematoma at the injection site [see Adverse Reactions (6)].

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 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.

Periodic platelet counts and hematocrits are recommended during the entire course of heparin 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 150 lb (68 kg) patient]
Deep Subcutaneous (Intrafat) Injection Initial dose 5,000 units by intravenous 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 orEvery 12 hours 8,000 to 10,000 units of a concentrated solution 15,000 to 20,000 units of a concentrated solution
Intermittent Intravenous Injection Initial doseEvery 4 to 6 hours 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP
Intravenous Infusion Initial doseContinuous 5,000 units by intravenous injection 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

2.4 Pediatric Use

Do not use this product in neonates and infants. 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:

Initial Dose 75 to 100 units/kg (IV bolus over 10 minutes)
Infants: 25 to 30 units/kg/hour;
Infants < 2 months have the highest requirements (average 28 units/kg/hour)

Maintenance Dose Children > 1 year of age: 18 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 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 Blood Transfusion

Add 450 to 600 USP units of heparin sodium per 100 mL of whole blood 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 per 1,000 mL of 0.9% Sodium Chloride Injection, USP) and mixed; from this sterile solution, 6 to 8 mL are added per 100 mL of whole blood.

2.8 Converting to Oral Anticoagulants other than 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)].

2.9 Extracorporeal Dialysis

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.

2.10 Laboratory Samples

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.

3 DOSAGE FORMS & STRENGTHS

Heparin Sodium Injection, USP is available as 5,000 USP units per mL preserved with benzyl alcohol clear solution in 1 mL single-dose vials.

4 CONTRAINDICATIONS

The use of heparin sodium is contraindicated in patients with the following conditions:

• History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)]
• Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1)]
• In whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there
is usually no need to monitor coagulation parameters in patients receiving low-dose heparin)
• An uncontrolled active bleeding state [see Warnings and Precautions (5.4)] , except when this is due to disseminated intravascular coagulation

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