heparin sodium in 0.45% sodium chloride injection Dosage and Administration

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2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Confirm the selection of the correct formulation and strength prior to administration of the drug.

Do not use HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION as a "catheter lock flush" product.

Administer this product by intravenous infusion.

Do not admix with other drugs.

This product should not be infused under pressure.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer unless the solution is clear and container is undamaged.

Discard unused portion

To Open

Tear outer wrap and remove solution container. For PVC bags, some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

(Use aseptic technique)

1.
Close flow control clamp of administration set.
2.
Remove cover from outlet port at bottom of container.
3.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.
NOTE: See full directions on administration set carton.
4.
Suspend container from hanger.
5.
Squeeze and release drip chamber to establish proper fluid level in chamber.
6.
Open flow control clamp and clear air from set. Close clamp.
7.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8.
Regulate rate of administration with flow control clamp.

Warning: Do not use flexible container in series connections.

2.2 Laboratory Monitoring for Efficacy and Safety

The dosage of heparin sodium 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 4 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.

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy.

2.3 Therapeutic Anticoagulant Effect with Full-Dose Heparin

The dosing recommendations in Table 1 are based on clinical experience. 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:

Table 1: Recommended Adult Full-Dose Heparin Regimens for Therapeutic Anticoagulant Effect
*
Based on 150 lb. (68 kg) patient.

Method of
Administration

Frequency

Recommended Dose*

Intermittent
Intravenous Injection

Initial Dose

10,000 Units

Every 4 to 6 hours

5,000 Units to 10,000 Units

Continuous
Intravenous Infusion

Initial Dose

5,000 Units by intravenous injection

Continuous

20,000 Units to 40,000 Units/24 hours

2.4 Pediatric Use

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 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 Converting to Warfarin

To ensure continuous anticoagulation when converting from heparin sodium 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 (7.4)].

2.7 Converting to Oral Anticoagulants other than Warfarin

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.

2.8 Extracorporeal Dialysis

Follow equipment manufacturer's operating directions carefully. A dose of 25 units/kg to 30 units/kg followed by an infusion rate of 1,500 units/hour to 2,000 units/hour is suggested based on pharmacodynamic data if specific manufacturers' recommendations are not available.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Confirm the selection of the correct formulation and strength prior to administration of the drug.

Do not use HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION as a "catheter lock flush" product.

Administer this product by intravenous infusion.

Do not admix with other drugs.

This product should not be infused under pressure.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer unless the solution is clear and container is undamaged.

Discard unused portion

To Open

Tear outer wrap and remove solution container. For PVC bags, some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

(Use aseptic technique)

1.
Close flow control clamp of administration set.
2.
Remove cover from outlet port at bottom of container.
3.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.
NOTE: See full directions on administration set carton.
4.
Suspend container from hanger.
5.
Squeeze and release drip chamber to establish proper fluid level in chamber.
6.
Open flow control clamp and clear air from set. Close clamp.
7.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8.
Regulate rate of administration with flow control clamp.

Warning: Do not use flexible container in series connections.

2.2 Laboratory Monitoring for Efficacy and Safety

The dosage of heparin sodium 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 4 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.

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy.

2.3 Therapeutic Anticoagulant Effect with Full-Dose Heparin

The dosing recommendations in Table 1 are based on clinical experience. 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:

Table 1: Recommended Adult Full-Dose Heparin Regimens for Therapeutic Anticoagulant Effect
*
Based on 150 lb. (68 kg) patient.

Method of
Administration

Frequency

Recommended Dose*

Intermittent
Intravenous Injection

Initial Dose

10,000 Units

Every 4 to 6 hours

5,000 Units to 10,000 Units

Continuous
Intravenous Infusion

Initial Dose

5,000 Units by intravenous injection

Continuous

20,000 Units to 40,000 Units/24 hours

2.4 Pediatric Use

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 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 Converting to Warfarin

To ensure continuous anticoagulation when converting from heparin sodium 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 (7.4)].

2.7 Converting to Oral Anticoagulants other than Warfarin

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.

2.8 Extracorporeal Dialysis

Follow equipment manufacturer's operating directions carefully. A dose of 25 units/kg to 30 units/kg followed by an infusion rate of 1,500 units/hour to 2,000 units/hour is suggested based on pharmacodynamic data if specific manufacturers' recommendations are not available.

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