Uses for Heparin Sodium Injection
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.
Dosage for Heparin Sodium Injection
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]. 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. 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 IV
injection, IV 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].
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 (SC) injections, tests for adequacy of
dosage are best performed on samples drawn 4 to 6 hours after the injections.
Periodic platelet counts and hematocrits are recommended
during the entire course of HEPARIN SODIUM INJECTION therapy, regardless of the
route of administration.
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* |
| Deep Subcutaneous (Intrafat) Injection Use 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 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 20.000 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 |
| Continuous |
| * Based on 150 lb (68 kg) patient |
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 to 100 units/kg (IV bolus over 10 minutes) Infants: 25 to 30 units/kg/hour; |
| Maintenance Dose |
Infants < 2 months have the highest requirements (average 28 units/kg/hour) 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. |
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.
Low-Dos e 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.
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 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.
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].
Converting To Dabigatran
For patients currently receiving intravenous heparin,
stop intravenous infusion of heparin sodium immediately after administering the
first dose of oral dabigatran (PRADAXA®);
or for intermittent intravenous administration of heparin sodium, start oral
dabigatran 0 to 2 hours before the time that the Based on 150 lb (68 kg)
patient next dose of heparin was to have been administered.
Extracorporeal Dialysis
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.
HOW SUPPLIED
Dosage Forms And Strengths
HEPARIN SODIUM INJECTION is available as:
- 1,000 USP units/mL preservative-free
Vial: 2,000 USP units/2 mL
- 1,000 USP units/mL preserved with benzyl alcohol
Vial: 10,000 USP units/10 mL
Vial: 30,000 USP units/30 mL
- 5,000 USP units/mL preserved with benzyl alcohol
Vial: 50,000 USP units/10 mL
Vial: 5,000 USP units/1 mL
- 10,000 USP units/mL preserved with benzyl alcohol
Vial: 10,000 USP units/1 mL
Storage And Handling
HEPARIN SODIUM INJECTION pres ervative-free is available
in the following strengths and package sizes:
| DESCRIPTION |
NDC |
| 1,000 USP units/mL |
| Preservative-free, 1 vial: 2,000 USP units/2 mL, singledose* |
0069-0043-02 |
| Preservative-free, 25 vials: 2,000 USP units/2 mL, single-dose* |
0069-0043-01 |
| *Discard unused portion |
HEPARIN SODIUM INJECTION preserved with benzyl alcohol is
available in the following strengths and package sizes:
| DESCRIPTION |
NDC |
| 1,000 USP units/mL |
| 1 vial: 10,000 USP units/10 mL, multiple-dose |
0069-0058-02 |
| 25 vials: 10,000 USP units/10 mL, multiple-dose |
0069-0058-01 |
| 1 vial: 30,000 USP units/30 mL, multiple-dose |
0069-0137-01 |
| 10 vials: 30,000 USP units/30 mL, multiple-dose |
0069-0137-03 |
| 5,000 USP units/mL |
| 1 vial: 50,000 USP units/10 mL, multiple-dose |
0069-0059-02 |
| 25 vials: 50,000 USP units/10 mL, multiple-dose |
0069-0059-01 |
| 1 vial: 5,000 USP units/1 mL, multiple-dose |
0069-0059-04 |
| 25 vials: 5,000 USP units/1 mL, multiple-dose |
0069-0059-03 |
| 10,000 USP units/mL |
| 1 vial: 10,000 USP units/1 mL, multiple-dose |
0069-0062-02 |
| 25 vials: 10,000 USP units/1 mL, multiple-dose |
0069-0062-01 |
Store at 20° to 25°C (68° to 77°F) [see USP Controlled
Room Temperature]. Use only if solution is clear and the seal is intact. Do
not use if solution is discolored or contains a precipitate.
Distributed by: Pfizer Labs Division of Pfizer Inc., New
York, NY, NY 10017. Revised: Mar 2013