DOSAGE AND ADMINISTRATION
Heparin sodium is not effective by oral administration and should be given
by intermittent intravenous injection, after dilution in 50 or 100 mL of 5%
Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, or by intravenous
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.
Converting to Oral Anticoagulant
When an oral anticoagulant of the coumarin or similar type is to be begun in
patients already receiving heparin sodium, baseline and subsequent tests of
prothrombin activity must be determined at a time when heparin activity is too
low to affect the prothrombin time. If continuous I.V. 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
Therapeutic Anticoagulant Effect with Full-Dose Heparin
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
|Intermittent Intravenous Injection
||10,000 Units, in 50—100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride
||Every 4 to 6 hours
||5000—10,000 Units, in 50—100 mL of 5% Dextrose Injection or 0.9% Sodium
|Continuous Intravenous Infusion
||5000 Units by I.V. Injection
||20,000—40,000 Units/24 hours in 5% Dextrose Injection or 0.9% Sodium
|* Based on 150 lb. (68 kg) patient.
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
Initial Dose: 75 to 100 units/kg (IV bolus over 10 minutes)
Maintenance Dose Infants: 25 to 30 units/kg/hour;
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
Adjust heparin to maintain a PTT of 60 to 85 seconds, assuming this reflects
an anti-Factor Xa level of 0.35 to 0.70.
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 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-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 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. A concentrated solution of heparin sodium
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 brain or spinal cord surgery, spinal anesthesia, eye surgery, or
potentially sanguineous operations should be excluded, as should 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. Prior to initiating heparinization the physician should
rule out bleeding disorders by appropriate history and laboratory tests, and
appropriate coagulation tests should be repeated just prior to surgery. Coagulation
test values should be normal or only slightly elevated at these times.
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. See PRECAUTIONS.
Instructions For Use
To Open Diluent Container
Peel overwrap from the corner and remove container. 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.
To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique)
1. Remove the protective covers from the top of the vial and the vial port
on the diluent container as follows:
a. To remove the breakaway vial cap, swing the pull ring over the top of the
vial and pull down far enough to start the opening (see Figure 1.), then pull
straight up to remove the cap. (see Figure 2.) NOTE: Once the breakaway
cap has been removed, do not access vial with syringe.
b. To remove the vial port cover, grasp the tab on the pull ring, pull up to
break the three tie strings, then pull back to remove the cover. (see Figure
2. Screw the vial into the vial port until it will go no further. THE VIAL
MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately ½ turn
(180°) after the first audible click. (see Figure 4.) The clicking sound
does not assure a seal; the vial must be turned as far as it will go. NOTE:
Once vial is seated, do not attempt to remove. (see Figure 4.)
3. Recheck the vial to assure that it is tight by trying to turn it further
in the direction of assembly.
4. Label appropriately
To Prepare Admixture
1. Squeeze the bottom of the diluent container gently to inflate the portion
of the container surrounding the end of the drug vial.
2. With the other hand, push the drug vial down into the container telescoping
the walls of the container. Grasp the inner cap of the vial through the walls
of the container. (see Figure 5.)
3. Pull the inner cap from the drug vial. (see Figure 6.) Verify that the rubber
stopper has been pulled out, allowing the drug and diluent to mix.
4. Mix container contents thoroughly and use within the specified time.
Preparation for Administration (Use Aseptic Technique)
Confirm the activation and admixture of vial contents.
Check for leaks by squeezing container firmly. If leaks are found, discard
unit as sterility may be impaired.
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion
until the pin is firmly seated. NOTE: See full directions on administration
Lift the free end of the hanger loop on the bottom of the vial, breaking
the two tie strings. Bend the loop outward to lock it in the upright position,
then suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Open flow control clamp and clear air from set. Close clamp.
Attach set to venipuncture device. If device is not indwelling, prime and
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
Heparin Sodium Injection, USP is supplied in the ADD-Vantage™ vials as
||Total Units Heparin/vial
||Total mg Sodium Chloride/vial
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Caution: Federal (USA) law prohibits dispensing without prescription.
Revised: October, 2011. Hospira, Inc., Lake Forest,
IL 60045 USA