DOSAGE AND ADMINISTRATION
Heparin sodium is not effective by oral administration and these premixed formulations should be given by intermittent intravenous injection or intravenous infusion.
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, regardless of the route of administration.
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 without tapering.
Therapeutic Anticoagulant Effect with Full-Dose Heparin
|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:|
| Method of Administration || Frequency || Recommended Dose* |
|* Based on 150 lb. (68 kg) patient.|
|Intermittent Intravenous Injection||Initial Dose||10,000 Units, either undiluted or in 50 – 100 mL of 5% Dextrose Injection|
|Every 4 to 6 hours||5000 – 10,000 Units, either undiluted or in 50 – 100 mL of 5% Dextrose Injection|
|Continuous Intravenous Infusion||Initial Dose||5000 Units by I.V. injection|
|Continuous||20,000 – 40,000 Units/24 hours in 1000 mL of 5% Dextrose Injection|
Pediatric Use: Follow recommendations of appropriate pediatric reference texts. In general, the following dosage schedule may be used as a guideline:
|Initial Dose:||50 Units/kg (I.V. drip)|
|Maintenance Dose:||100 Units/kg (I.V. drip) every four hours, or 20,000 Units/M2/24 hours continuously|
Geriatric Use: Patients over 60 years of age may require lower doses of heparin.
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.
Extracorporeal Dialysis: Follow equipment manufacturers’ operating directions carefully.
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
Tear outer wrap at notch and remove solution 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.
Preparation for Administration
(Use aseptic technique)
- 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 set is firmly seated. NOTE: See full directions on administration set carton.
- 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 make venipuncture.
- Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.