Heparin Lock Preservative Free
"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
HEP-LOCK U/P (Preservative-Free Heparin Lock Flush Solution, USP) is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. Heparin Lock Flush Solution may be used following initial placement of the device in the vein, after each injection of a medication or after withdrawal of blood for laboratory tests. (See DOSAGE AND ADMINISTRATION, Maintenance of Patency of Intravenous Devices for directions for use.)
HEP-LOCK U/P (preservative-free heparin lock flush solution) is not to be used for anticoagulant therapy.
DOSAGE AND ADMINISTRATION
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.
Preservative-Free Heparin Lock Flush Solution in the 100 unit/mL concentration is not recommended for use in neonates and infants (see WARNINGS, Use In Neonates and Infants).
Maintenance of Patency of Intravenous Devices
To prevent clot formation in a heparin lock set or central venous catheter following its proper insertion, Preservative-Free Heparin Lock Flush Solution, USP is injected via the injection hub in a quantity sufficient to fill the entire device. This solution should be replaced each time the device is used. Aspirate before administering any solution via the device in order to confirm patency and location of needle or catheter tip. If the drug to be administered is incompatible with heparin, the entire device should be flushed with normal saline before and after the medication is administered; following the second saline flush, Preservative-Free Heparin Lock Flush Solution, USP may be reinstilled into the device. The device manufacturer's instructions should be consulted for specifics concerning its use. Usually this dilute heparin solution will maintain anticoagulation within the device for up to 4 hours.
NOTE: Since repeated injections of small doses of heparin can alter tests for activated partial thromboplastin time (APTT), a baseline value for APTT should be obtained prior to insertion of an intravenous device.
Withdrawal of Blood Samples
Preservative-Free Heparin Lock Flush Solution, USP may also be used after each withdrawal of blood for laboratory tests. When heparin would interfere with or alter the results of blood tests, the heparin solution should be cleared from the device by aspirating and discarding it before withdrawing the blood sample.
HEP-LOCK U/P (Preservative-Free Heparin Lock Flush Solution, USP)
10 USP units/mL
1 mL DOSETTE vials packaged in 25s (NDC 0641-0272-25)
100 USP units/mL
1 mL DOSETTE vials packaged in 25s (NDC 0641-0273-25)
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
7. Tahata T, Shigehito M, Kusuhara K, Ueda Y, et al. Delayed-Onset of Heparin Induced Thrombocytopenia – A Case Report – J Jpn Assn Torca Surg.1992;40(3):110-111.
8. Warkentin T, Kelton J. Delayed-Onset Heparin-Induced Thrombocytopenia and Thrombosis. Annals of Internal Medicine. 2001;135:502-506.
9. Rice L, Attisha W, Drexler A, Francis J. Delayed-Onset Heparin Induced Thrombocytopenia. Annals of Internal Medicine, 2002;136:210-215.
10. Dieck J., C. Rizo-Patron, et al. (1990). “A New Manifestation and Treatment Alternative for Heparin-Induced Thrombosis.” Chest 98(1524-26).
11. Smythe M, Stephens J, Mattson. Delayed-Onset Heparin Induced Thrombocytopenia. Annals of Emergency Medicine, 2005;45(4):417-419.
12. Divgi A. (Reprint), Thumma S., Hari P., Friedman K., Delayed Onset Heparin-Induced Thrombocytopenia (HIT) Presenting After Undocumented Drug Exposure as Post-Angiography Pulmonary Embolism. Blood. 2003;102(11):127b.
ESI logo, Hep-Lock and Dosette are registered trademarks of Baxter International, Inc., or its subsidiaries.
Manufactured by : Baxter Healthcare Corporation, Deerfield, IL 60015 USA. For Product Inquiry 1 800 ANA DRUG (1-800-262-3784). FDA revision date: 10/4/2006This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/26/2009
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