Heparin Lock Flush
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Questions & Answers
Side Effects & Adverse Reactions
Benzyl alcohol, a preservative in the multiple-dose vial preparations of Heparin Lock Flush Solution, USP has been associated with toxicity in neonates. Benzyl alcohol has been reported to be associated with a fetal “Gasping Syndrome” in premature infants. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Heparin Lock Flush Solution, USP should be used for maintaining patency of intravenous injection devices in neonates. Heparin Lock Flush Solution, USP is not intended for intramuscular use, systemic anticoagulation or injection by any parenteral route of administration.
Hypersensitivity: Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations.
Hemorrhage: Hemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in hematocrit, fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a hemorrhagic event. Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists are:
Cardiovascular— Subacute bacterial endocarditis. Severe hypertension.
Surgical— During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye.
Hematologic — Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia, and some vascular purpuras.
Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
Other— Menstruation, liver disease with impaired hemostasis.
Coagulation Testing: If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly. Heparin solutions having a concentration of 10 USP Heparin Units/mL may alter the results of blood coagulation tests. Heparin concentrations greater than 10 USP Heparin Units/mL will alter the results of blood coagulation tests.
Thrombocytopenia: Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%. Mild thrombocytopenia (count greater than 100,000/mm3) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely. If the count falls below 100,000/mm3 or if recurrent thrombosis
develops (see White Clot Syndrome, PRECAUTIONS), the heparin product should be discontinued. If continued heparin therapy is essential, administration of heparin from a different organ source can be reinstituted with caution. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Heparin Lock Flush Solution, USP is indicated only to maintain patency of an intravenous injection device. It 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 analysis. The solution is not to be used for anticoagulation therapy.
History
There is currently no drug history available for this drug.
Other Information
SOLUTION IS INTENDED FOR MAINTENANCE OF PATENCY OF INTRAVENOUS INJECTION DEVICES ONLY AND IS NOT TO BE USED FOR ANTICOAGULANT THERAPY.
Heparin Lock Flush Solution, USP is a sterile, nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
Each milliliter (mL) contains: Heparin sodium, 10 or 100 USP units (derived from porcine intestinal mucosa); sodium chloride 9 mg; edetate disodium, anhydrous 0.1 mg added as a stabilizer; and benzyl alcohol 9 mg added as preservative in water for injection. May contain sodium hydroxide for pH adjustment. pH 6.5 (5.0 to 7.5). The osmolar concentrations of these solutions are 392 mOsmol/L (calc). Repeated withdrawals may be made from the multiple-dose vial.
Heparin Lock Flush Solution, USP is intended for maintenance of patency of intravenous injection devices only and is not to be used for anticoagulant therapy.
Heparin Sodium, USP is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) a-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-a-D-glucose 6-sulfate, (3) b-D-glucuronic acid, (4) 2-acetamido-2-deoxy-a-D-glucose, and (5) a-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)greater than(1)greater than(4)greater than(3)greater than(5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.
Structure of Heparin Sodium (representative subunits):
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vials are fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires
no vapor barrier to maintain the proper drug concentration.
Sources
Heparin Lock Flush Manufacturers
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General Injectables & Vaccines, Inc
![Heparin Lock Flush (Heparin Sodium) Solution [General Injectables & Vaccines, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Heparin Lock Flush | General Injectables & Vaccines, Inc
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.) Heparin Lock Flush Solution, USP 10 or 100 USP Units/mL, is injected as a single dose into an intravenous injection device using a volume of solution equivalent to that of the indwelling venipuncture device. A single dose should be injected following venipuncture when the indwelling device is not to be used immediately. After each use
of the indwelling venipuncture device for injection or infusion of medication, or withdrawal of blood samples, another dose should be injected to restore the effectiveness of the heparin lock. The amount of heparin solution is sufficient to prevent clotting within the lumen of indwelling venipuncture devices (usually not holding more than 0.2 to 0.3 mL) for up to twenty-four hours. When the indwelling device is used to administer a drug which is incompatible with heparin, the entire heparin lock set should be flushed with 0.9% Sodium Chloride Injection, USP before and after the medication is administered. Following the second flush, another dose of heparin solution should be injected to restore the effectiveness of the heparin lock. When the indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter results of the desired blood tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding 1 mL before the desired blood sample is drawn. (See PRECAUTIONS.) -
App Pharmaceuticals, Llc
Heparin Lock Flush | App Pharmaceuticals, Llc
Parental 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.
Heparin Lock Flush Solution, USP is not recommended for use in the neonate (see WARNINGS).
Maintenance of Patency of IV Devices
To prevent clot formation in a heparin lock set or central venous catheter following its proper insertion, 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, the heparin lock flush solution 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 a heparin lock set.
Withdrawal of Blood Samples
Heparin lock flush solution 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.
Maintenance of Patency of IV Devices
To prevent clot formation in a heparin lock set or central venous catheter following its proper insertion, 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, the heparin lock flush solution 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 a heparin lock set.
Withdrawal of Blood Samples
Heparin lock flush solution 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.
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General Injectables & Vaccines, Inc
Heparin Lock Flush | General Injectables & Vaccines, Inc
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.) Heparin Lock Flush Solution, USP 10 or 100 USP Units/mL, is injected as a single dose into an intravenous injection device using a volume of solution equivalent to that of the indwelling venipuncture device. A single dose should be injected following venipuncture when the indwelling device is not to be used immediately. After each use
of the indwelling venipuncture device for injection or infusion of medication, or withdrawal of blood samples, another dose should be injected to restore the effectiveness of the heparin lock. The amount of heparin solution is sufficient to prevent clotting within the lumen of indwelling venipuncture devices (usually not holding more than 0.2 to 0.3 mL) for up to twenty-four hours. When the indwelling device is used to administer a drug which is incompatible with heparin, the entire heparin lock set should be flushed with 0.9% Sodium Chloride Injection, USP before and after the medication is administered. Following the second flush, another dose of heparin solution should be injected to restore the effectiveness of the heparin lock. When the indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter results of the desired blood tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding 1 mL before the desired blood sample is drawn. (See PRECAUTIONS.)
![Heparin Lock Flush (Heparin Sodium) Injection, Solution [App Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cbc26e3c-aee9-4c0d-bdb1-bf350308fbce&name=heparin-lock-flush-solution,-usp-figure-3-504901-vial-2.jpg)
![Heparin Lock Flush (Heparin Sodium) Solution [General Injectables & Vaccines, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=21bfd9fb-6963-4149-ba3d-e2c79f8b05d8&name=Label1.jpg)
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