Heparin Sodium In Dextrose
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Questions & Answers
Side Effects & Adverse Reactions
Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations.
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 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.
When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly (see Overdosage).
Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%. Platelet counts should be obtained at baseline and periodically during heparin administration. 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 Heparin-induced Thrombocytopenia (HIT) With or Without Thrombosis), the heparin product should be discontinued and, if necessary, an alternative anticoagulant administered.
HIT is a serious immune-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as HIT with thrombosis. Thrombotic events may also be the initial presentation for HIT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and fatal outcomes.
Once HIT (with or without thrombosis) is diagnosed or strongly suspected, all heparin sodium sources (including heparin flushes) should be discontinued and an alternative anticoagulant used. Future use of heparin sodium, especially within 3 to 6 months following the diagnosis of HIT (with or without thrombosis), and while patients test positive for HIT antibodies, should be avoided.
Immune-mediated HIT is diagnosed based on clinical findings supplemented by laboratory tests confirming the presence of antibodies to heparin sodium, or platelet activation induced by heparin sodium. A drop in platelet count greater than 50% from baseline is considered indicative of HIT. Platelet counts begin to fall 5 to 10 days after exposure to heparin sodium in heparin sodium–naïve individuals, and reach a threshold by days 7 to 14. In contrast, “rapid onset” HIT can occur very quickly (within 24 hours following heparin sodium initiation), especially in patients with a recent exposure to heparin sodium (i.e. previous 3 months). Thrombosis development shortly after documenting thrombocytopenia is a characteristic finding in almost half of all patients with HIT.
Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered if patients require continued anticoagulation.
Heparin-induced thrombocytopenia (with or without thrombosis) can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin sodium should be evaluated for HIT (with or without thrombosis).
Dextrose solutions with low electrolyte concentrations should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The bag container label for these solutions bears the statement: Do not administer simultaneously with blood.
The intravenous administration of solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
Heparin Sodium in 5% Dextrose Injection contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Excessive administration of potassium-free solutions may result in significant hypokalemia.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Heparin Sodium is indicated for:
Anticoagulant therapy in prophylaxis and treatment of venous and arterial thrombosis and its extension;
Prophylaxis and treatment of pulmonary embolism;
Atrial fibrillation with embolization;
Diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and heart surgery;
Prophylaxis and treatment of peripheral arterial embolism.
History
There is currently no drug history available for this drug.
Other Information
Heparin Sodium in 5% Dextrose Injection is a buffered, sterile, nonpyrogenic solution of Heparin Sodium, USP, derived from porcine intestinal mucosa, standardized for anticoagulant activity, and dextrose in water for injection. 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) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) ß-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (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 of the heparin is determined by biological assay using USP reference standard based upon units of heparin activity per milligram.
Dextrose Hydrous, USP, is chemically designated D-gluco pyranose monohydrate, a hexose sugar freely soluble in water. It has the following structural formula:
The solution is intended for intravenous use only. It contains no antimicrobial agents or bacteriostatic agents.
Each 100 mL contains 4,000 or 5,000 or 10,000 USP Heparin Units Heparin Sodium, USP with 5 g Dextrose Hydrous, USP, 103 mg Dibasic Sodium Phosphate Dried, USP (Na2HPO4) and 51 mg Citric Acid Anhydrous, USP (C6H8O7) added as buffers. 20 mg sodium bisulfite is added as a stabilizer. pH 5.5 (5.0 - 6.0). pH may have been adjusted with citric acid and/or sodium hydroxide. Osmolarity 298 mOsmol/L (Actual).
This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Sources
Heparin Sodium In Dextrose Manufacturers
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Baxter Healthcare Corporation
![Heparin Sodium In Dextrose (Heparin Sodium) Injection, Solution [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Heparin Sodium In Dextrose | Baxter Healthcare Corporation
Heparin Sodium in 5% Dextrose Injection is for intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.
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. Physicians should refer to medical literature.
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 AnticoagulantWhen 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. This is about 5 hours after the last I.V. bolus and 24 hours after the last subcutaneous dose. If continuous I.V. heparin infusion is used, prothrombin time can usually be measured at any time.
In converting from heparin to 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 HeparinAlthough dosage must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage may be used as a guideline for continuous intravenous infusion (based on 150 lb [68 kg] patient):
Initial Dose: 5,000 units by I.V. Injection Continuous Dose: 20,000 - 40,000 units/24 hours Pediatric UseFollow 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 UsePatients over 60 years of age may require lower doses of heparin.
Surgery of the Heart and Blood VesselsPatients 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.
All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.
Because dosages of this drug are titrated to response, no additives should be made to Heparin Sodium in 5% Dextrose Injection.
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B. Braun Medical Inc.
Heparin Sodium In Dextrose | B. Braun Medical Inc.
Heparin Sodium in 5% Dextrose Injection is for intravenous use only. Do not use Heparin Sodium in 5% Dextrose Injection as a "catheter lock flush" product.
Heparin Sodium is not effective by oral administration and Heparin Sodium in 5% Dextrose Injection should not be given orally.
This product should not be infused under pressure.
The dosage of heparin sodium should be adjusted according to the patient's coagulation test results. When heparin sodium is administered by continuous intravenous infusion, coagulation tests should be performed approximately every 4 hours during the early stages of therapy. 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.
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. This is about 5 hours after the last IV bolus and 24 hours after the last subcutaneous dose. If continuous IV 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.
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. Initial dose 5,000 USP units by IV injection Continuous Intravenous infusion Continuous 20,000 – 40,000 USP units/24 hours Pediatric UseThere 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 USP units/kg (IV bolus over 10 minutes)
Maintenance Dose Infants: 25 to 30 USP units/kg/hour; Infants less than 2 months have the highest requirements (average 28 USP units/kg/hour)
Children greater than 1 year of age: 18 to 20 USP 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.
Geriatric UsePatients over 60 years of age may require lower doses of heparin. (See PRECAUTIONS.)
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
![Heparin Sodium In Dextrose (Heparin Sodium And Dextrose) Injection [B. Braun Medical Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=92a6f533-1a3d-4734-b413-d245592454e3&name=heparin-sodium-in-dextrose-injection-in-excel-10.jpg)
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