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Heparin Sodium
Overview
What is Heparin Sodium?
Heparin Sodium Injection, USP is a sterile, nonpyrogenic solution of heparin sodium (derived from porcine intestinal mucosa) in water for injection. Each container contains 10000, 12500, 20000 or 25,000 USP Heparin Units; 40 or 80 mg sodium chloride added to render isotonic (see HOW SUPPLIED section for various sizes and strength). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.0 (5.0 to 7.5). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. Whensmaller doses are required, the unused portion should be discarded. Heparin sodium in the ADD-Vantage® system is intended for intravenous administration only after dilution. 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):
What does Heparin Sodium look like?
What are the available doses of Heparin Sodium?
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What should I talk to my health care provider before I take Heparin Sodium?
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How should I use Heparin Sodium?
Heparin sodium is indicated for:Atrial fibrillation with embolization:Diagnosis and treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);Prevention of clotting in arterial and heart surgery;Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;(In a low-dose regimen) for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION);Prophylaxis and treatment of pulmonary embolism;Prophylaxis and treatment of peripheral arterial embolism.
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 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.
Converting to Oral Anticoagulant:
Therapeutic Anticoagulant Effect with Full-Dose Heparin
What interacts with Heparin Sodium?
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What are the warnings of Heparin Sodium?
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What are the precautions of Heparin Sodium?
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What are the side effects of Heparin Sodium?
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What should I look out for while using Heparin Sodium?
Heparin sodium should not be used in patients:With severe thrombocytopenia;In whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc. — cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);With an uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation.Intravenous solutions with Heparin Sodium Injection are contraindicated in patients who are hypersensitive to heparin.
Heparin is not intended for intramuscular use.
: 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 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:
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 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 thrombosisdevelops (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.
What might happen if I take too much Heparin Sodium?
Symptoms
Treatment
No more than 50 mg
very slowly
How should I store and handle Heparin Sodium?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F). [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot in inhibiting the activation of the fibrin stabilizing factor. Bleeding time is usually unaffected by heparin. Clotting time is prolonged by full therapeutic doses of heparin; in most cases, it is not measurably affected by low doses of heparin. Peak plasma levels of heparin are achieved 2 to 4 hours following subcutaneous administration, although there are considerable individual variations. Loglinear plots of heparin plasma concentrations with time for a wide range of dose levels are linear which suggests the absence of zero order processes. Liver and the reticuloendothelial system are the site of biotransformation. The biphasic elimination curve, a rapidly declining alpha phase (t½ = 10#) and after the age of 40 a slower beta phase, indicates uptake in organs. The absence of a relationship between anticoagulant half-life and concentration half-life may reflect factors such as protein binding of heparin.Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.
Non-Clinical Toxicology
Heparin sodium should not be used in patients:With severe thrombocytopenia;In whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc. — cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);With an uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation.Intravenous solutions with Heparin Sodium Injection are contraindicated in patients who are hypersensitive to heparin.Heparin is not intended for intramuscular use. : 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 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: 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 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 thrombosisdevelops (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.
General
a. White Clot Syndrome:
b. Heparin Resistance:
c. Increased Risk in Older Women:
Laboratory Tests:
Drug Interactions
Oral anticoagulants:
Platelet inhibitors:
Other interactions:
Drug/Laboratory Test Interactions:
Hyperaminotransferasemia:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Pregnancy
Nonteratogenic Effects
Nursing Mothers:
Pediatric Use
Hemorrhage
It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion
Hypersensitivity
Miscellaneous
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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