Heparin Sodium 5000 [USP'U]/mL
Heparin Sodium · INJECTION, SOLUTION · Henry Schein, Inc.
Heparin Sodium is a injection, solution containing heparin sodium at 5000 [USP'U]/mL, taken intravenous. Manufactured by Henry Schein, Inc..
Key Facts
- Brand Name
- Heparin Sodium
- Generic Name
- Heparin Sodium
- NDC Code (Product)
0404-9872- Manufacturer
- Henry Schein, Inc.
- Strength
- 5000 [USP'U]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA090808
- Marketing Start
- 01/11/2022
Recall History
Cantrell Drug Company
Stability Data Does Not Support Expiry
Pharmedium Services, LLC
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
B. Braun Medical Inc
Subpotent Drug: low Anti-Factor IIa potency.
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
B. Braun Medical Inc
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
Baxter Healthcare Corporation
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Baxter Healthcare Corp
Subpotent Drug; out of specification results for heparin raw material
Avella of Deer Valley, Inc. Store 38
Lack of Assurance of Sterility: Potential leakage of bags.
Avella of Deer Valley, Inc. Store 38
Lack of Assurance of Sterility: Potential leakage of bags.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. HEPARIN SODIUM INJECTION is an anticoagulant indicated for ( 1 ) Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease Atrial fibrillation with embolization Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) Prevention of clotting in arteria…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Adult Dosages: Therapeutic Anticoagulant Effect with Full-Dose Heparin † ( 2.4 ) † Based on 150 lb (68 kg) patient. Adjust dose based on laboratory monitoring. Deep Subcutaneous (Intrafat) Injection Use a different site for each injection Initial Dose 5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously Every 8 hours or Every 12 hours 8,000 to 10,000 units of a concentrated solution 15,000 to 20,000 units of a concentrated solution Intermittent Intravenous Injection Initial dose 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Every 4 to 6 hours 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Intravenous Infusion Initial dose 5,000 units by intravenous injection Continuous 20,000 to 40,000 units/24 hours in 1000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion 2.1 Preparation for Administration Confirm the choice of the correct Heparin Sodium Injection vial to ensure that the 1 mL vial is not confused with a “catheter lock flush” vial or other 1 mL vial o…
Contraindications
4 CONTRAINDICATIONS The use of Heparin Sodium Injection is contraindicated in patients with the following conditions: History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions ( 5.3 )] ; Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions ( 6.1 )] ; 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); An uncontrolled active bleeding state [see Warnings and Precautions ( 5.2 )] , except when this is due to disseminated intravascular coagulation. Severe thrombocytopenia ( 4 ) When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals ( 4 ) An uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drugs that interfere with platelet aggregation: May induce bleeding ( 7.2 ) 7.1 Oral Anticoagulants Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn, if a valid prothrombin time is to be obtained. 7.2 Platelet Inhibitors Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium. To reduce the risk of bleeding, a reduction in the dose of antiplatelet agent or heparin is recommended. 7.3 Other Interactions Digitalis, tetracyclines, nicotine or antihistamines may partially counteract the anticoagulant action of heparin sodium. Intravenous nitroglycerin…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.2 )] Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see Warnings and Precautions ( 5.3 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [ see Warnings and Precautions ( 5.4 ) ] Thrombocytopenia [see Warnings and Precautions ( 5.5 )] Heparin Resistance [see Warnings and Precautions ( 5.7 )] Hypersensitivity [see Warnings and Precautions ( 5.8 )] Hyperkalemia [see Warnings and Precautions ( 5.9 )] Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Postmarketing Experience The following adverse reactions have been identified during post approval use of Heparin Sodium Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is …
Frequently Asked Questions
What is Heparin Sodium used for?
Heparin Sodium contains Heparin Sodium. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Heparin Sodium a controlled substance?
Heparin Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Heparin Sodium?
The generic name for Heparin Sodium is Heparin Sodium. There are 3 other brand versions of Heparin Sodium.
What is the NDC code for Heparin Sodium 5000 [USP'U]/mL?
The NDC (National Drug Code) for Heparin Sodium 5000 [USP'U]/mL is 0404-9872, listed by Henry Schein, Inc..
Other Heparin Sodium Dosages
- Heparin Sodium1000 [USP'U]/mL0641-0391
- Heparin Sodium1000 [USP'U]/mL0781-3543
- Heparin Sodium10000 [USP'U]/mL25021-403
- Heparin Sodium5000 [USP'U]/100mL63323-518
- Heparin Sodium1000 [USP'U]/mL63739-942
- Heparin Sodium1000 [USP'U]/mL67457-372
- Heparin Sodium5000 [USP'U]/mL70518-4547
- Heparin Sodium10000 [USP'U]/mL71288-451
- Heparin Sodium5000 [USP'U]/100mL0409-3150
Other Heparin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)