Heparin Sodium and Dextrose 10000 [USP'U]/100mL

HEPARIN SODIUM · INJECTION, SOLUTION · Hospira, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Heparin Sodium and Dextrose is a injection, solution containing heparin sodium at 10000 [USP'U]/100mL, taken intravenous. Manufactured by Hospira, Inc..

Key Facts

Brand Name: Heparin Sodium and Dextrose
Generic Name: HEPARIN SODIUM
NDC Code (Product): 0409-4520
Manufacturer: Hospira, Inc.
Strength: 10000 [USP'U]/100mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA019339
Marketing Start: 12/12/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

heparin-induced thrombocytopenia1,249 reports

drug ineffective957 reports

off label use722 reports

nausea719 reports

drug hypersensitivity616 reports

vomiting584 reports

hypotension553 reports

dyspnoea530 reports

pyrexia481 reports

pulmonary embolism477 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Heparin Sodium in 5% Dextrose Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation • Treatment of acute and chronic consumption 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 in 5% Dextrose Injection is indicated for: ( 1 ) • Prophylaxis and treatment of venous thrombosis and pulmonary embolism. • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation. • Treatment of acute and chronic consumption 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.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Recommended Adult Dosages: • Therapeutic Anticoagulant Effect with Full-Dose Heparin* ( 2.3 ) Intermittent Intravenous Injection Initial Dose 10,000 Units, either undiluted or in 50 to 100 mL of 5% Dextrose Injection Subsequent Doses 5,000 to 10,000 Units every 4 to 6 hours, either undiluted or in 50 to 100 mL of 5% Dextrose Injection Continuous Intravenous Infusion Initial Dose 5,000 Units by intravenous injection Continuous 20,000 to 40,000 Units every 24 hours in 1000 mL of 5% Dextrose Injection *Based on 150 lb. (68 kg) patient. • Cardiovascular Surgery ( 2.5 ) Intravascular via Total Body Perfusion Initial Dose Greater than or equal to 150 units/kg; adjust for longer procedures • Extracorporeal Dialysis ( 2.8 ) For pediatric dosing see section 2.4 of full prescribing information. Intravascular via Extracorporeal Dialysis Follow equipment manufacturer's operating directions carefully. 2.1 Preparation for Administration Confirm the selection of the correct formulation and strength prior to administration of the drug. This product should be administered by intravenous infusion. Do not use Heparin Sodium in 5% Dextrose Injection as a “catheter lock flus…

Contraindications

4 CONTRAINDICATIONS The use of Heparin Sodium in 5% Dextrose Injection is contraindicated in patients with the following conditions: • History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) [see Warnings and Precautions (5.3) ] • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions (5.7) , 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) [see Warnings and Precautions (5.5) ] • Uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation [see Warnings and Precautions (5.2) ]. • History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT). ( 4 ) • Known hypersensitivity to heparin or pork products. ( 4 ) • In whom suitable blood coagulation tests cannot be performed at appropriate intervals. ( 4 ) …

Drug Interactions

7 DRUG INTERACTIONS Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. ( 7 ) 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 acetylsalicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIv/IIa 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 Medications that May Interfere with Heparin Digitalis, tetracyclines, nicotine, antihistamines, or intraveno…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hemorrhage [see Warnings and Precautions (5.2) ] • Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis [see Warnings and Precautions (5.3) ] • Thrombocytopenia [see Warnings and Precautions (5.4) ] • Heparin Resistance [see Warnings and Precautions (5.6) ] • Hypersensitivity [see Warnings and Precautions (5.7) ] • Hyperkalemia [see Warnings and Precautions (5.8) ] • Elevations of Serum Aminotransferases [see Warnings and Precautions (5.9) ] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, heparin resistance, hypersensitivity reactions, hyperkalemia, and elevations of aminotransferase levels. (6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. • Hemorrhage - Hemorrhage is…

Frequently Asked Questions

What is Heparin Sodium and Dextrose used for?

Heparin Sodium and Dextrose contains HEPARIN SODIUM. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Heparin Sodium and Dextrose a controlled substance?

Heparin Sodium and Dextrose is not classified as a controlled substance by the DEA.

What is the generic name for Heparin Sodium and Dextrose?

The generic name for Heparin Sodium and Dextrose is HEPARIN SODIUM. There are 12 other brand versions of HEPARIN SODIUM.

What is the NDC code for Heparin Sodium and Dextrose 10000 [USP'U]/100mL?

The NDC (National Drug Code) for Heparin Sodium and Dextrose 10000 [USP'U]/100mL is 0409-4520, listed by Hospira, Inc..

Product NDC

0409-4520

Package NDC

0409-4520-30

Other Heparin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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