Heparin Sodium and Dextrose

Heparin Sodium and Dextrose is an FDA-registered drug product whose active ingredient is HEPARIN SODIUM. It is labelled by Hospira, Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 0409-4520, application NDA019339, label effective 20260525. It is one of 15 FDA drug label records sharing the active ingredient HEPARIN SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HEPARIN SODIUM are most often described in connection with: heparin sodium, dextrose injection, treatment venous, pulmonary embolism, thromboembolic complications, atrial fibrillation, chronic consumption, coagulopathies disseminated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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 flush” product. Do not admix with other drugs. Discard unused portion. Do not use plastic containers in series connection. This product should not be infused under pressure. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if solution is clear and container and seals are intact. To Open Tear outer wrap and remove solution container. (Use aseptic technique) 1. Close flow control clamp of administration set. 2. Remove cover from outlet port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber. 6. Open flow control clamp and clear air from set. Close clamp. 7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 8. Regulate rate of administration with flow control clamp. Warning: Do not use flexible container in series connections. 2.2 Laboratory Monitoring for Efficacy and Safety Adjust the dosage of heparin sodium according to the patient's coagulation test results. When heparin is given by continuous intravenous infusion, determine the coagulation time approximately every 4 hours in the early stages of treatment. When the drug is administered intermittently by intravenous injection, perform coagulation tests 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 the 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. 2.3 Therapeutic Anticoagulant Effect with Full-Dose Heparin The dosing recommendations in Table 1 are based on clinical experience. 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: Table 1: Recommended Adult Full-Dose Heparin Regimens for Therapeutic Anticoagulant Effect Method of Administration Frequency Recommended Dose Based on 150 lb. (68 kg) patient. 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 1,000 mL of 5% Dextrose Injection 2.4 Pediatric Use There 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 units/kg to 100 units/kg (intravenous bolus over 10 minutes) Maintenance Dose Infants: 25 units/kg/hour to 30 units/kg/hour; Infants < 2 months have the highest requirements (average 28 units/kg/hour) Children > 1 year of age: 18 units/kg/hour to 20 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. 2.5 Cardiovascular Surgery Patients 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. 2.6 Converting to Warfarin To ensure continuous anticoagulation when converting from heparin sodium to warfarin, continue full heparin therapy for several days until the INR (prothrombin time) has reached a stable therapeutic range. Heparin therapy may then be discontinued without tapering [see Drug Interactions (7.1) ] . 2.7 Converting to Oral Anticoagulants other than Warfarin For patients currently receiving intravenous heparin, stop intravenous infusion of heparin sodium immediately after administering the first dose of oral anticoagulant; or for intermittent intravenous administration of heparin sodium, start oral anticoagulant 0 to 2 hours before the time that the next dose of heparin was to have been administered. 2.8 Extracorporeal Dialysis Follow equipment manufacturer's operating directions carefully. A dose of 25 to 30 units/kg followed by an infusion rate of 1,500 to 2,000 units/hour is suggested based on pharmacodynamic data if specific manufacturers' recommendations are not available.

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 ) • Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation. ( 4 )

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 the chief complication that may result from heparin therapy [see Warnings and Precautions (5.2) ] . An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug [see Overdosage (10) ] . Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect: - Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases. - Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. - Retroperitoneal hemorrhage. • Vascular Disorders – Contusion, vasospastic reactions (including episodes of painful, ischemic, and cyanosed limbs). • HIT and HITT, including delayed onset cases, and Thrombocytopenia - [see Warnings and Precautions (5.3 , 5.4) ] • Histamine-like reactions – Such reactions have been observed at the site of injections. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin, occasionally requiring skin grafting. • Hypersensitivity – Generalized hypersensitivity reactions have been reported with chills, fever, and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the plantar site of the feet, may occur [see Warnings and Precautions (5.7) ] . • Musculoskeletal, Connective Tissue and Bone Disorders – Osteoporosis with long-term administration of heparin. • Metabolism and Nutrition Disorders – Hyperkalemia. • General Disorders and Administration Site Conditions – Erythema, mild pain, ulceration. • Elevations of Serum Aminotransferases – Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin. • Others – Osteoporosis following long-term administration of high-doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported.

FDA lists 15 drug label records with HEPARIN SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Heparin Sodium and Dextrose used for?
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 …

Who makes Heparin Sodium and Dextrose?
Hospira, Inc. is the labeler of record for Heparin Sodium and Dextrose. 15 FDA label records share the active ingredient HEPARIN SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Heparin Sodium and Dextrose come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Heparin Sodium and Dextrose prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HEPARIN SODIUM?
Yes. 15 FDA drug label records list HEPARIN SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Heparin Sodium and Dextrose been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.