Quick answers
- What is Heparin sodium and dextrose used for?
- The FDA-approved label (Heparin Sodium in Dextrose, B. Braun Medical Inc., July 31, 2023) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Heparin sodium and dextrose?
- The “Adverse Reactions” section of the FDA label (Heparin Sodium in Dextrose, B. Braun Medical Inc., July 31, 2023) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Heparin sodium and dextrose?
- The “Drug Interactions” section of the FDA label (Heparin Sodium in Dextrose, B. Braun Medical Inc., July 31, 2023) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Heparin sodium and dextrose have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Heparin sodium and dextrose?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Heparin sodium and dextrose been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 9, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Heparin sodium and dextrose?
- 1 company lists prescription products of Heparin sodium and dextrose in the FDA NDC Directory, including B. Braun Medical Inc.
What Heparin sodium and dextrose is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, intravenous), Heparin Sodium in Dextrose, B. Braun Medical Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Heparin sodium and dextrose side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
Read more of this section
(6) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-227-2862 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 and 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 label: Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023. Read the full label on DailyMed →
Heparin sodium and dextrose drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
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.
Read more of this section
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 intravenous nitroglycerin may partially counteract the anticoagulant action of heparin sodium. Intravenous nitroglycerin administered to heparinized patients may result in a decrease of the partial thromboplastin time with subsequent rebound effect upon discontinuation of nitroglycerin. Careful monitoring of partial thromboplastin time and adjustment of heparin dosage are recommended during coadministration of heparin and intravenous nitroglycerin. Antithrombin III (human) – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, a reduced dosage of heparin is recommended during treatment with antithrombin III (human).
— FDA label: Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023. Read the full label on DailyMed →
Heparin sodium and dextrose dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Recommended Adult Dosages: Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3) Intermittent Intravenous Injection Initial Dose 10,000 Units Subsequent Doses 5,000 to 10,000 Units every 4 to 6 hours Continuous Intravenous Infusion Initial Dose 5,000 Units by intravenous injection Continuous 20,000 to 40,000 Units every 24 hours * Based on 150 lb. (68 kg) patient.
Read more of this section
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) Intravascular via Extracorporeal Dialysis Follow equipment manufacturer's operating directions carefully. For pediatric dosing see section 2.4 of full prescribing information. 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. 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 Subsequent Doses 5,000 to 10,000 Units every 4 to 6 hours Continuous Intravenous Infusion Initial Dose 5,000 Units by intravenous injection Continuous 20,000 to 40,000 Units every 24 hours 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.
Table from the label
| Intermittent Intravenous Injection | Initial Dose | 10,000 Units |
|---|---|---|
| Subsequent Doses | 5,000 to 10,000 Units every 4 to 6 hours | |
| Continuous Intravenous Infusion | Initial Dose | 5,000 Units by intravenous injection |
| Continuous | 20,000 to 40,000 Units every 24 hours |
— FDA label: Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023. This is part of the section. Read the full label on DailyMed →
When Heparin sodium and dextrose should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
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) and Adverse Reactions (6.1)] In whom suitable blood coagulation tests – e.g., the whole blood …
— FDA label: Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023. This is part of the section. Read the full label on DailyMed →
Heparin sodium and dextrose overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
An overdose requires immediate medical attention and treatment. Symptoms Bleeding is the chief sign of heparin overdosage. Easy bruising, petechial formations, nosebleeds, blood in urine or tarry stools may be the first signs or symptoms of a heparin overdose. In the event of symptomatic heparin overdose, consider stopping heparin infusion.
Read more of this section
Treatment Neutralization of heparin effect: When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly, in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100 USP Heparin units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 30 minutes after intravenous injection. Ideally, the dose required to neutralize the action of heparin should be guided by blood coagulation tests or calculated from a protamine neutralization test. Because fatal reactions often resembling anaphylaxis have been reported, protamine sulfate should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. For additional information, consult the prescribing information for Protamine Sulfate Injection, USP. Blood or plasma transfusions may be necessary; these dilute but do not neutralize heparin.
— FDA label: Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- B. Braun Medical Inc.3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019952 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | B Braun | July 20, 1992 | 20, latest October 26, 2026 2026: Labeling · 2023: Labeling · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 9, 2023 · Class II · Terminated · D-0579-2023
Subpotent: Low anti-factor IIa Potency.
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20, — B. Braun Medical Inc
-
March 1, 2023 · Class II · Terminated · D-0434-2023
Subpotent Drug: low Anti-Factor IIa potency.
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20. — B. Braun Medical Inc
-
June 13, 2019 · Class II · Terminated · D-1343-2019
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.
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20. — B. Braun Medical Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1361607, 1658717, 1659195 |
|---|---|
| SPL set ID of the quoted label | 92a6f533-1a3d-4734-b413-d245592454e3 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA019952 |
| Active ingredients (FDA) | DEXTROSE MONOHYDRATE / HEPARIN SODIUM |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Atrial fibrillationCondition named on the label: hospitals that treat it
- B. Braun Medical Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Heparin Sodium in Dextrose, B. Braun Medical Inc., effective July 31, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →