![Heparin Sodium 10000 [USP'U]/100mL Injection, Solution — NDC 63323-0523-74 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cb1c1e7a-c9ca-4a07-8833-e45ce436d287&name=fre0i-0003-10.jpg)
Heparin Sodium 10000 [USP'U]/100mL Injection, Solution
Other active recalls for Heparin Sodium (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Unfractionated Heparin class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Heparin is used to: prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures. stop the growth of clots that have already formed in the blood vessels. prevent blood clots from forming in catheters (small plastic tubes through which medication can be administered or blood drawn). treat certain types of blood disorders. Heparin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.
Read the full MedlinePlus article ↗- Heparin is a powerful blood thinner that stops dangerous clots from forming or getting bigger. Depending on your situation, it might be preventing a clot from traveling to your lun...
- Why do I need heparin — what is it actually doing for me?
- Heparin is always injected — your stomach can't absorb it, so pills aren't an option. In the hospital, it's often given as a continuous drip into a vein (IV infusion) or as an inte...
- How is heparin given — do I have to get it through an IV the whole time?
Patient education
Supplement & herbal interactions
Heparin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
UNII LX22YL083G
A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
-
UNII 4VON5FNS3C
Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
-
UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.5958 | $3,574.80 / 6000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1644 | $0.199 / J1644 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Heparin Sodium in Sodium Chloride 10000 [USP'U]/100mL 00264-3462-20 | B. | 250 ml | — | AP | FDA listed | — |
| Heparin Sodium in Dextrose 10000 [USP'U]/100mL; 5 g/100mL 00264-9587-20 | B. | 250 ml | — | — | FDA listed | — |
| Heparin Sodium and Dextrose 10000 [USP'U]/100mL 00409-4520-30 | Hospira, | 30 pouches | — | AP | FDA listed | — |
| Heparin Sodium 10000 [USP'U]/100mL 00409-7650-62 | Hospira, | 24 pouches | — | AP | Discontinued | — |
| Heparin Sodium 10000 [USP'U]/100mL 51662-1411-01 | HF | 1 pouch | — | AP | FDA listed | — |
| Heparin Sodium In Sodium Chloride 10000 [USP'U]/100mL 51662-1578-01 | HF | 250 ml | — | AP | FDA listed | — |
| Heparin Sodium 10000 [USP'U]/100mL 51662-1687-03 | HF | 30 pouches | — | AP | FDA listed | — |
| Heparin Sodium 10000 [USP'U]/100mL 63323-0517-74 | Fresenius | 250 ml | — | AP | FDA listed | — |
| Heparin Sodium 10000 [USP'U]/100mLthis 63323-0523-74 | Fresenius | 250 ml | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0523-74 You're viewing this | 24 BAG in 1 CASE (63323-523-74) / 250 mL in 1 BAG (63323-523-01) | 2017-08-24 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Heparin sodium is indicated for: Prophylaxis and treatment of venous thromboembolism and pulmonary embolism; 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 is an anticoagulant indicated for: ( 1 ) Prophylaxis and treatment of venous thromboembolism and pulmonary embolism 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.
⏱️ Dosage and 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 Every 4 to 6 hours 5,000 to 10,000 units Continuous Intravenous Infusion Initial Dose 5,000 units by intravenous injection Continuous 20,000 to 40,000 units/24 hours *Based on 150 lb. (68 kg) patient. Surgery of the Heart and Blood Vessels ( 2.5 ) Intravascular via Total Body Perfusion Initial Dose ≥ 150 units/kg; adjust for longer procedures Extracorporeal Dialysis ( 2.8 ) Intravascular via Extracorporeal Dialysis Follow equipment manufacturer’s operating directions carefully.
See full prescribing information for recommended pediatric dosage. ( 2.4 )
2.1Preparation for Administration Confirm the selection of the correct formulation and strength prior to administration of the drug. INSTRUCTIONS FOR USE for the free flex ® Bag Leave bag in the overwrap until time of use. The intact port cap provides visual tamper evidence.
Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling. To Open: Always inspect the bag before and after removal from the overwrap.
Place the bag on a clean, flat surface. Starting in the bottom corner, peel the overwrap open and remove the bag. Check the bag for leaks by squeezing firmly.
If leaks are found, discard the bag. Do not use if the solution is cloudy or a precipitate is present. To Prepare for Administration: Immediately before connecting the infusion set, firmly grasp the BLUE infusion port cap with the arrow pointing away from the bag between index finger and thumb.
Gently break off the port cap. The membrane of the infusion port is sterile, and disinfection before initial use is not necessary if proper aseptic handling technique is followed. Use a non-vented infusion set or close the air-inlet on a vented set.
The BLUE infusion port is compatible with spike systems produced according to ISO 8536-4, with an external spike diameter of 5.5 to 5.7 mm. Close the roller clamp of the infusion set. Hold the base of the BLUE infusion port and insert the spike by rotating your wrist slightly until the spike is fully inserted.
The port membrane contains a self-sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once. Hang from the hole at the top of the bag.
For Single Use Only. Discard unused portion. Do not admix with other drugs.
Do not use flexible container in series connections. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2.2Laboratory 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.
2.3Therapeutic 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* Intermittent I…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Heparin Sodium in 0.45% Sodium Chloride Injection is available as: Injection: 50 USP units per mL in 0.45% Sodium Chloride clear solution (25,000 USP units per 500 mL) in single-dose free flex ® bag Injection: 100 USP units per mL in 0.45% Sodium Chloride clear solution (25,000 USP units per 250 mL) in single-dose free flex ® bag Heparin Sodium in 5% Dextrose Injection is available as: Injection: 50 USP units per mL in 5% Dextrose clear solution (25,000 USP units per 500 mL) in single-dose free flex ® bag Injection: 100 USP units per mL in 5% Dextrose clear solution (25,000 USP units per 250 mL) in single-dose free flex ® bag Heparin sodium is available as: ( 3 ) Heparin Sodium in 0.45% Sodium Chloride Injection : Injection: 50 USP units per mL in 0.45% Sodium Chloride clear solution (25,000 USP units per 500 mL) in single-dose free flex ® bag Injection: 100 USP units per mL in 0.45% Sodium Chloride clear solution (25,000 USP units per 250 mL) in single-dose free flex ® bag Heparin Sodium in 5% Dextrose Injection : Injection: 50 USP units per mL in 5% Dextrose clear solution (25,000 USP units per 500 mL) in single-dose free flex ® bag Injection: 100 USP units per mL in 5% Dextrose clear solution (25,000 USP units per 250 mL) in single-dose free flex ® bag
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of Heparin Sodium in 0.45% Sodium Chloride Injection or 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 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 )] An uncontrolled bleeding state [see Warnings and Precautions ( 5.2 )] , except when this is due to disseminated intravascular coagulation.
History of Heparin-Induced Thrombocytopenia (HIT) and 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Fatal Medication Errors: Confirm choice of correct strength prior to administration. ( 5.1 ) Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage.
( 5.2 ) HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT and HITT. ( 5.3 ) Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin.
( 5.5 )
5.1Fatal Medication Errors Do not use this product as a “catheter lock flush” product. Heparin is supplied in various strengths. Fatal hemorrhages have occurred due to medication errors. Carefully examine all heparin products to confirm the correct container choice prior to administration of the drug.
5.2Hemorrhage Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. Hemorrhage, including fatal events, has occurred in patients receiving Heparin Sodium. Hemorrhage can occur at virtually any site in patients receiving heparin.
Adrenal hemorrhage (with resultant acute adrenal insufficiency), ovarian hemorrhage, and retroperitoneal hemorrhage have occurred during anticoagulant therapy with heparin [see Adverse Reactions ( 6.1 )] . A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Clinical Pharmacology ( 12.3 )] . An unexplained fall in hematocrit or fall in blood pressure should lead to serious consideration of a hemorrhagic event.
Use heparin sodium with caution in disease states in which there is increased risk of hemorrhage, including: Cardiovascular — 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.
Patients with hereditary antithrombin III deficiency receiving concurrent antithrombin III therapy — 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, reduce the heparin dose during concomitant treatment with antithrombin III (human). Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
Other — Menstruation, liver disease with impaired hemostasis.
5.3Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) HIT is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor 4-heparin complex that induce in vivo platelet aggregation. HIT may progress to the development of venous and arterial thromboses, a condition known as heparin-induced thrombocytopenia and thrombosis (HITT).
Thrombotic events may also be the initial presentation for HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, thrombus formation on a prosthetic cardiac valve, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. Monitor thrombocytopenia of any degree closely.
If the platelet count falls below 100,000/mm 3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant. HIT or HITT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT or HITT.
5.4 Thrombocytopenia Thrombocytope…
🤒 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 (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) [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 )] Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity reactions, and elevations of aminotransferase levels.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA , LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Postmarketing 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 )] .
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.
HIT and HITT, including delayed onset cases [see Warnings and Precautions ( 5.3 and 5.4 )] . 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 side of the feet, may occur [see Warnings and Precautions ( 5.7 )].
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.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. ( 7 )
7.1Oral 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.
7.2Platelet 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.
7.3Other Interactions Digitalis, tetracyclines, nicotine, antihistamines, or intravenous nitroglycerin may partially counteract the anticoagulant action of heparin sodium. Heparin Sodium in 5% Dextrose Injection 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).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on heparin sodium use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 40,000 units/24 hours infusion (see Data).
Consider the benefits and risks of Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection to a pregnant woman and possible risks to the fetus when prescribing Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications.
Animal Data In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 USP units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects.
8.2Lactation Risk Summary There is no information regarding the presence of Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection in human milk, the effects on the breastfed infant, or the effects on milk production. Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection or from the underlying maternal condition [see Use in Specific Populations ( 8.4 )].
8.4Pediatric Use There are no adequate and well-controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration ( 2.4 )] .
8.5Geriatric Use There are limited adequate and well-controlled studies in patients 65 years and older. However, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see Warnings and Precautions ( 5.2 )] . Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on heparin sodium use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 40,000 units/24 hours infusion (see Data).
Consider the benefits and risks of Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection to a pregnant woman and possible risks to the fetus when prescribing Heparin Sodium in 0.45% Sodium Chloride Injection or Heparin Sodium in 5% Dextrose Injection to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications.
Animal Data In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 USP units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects.
🧒 Pediatric Use ▾
8.4Pediatric Use There are no adequate and well-controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration ( 2.4 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use There are limited adequate and well-controlled studies in patients 65 years and older. However, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see Warnings and Precautions ( 5.2 )] . Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology ( 12.3 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Bleeding may result from heparin overdosage. Neutralization of heparin effect When circumstances (e.g., 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 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 1/2 hour after intravenous injection.
Because fatal reactions often resembling anaphylaxis have been reported, the drug 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.
Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.
12.2Pharmacodynamics Bleeding time is usually unaffected by heparin. Various times (activated clotting time, activated partial thromboplastin time, prothrombin time, whole blood clotting time) are prolonged by full therapeutic doses of heparin; in most cases it is not measurably affected by low doses of heparin.
12.3Pharmacokinetics Absorption Heparin is not absorbed through the gastrointestinal tract and therefore administered via parenteral route. Peak plasma concentration and the onset of action are achieved immediately after intravenous administration. Distribution Heparin is highly bound to antithrombin, fibrinogens, globulins, serum proteases and lipoproteins. The volume of distribution is
0.07L/kg. Elimination Metabolism Heparin does not undergo enzymatic degradation. Excretion Heparin is mainly cleared from the circulation by liver and reticuloendothelial cells mediated uptake into extravascular space.
Heparin undergoes biphasic clearance, a) rapid saturable clearance (zero order process due to binding to proteins, endothelial cells and macrophage) and b) slower first order elimination. The plasma half-life is dose-dependent and it ranges from 0.5 to 2 h. Specific Population Geriatric patients Patients over 60 years of age, following similar doses of heparin, may have higher plasma levels of heparin and longer activated partial thromboplastin times (APTTs) compared with patients under 60 years of age [see Use in Specific Populations ( 8.5 )] .
🧬 Mechanism of Action ▾
12.1Mechanism of Action Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.
Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Heparin Sodium in 0.45% Sodium Chloride Injection is supplied as follows: Product Code Unit of Sale Strength Each 518077 NDC 63323-518-77 Unit of 24 25,000 USP units per 500 mL (50 USP units per mL) NDC 63323-518-01 500 mL Single Dose free flex ® Bag 517074 NDC 63323-517-74 Unit of 24 25,000 USP units per 250 mL (100 USP units per mL) NDC 63323-517-01 250 mL Single Dose free flex ® Bag Heparin Sodium in 5% Dextrose Injection is supplied as follows: Product Code Unit of Sale Strength Each 507277 NDC 63323-522-77 Unit of 24 25,000 USP units per 500 mL (50 USP units per mL) NDC 63323-522-01 500 mL Single Dose free flex ® Bag 507374 NDC 63323-523-74 Unit of 24 25,000 USP units per 250 mL (100 USP units per mL) NDC 63323-523-01 250 mL Single Dose free flex ® Bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Avoid excessive heat. Do not freeze. The container closure is not made with natural rubber latex.
Non-PVC, Non-DEHP, Sterile.
📋 Description ▾
11 DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of Heparin Sodium (representative subunits): Heparin Sodium in 0.45% Sodium Chloride Injection and Heparin Sodium in 5% Dextrose Injection are sterile, nonpyrogenic solutions prepared from heparin sodium (derived from porcine intestinal mucosa) for intravenous administration.
The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium in 0.45% Sodium Chloride Injection, is available as follows: Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; sodium chloride, 0.45 g; edetate disodium, dihydrate, 0.0111 g added as a stabilizer and water for injection, q.s. Each liter contains the following electrolytes: Sodium 77 mEq and chloride 77 mEq; pH 5.0 to 7.5.
The solution may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. Heparin Sodium in 5% Dextrose Injection, is available as follows: Each 100 mL contains heparin sodium 5,000 or 10,000 USP Units; dextrose hydrous, 5 g; citric acid anhydrous, 51 mg and sodium citrate dihydrate, 334 mg added as buffers; and sodium metabisulfite, 20 mg added as an antioxidant. Each liter contains the following electrolytes: Sodium 39 mEq and citrate 42 mEq; pH 5.0 to 7.5.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hemorrhage Inform patients that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they are treated with heparin, and that they should report any unusual bleeding or bruising to their physician. Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred [see Warnings and Precautions ( 5.2 )] .
Prior to Surgery Advise patients to inform physicians and dentists that they are receiving heparin before any surgery is scheduled [see Warnings and Precautions ( 5.2 )] . Heparin-Induced Thrombocytopenia Inform patients of the risk of heparin-induced thrombocytopenia (HIT). HIT may progress to the development of venous and arterial thromboses, a condition known as heparin-induced thrombocytopenia and thrombosis.
HIT and HITT can occur up to several weeks after the discontinuation of heparin therapy [see Warnings and Precautions ( 5.3 and 5.4 )] . Hypersensitivity Inform patients that generalized hypersensitivity reactions have been reported [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6 )] . Other Medications Because of the risk of hemorrhage, advise patients to inform their physicians and dentists of all medications they are taking, including non-prescription medications, and before starting any new medication [see Drug Interactions ( 7.2 )] .
Manufactured for: Made in Norway www.fresenius-kabi.com/us 451475C Revised: December 2019 Fresenius Kabi Logo