Mode
Text Size
Log in / Sign up

FDA approved Heparin Sodium in 5% Dextrose for Thrombosis, Embolism, and Anticoagulation UsesFDA approved premixed blood thinner heparin in a plastic IV container

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Note that heparin dosing requires adjustment to APTT and periodic platelet, hematocrit, and occult blood monitoring.

The FDA has approved Heparin Sodium in 5% Dextrose Injection (25,000 units) in a plastic container for a range of anticoagulant indications. These include 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 including disseminated intravascular coagulation, prevention of clotting in arterial and cardiac surgery, prophylaxis and treatment of peripheral arterial embolism, and anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

The approval provides clinicians with a premixed intravenous formulation of unfractionated heparin. The label emphasizes that dosing must be adjusted to coagulation test results, with adequacy defined as an activated partial thromboplastin time of 1.5 to 2 times normal or a whole blood clotting time elevated approximately 2.5 to 3 times control. Periodic platelet counts, hematocrits, and stool occult blood testing are recommended throughout therapy.

The label cautions that the product is for intravenous infusion only, must not be used as a catheter lock flush, should not be admixed with other drugs, and should not be infused under pressure or used in series connection. Trial data are not available in the label.

+ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

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; and anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. Pediatric dosing recommendations are based on clinical experience; there are no adequate and well-controlled studies in pediatric patients.

Dosing & Administration

Administer by intravenous infusion. Do not use as a catheter lock flush. Do not admix with other drugs. Discard unused portion. Do not use plastic containers in series connection. Do not infuse under pressure. Inspect visually for particulate matter and discoloration; use only if solution is clear and container and seals are intact.

Adult full-dose therapeutic anticoagulation (based on a 150 lb/68 kg patient): intermittent IV injection with an initial dose of 10,000 units, then 5,000 to 10,000 units every 4 to 6 hours; or continuous IV infusion with an initial 5,000 units by IV injection, then 20,000 to 40,000 units every 24 hours.

Cardiovascular surgery via total body perfusion: initial dose greater than or equal to 150 units/kg, adjusted for longer procedures; frequently 300 units/kg for procedures under 60 minutes or 400 units/kg for longer procedures.

Extracorporeal dialysis: follow equipment manufacturer's operating directions carefully.

Pediatric guidance: initial 75 to 100 units/kg IV bolus over 10 minutes; maintenance for infants 25 to 30 units/kg/hour (infants under 2 months average 28 units/kg/hour); children over 1 year 18 to 20 units/kg/hour. Adjust to maintain APTT of 60 to 85 seconds.

Monitoring: adjust dosage to coagulation tests. With continuous infusion, check coagulation time about every 4 hours early in treatment. With intermittent injection, test before each injection early in treatment and at appropriate intervals thereafter. Dosage is adequate when APTT is 1.5 to 2 times normal or whole blood clotting time is elevated approximately 2.5 to 3 times control. Obtain periodic platelet counts, hematocrits, and stool occult blood tests throughout therapy.

Converting to warfarin: continue full heparin for several days until INR reaches a stable therapeutic range, then discontinue without tapering. Converting to oral anticoagulants other than warfarin: for IV infusion, stop heparin immediately after the first oral dose; for intermittent IV dosing, start the oral agent 0 to 2 hours before the next scheduled heparin dose.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The FDA has approved a new premixed version of heparin, a well-known blood thinner, packaged in a plastic container for intravenous use. Heparin helps stop blood from clotting. Doctors use it to prevent and treat serious clots in the veins and lungs, to lower clot risk in people with an irregular heartbeat called atrial fibrillation, and to prevent clotting during heart surgery, dialysis, and blood transfusions.

This form is for hospital and clinic settings, where it is given through a vein. It is not a pill and not for home use. The approval gives health care teams a ready-to-use option, which can save time and reduce the chance of mixing errors.

The label says dosing must be adjusted based on blood test results, and that platelet counts and other tests should be checked during treatment. It also warns that the product is for intravenous infusion only, must not be used to flush catheters, and should not be mixed with other drugs.

One honest caveat: this news does not mean patients should ask for or change any blood thinner on their own. If you have questions about heparin or clot treatment, talk with your doctor.

What this means for you:
A ready-to-use heparin IV is approved for treating and preventing blood clots in hospitals.

Study Details

Study typeFda approval
PublishedJul 1992
View Original Abstract ↓
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 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.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.