Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.2 )] Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see Warnings and Precautions ( 5.3 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [ see Warnings and Precautions ( 5.4 ) ] Thrombocytopenia [see Warnings and Precautions ( 5.5 )] Heparin Resistance [see Warnings and Precautions ( 5.7 )] Hypersensitivity [see Warnings and Precautions ( 5.8 )] Hyperkalemia [see Warnings and Precautions ( 5.9 )] Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc.
at 1-844-824-8426 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 Injection.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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 heparin therapy.
Retroperitoneal hemorrhage.
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 HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS ( 5.3 ) Benzyl Alcohol Toxicity: Do not use benzyl alcohol-preserved drugs in neonates and infants.
( 5.4 ) Monitoring: Blood coagulation tests guide therapy for full-dose heparin.
Monitor platelet count and hematocrit in all patients receiving heparin ( 5.5 , 5.6 ) Hyperkalemia: Measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients ( 5.9 ) 5.1 Fatal Medication Errors Do not use Heparin Sodium Injection as a “catheter lock flush” product.
Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL.
Like all medications, Heparin Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: