Heparin Sodium In Sodium Chloride

1 INDICATIONS AND USAGE Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency. HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION at the concentration of 2 USP units/mL is an anticoagulant indicated for: • Maintenance of catheter patency (1)

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 and Thrombosis [see Warnings and Precautions (5.3) ] Thrombocytopenia [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Heparin Resistance [see Warnings and Precautions (5.6) ] Hyperkalemia [see Warnings and Precautions (5.7) ] Elevations of Serum Aminotransferases [see Warnings and Precautions (5.8) ] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, hypersensitivity reactions, heparin resistance, hyperkalemia, and elevations of aminotransferase levels.

8.1 Pregnancy Risk Summary 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 was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses, approximately 2777 times the recommended human dose (MRHD) for maintenance of catheter patency of heparin [ see Data ] . In pregnant animals, doses up to 2777 times higher than the human daily dose of heparin resulted in increased resorptions.

5 WARNINGS AND PRECAUTIONS Fatal Medication Errors: Confirm choice of correct strength prior to administration. ( 5.1 ) Hemorrhage: Fatal cases have occurred. Monitor for signs of bleeding and manage promptly. ( 5.2 ) HIT or HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. ( 5.3 ) Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin in HIT or HITT is suspected. ( 5.4 ) Hypersensitivity Reactions: Use in patients with prior reactions only in life-threatening situations. ( 5.5 ) Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients. 4 CONTRAINDICATIONS The use of HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION is contraindicated in patients with the following conditions: 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) [see Warn...