FDA label 15500ed6-e5d0-4bd0-b2bf-6f7883f2448e

FOR IV FLUSH ONLY

WARNINGS Heparin Lock Flush Solution, USP is not intended for intramuscular use, systemic anticoagulation or injection by any parenteral route of administration. Repeated flushing of a catheter device with the Heparin 100 USP Units/mL may result in a systemic anticoagulant effect. Hypersensitivity: Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations. Hemorrhage: Hemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in hematocrit, fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a hemorrhagic event. Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists are: 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. Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine. Other — Menstruation, liver disease with impaired hemostasis. Coagulation Testing: If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly. Heparin solutions having a concentration of 100 USP Heparin Units/mL will alter the results of blood coagulation tests. Thrombocytopenia: Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%. Mild thrombocytopenia (count greater than 100,000/mm 3 ) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely. If the count falls below 100,000/mm 3 or if recurrent thrombosis develops (see White Clot Syndrome, PRECAUTIONS ), the heparin product should be discontinued. If continued heparin therapy is essential, administration of heparin from a different organ source can be reinstituted with caution. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

ADVERSE REACTIONS Heparin Lock Flush Solution is not known to cause adverse local or systemic effects of any kind. Although a remote possibility of hypersensitivity reaction exists with entry of extremely small subtherapeutic amounts of the solution into the circulation, such an occurrence has not been reported.