FDA label 8ea9779d-3507-4f5e-a74e-41220bdf040f

Boxed Warning WARNING: NOT FOR USE IN NEONATES

Warnings Benzyl alcohol, a preservative in the multiple-dose vial preparations of Heparin Lock Flush Solution, USP has been associated with toxicity in neonates. Benzyl alcohol has been reported to be associated with a fetal “Gasping Syndrome” in premature infants. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Heparin Lock Flush Solution, USP should be used for maintaining patency of intravenous injection devices in neonates. Heparin Lock Flush Solution, USP is not intended for intramuscular use, systemic anticoagulation or injection by any parenteral route of administration. 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 Testin g: If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly. Heparin solutions having a concentration of 10 USP Heparin Units/mL may alter the results of blood coagulation tests. Heparin concentrations greater than 10 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/mm3) 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/mm3 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 Although adverse reactions to intravenous intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to 6 kg infant is potentially capable of producing blood pressure changes. 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.