"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Benzyl alcohol, a preservative in the multiple-dose vial preparations of Heparin Lock Flush Solution, USP has been associated with toxicity in newborns. 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 potency of intravenous injection devices in newborns.
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 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
PRECAUTIONS; General: a.White Clot Syndrome), 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.
Do not use unless solution is clear and container is undamaged. Use aseptic technique for single or multiple entry and withdrawal from all containers.
Interference with Laboratory Tests
Heparin Lock Flush Solution may interfere with laboratory analyses or alter the results of blood chemistry tests such as glucose, serum sodium and serum chloride, blood coagulation studies, etc. See CLINICAL PHARMACOLOGY.
The following information which pertains to the use of heparin sodium as a systemic anticoagulant is included as a matter of interest only since it is not known to apply to the use of the drug for heparin lock.
a. White Clot Syndrome: It has been reported that patients on heparin may develop new thrombus formation in association with thrombocytopenia resulting from irreversible aggregation of platelets induced by heparin, the so-called "white clot syndrome". The process may lead to severe thromboembolic complications like skin necrosis, gangrene of the extremities that may lead to amputation, myocardial infarction, pulmonary embolism, stroke, and possibly death. Therefore, heparin administration should be promptly discontinued if a patient develops new thrombosis in association with thrombocytopenia.
b.Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.
c.Increased Risk in Older Women: A higher incidence of bleeding has been reported in women over 60 years of age.
No long term studies in animals have been performed to evaluate carcinogenic potential of heparin. Also, no reproduction studies in animals have been performed concerning mutagenesis or impairment of fertility.
Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with heparin sodium or sodium chloride. It is also not known whether heparin sodium or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Heparin sodium or sodium chloride should be given to a pregnant woman only if clearly needed.
Nonteratogenic Effects: Heparin does not cross the placental barrier.
Heparin is not excreted in human milk.
NOT FOR USE IN NEWBORNS
Last reviewed on RxList: 1/10/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Lok Pak Information
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