nknown.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in humanmilk, caution should be exercised when 10% FreAmine® III (Amino Acid Injection) is administered to anursing woman.
Pediatric Us e
Safety and effectiveness of amino acid injections in pediatric patients have not been established byadequate and well-controlled studies. However, the use of amino acid injections in pediatric patients asan adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is well
established in the medical literature.
See INDICATIONS AND USAGE, WARNINGS, and DOSAGE AND ADMINISTRATION.
Geriatric Us e
Clinical studies of 10% FreAmine® III (Amino Acid Injection) did not include sufficient numbers ofsubjects age 65 and over to determine whether they respond differently from younger subjects. Otherreported clinical experience has not identified differences in responses between the elderly andyounger patients. In general, dose selection for an elderly patient should be cautious, usually starting atthe low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiacfunction, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drugmay be greater in patients with impaired renal function. Because elderly patients are more likely to havedecreased renal function, care should be taken in dose selection, and it may be useful to monitor renalfunction.
See WARNINGS.
Special Precautions for Central Venous Nutrition
Administration by central venous catheter should be us ed only by thos e familiar with thistechnique and its complications.
Central venous nutrition may be associated with complications which can be prevented or minimized bycareful attention to all aspects of the procedure including solution preparation, administration, andpatient monitoring. It is ess ential that a carefully prepared protocol, bas ed on current medicalpractices, be followed, preferably by an experienced team.
Although a detailed discussion of the complications of central venous nutrition is beyond the scope ofthis insert, the following summary lists those based on current literature:
Technical
The placement of a central venous catheter should be regarded as a surgical procedure. One should befully acquainted with various techniques of catheter insertion as well as recognition and treatment ofcomplications. For details of techniques and placement sites, consult the medical literature. X-ray is the
best means of verifying catheter placement. Complications known to occur from the placement of centralvenous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury tothe brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis,thrombosis, and air and catheter embolus.
Septic
The constant risk of sepsis is present during central venous nutrition. Since contaminated solutions andinfusion catheters are potential sources of infection, it is imperative that the preparation of parenteralnutrition solutions and the placement and care of catheters be accomplished under controlled asepticconditions.
Solutions should ideally be prepared in the hospital pharmacy in a laminar flow hood. The key factor intheir preparation is careful asep |
