horoughly. Do not store.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with TrophAmine®.
Pregnancy
Teratogenic Effects - Pregnancy Category C
Animal reproduction studies have not been conducted with TrophAmine® (Amino Acid Injetions). It is also not known whether TrophAmine® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TrophAmine® should be given to a pregnant woman only if clearly needed.
Labor and Delivery
Information is unknown.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised with TrophAmine® if administered to a nursing woman.
Pediatric Use
As in all cases of fluid and electrolyte replacement and parenteral nutrition, careful monitoring and special caution is required in pediatric use, especially in pediatric patients with renal failure, acute sepsis, or low birth weight.
The total volume of nutritional fluid and the rate of administration in each patient will be based on individually calculated maintenance and/or replacement fluid requirements, and nutritional needs, and will vary with the child's age, body weight and renal function.
In neonates and very small infants, particularly careful monitoring will be required to maintain fluid and electrolyte balance, including monitoring of blood glucose.
See INDICATIONS AND USAGE, WARNINGS, and DOSAGE AND ADMINISTRATION.
Geriatric Use
TrophAmine® has not been studied in geriatric patients. Elderly patients are known to be more prone to fluid overload and electrolyte imbalance than younger patients. This may be related to impairment of renal function which is more frequent in an elderly population. As a result the need for careful monitoring of fluid and electrolyte therapy is greater in the elderly.
All patients, including the elderly, require an individual dose of all parenteral nutrition products to be determined by the physician on an individual case-by-case basis, which will be based on body weight, clinical condition and the results of laboratory monitoring tests. There is no specific geriatric dose.
See WARNINGS.
Special Precautions for Central Venous Nutrition
Administration by central venous catheter should be used only by those familiar with this technique and its complications.
Central venous nutrition may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure, including solution preparation, administration, and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team.
Although a detailed discussion of the complications is beyond the scope of this 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 be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. 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 central venous catheters are pneumothorax, hemothorax, hydrothorax |
