Because of its anti-anabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effect of infused amino acids.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema; particularly in patients with renal disease, pulmonary insufficiency, and heart disease.

Administration of admixed amino acid/dextrose injections and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to 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. The physician 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, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, cardiac arrhythmia, and catheter embolus.

Septic:The constant risk of sepsis is present during total parenteral nutrition. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of solution and the placement and care of catheters be accomplished under controlled aseptic conditions. If fever develops, the solution, its delivery system, and the site of the indwelling catheter should be changed.

Metabolic:The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, and hyperammonemia. Frequent clinical eva luation and laboratory determinations are necessary, especially during the first few days of therapy to prevent or minimize these complications.

Caution must be exercised in the administration of these admixed amino acid/dextrose injections to patients receiving corticosteroids or corticotropin.

These admixed injections should be used with caution in patients with overt or known subclinical diabetes mellitus.

Drug product contains no more than 25 mcg/L of aluminum.

Carcinogenesis, Mutagenesis, Impairment of FertilityStudies with CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections have not been performed to eva luate carcinogenic potential, mutagenic potential, or effects on