Proper administration of these admixed amino acid/dextrose injections requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.

Laboratory TestsFrequent clinical eva luation and laboratory determinations are necessary for proper monitoring during administration. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, complete blood count with differential, carbon dioxide combining power or content, serum osmolarities, blood cultures, and blood ammonia levels.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor, and coma.

Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.

Conservative doses of these admixed amino acid/dextrose injections should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient’s clinical status be reeva luated.

Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.

These admixed injections should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS

With the administration of these CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections, hyperglycemia, glycosuria, and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy.

Use with caution when administering to patients with anuria or renal failure.

Electrolytes may be added to the admixed amino acid/dextrose injections as dictated by the patient’s electrolyte profile.

The metabolizable acetate anion and amino acid profiles in these admixed injections were designed to minimize or prevent occurrences of hyperchloremic metabolic acidosis and hyperammonemia. However, the physician should be aware of appropriate countermeasures if they become necessary.

Clinical eva luation and periodic laboratory determ