Normosol-R

• Abbott Hospital Products

• Hospira, Inc.

None known.

Normosol-R should be used with caution in severe renal impairment because of the danger of hyperkalemia. As with all intravenous solutions, care should be taken to avoid circulatory overload, especially in patients with cardiac or pulmonary disorders. Normosol-R is not intended to correct acidosis or large deficits of individual electrolytes, nor to replace blood or plasma expanders when these are indicated.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Solutions containing acetate or gluconate ions should be used with caution, as excess administration may result in metabolic alkalosis.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-R. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

Pediatric Use. The safety and effectiveness of Normosol-R have been established in the age groups of birth to 16 years. Use of Normosol-R is supported by evidence from adequate and well-controlled clinical studies in adults with additional data from post-marketing experience in the pediatric population.

Geriatric Use: Clinical studies of Normosol-R did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Elderly patients have been shown to secrete higher levels of antidiuretic hormone than younger patients, which may increase the risk of fluid overloading, and dilutional hyponatremia in these patients. (See WARNINGS.)

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See WARNINGS.)

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.)