Dianeal Low Calcium peritoneal dialysis solutions are sterile, nonpyrogenic solutions in Ambu-Flex III containers with flanged port for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.

Composition, calculated osmolarity, pH and ionic concentrations are shown in Table 1.

Potassium is omitted from peritoneal dialysis solutions because dialysis may be performed to correct hyperkalemia. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.

Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Frequent monitoring of serum electrolytes is indicated.

In some patients calcium carbonate is used as a phosphate binder. Because serum calcium levels have been observed to be elevated in these patients (Slatopolsky et al. 1986), the calcium concentration of Dianeal Low Calcium peritoneal dialysis solutions has been reduced to 2.5 mEq/L. Serum calcium levels should be monitored and if low, the amount of oral calcium carbonate phosphate binder may be increased or peritoneal dialysis solutions containing higher calcium concentrations may be used. If serum calcium levels rise, adjustments to the dosage of the calcium carbonate phosphate binder and/or vitamin D analogs should be considered by the physician.

Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated (Nolph et al. 1981), the magnesium concentration of this formulation has been reduced to 0.5 mEq/L. Average plasma magnesium levels have not been reported for chronic IPD and CCPD patients. Serum magnesium levels should be monitored and if low, oral magnesium supplements, oral magnesium containing phosphate binders, or peritoneal dialysis solutions containing higher magnesium concentrations may be used.

Because average serum bicarbonate levels in some chronic CAPD patients (Nolph et al. 1981), some chronic IPD patients (La Greca et al. 1980), and some chronic CCPD patients (Diaz-Buxo et al. 1983), have been observed to be somewhat lower than normal values, the bicarbonate precursor (lactate) concentration of Dianeal Low Calcium peritoneal dialysis solutions has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.

The osmolarities shown in Table 1 are calculated values. Calculated osmolarity of Dianeal Low Calcium peritoneal dialysis solution with 1.5% dextrose is 344 mOsmol/L, compared with measured values in normal human serum of 280 mOsmol/L.

The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), at not more than 0.4 parts per million. This level is well below the daily, tolerable intake level established by the FDA for DEHP. Biological testing supports the safety of the plastic container materials.