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
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
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.
Last reviewed on RxList: 11/14/2008
This monograph has been modified to include the generic and brand name in many instances.