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Dianeal Low Calcium

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Dianeal Low Calcium

WARNINGS

Peritoneal dialysis should be done with great care, if at all, in patients with a number of abdominal conditions including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, and large polycystic kidneys (Vaamonde and Perez 1977). Other conditions include recent aortic graft replacement and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.

An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure, volume depletion, and shock.

Excessive use of Dianeal Low Calcium peritoneal dialysis solution with 3.5% or 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.

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.

Not for use in the treatment of lactic acidosis.

Potassium is omitted from Dianeal Low Calcium peritoneal dialysis solutions because dialysis may be performed to correct hyperkalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician.

The use of 5 or 6 liters of dialysis solution is not indicated in a single exchange.

Do not use 6 liter product with Pac-X or Pac-Xtra hardware.

Refer to manufacturer's directions accompanying drugs to obtain full information on additives.

If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.

After removing overpouch, check for minute leaks by squeezing container firmly. If leaks are found, discard the solution because the sterility may be impaired.

Freezing of solution may occur at temperatures below 0° C (32° F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

PRECAUTIONS

Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Peritoneal dialysis solutions may be warmed in the overpouch to 37° C (98.6° F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort.

Significant losses of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

Pregnancy: Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with Dianeal Low Calcium peritoneal dialysis solutions. It is also not known whether Dianeal Low Calcium peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dianeal Low Calcium peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed.

Do not administer unless solution is clear and seal is intact.

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

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