FDA label 45197a68-4a66-471d-9311-b321b08d9126

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. 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 the pull ring has been removed, inspect connector of solution container for fluid flow. A few drops of solution within the connector or pull ring may be present due to condensation of water resulting from the sterilization process. If a continuous stream of fluid is noted, discard solution because sterility may be impaired. 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.

ADVERSE REACTIONS Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a chronic peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome, and muscle cramping. When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. For example, rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs; digitalis toxicity may be masked by elevated potassium or magnesium, or by hypocalcemia. Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess. Conversely, toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high. Azotemic diabetics require careful monitoring of insulin requirements during and following dialysis with dextrose containing solutions.