warnings and cautions
5 WARNINGS AND PRECAUTIONS Monitor patient for electrolyte, fluid, and nutrition imbalances. ( 5.1 ) Encapsulating Peritoneal Sclerosis (EPS) ( 5.2 ) Peritonitis: Initiate appropriate antimicrobial therapy ( 5.2 ) Monitor for Lactic Acidosis in patients at risk. ( 5.3 ) 5.1 Electrolyte, Fluid and Nutrition Imbalances Peritoneal dialysis may affect a patient's protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically and take appropriate clinical action. Potassium is omitted from DELFLEX solutions because dialysis may be performed to correct hyperkalemia. In situations where 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. To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange. Significant loss of protein, amino acids and water-soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary. 5.2 Peritonitis and Encapsulating Peritoneal Sclerosis Infectious and aseptic peritonitis has been associated with peritoneal dialysis therapy. Following DELFLEX use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy. Encapsulating peritoneal sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy. 5.3 Lactic Acidosis Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute kidney failure, inborn errors of metabolism, treatment with drugs such as nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs)] for lactic acidosis before the start of treatment and during treatment with DELFLEX. Solutions containing the lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. 5.4 Over Infusion Over infusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat over infusion.