nitis has been associated with DIANEAL peritoneal dialysis solution use. Following use, inspect the drainedfluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping orpriming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/orperitonitis. If peritonitis occurs, treat with appropriate therapy.
Encapsulating Peritoneal Sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and hasbeen reported in patients using DIANEAL solutions.
5.2 Lactic Acidosis
Monitor patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis thatcan be associated with acute renal failure, hepatic failure, inborn errors of metabolism, and treatment with drugssuch as nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions. Use of DIANEAL solutions in patients with severe lacticacidosis is contraindicated [see Contraindications (4)].
5.3 Overinfusion
Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominaldistention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritonealcavity to treat overinfusion.
5.4 Electrolyte, Fluid, and Nutrition Imbalances
Peritoneal dialysis may affect a patient’s protein, water-soluble vitamin, potassium, bicarbonate, calcium, andmagnesium levels and volume status. Monitor hematology, electrolytes, blood chemistry and fluid statusperiodically and take appropriate clinical action.
Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. Insituations where there is a normal serum potassium level or hypokalemia, addition of potassium chloride (up to aconcentration of 4 mEq/L) to the solution may be necessary to prevent severe hypokalemia. Monitor fluid status to
avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volumedepletion and hypovolemic shock.
5.5 Hyperglycemia
DIANEAL solutions contain dextrose and may increase the risk for hyperglycemia in patients with impaired glucose
tolerance. Patients may require initiation or modification of antidiabetic therapy during treatment with DIANEAL
solutions. Monitor blood glucose.
6 ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere in the label:
Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1)]
Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4)]
6.1 Clinical Trials Experience
There are no data available on adverse reactions from controlled clinical trials conducted to eva luate the safety of
DIANEAL peritoneal dialysis solutions.
6.2 Post-Marketing Experience
The following adverse experiences have been identified during post-approval use of DIANEAL solutions or inconjunction with performing the peritoneal dialysis procedure. Because these experiences are reported voluntarilyfrom a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causalrelationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneald |
