Dianeal Pd-2 With Dextrose Recall
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Questions & Answers
Side Effects & Adverse Reactions
Encapsulating Peritoneal Sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including DIANEAL. Infrequently, fatal outcomes of EPS have been reported with DIANEAL.
Because Dianeal is a dextrose-based solution, patients with allergy to corn or corn products are at increased risk for allergic reaction, which may include anaphylactic/anaphylactoid reactions. Stop the infusion immediately, drain the solution from the peritoneal cavity and treat appropriately if any signs or symptoms of a suspected hypersensitivity reaction develop.
Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis solutions (See CONTRAINDICATIONS). Patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute renal failure, hepatic failure, inborn errors of metabolism, and treatment with drugs such as nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] must be monitored for the occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions.
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. Serum potassium levels should be monitored carefully in patients treated with cardiac glycosides. For example, rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs; digitalis toxicity may be masked by hyperkalemia, hypermagnesemia, or 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 is high.
Diabetics require careful monitoring of insulin requirements and other treatments for hyperglycemia during and following dialysis with dextrose containing solutions.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate.
There is currently no drug history available for this drug.
DIANEAL Peritoneal Dialysis Solutions are sterile, nonpyrogenic solutions in AMBU-FLEX and ULTRABAG containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents.
Composition, calculated osmolarity, pH, and ionic concentrations are shown in Tables 1-4. DIANEAL is a hyperosmolar solution.
The plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap 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), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies.