IcodextrinU.S. Brand Names: Extraneal�(r)
Generic Available: No
Use: Daily exchange for the long dwell (8- to 16-hour) during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease (ESRD); improvement of long-dwell ultrafiltration and clearance of creatinine and urea nitrogen (compared to 4.25% dextrose) in patients with high/average or greater transport characteristics as measured by peritoneal equilibration test (PET)
Pregnancy Risk Factor: C
Pregnancy Implications: Complete reproduction studies have not been conducted.
Lactation: Excretion in breast milk unknown/use caution
Contraindications: Hypersensitivity to icodextrin, cornstarch, or any component of the formulation; patients with glycogen storage disease
Warnings/Precautions: Not for I.V. injection. Careful attention must be given to glucose monitoring. Only glucose monitors and test strips which employ the glucose-specific method should be used. Use with caution with a history of abdominal surgery (within 30 days), abdominal fistulae, tumors, open wounds, hernia or other conditions which compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity. Caution should be used in patients who are malnourished, have decreased respiratory function, decreased potassium, or increased calcium levels. Safety and efficacy have not been established in pediatric patients.
Adverse Reactions: >10%: Cardiovascular: Hypertension (13% vs 8% in controls) Respiratory: Upper respiratory infection (15% vs 13% in controls) Miscellaneous: Peritonitis (26% vs 25% in controls) 5% to 10%: Cardiovascular: Edema (up to 6%), chest pain (5%), hypervolemia, hypotension Central nervous system: Headache (9%), dizziness Dermatological: Rash (10%), pruritus, skin disorder Endocrine & metabolic: Hyperglycemia (5%), hyperphosphatemia, hypokalemia, hypoproteinemia Gastrointestinal: Abdominal pain (8%), nausea (7%), dyspepsia (5%), diarrhea, vomiting Hematologic: Anemia Neuromuscular & skeletal: Arthralgia, pain, weakness Respiratory: Cough increased (7%), dyspnea Miscellaneous: Accidental injury (6%), flu syndrome (7%), infection <5%: Cardiovascular: Postural hypotension, CHF Central nervous system: Confusion Dermatologic: Exfoliative dermatitis, erythema multiforme, eczema, maculopapular rash, vesicobullous rash Endocrine & metabolic: Hypercalcemia, hypochloremia, hypoglycemia, hyponatremia, alkaline phosphatase increased Gastrointestinal: Abdominal enlargement, cramps Hepatic: ALT/AST increased Local: Infusion pain Miscellaneous: Cloudy effluent
Overdosage/Toxicology: No data available. May result in high levels of icodextrin and metabolites; subsequent peritoneal dialysis should utilize glucose-based solutions.
Stability: Store at controlled room temperature of 15°C to 30°C (68°F to 86°F) in moisture barrier overwrap in carton; do not freeze. Potassium chloride may be added to Extraneal�(r) up to a concentration of 4 mEq/L.
Mechanism of Action: Exerts osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell while providing electrolytes and lactate for the maintenance of both the electrolyte and acid-base balance.
Pharmacodynamics/Kinetics: Absorption: 40% Metabolism: Primarily by alpha-amylase into maltose (DP2), maltotriose (DP3), maltotetraose (DP4), and higher molecular weight species Time to peak, plasma: 13 hours Excretion: Renal (major); diffusion into peritoneal cavity (minor)
Dosage: Adults: Intraperitoneal: Given as a single daily exchange in CAPD or APD; dwell time of 8-16 hours is suggested
Administration: Intraperitoneal administration only; not for I.V. injection. If using manual method, infuse into intraperitoneal cavity over 10-20 minutes. For increased comfort, dry heat (such as that derived from a heating pad) may be used to warm the Extraneal�(r) solution in the over pouch to 37°C (98.6°F) prior to administration. Neither warm water nor the microwave should be used for warming. Osmolarity: 282-286 mOsm/L pH: 5.0-6.0.
Monitoring Parameters: Serum electrolytes (chloride and sodium may be decreased); fluid balance
Test Interactions: Falsely elevated blood glucose levels may occur when glucose monitoring devices and test strips utilizing the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based methods are used. Glucose monitoring devices and test strips which utilize the glucose-specific method are recommended. Inaccurate serum amylase levels may be reported. Icodextrin and the metabolites of Extraneal�(r) may interfere with enzymatic-based amylase assays.
Dietary Considerations: Monitor fluid intake; avoid over-/under hydration
Patient Education: You will be monitored closely while undergoing peritoneal dialyses. Report any persistent or unusual adverse reactions: Acute headache, dizziness, palpitations, visions changes; signs of upper respiratory infection (cough, runny nose, sore throat, unusual cough); nausea, vomiting, diarrhea, swelling of the abdomen, abdominal pain; rash; unusual weakness, dizziness, fatigue, pain at site of infusion, or other persistent adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant or breast-feed.
Additional Information: For a list of glucose monitor and test strip manufacturers for verification, the Baxter Renal Clinical Help Line at 1-888-Renal-Help may be called. Extraneal�(r) solution contains the following electrolytes: Sodium 132 mEq/L, calcium 3.5 mEq/L, magnesium 0.5 mEq/L, chloride 96 mEq/L, and lactate 40 mEq/L.
Mental Health: Effects on Mental Status: May cause dizziness and confusion
Mental Health: Effects on Psychiatric Treatment: None reported
Dosage Forms: Solution, for peritoneal dialysis: 7.5 g/100 mL (1.5 L, 2 L, 2.5 L) [contains sodium chloride 535 mg, sodium lactate 448 mg, calcium chloride 25.7 mg, and magnesium chloride 5.08 mg per 100 mL]
International Brand Names: Extraneal�(r) (AT, CH, NO, NZ, SI)
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