Version May 2024
CAPD or APD (Extraneal): Intraperitoneal: Given as a single daily exchange in CAPD or APD; dwell time of 8 to 16 hours is suggested.
Laparoscopic gynecologic surgery (Adept): Intraperitoneal: Irrigate with at least 100 mL every 30 minutes during surgery; aspirate remaining fluid after surgery is completed, then instill 1 L into the cavity.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
CAPD or APD (Extraneal®):
>10%:
Cardiovascular: Hypertension (13%)
Respiratory: Upper respiratory infection (15%)
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: Orthostatic 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 increased, AST increased
Local: Infusion pain
Miscellaneous: Cloudy effluent
Laparoscopic surgery (Adept®):
>10%:
Central nervous system: Headache (35%)
Endocrine & metabolic: Dysmenorrhea (13%)
Gastrointestinal: Nausea (6% to 17%), constipation (11%)
1% to 10%:
Central nervous system: Pyrexia (6%), insomnia (5%)
Gastrointestinal: Flatulence (8%), abdominal pain (7%), abdominal distention (6%), vomiting (6%), diarrhea (1%)
Genitourinary: Dysuria (7%), urinary tract infection (7%); labial, vulvar, or vaginal swelling (6%); vaginal bleeding (6%)
Neuromuscular & skeletal: Arthralgia (9%), back pain (8%)
Respiratory: Nasopharyngitis (7%), cough (4%)
Postmarketing and/or case reports: Sterile peritonitis
Hypersensitivity to icodextrin, cornstarch, or any component of the formulation; glycogen storage disease; maltose or isomaltose intolerance; severe lactic acidosis (Extraneal only); infection (eg, peritonitis) of the abdominopelvic cavity, procedures with laparotomy incision, bowel resection or repair, appendectomy (Adept only).
Canadian labeling (Extraneal): Additional contraindications (not in US labeling): Acute renal failure, uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase the risk of infection, documented loss of peritoneal function or extensive adhesions that compromise peritoneal function, history of abdominal surgery in the month prior to beginning therapy, abdominal fistulae, tumors, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity.
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious reactions, including anaphylaxis, toxic epidermal necrolysis, angioedema, serum sickness, erythema multiforme, and vasculitis have been reported. Discontinue infusion immediately and drain solution from the peritoneal cavity if signs or symptoms of a suspected hypersensitivity reaction develop. Rash has also been reported, usually within the first few weeks of treatment, and resolves with treatment discontinuation or, in some patients, with continued treatment.
• Peritonitis: Infectious and aseptic/sterile peritonitis have been reported; monitor for signs and symptoms of infection. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, resulting in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy.
Dosage form specific issues:
• Adept: Safety and efficacy have not been established for volumes left in peritoneal cavity >1 L, hepatic or renal dysfunction, or with a breach in the vaginal epithelium. Effectiveness has not been established for long-term clinical outcomes following gynecologic surgery (eg, pregnancy, pain). Serious postoperative complications (dehiscence, cutaneous fistula formation) have been associated with laparotomy incision; anastomotic failure, ileus, and peritonitis have been reported following bowel resection or repair or appendectomy; use is contraindicated with these procedures. Postoperative leaking may occur through laparoscopic port site and may be associated with wound complications (eg, subcutaneous fluid collection, skin separation, and infection); meticulous closure of the fascia may help reduce complications. Use may be associated with vulvar swelling, most cases resolving within 1 week. Pulmonary edema, pulmonary effusion and arrhythmia have been reported (rarely); most commonly in elderly or debilitated patients.
• Extraneal: Over infusion may cause abdominal distention, feeling of fullness and/or shortness of breath; drain dialysis solution from the peritoneal cavity if over infusion occurs. Monitor for lactic acidosis before and during treatment in patients at higher risk for developing lactic acidosis (eg, severe hypotension or sepsis associated with acute renal failure, inborn errors of metabolism, use of nucleoside/nucleotide reverse transcriptase inhibitors). Cases of encapsulating peritoneal sclerosis (some fatal) have been reported. Peritoneal dialysis may cause fluid, electrolyte, and nutrition imbalances; monitor closely to avoid hyper- or hypovolemia and potentially severe consequences including heart failure, volume depletion, and hypovolemic shock.
Other warnings/precautions:
• Monitoring: Do not use glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ), glucose-dye-oxidoreductase methods (GDO), and some glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods to measure blood glucose levels; may result in falsely elevated glucose readings due to the presence of maltose. Falsely elevated glucose readings may lead to the withholding of treatment for hypoglycemia or may prompt the administration of insulin, leading to unrecognized hypoglycemia. Falsely elevated glucose levels may be measured up to 2 weeks following cessation of icodextrin therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and test strips are used. Other glucose-measuring technologies (eg, continuous glucose monitoring systems) may or may not be compatible with icodextrin. Contact the device manufacturer for more information.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intraperitoneal:
Extraneal: 7.5% (2000 mL, 2500 mL)
No
Solution (Extraneal Intraperitoneal)
7.5% (per mL): $0.07
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intraperitoneal:
Generic: 7.5% (2000 mL, 2500 mL)
Intraperitoneal administration only; not for IV or intra-arterial administration.
Adept: Warm to body temperature prior to use.
Osmolarity: 278 mOsm/L.
Extraneal: If using manual method, infuse into intraperitoneal cavity over 10 to 20 minutes. For increased comfort, may warm, using dry heat (eg, heating pad, warming plate), to 37°C (98.6°F) prior to administration; do not heat above 40°C (104°F). Do not immerse in water for warming or use a microwave oven to warm.
Osmolarity: 282 to 286 mOsm/L.
pH: 5.0 to 6.0.
An FDA-approved patient medication guide, which is available with the product information and at https://www.fda.gov/media/75686/download, must be dispensed with this medication.
Adept: Adjunct to surgery for the reduction of postsurgical adhesions in gynecologic laparoscopic adhesiolysis.
Extraneal: Single 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 kidney disease; 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).
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
Special care is warranted in patients with diabetes: Due to potential interference by maltose, careful attention must be given to glucose monitoring; only glucose monitors and test strips which employ the glucose-specific method should be used. Inaccurate methods (glucose dehydrogenase pyrroloquinolinequinone [GDH-PQQ], glucose-dye-oxidoreductase [GDO], and some glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods) can result in falsely elevated readings. Inaccurate readings may mask recognition of true hypoglycemia, or may prompt the administration of insulin, potentially leading to life-threatening consequences.
None known.
There are no known significant interactions.
Pregnancy, including ectopic pregnancy, was an exclusion for intraperitoneal use to reduce post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis. The effect on pregnancy following gynecologic surgery has not been evaluated.
It is not known if icodextrin is present in breast milk.
The manufacturer recommends that caution be exercised when administering icodextrin to breastfeeding women.
Serum electrolytes, blood chemistry; fluid balance, BP (Silver 2014), weight.
Extraneal: Monitor for lactic acidosis before and during treatment in patients at higher risk for developing lactic acidosis (eg, severe hypotension or sepsis associated with acute renal failure, inborn errors of metabolism, use of nucleoside/nucleotide reverse transcriptase inhibitors).
When used for dialysis, icodextrin 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. When used for laparoscopic surgery, the colloidal osmotic action allows the fluid to be retained in the peritoneal cavity for 3 to 4 days, physically providing a temporary separation of peritoneal surfaces and minimizing adhesion formation.
Absorption: 40% during 12-hour dwell (CAPD); slowly transferred into systemic circulation via peritoneal lymphatic drainage
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 (amount proportional to residual renal function); diasylate
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