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icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Overview
What is EXTRANEAL?
EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is:
Each 100 mL of EXTRANEAL contains:
Electrolyte content per liter:
Water for Injection, USP qs
HCl/NaOH may have been used to adjust pH.
EXTRANEAL contains no bacteriostatic or antimicrobial agents.
Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0
EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride.
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 tissue culture toxicity studies.
What does EXTRANEAL look like?
What are the available doses of EXTRANEAL?
7.5% icodextrin (75 grams icodextrin per 1000 milliliters) in an electrolyte solution containing 40 mEq/L lactate ()
What should I talk to my health care provider before I take EXTRANEAL?
How should I use EXTRANEAL?
EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET)
EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection. Administer as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis. The recommended dwell time is 8- to 16- hours. Administer over a period of 10-20 minutes at a rate that is comfortable for the patient.
The mode of therapy, frequency of treatment, exchange volume, duration of dwell, and length of dialysis should be initiated and supervised by the prescribing physician experienced in the treatment of end-stage renal disease with peritoneal dialysis. It is recommended that patients being placed on peritoneal dialysis should be appropriately trained in a program that is under supervision of a physician.
What interacts with EXTRANEAL?
Sorry No Records found
What are the warnings of EXTRANEAL?
Sorry No Records found
What are the precautions of EXTRANEAL?
Sorry No Records found
What are the side effects of EXTRANEAL?
Sorry No records found
What should I look out for while using EXTRANEAL?
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What might happen if I take too much EXTRANEAL?
No clinical trial data are available on experiences of overdosage with EXTRANEAL. Overdosage of EXTRANEAL would be expected to result in higher levels of serum icodextrin and metabolites, but it is not known what signs or symptoms might be caused by exposure in excess of the exposures used in clinical trials. An increase in plasma osmolality or clinical manifestations of hypovolemia may occur. In the event of overdosage with EXTRANEAL, continued peritoneal dialysis with glucose-based solutions should be provided.
How should I store and handle EXTRANEAL?
Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from freezing.Store in moisture barrier overwrap and in carton until ready to use.EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from freezing.Store in moisture barrier overwrap and in carton until ready to use.EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from freezing.Store in moisture barrier overwrap and in carton until ready to use.EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from freezing.Store in moisture barrier overwrap and in carton until ready to use.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
EXTRANEAL is an isosmotic peritoneal dialysis solution containing glucose polymers (icodextrin) as the primary osmotic agent. Icodextrin functions as a colloid osmotic agent to achieve ultrafiltration during long peritoneal dialysis dwells. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, EXTRANEAL also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status.
Non-Clinical Toxicology
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Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.
Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using EXTRANEAL (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. In addition, some blood glucose monitoring systems using glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods must not be used. Use of GDH-PQQ, GDO, and GDH-FAD-based glucose monitors and test strips has resulted in falsely elevated glucose readings (due to the presence of maltose). Falsely elevated glucose readings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of EXTRANEAL (icodextrin) and its metabolites return to baseline within approximately 14 days following cessation of EXTRANEAL (icodextrin) administration. Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of EXTRANEAL (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and test strips are used.
Because GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors may be used in hospital settings, it is important that the health care providers of all peritoneal dialysis patients using EXTRANEAL (icodextrin) carefully review the product information of the blood glucose testing system, including that of test strips, to determine if the system is appropriate for use with EXTRANEAL (icodextrin).
To avoid improper insulin administration, educate all patients to alert health care providers of this interaction whenever they are admitted to the hospital.
The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose readings. For a list of toll free numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visit .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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