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icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

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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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4.3


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.