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Extraneal

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Extraneal

Indications
Dosage
How Supplied

INDICATIONS

Extraneal (icodextrin peritoneal dialysis solution) 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 (icodextrin peritoneal dialysis solution) 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) (See CLINICAL PHARMACOLOGY, Clinical Studies).

DOSAGE AND ADMINISTRATION

Extraneal (icodextrin peritoneal dialysis solution) is intended for intraperitoneal administration only. It should be administered only 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.

Not for intravenous injection.

Patients should be carefully monitored to avoid under- or over-hydration. An accurate fluid balance record must be kept and the patient's body weight monitored to avoid potentially severe consequences including congestive heart failure, volume depletion, and hypovolemic shock.

Aseptic technique should be used throughout the peritoneal dialysis procedure.

To reduce possible discomfort during administration, solutions may be warmed prior to use (See Directions for Use).

Extraneal (icodextrin peritoneal dialysis solution) should be administered over a period of 10-20 minutes at a rate that is comfortable for the patient.

Do not use Extraneal (icodextrin peritoneal dialysis solution) if it is cloudy or discolored, if it contains particulate matter, or if the container is leaky.

Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.

For single use only. Discard unused portion.

Addition of Potassium

Potassium is omitted from Extraneal (icodextrin peritoneal dialysis solution) solutions because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. The decision to add potassium chloride should be made by the physician after careful evaluation of serum potassium.

Addition of Insulin

Addition of insulin to Extraneal (icodextrin peritoneal dialysis solution) was evaluated in 6 insulin-dependent diabetic patients undergoing CAPD for end stage renal disease. No interference of Extraneal (icodextrin peritoneal dialysis solution) with insulin absorption from the peritoneal cavity or with insulin's ability to control blood glucose was observed (See Drug/Laboratory Test Interactions). Appropriate monitoring of blood glucose should be performed when initiating Extraneal (icodextrin peritoneal dialysis solution) in diabetic patients and insulin dosage adjusted if needed (See PRECAUTIONS).

Addition ofHeparin

No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with Extraneal (icodextrin peritoneal dialysis solution) .

Addition of Antibiotics

No formal clinical drug interaction studies have been performed. In vitro compatibility studies with Extraneal (icodextrin) and the following antibiotics have demonstrated no effects with regard to minimum inhibitory concentration (MIC): vancomycin, cefazolin, ampicillin, ampicillin/flucoxacillin, ceftazidime, gentamicin, and amphotericin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

Patients undergoing peritoneal dialysis should be under careful supervision of a 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.

Directions for Use

For complete CAPD and APD system preparation, see directions accompanying ancillary equipment.

Aseptic technique should be used.

Warming

For patient comfort, Extraneal (icodextrin peritoneal dialysis solution) L can be warmed to 37°C (98°F). Only dry heat should be used. It is best to warm solutions within the overwrap using a heating pad. Do not immerse Extraneal (icodextrin peritoneal dialysis solution) in water for warming. Do not use a microwave oven to warm Extraneal (icodextrin peritoneal dialysis solution) . Heating above 40°C (104°F) may be detrimental to the solution.

To Open

To open, tear the overwrap down at the slit and remove the solution container. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap.

Inspect for Container Integrity

Inspect the container for signs of leakage and check for minute leaks by squeezing the container firmly.

Adding Medications

Some drug additives may be incompatible with Extraneal (icodextrin peritoneal dialysis solution) . See DOSAGE AND ADMINISTRATION section for additional information. If the re-sealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added.

  1. Put on mask. Clean and/or disinfect hands.
  2. Prepare medication port site using aseptic technique.
  3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive.
  4. Reposition container with container ports up and evacuate medication port by squeezing and tapping it.
  5. Mix solution and additive thoroughly.

Preparation for Administration

  1. Put on mask. Clean and/or disinfect hands.
  2. Place Extraneal (icodextrin peritoneal dialysis solution) on work surface.
  3. Remove pull ring from connector of solution container. If continuous fluid flow from connector is observed, discard solution container.
  4. Remove tip protector from tubing set and immediately attach to connector of solution container.
  5. Continue with therapy set-up as instructed in user manual or directions accompanying tubing sets.
  6. Upon completion of therapy, discard any unused portion.

HOW SUPPLIED

Extraneal (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:

Container Fill Volume NDC
ULTRABAG 1.5 L NDC 094 1-0679-51
ULTRABAG 2.0 L NDC 0941-0679-52
ULTRABAG 2.5 L NDC 0941-0679-53
AMBU-FLEX III 1.5 L NDC 0941-0679-45
AMBU-FLEX III 2.0 L NDC 0941-0679-47
AMBU-FLEX III 2.5 L NDC 0941-0679-48
AMBU-FLEX II 2.0 L NDC 0941-0679-06
AMBU-FLEX II 2.5 L NDC 0941-0679-05

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]. Store in moisture barrier overwrap in carton until ready to use. Protect from freezing.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Revised: Nov 2010

Last reviewed on RxList: 4/29/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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