ADEPT ® Adhesion Reduction Solution [4% Icodextrin]

ADEPTĀ® [4% Icodextrin] Solution

Instructions for Use

The information contained in this page is intended for healthcare professionals only.

ADEPT® is an icodextrin solution that keeps the peritoneal surfaces apart for 3 to 4 days during the critical post-surgery period when the patient is at greatest risk of adhesion formation following laparoscopic gynecologic adhesiolysis.1,2

Indications & Usage

ADEPT® Adhesion Reduction Solution [4% Icodextrin] is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

Features

  • ADEPT® provides a temporary separation of peritoneal surfaces by hydroflotation as a result of maintaining a fluid reservoir. Icodextrin functions as a colloid osmotic agent. This colloidal osmotic action of icodextrin allows the retention of a reservoir of fluid within the peritoneal cavity for 3-4 days.1,3
  • ADEPT® minimizes tissue apposition during the critical period of fibrin formation and mesothelial regeneration following surgery, thereby providing a barrier to adhesion formation.1

Easy To Use

  • Requires no significant change to surgical routine2
  • Does not impair tissue handling and visibility of the surgical field2

Important Risk Information

ADEPT is for direct intraperitoneal administration only. NOT for intravenous (IV) administration. Adept is contraindicated in patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with maltose or isomaltose intolerance, or with glycogen storage disease. ADEPT is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with frank abdomino-pelvic infection.

There have been rare reports of sterile peritonitis following the use of icodextrin. Leakage of ADEPT from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage through laparoscopic port sites post-operatively. There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia. Anaphylaxis has been reported in a few patients. Maltose metabolites of icodextrin may interefere with blood glucose measurement in diabetic patients who use rapid blood glucose systems that are not glucose specific.

In the pivotal study, the most frequently occurring treatment-related adverse events between surgeries were post procedural leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.

RX Only: For safe and proper use of this device, please refer to full device Instructions For Use.

References

1. ADEPT-Adhesion Reduction Solution, Instructions for Use 8/10/06 620850IEHOI, Baxter Healthcare Corporation.

2.Sutton C, Minelli L, Garcia E, et al. Use of icodextrin 4% solution in the reduction of adhesion formation after gynaecological surgery. Gynecol Surg 2005;2: 287-296.

3. Hosie K, Glibert JA, Kerr D, et al. Fluid dynamics in man of an intraperitoneal drug delivery solution: 4% icodextrin. Drug Deliv 2001;8: 9-12.

Adept is a registered trademark of Innovata Limited, used under license.

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