CADRESS Ointment (Cadexomer iodine)

Table of Content

Chronic wounds are often termed ‘ulcers’ and can be defined as wounds with a full thickness in depth and a slow healing tendency. Often disguised as a comorbid condition, chronic wounds represent a silent epidemic that affects a large fraction of the world population. It is estimated that, in developed countries, 1 to 2% of the population will experience a chronic wound during their lifetime.

Complications of chronic wounds include infections, such as cellulitis, and can lead to loss of function and decreased quality of life, and are a significant cause of morbidity.

Topical antiseptics are antimicrobial agents that kill, inhibit or reduce the number of microorganisms and are thought to be essential for wound infection control.

Iodine is a natural element of the halogen group that has been used throughout history in wound care for its antiseptic properties, but modern clinicians have concerns regarding its use over fears of its systemic absorption, impact on metabolic function and wound healing.

Cadexomer iodine represents an advancement in iodine preparations that overcomes the drawback of existing iodine preparations. Cadexomer iodine is a well-known iodophor that facilitates the formation of a hydrophilic complex between iodine and a polymer (e.g. dextrin, epichlorohydrin) that acts as a carrier and, upon swelling, releases iodine at the wound site. It is water-soluble and able to provide sustained release of iodine at the wound site. An in vitro study showed no toxicity of cadexomer iodine to human cells at a concentration of 0.45% (weight per volume, w/v). Nevertheless, this iodophor was found to reduce the number of Staphylococcus aureus pathogens and capture different microorganisms onto cardmember iodine.

CADRESS (Cadexomer iodine) is indicated for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic foot ulcers, and infected traumatic and surgical wounds.

Cadexomer iodine has proven to be very effective in chronic wounds while povidone iodine has been noted to be more effective in infected acute wounds.

With respect to human comparison studies, the use of cadexomer iodine has resulted in improved wound healing when compared with hydrocolloid dressing or paraffin gauze, saline wet–to-dry compressive dressings, zinc paste dressing, saline dressings, enzyme-based debriding agents or non-adhesive dressings, dextranomer, non-adherent dressings, and other standard treatments.

Composition

Each gram contains

Cadexomer Iodine ….. 500 mg

(Equivalent to 0.9% w/w Iodine)

Excipients……………q.s

Dosage Form

Topical ointment

Pharmacology

Pharmacodynamics

When in contact with wound exudates, cadexomer iodine ointment absorbs fluid and removes exudates, pus and debris from the wound surface. One gram of cadexomer iodine ointment can absorb a minimum of 2.5 ml of fluid. Iodine is physically immobilized within the matrix of the dry cadexomer iodine and is slowly released in an active form during uptake of wound fluid. This mechanism of release provides antibacterial activity both at the wound surface and within the formed gel. There is no evidence of the development of bacterial resistance to iodine. The formed layer can easily be removed without damaging the fragile new epithelium underneath.

Cadexomer iodine ointment reduces the bacterial count, facilitates de-sloughing, absorbs exudates, and maintains a moist environment to promote healing of chronic skin ulcers.

Pharmacokinetics

Iodine absorbed systemically from cadexomer iodine ointment is rapidly and almost exclusively excreted in urine. Cadexomer is biodegradable by amylases, normally present in wound fluid.

Indications

Cadexomer Iodine is indicated for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and infected traumatic and surgical wounds.

Dosage and Administration

Clean the wound and surrounding area with sterile water or saline. Do not dry the wound surface. With a gloved finger, apply cadexomer iodine ointment onto a piece of dry sterile gauze, ensuring an adequate amount to cover the entire wound to a depth of 3 mm; then place the gauze on the wound. Place a secondary dressing over the gauze and then lightly run a finger over the dressing to smoothen it out and spread the ointment underneath to the shape of the wound and to a minimum depth of 3 mm.

A single application of cadexomer iodine should not exceed 50 g. The total amount of cadexomer iodine used in 1 week should not exceed 150 g.

The duration of treatment should not exceed 3 months in any single course of treatment.

Removal of the Dressing

  • Remove the secondary dressing.
  • Loss of dark-brown colouration confirms need to change the dressing (usually two to three times a week or daily if the wound is discharging heavily).
  • If necessary, use some sterile water or saline to soak the dressing for a few minutes, and then remove.
  • Remove the cadexomer iodine remnants using a gentle stream of sterile water or saline, or using a sterile, wet swab if necessary.
  • Gently blot excess fluid, leaving the wound surface slightly moist, before reapplying the ointment.
  • The number of applications should be reduced as the exudate diminishes

Contraindications

  • Patients with known or suspected iodine sensitivity.
  • Hashimoto's thyroiditis.
  • Non-toxic nodular goitre.
  • Children under 12 years of age.
  • Pregnant or lactating women.
  • Patient with history of grave’s disease or Non-toxic nodular goitre
  • Cadexomer Iodine is not effective in treating dry wounds

Warnings and Precautions

General

Iodine may be absorbed systematically when large wounds are treated. Patients with severely impaired renal function or a past history of any thyroid disorder are more susceptible to alterations in thyroid metabolism with long-term cadexomer iodine ointment therapy. In endemic goitre, there have been isolated reports of hyperthyroidism associated with exogenous iodine. It has been observed occasionally that an adherent crust can form when cadexomer iodine ointment dressing is not changed at the required frequency.

Drug Interactions

There is a potential risk of interaction with lithium, resulting in an increased possibility of hypothyroidism. Cadexomer iodine ointment should not be used concomitantly with taurolidine (since there is a risk of metabolic acidosis) or with mercurial antiseptics, e.g. mercurochrome and thiomersal. Since iodine may be absorbed systematically, the result of tests of thyroid function can be influenced.

Pregnancy

Iodine can cross the placental barrier. Clinical experience of use in pregnant women is limited. Therefore, cadexomer iodine should not be used in pregnant women.

Lactation

Iodine is secreted into breast milk. Clinical experience of use in lactating women is limited. Therefore, cadexomer iodine should not be used in lactating women.

Pediatric Use

Efficacy and safety not established

Undesirable Effects

Patients treated with cadexomer iodine ointment may experience a transient smarting or pain within the first hour after application. Minor reddening or swelling around the wound may occur without necessarily being an allergic reaction.

Overdosage

There have been no reported overdosages. In case of excessive topical use of cadexomer iodine, the treatment should be stopped, the area should be washed and symptomatic treatment should be initiated.

Storage and Handling Instructions

Store below 30°C.

Do not expose to sunlight.

Packaging Information

Available in 10 gm aluminium tube

Last Updated: Aug 2018

Last Reviewed: Aug 2018