PProduct Name: IODOSORB OINTMENT™ Classification Name: Dressing Polysaccharide Beads, Ointment, Medicated Manufacturer: Smith and Nephew Healthcare Ltd Product description Iodosorb Ointment consists of a macrogol ointment base incorporating sterile, yellow- brown microspheres or beads 0.1-0.3 mm in diameter. The beads, which are formed from a three-dimensional network of cadexomer - a chemically modified starch, contain elemental iodine within their structure. The iodine content of the beads used to produce the paste is higher than that of standard Iodosorb in order to produce a final concentration of iodine in the paste of 0.9% w/w. In the presence of aqueous solutions or wound fluid, the beads in the ointment take up liquid and swell, slowly releasing the iodine, which imparts antibacterial properties to the dressing. Indications Iodosorb Ointment is used for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic ulcers, particularly when infection is present or suspected. Contra-indications As Iodosorb Ointment contains iodine it should not be used in patients with known or suspected iodine sensitivity. Usage is also contraindicated in patients with Hashimoto's Thyroiditis and in the case of non-toxic nodular goitre. Iodine is absorbed systemically and patients with severely impaired renal function or with a past history of any thyroid disorder are more susceptible to alteration in thyroid metabolism with chronic Iodosorb Ointment therapy. In endemic goitre there have been isolated reports of hyperthyroidism associated with Iodosorb Ointment. Method of use Iodosorb Ointment is placed directly onto the wound to a depth of about 3mm and covered with a dry dressing or absorbent pad, which is secured in the normal manner. Removal is best accomplished by irrigating the wound with sterile water or normal saline, using a syringe. Once the wound has been cleansed, a second dressing is applied while the area is still moist. Frequency of change The frequency of dressing changes will depend upon the nature of the wound. Daily changes may be required initially, but after the first few days the interval between changes can be extended until eventually the dressing is changed about three times per week. More frequent changes will be required if the ointment becomes saturated with exudate as indicated by a loss of colour. Warnings and precautions Iodine is absorbed systemically especially when applied to large wounds and therefore Iodosorb Ointment should be used with care on patients who have a history of thyroid disorders. Iodosorb Ointment should not be used on children and as iodine can cross the placental barrier and is secreted into milk Iodosorb Ointment should not be applied to pregnant women or lactating mothers. There is a potential interaction of iodine with lithium and therefore co-administration is not recommended. Iodosorb Ointment should not be used concomitantly with mercurial antiseptics, e.g. mercurochrome and thiomersal, or taurolidine. A single application should not exceed 50 grams and not more than 150 grams of Iodosorb Ointment should be applied during the course of one week. A single course of treatment with Iodosorb Ointment should not exceed 3 months. Iodosorb Ointment should not be used on dry wounds. Presentation Iodosorb Ointment is supplied sterile in collapsible tubes each containing 10 or 20 grams and each tube is for single patient use. Storage and shelf life Iodosorb Ointment should be stored in a dry place below 25º Legal category Iodosorb Ointment is a Pharmacy item [P] and is the subject of a Product Licence (PL 14038/0008) Bibliography 1. Hansson C., The effects of cadexomer iodine paste in the treatment of venous leg ulcers compared with hydrocolloid dressing and paraffin gauze dressing. Cadexomer Iodine Study Group. Int J Dermatol 1998; 37(5): 390-396. 2. Ormiston M.C., et al, in Cadexomer Iodine. 1983 109: 77-83 3. Mertz P.M. et al, The evaluation of a cadexomer iodine wound dressing on methicillin resistant Staphylococcus aureus (MRSA) in acute wounds. Dermatol Surg 1999; 25(2): 89-93. 4. Zhou LH, Nahm WK, Badiavas E, et al. Slow release iodine preparation and wound healing: in vitro effects consistent with lack of in vivo toxicity in human chronic wounds. Br J Dermatol 2002;146: 365-367 5. Mertz PM et al., Wounds 1996; 8 (1): 1-8. 6. Falanga V. Proceedings of the 6th European Conference on Advances in Wound Management, Macmillan magazines Ltd. London 1997. ©1992-2001, SMTL, Princess of Wales Hospital, Bridgend South Wales Date of preparation: 11/07/02 Iodosorb Ointment Datacard Page 1 of 1