Class: Local Anti-infectives, Miscellaneous
ATC Class: D08AG03
VA Class: DX101
CAS Number: 7553-56-2
Brands: Iodoflex, Iodosorb

Introduction

Nonmetallic element; a topical anti-infective agent.a b c e f

Uses for Iodine

Antisepsis

Prevention of infection in the management of minor, superficial skin wounds,a b c wet wounds, and wet ulcers;h i reduces microbial load in wound environment.h i

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Cadexomer iodine pad and gel used in the cleansing of wet ulcers and wounds (e.g., venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds).h i Not effective in cleaning dry wounds.h i

Has been used to disinfect the skin preoperatively.a c

Wound Healing

Cadexomer iodine pad and gel used to slow the formation of eschar; keeps lesions soft and pliable.h i

Iodine Dosage and Administration

Administration

Topical Administration

Apply topically to affected areas as a solution containing iodine 2%, a tincture containing iodine 2% with alcohol 47%, or as a cadexomer iodine 0.9% pad or gel.a b c h i

To avoid irritation, iodine solution or tincture-treated wounds should not be covered tightly with occlusive dressings.a b (See Dermatologic Effects under Cautions.)

For external use only;a b h i do not use in eyesb g h i or mouth.g

For self-medication, do not apply over large areas of body.b Consult a doctor for deep or puncture wounds, animal bites, or serious burns.b

Cadexomer Iodine Pad

Prior to topical application, cleanse wound and surrounding area with sterile water or saline.h Gently blot wound surface to remove excess fluid; wound surface should be slightly moist.h

While wearing gloves, remove gauze from one or both sides of the pad and then place pad on wound surface.h Cover with dry sterile dressing (e.g., gauze); apply compression bandage if appropriate (i.e., for venous stasis ulcers).h i

Remove pad from wound site with sterile water or saline; if necessary, soak gauze for a few minutes prior to removal.h Prior to reapplying pad, gently blot wound surface to remove excess fluid, leaving wound surface slightly moist.h

Cadexomer Iodine Gel

Prior to topical application, cleanse wound and surrounding area with a gentle stream of sterile water or saline; do not dry wound surface.i

While wearing gloves, apply a sufficient amount of gel to entirely cover wound (i.e., 0.3–0.6 cm [0.125–0.25 inch] thick) to a clean, dry sterile gauze and then apply gauze to wound site.i

Remove gel from wound site with a gentle stream of sterile water or saline; may use a sterile wet swab if necessary.i Prior to reapplying gel, gently blot wound surface to remove excess fluid, leaving wound surface slightly moist.i

Dosage

Dosage varies depending on whether the drug is administered as conventional iodine (solution or tincture) or as cadexomer iodine (pad or gel).b h i

Pediatric Patients

Antisepsis
Topical

Solution or tincture: Apply to affected areas as necessary.a

Self-medication (solution or tincture): Apply a small amount to affected areas 1–3 times daily for a maximum of 10 days.b

Adults

Antisepsis
Topical

Solution or tincture: Apply to affected areas as necessary. a

Self-medication (solution or tincture): Apply a small amount to affected areas 1–3 times daily for a maximum of 10 days.b

Cadexomer iodine pad: Apply pad to wound site; change pad 3 times weekly or whenever product color has changed from brown to yellow-gray.h Reduce number of applications as exudate diminishes at wound site;h discontinue therapy when wound is free of exudate.h

Cadexomer iodine gel: Apply a sufficient amount of gel to entirely cover wound (i.e., 0.3–0.6 cm [0.125–0.25 inch] thick) to a clean, dry sterile gauze and then apply gauze to wound site.i Reapply gel 3 times weekly or whenever product color has changed from brown to yellow-gray.i Reduce number of applications as exudate diminishes at wound site;i discontinue therapy when wound is free of exudate.i

Prescribing Limits

Pediatric Patients

Antisepsis
Topical

Self-medication (solution or tincture): Do not use for >10 days.b

Adults

Antisepsis
Topical

Self-medication (solution or tincture): Do notuse for >10 days.b

Cadexomer iodine pad: Do not use continuously for >3 months.h

Cadexomer iodine gel: Maximum 1.8 oz. (50 g) as a single application; maximum 5.3 oz. (150 g) per week.i Do not use continuously for >3 months.i

Special Populations

No special population dosage recommendations at this time.a b c h i

Cautions for Iodine

Contraindications

  • Known hypersensitivity to iodine or any ingredient in the formulation.c h i

  • Cadexomer Iodine Gel and Pad
  • Thyroid disorders (e.g., Hashimoto’s thyroiditis, history of Graves disease or non-toxic nodular goiter.)h i

  • Pregnancy or breast-feeding.d h i (See Absorption under Pharmacokinetics.)

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Possible sensitization,a c edema,h i or allergy.c h i

Serious and occasionally fatal hypersensitivity reactions, including rash, angioedema, fever, arthralgia, cutaneous/mucosal hemorrhage, eosinophilia, urticaria, thrombotic thrombocytopenic purpura, or periarteritis reported.c

General Precautions

Dermatologic Effects

Possible tissue irritation (e.g., stinging sensation, iodine burn);a c g h i usually associated with hydroalcoholic solutions and with occluded skina or redness.h i

May stain skin;a b c g sodium thiosulfate solutions may remove skin stains.a g

Endocrine Effects

Risk of altered thyroid metabolism with chronic cadexomer iodine therapy, especially in patients with history of thyroid disorder.h i

Increased TSH levels reported with cadexomer iodine therapy; however, TSH levels remained within the normal range.h i

Cross Contamination

Risk of cross contamination with using cadexomer iodine pad or tube of gel for >1 patient; limit use of a single pad or tube of gel to one patient to reduce the possibility of cross contamination.h i

Wound Size

Wound may appear larger during the first days of therapy with cadexomer iodine pads or gel due to reduction of edema.h i

Other Effects

Vapors may cause eye or respiratory tract irritation.g

Possible slight transient pain within the first hour following application of cadexomer iodine.h i Less frequently, moderate pain may persist for several hours.h i

Specific Populations

Pregnancy

Category D.d

Cadexomer iodine pad and gel: Use not recommended in pregnant women.h i (See Contraindications.)

Lactation

Distributed into milk; however, AAP states topical iodine is compatible with breast feeding, although use during lactation may affect infant’s thyroid activity.d

Cadexomer iodine pad and gel: Use not recommended.h i

Renal Impairment

Use of cadexomer iodine pad or gel not recommended in patients with severe renal impairment.j

Use sodium iodide solution and tincture with caution.c

Common Adverse Effects

Irritation,a c h i sensitization,a c staining of skin.a b c g

Iodine Pharmacokinetics

Absorption

Bioavailability

Absorbed systemically following application of cadexomer iodine pad or gel.h i

Duration

Following application of cadexomer pad or gel, iodine released slowly over 24–72 hours (depending on amount of wound exudate) from cadexomer beads as they absorb fluid.h i

Distribution

Extent

Iodide readily crosses the placenta and is distributed into milk.d

Stability

Storage

Topical

Solution and Tincture

Tight, light-resistant containers at ≤35°C.a

Cadexomer Gel and Pad

15–30°C.h i

Actions

  • Bactericidal;a h i potent and rapidly acting germicide.a

  • Active against gram-positive and gram-negative bacteria.a Highly effective against methicillin-resistant strains of Staphylococcus aureus.j

  • Fungicidal, protozoacidal (e.g., trichomonocidal), cysticidal, virucidal, and some sporicidal activity.a

  • Readily penetrates microbial cell walls.a

  • Germicidal mechanism of action not fully determined;a may form N-iodo derivatives by reacting with basic NH groups on amino acids and nucleotide bases;a may disrupt protein synthesis by oxidizing the sulfhydryl group of cysteine;a may sterically hinder hydrogen bonding of tyrosine by reacting with the phenolic group of tyrosine;a and may disrupt physical properties of lipids by reacting with carbon-carbon double bonds of unsaturated fatty acids.a

  • Cadexomer pad and gel highly absorb fluid, plasma proteins, fibrinogen, bacteria, and other microbes.h i May also absorb inflammatory substances from the wound surface.h i Each gram of the pad formulation absorbs up to approximately 3 mL of fluid while each gram of the gel formulation absorbs up to approximately 6 mL of fluid; h i as fluid is absorbed, iodine is slowly released, reducing microbial load, odor, and pain associated with the wound.h i

  • Cadexomer pad and gel exhibit ion exchange, which lowers wound pH and results in potentiated iodine release.h i

Advice to Patients

  • Importance of avoiding contact with eyes and mucous membranes.b g h i

  • Importance of keeping iodine preparations out of the reach of children.b h i

  • Importance of informing patients that topical iodine can stain skin and clothing and that a sodium thiosulfate solution may remove the stain.a b c g

  • Importance of washing hands thoroughly prior to and after use of cadexomer preparations.h i

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a d h i

  • Importance of informing patients of other important precautionary information.a b h i (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Iodine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Solution

Iodine 2% and Sodium Iodide 2.4%*

Tincture

Iodine 2% and Sodium Iodide 2.4% with Alcohol 47%*

Cadexomer Iodine

0.9% w/w Iodine

Cadexomer Iodine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

0.9% w/w Iodine

Iodosorb (with polyethylene glycols and poloxamer)

Smith & Nephew

Pad

0.9% w/w Iodine

Iodoflex (with polyethylene glycols)

Smith & Nephew

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS Drug Information 2007. McEvoy GK, ed. Iodine. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3518-9.

b. Walgreens. Iodine Tincture product information. Available from website. Accessed 2008 Feb, .

c. MedlinePlus. Iodine. Available from website. Accessed 2008 Feb.

d. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th edition. Philadelphia, PA: Lippincott, Williams, & Wilkins, 2005: 842 & 1326-7.

e. Calfee DP and Farr BM. Comparison of four antiseptic preparations for skin in the prevention of contamination of percutaneously drawn blood cultures: a randomized trial. J Clin Microbiol. 2002; 40:1660-5. [PubMed 11980938]

f. Barenfanger J, Drake C, Lawhorn J et al. Comparison of chlorhexidine and tincture of iodine for skin antisepsis in preparation for blood sample collection. J Clin Microbiol. 2004; 42: 2216-7. [PubMed 15131193]

g. Mallinckrodt Baker, Inc. Material safety data sheet for iodine tincture 2%. Phillipsburg, NJ; 1999 Sep. Availabe from website. Accessed Nov 2007.

h. Smith & Nephew, Inc. Iodoflex (0.9% cadexomer iodine) pad for dermatologic use prescribing information. Largo, FL (undated).

i. Smith & Nephew, Inc. Iodosorb (0.9% cadexomer iodine) gel for dermatologic use prescribing information. Largo, FL (undated),

j. Smith & Nephew, Inc. Iodosorb/Iodoflex (0.9% cadexomer iodine) gel and pad FAQ. Available from website. Accessed 2008 Jun 9.

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