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Iodoquinol topical

Class: Local Anti-infectives, Miscellaneous
ATC Class: G01AC01
VA Class: DE400
CAS Number: 83-73-8
Brands: Alcortin, Dermazene, Vytone

Introduction

Anti-infective agent;b c d e f halogenated 8-hydroxyquinoline.a

Uses for Iodoquinol

Dermatoses

Principally used in combination with hydrocortisone for the topical treatment of subacute and chronic dermatoses.a

National Research Council and FDA state that iodoquinol/hydrocortisone combinations are “possibly” effective for topical treatment of eczema (e.g., impetiginized eczema, nummular eczema, infantile eczema, nuchal eczema) and dermatitis (e.g., contact, atopic, endogenous chronic infectious, stasis, localized or disseminated neurodermatitis). Also may be effective for treatment of bacterial dermatoses, mycotic dermatoses [e.g., tinea (capitis, cruris, corporis, pedis), pyoderma, chronic eczematoid otitis externa, acne urticata, lichen simplex chronicus, anogenital pruritus (vulvae, scroti, ani), folliculitis, moniliasis, and intertrigo.b c d e f .b c d e f

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Has been used topically in a suitable dermatologic vehicle alone or in combination with coal tar in the treatment of bacterial and fungal infections of the skin.a

Has been used in the treatment of diaper rash (diaper dermatitis); however, use in children currently is not recommended.104 114 e (See Pediatric Use under Cautions.)

Seborrheic Dermatitis

Has been used as a shampoo (no longer commercially available in the US) for control of seborrheic dermatitis of the scalp; however, relapse usually occurs when the drug is discontinued.a

Iodoquinol Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a cream or gel.a b c d e f

For external use only;b c d e f avoid contact with the eyes.a b c d e f

Do not use over large areas of skin for long periods.a

Dosage

Adults

Dermatoses
Topical

Apply combination cream or gel (iodoquinol 1% and hydrocortisone 1–2%) to affected area(s) 3 or 4 times daily as directed.b c d e f

Prescribing Limits

Adults

Dermatoses
Topical

Not recommended for prolonged use.a b c d e f (See Superinfection under Warnings.)

Special Populations

Geriatric Patients

Generally, select dosage with caution, usually initiating at the lower end of the usual range, because of age related decreases in hepatic, renal, and/or cardiac function and concomitant disease or drug therapy.c

Cautions for Iodoquinol

Contraindications

  • Known hypersensitivity to iodoquinol or any ingredient in the formulation.a b c d e f

  • Iodine intolerance.a

Warnings/Precautions

Sensitivity Reactions

Cross-sensitivity Reactions

Cross-sensitivity may occur between halogenated hydroxyquinolines (e.g., clioquinol).a

General Precautions

Topical Effects

Possible local irritation (e.g., burning, itching, irritation, dryness).b c d e f If irritation occurs, discontinue the drug and institute appropriate therapy.a b c d e f

May stain skin and fabrics.108 b c d e f

Superinfection

Possible overgrowth of nonsusceptible organisms with prolonged therapy.108 b c d e f Institute appropriate therapy if superinfection occurs.108 c d e f

Systemic Effects

Adverse systemic effects may occur when fixed-combination preparation also containing hydrocortisone is used on large areas of the body or with occlusive dressing.b c d e f

Children may be more susceptible to adverse systemic effects.b c d e f (See Use of Fixed Combinations and also Pediatric Use, under Cautions.)

Use of Fixed Combinations

When used topically in fixed combination with hydrocortisone, consider the usual cautions, precautions, and contraindications associated with topical corticosteroid therapy.108 b c d e f

Specific Populations

Pregnancy

Category C.b c d e f g

Lactation

Not known if distributed into milk.b c d e f Use caution in nursing women.b c d e f

Pediatric Use

Safety and efficacy not established in children <12 years of age.108 b c d e f

Use in pediatric patients currently is not recommended given the association between oculotoxic/neurotoxic effects (e.g., optic neuritis, optic atrophy, subacute myelo-optic neuropathy [SMON]) and oral therapy with halogenated hydroxyquinoline derivatives100 101 104 109 114 115 116 117 118 119 120 121 122 123 124 125 and the availability of effective alternative topical anti-infectives.104 114

Geriatric Use

Clinical studies of fixed-combination iodoquinol and hydrocortisone cream did not include sufficient number of patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.c Other reported clinical experience has not identified differences in responses between geriatric patients and younger patients.c

Common Adverse Effects

Burning, itching, irritation, dry skin.b c d e f

Interactions for Iodoquinol

Specific Tests

Tests

Interaction

Comments

Test, phenylketonuria (ferric chloride)

May produce false-positive results when the drug is present in urine or the diaper108 b c d e f

Tests, thyroid function

May interfere with certain thyroid function tests (e.g., protein-bound iodine)101 108 109 111 126 127 b c d e f

Allow ≥1 month between discontinuance of topical iodoquinol therapy and performance of tests108 b c d e f

Iodoquinol Pharmacokinetics

Absorption

Bioavailability

Percutaneous absorption of iodoquinol not known.108 b c d e f However, other halogenated hydroxyquinoline derivates (e.g., chlorquinaldol, clioquinol) are absorbed systemically following topical application to the skin.100 101 102 103 104 105 106 107

Distribution

Extent

Not known if distributed into milk.b c d e f

Elimination

Metabolism

Following oral administration, 3–5% of the dose is recovered in urine as a glucuronide.b c d e f

Stability

Storage

Topical

Cream or Gel

Fixed - combination with hydrocortisone: Tightly closed containers at room temperature.b e

Actions

  • Possesses amebicidal, antitrichomonal,a and slight antibacterial and antifungal activity.a b c d e f

  • May function as an antibacterial agent by chelating, at bacterial surfaces, trace metals essential for bacterial growth.a

  • May also have antieczematous and antiseborrheic properties.a

Advice to Patients

  • Importance of not using in the eyes or applying over large areas of the body for prolonged periods.a b c d e f

  • Importance of discontinuing use if irritation occurs during therapy.b c d e f

  • Keep out of reach of children.b c d e f

  • Inform patients that the drug may stain the skin or fabrics.108 b c d e f

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b

  • Importance of informing clinician of existing or contemplated tests (e.g., thyroid function) or concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.b c d e f

  • Importance of informing patients of other important precautionary information.b (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

Iodoquinol Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

1% with Hydrocortisone 1%*

Dermazene

Stratus

Vytone

Dermik

Iodoquinol and Hydrocortisone Cream

1% with Hydrocortisone 2%

Gel

Alcortin A (with aloe, benzyl alcohol, propylene glycol, and SD alcohol 40-B)

Primus

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Food and Drug Administration. Topical antifungal drug products for over-the-counter human use; establishment of a monograph. Advance notice of proposed rulemaking. [21 CFR Part 333] Fed Regist. 1982; 47:12480-566.

101. American Pharmaceutical Association. Handbook of nonprescription drugs. 9th ed. Washington, DC: American Pharmaceutical Association; 1990:983.

102. Ezzedeen FW, Stohs SJ, Kilzer KL et al. Percutaneous absorption and disposition of iodochlorhydroxyquin in dogs. J Pharm Sci. 1984; 73:1369-72. [PubMed 6239025]

103. Stohs SJ, Ezzedeen FW. Percutaneous absorption of iodochlorhydroxyquin in humans and dogs. Pediatrics. 1984; 73:880-1. [IDIS 186457] [PubMed 6233531]

104. American Academy of Pediatrics Committee on Drugs. Clioquinol (iodochlorhydroxyquin, Vioform) and iodoquinal (diiodohydroxyquin): blindness and neuropathy. Pediatrics. 1990; 86:797-8. [IDIS 273356] [PubMed 2146587]

105. Fischer T, Hartvig P. Skin absorption of 8-hydroxyquinolines. Lancet. 1977; 1:603. [IDIS 68622] [PubMed 65689]

106. Fischer T, Fagerlund C, Hartvig P. Absorption of 8-hydroxyquinolines through the human skin. Acta Derm Venereol. 1978; 58:407-11. [PubMed 82350]

107. Stohs SJ, Ezzedeen FW, Anderson AK et al. Percutaneous absorption of iodochlorhydroxyquin in humans. J Invest Dermatol. 1984; 82:195-8. [IDIS 181580] [PubMed 6229586]

108. Vytone (iodoquinol and hydrocortisone) cream prescribing information. In: Barnhart ER, publisher. Physicians’ desk reference. 45th ed. Oradell, NJ: Medical Economics Inc; 1991:893.

109. Yodoxin (iodoquinol) tablets prescribing information. In: Barnhart ER, publisher. Physicians’ desk reference. 45th ed. Oradell, NJ: Medical Economics Company Inc; 1991:1045.

110. Carpenter CL, Jolly HW, McCormick GE et al. Combined steroid-antiinfective topical therapy in common dermatoses: a double-blind, multi-center study of iodochlorhydroxyquin-hydrocortisone in 277 patients. Curr Ther Res. 1973; 15:650-9. [IDIS 40905] [PubMed 4270829]

111. Fradkin JE, Wolff J. Iodide-induced thyrotoxicosis. Medicine (Baltimore). 1983; 62:1-20. [IDIS 164562] [PubMed 6218369]

112. Soesman-van Waadenoijen Kernekamp A, van Ketel WG. Persistence of patch test reactions to clioquinol (Vioform) and cross-sensitization. Contact Dermatitis. 1980; 6:455-60. [PubMed 6452247]

113. Hutzler D, Pevny I. [Allergies to 8-hydroxyquinoline derivatives.] (German; with English abstract.) Dermatosen Beruf Umwelt. 1988; 36:86-90.

114. American Academy of Pediatrics Committee on Drugs. Blindness and neuropathy from diiodohydroxyquin-like drugs. Pediatrics. 1974; 54:378-9. [IDIS 47325] [PubMed 4278011]

115. Reich JA, Billson FA. Toxic optic neuritis: clioquinol ingestion in a child. Med J Aust. 1973; 2:593-5. [IDIS 44255] [PubMed 4273528]

116. Ferrier TM, Eadie MJ. Clioquinol encephalopathy. Med J Aust. 1973; 2:1008-9. [IDIS 38630] [PubMed 4272640]

117. Kosaka K, Shimada Y. SMON. JAMA. 1974; 228:566-7. [IDIS 41007] [PubMed 4406178]

118. Oakley GP Jr. The neurotoxicity of the halogenated hydroxyquinolines: a commentary. JAMA. 1973; 225:395-7. [IDIS 36896] [PubMed 4270059]

119. Nakae K. Yamamoto SI, Shigematsu I. Relation between subacute myelo-optic neuropathy (SMON) and clioquinol: nationwide survey. Lancet. 1973; 1:171-3. [IDIS 31703] [PubMed 4118793]

120. Anon. Iodochlorhydroxyquin and travelers’ diarrhea. FDA Drug Bull. 1972; 2:2.

121. Selby G. Subacute myelo-optic neuropathy in Australia. Lancet. 1972; 1:123-5. [IDIS 22957] [PubMed 4108984]

122. Kean BH. Subacute myelo-optic neuropathy: a probable case in the United States. JAMA. 1972; 220:243-4. [IDIS 24292] [PubMed 4258565]

123. Igata A. Halogenated oxyquinoline derivatives and neurological syndromes. Lancet. 1971; 2:42-3.

124. Nakae K, Yamamoto SI, Igata A. Subacute myelo-optico-neuropathy (SMON) in Japan. Lancet. 1971; 2:510-2. [IDIS 20565] [PubMed 4105662]

125. Anon. Entero-Vioform and organic neurologic disease. Med Lett Drugs Ther. 1971; 13:51-2. [PubMed 4326942]

126. Upjohn AC, Galbraith HJ, Solomons B. Raised serum protein-bound iodine after topical clioquinol. Postgrad Med J. 1971; 47:515-6. [PubMed 4254353]

127. Caravati CM, Richardson DR, Wood BT. Topical iodochlorhydroxyquin—effect on thyroid function studies. Cutis. 1967; 5:447-50.

a. AHFS drug information 2007. McEvoy GK, ed. Iodoquinol. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3519-20.

b. Dermik Laboratories. Vytone 1% cream (iodoquinol 10 mg and hydrocortisone 10 mg) prescribing information. Bridgewater, NJ; 2006 Sept.

c. Ethex Corp. Iodoquinol and hydrocortisone 1% cream prescribing information. St. Louis, MO; 2000 Oct.

d. Stratus Pharmaceuticals. Dermazene cream (iodoquinol 1% and hydrocortisone 1%) cream prescribing information. Miami, FL; 1999 Dec

e. Primus Pharmaceuticals. Alcortin A gel (iodoquinol 1% and hydrocortisone 2%) prescribing information. Scottsdale, AZ; 2007.

f. Glades Pharmaceuticals. Iodoquinol and hydrocortisone 1% cream prescribing information. Coral Gables, FL; 2005 Jan.

g. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:843.

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