Iodoquinol (Topical) (Monograph)

Brand names: Alcortin, Dermazene, Vytone
Drug class: Local Anti-infectives, Miscellaneous
CAS number: 83-73-8

Introduction

Anti-infective agent; halogenated 8-hydroxyquinoline.

Uses for Iodoquinol (Topical)

Dermatoses

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

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. .

Has been used topically in a suitable dermatologic vehicle alone or in combination with coal tar^{† [off-label]} in the treatment of bacterial and fungal infections of the skin.

Has been used in the treatment of diaper rash (diaper dermatitis); however, use in children currently is not recommended. (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^{† [off-label]}; however, relapse usually occurs when the drug is discontinued.

Iodoquinol (Topical) Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a cream or gel.

For external use only; avoid contact with the eyes.

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

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.

Prescribing Limits

Adults

Dermatoses

Topical

Not recommended for prolonged use. (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.

Cautions for Iodoquinol (Topical)

Contraindications

• Known hypersensitivity to iodoquinol or any ingredient in the formulation.

• Iodine intolerance.

Warnings/Precautions

Sensitivity Reactions

Cross-sensitivity Reactions

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

General Precautions

Topical Effects

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

May stain skin and fabrics.

Superinfection

Possible overgrowth of nonsusceptible organisms with prolonged therapy. Institute appropriate therapy if superinfection occurs.

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.

Children may be more susceptible to adverse systemic effects. (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.

Specific Populations

Pregnancy

Category C.

Lactation

Not known if distributed into milk. Use caution in nursing women.

Pediatric Use

Safety and efficacy not established in children <12 years of age.

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 derivatives and the availability of effective alternative topical anti-infectives.

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. Other reported clinical experience has not identified differences in responses between geriatric patients and younger patients.

Common Adverse Effects

Burning, itching, irritation, dry skin.

Drug Interactions

Specific Tests

Iodoquinol (Topical) Pharmacokinetics

Absorption

Bioavailability

Percutaneous absorption of iodoquinol not known. However, other halogenated hydroxyquinoline derivates (e.g., chlorquinaldol, clioquinol) are absorbed systemically following topical application to the skin.

Distribution

Extent

Not known if distributed into milk.

Elimination

Metabolism

Following oral administration, 3–5% of the dose is recovered in urine as a glucuronide.

Stability

Storage

Topical

Cream or Gel

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

Actions

• Possesses amebicidal, antitrichomonal, and slight antibacterial and antifungal activity.

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

• May also have antieczematous and antiseborrheic properties.

Advice to Patients

• Importance of not using in the eyes or applying over large areas of the body for prolonged periods.

• Importance of discontinuing use if irritation occurs during therapy.

• Keep out of reach of children.

• Inform patients that the drug may stain the skin or fabrics.

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

• 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.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

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