Iodoquinol; hydrocortisone; aloe polysaccharides is a topical combination of an antifungal and antibacterial agent, a corticosteroid, and skin soother or moisturizer indicated for the treatment of acne urticata, anogenital pruritus, bacterial dermatoses, contact or atopic dermatitis, chronic infectious dermatitis, stasis dermatitis, eczema, chronic eczematoid otitis externa, folliculitis, intertrigo, lichen simplex chronicus, localized or disseminated neurodermatitis, monilasis, mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis), or pyoderma in adults and pediatric patients as young as 12 years. Hydrocortisone has anti-inflammatory, antipruritic, and vasoconstrictive properties, and iodoquinol has both antifungal and antibacterial properties. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. Prolonged use of iodoquinol; hydrocortisone; aloe polysaccharides may result in overgrowth of non-susceptible fungal or bacterial organisms requiring appropriate therapy.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Other Topical Formulations
-Apply a thin film sparingly to the affected area(s).
-Do not cover with an occlusive dressing.
-Avoid contact with eyes, lips, and mucous membranes.
Dermatologic adverse reactions associated with application of corticosteroids, such as iodoquinol; hydrocortisone; aloe polysaccharides, include skin irritation (including burning and itching), xerosis, folliculitis, hypertrichosis, acneiform rash, skin hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, striae, and miliaria.
Prolonged use of iodoquinol; hydrocortisone; aloe polysaccharides may result in overgrowth of non-susceptible fungal or bacterial organisms (superinfection) requiring appropriate therapy. Secondary infection has been reported with the use of topical steroids.
Iodoquinol; hydrocortisone; aloe polysaccharides is for external use only. Avoid accidental exposure to the eyes, lips, and mucous membranes.
Iodoquinol; hydrocortisone; aloe polysaccharides is contraindicated in patients with known iodoquinol hypersensitivity or a history of hypersensitivity reactions to any product components.
Iodoquinol; hydrocortisone; aloe polysaccharides can cause laboratory test interference. It should be used with caution in patients with thyroid disease since iodoquinol may be absorbed through the skin and interfere with thyroid function tests. Wait at least one month after discontinuation of therapy to perform thyroid function tests. Additionally, iodoquinol; hydrocortisone; aloe polysaccharides may produce a false positive ferric chloride test for phenylketonuria (PKU) if iodoquinol is present in the diaper or urine.
Iodoquinol; hydrocortisone; aloe polysaccharides should not be applied under an occlusive dressing. Tight-fitting diapers or plastic pants on children may constitute occlusive dressings. Application over large surface areas or under occlusive dressings increases the possibility of systemic absorption of corticosteroids.
It is not known if iodoquinol; hydrocortisone; aloe polysaccharides can cause fetal harm when administered during pregnancy. According to the manufacturer, iodoquinol; hydrocortisone; aloe polysaccharides should be used during pregnancy only when clearly needed or when potential benefits outweigh potential hazards to the fetus.
Caution should be exercised when iodoquinol; hydrocortisone; aloe polysaccharides is administered during breast-feeding. It is not known if iodoquinol; hydrocortisone; aloe polysaccharides is excreted in human milk. Elevated iodine concentrations in the breast-fed infant are theoretically possible in patients receiving iodoquinol, and neonates are among those persons susceptible to iodine-induced thyroid disorders. Hydrocortisone appears in breast milk following oral administration and there is a minimal possibility of systemic absorption following topical administration. Trace amounts of endogenous hydrocortisone (cortisol) are excreted in breast milk; however, no reports of exogenous hydrocortisone excretion into breast milk exist. The American Academy of Pediatrics (AAP) states that another steroid, prednisone, is usually compatible with breast-feeding. Another report states that systemic steroids used in asthma patients are compatible with breast-feeding.
For the treatment of contact dermatitis, atopic dermatitis, impetiginized eczema (impetigo), nummular eczema, endogenous chronic infectious dermatitis, stasis dermatitis, pyoderma, nuchal eczema, chronic eczematoid otitis externa, acne urticata, localized or disseminated neurodermatitis, lichen simplex chronicus, anogenital pruritus (vulvus, scrotum, anus), folliculitis, bacterial dermatoses, mycotic dermatoses (tinea capitis, tinea cruris, tinea corporis, tinea pedis), monliasis (candidiasis), and intertrigo:
Indications are based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug; the indications are listed as possibly effective.
Topical dosage (gel):
Adults: Apply a thin layer topically to the affected area(s) three to four times daily or as directed.
Children and Adolescents 12 to 17 years: Apply a thin layer topically to the affected area(s) three to four times daily or as directed.
Maximum Dosage Limits:
-Adults
4 applications/day topically.
-Geriatric
4 applications/day topically.
-Adolescents
4 applications/day topically.
-Children
12 years: 4 applications/day topically.
1 to 11 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Iodoquinol; Hydrocortisone; Aloe Polysaccharides products.
The mechanism of activity of iodoquinol; hydrocortisone; aloe polysaccharides is unknown.
-Iodoquinol: Iodoquinol has both antifungal and antibacterial activity.
-Hydrocortisone: Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. There is some evidence to suggest a correlation between vasoconstrictor potency and therapeutic efficacy in humans.
Iodoquinol; hydrocortisone; aloe polysaccharides is administered topically.
-Iodoquinol: There are no data available regarding the pharmacokinetics of topical iodoquinol; however, following oral administration, 3 to 5% of the dose was recovered in the urine as a glucuronide.
-Hydrocortisone: Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms, such as tetrahydrocortisone and tetrahydrocortisol. These metabolites are excreted in the urine, mainly as conjugated glucuronides. A small portion is excreted as unchanged hydrocortisone acetate.
-Route-Specific Pharmacokinetics
Topical Route
-Iodoquinol: There are no data available regarding the percutaneous absorption of iodoquinol.
-Hydrocortisone: Hydrocortisone can be absorbed from normal intact skin after topical application. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.