Vytone

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Vytone

Classes

Combinations of Corticosteroids with Antibacterials

Administration
Topical Administration Cream/Ointment/Lotion Formulations

Apply to affected area.
Do not apply to the eyes.
Wash hands thoroughly after administration.

Adverse Reactions
Severe

skin atrophy / Delayed / Incidence not known

Moderate

hyperthyroidism / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known

Mild

miliaria / Delayed / Incidence not known
skin discoloration / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
infection / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
skin irritation / Early / Incidence not known
hypertrichosis / Delayed / Incidence not known
striae / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known

Common Brand Names

Corti-Sav, Dermazene, Vytone

Dea Class

Rx

Description

Topical combination product containing steroid and antibacterial/antifungal agent
Used for the treatment of skin infections

Dosage And Indications
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 (declatoses), mycotic dermatoses (tinea capitis, tinea cruris, tinea corporis, tinea pedis), moniliasis, and intertrigo. Topical dosage Adults, Adolescents, and Children 12 years and older

Apply to affected area(s) 3 to 4 times daily or as directed by a physician. Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the drug is considered 'Possibly' effective for the listed conditions.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Hydrocortisone; Iodoquinol products.

How Supplied

Corti-Sav/Dermazene/Hydrocortisone Acetate, Iodoquinol/Hydrocortisone, Iodoquinol/Vytone Topical Cream: 1-1%, 1.9-1%

Maximum Dosage
Adults

Maximum dosage information is not available.

Geriatric

Maximum dosage information is not available.

Adolescents

Maximum dosage information is not available.

Children

12 years and older: Maximum dosage information is not available.
Less than 12 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Hydrocortisone: Hydrocortisone has anti-inflammatory, antipruritic, and vasoconstrictive properties. The exact mechanism of anti-inflammatory activity is unclear for topical steroids.  However, there is some evidence that a correlation exists between vasoconstrictor potency and therapeutic efficacy. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). These proteins may control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid, which is released from membrane phospholipids by phospholipase A2.
Iodoquinol: Iodoquinol has antifungal and antibacterial activity.

Pharmacokinetics

Hydrocortisone; iodoquinol is administered topically. 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. Based on oral administration, an absorbed iodoquinol would be recovered in the urine as a glucuronide.

Topical Route

Hydrocortisone: The extent of percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Hydrocortisone is absorbed through normal intact skin. Inflammation or inflammatory disease processes in the skin can increase percutaneous absorption. Occlusive dressings substantially increase percutaneous absorption of steroids.
Iodoquinol: There is no data regarding the percutaneous absorption of iodoquinol.

Pregnancy And Lactation
Pregnancy

Hydrocortisone; iodoquinol is classified as FDA pregnancy category C. The manufacturer recommends that hydrocortisone; iodoquinol should be used during pregnancy only when clearly needed. No animal reproduction studies have been conducted and no studies have been conducted in pregnant women. It is not known if topically administered hydrocortisone; iodoquinol can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity.

According to the manufacturer, caution should be used when administering hydrocortisone; iodoquinol to women who are breast-feeding as it is not known whether topically applied hydrocortisone; iodoquinol is excreted in breast 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. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.