Exsel
Administration
NOTE: Selenium sulfide lotion is available in the 2.5% strength (Rx only). Selenium sulfide foam is available in the 2.25% strength (Rx only). Selenium sulfide shampoo is available in the 2.25% (Rx only) and 1% strength (OTC).
For external use only. Avoid contact with the eyes, mucus membranes, and genital areas. Rinse hands well after use.
Do not use on inflamed or broken skin.
Topical lotion and shampoo:
Shake well before using. Selenium sulfide may damage jewelry; remove jewelry before application.
If used on blond, bleached, tinted, grey, or permed hair, rinse for at least 5 minutes to minimize the chance for hair discoloration. Do not use within 48 hours of applying hair color or permanent wave solutions.
Topical foam:
Clean and dry affected area.
Shake the canister vigorously before each use.
Invert the canister and apply foam to cover the affected skin.
Rub the foam into the skin until completely absorbed.
Adverse Reactions
contact dermatitis / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known
vomiting / Early / Incidence not known
pruritus / Rapid / Incidence not known
skin irritation / Early / Incidence not known
nausea / Early / Incidence not known
halitosis / Early / Incidence not known
metallic taste / Early / Incidence not known
anorexia / Delayed / Incidence not known
abdominal pain / Early / Incidence not known
tremor / Early / Incidence not known
ocular irritation / Rapid / Incidence not known
alopecia / Delayed / Incidence not known
hair discoloration / Delayed / Incidence not known
nail discoloration / Delayed / Incidence not known
Common Brand Names
Anti-Dandruff, Dandrex, Exsel, Selenos, SelRx, Selseb, Selsun Blue, Tersi Foam
Dea Class
Rx, OTC
Description
Topical antiseborrheic and antifungal
Used for the treatment of dandruff, seborrheic dermatitis, psoriasis, and tinea versicolor
Prescription-only products include 2.5% lotion, 2.25% foam, and 2.25% shampoo; 1% shampoo is a non-prescription formulation
Dosing Considerations
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Renal ImpairmentSpecific 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 Selenium Sulfide products.
How Supplied
Dandrex/Selenium Sulfide/Selenos/SelRx/Selseb/Selsun Blue Topical Shampoo: 1%, 2.25%, 2.3%
Exsel/Selenium Sulfide Topical Lotion: 2.5%
Tersi Foam Topical Foam: 2.25%
Maximum Dosage
No maximum dosage information is available.
ElderlyNo maximum dosage information is available.
AdolescentsNo maximum dosage information is available.
ChildrenNo maximum dosage information is available.
InfantsSafety and efficacy have not been established.
Mechanism Of Action
Selenium sulfide appears to have a cytostatic activity on the epidermis and follicular epithelium that reduces corneocyte production and subsequent flaking. It has local irritant, antibacterial, antiseborrheic and mild antifungal activity that contributes to its effectiveness. Selenium sulfide also reduces the spread of viable spores in the treatment of tinea capitis.
The following organisms are generally considered susceptible to selenium sulfide in vitro: Malassezia furfur, Microsporum sp. including Microsporum audouinii and Microsporum canis, Pityrosporon sp., Trichophyton sp. including Trichophyton schoenleinii and Trichophyton tonsurans. Selenium sulfide has been shown to be sporicidal to T. tonsurans, the most common etiologic agent of tinea capitis. One in vitro study demonstrated that 2.5% selenium sulfide was equivalent in sporicidal activity to both 1% and 2% zinc pyrithione.
Pharmacokinetics
Selenium sulfide is applied topically as a lotion, foam, or shampoo.
Topical RouteWhen applied to large areas of intact skin in single-dose studies, no significant absorption of selenium sulfide has been demonstrated. However, longer periods of application have resulted in significant absorption. Systemic absorption may occur if selenium sulfide is applied to open skin areas. The sporicidal activity of selenium sulfide remains on the skin even after rinsing.
Pregnancy And Lactation
There are no adequate and well-controlled studies of selenium sulfide use in pregnant women. According to the manufacturer, the use of the shampoo or lotion is not ordinarily recommended during pregnancy.[48890] [48891] The manufacturer of selenium sulfide foam recommends use in pregnant women only if necessary.[48889]
According to the manufacturer, selenium sulfide should be used with caution during breast-feeding. It is not known whether selenium sulfide is excreted in human milk. One case report describes a woman who experienced suppression of lactation one day after applying selenium sulfide to the upper portion of her body for tinea versicolor. There was a positive re-challenge. Causality from this one case report is difficult to establish, but selenium has been shown to inhibit DNA synthesis of animal mammary epithelial cells. 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 ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.