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  • CLASSES

    Topical Dermatological Antifungals
    Topical Scalp Antifungals

    DEA CLASS

    OTC, Rx

    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

    COMMON BRAND NAMES

    Anti-Dandruff, Dandrex, Exsel, Selenos, SelRx, Selseb, Selsun Blue, Tersi Foam

    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%

    DOSAGE & INDICATIONS

    For the treatment of dandruff and seborrheic dermatitis and associated pruritus and flaking.
    Topical dosage (shampoo or lotion)
    Adults and Children

    Apply 5 to 10 mL of the 1% shampoo or 2.5% lotion to wet scalp and massage in. Leave on for 2 to 3 minutes. Rinse thoroughly and repeat. Two applications weekly for 2 weeks usually brings control, followed with 1 application every 1 to 4 weeks as needed. Dandruff tends to recur if selenium sulfide therapy is discontinued. OTC formulations claim to be gentle enough for daily use. Selenium sulfide 2.5% has similar antidandruff activity to miconazole nitrate 2% shampoo.

    Topical dosage (2.25% shampoo)
    Adults

    Apply to wet scalp and massage in. Leave on for 2 to 3 minutes. Rinse thoroughly. Two applications per week for 2 weeks usually brings control. After 2 weeks, the shampoo may be used less frequently (e.g., weekly, every 2 weeks, or every 3 to 4 weeks) as needed.

    Topical dosage (foam)
    Adults

    Apply topically to affected area twice daily. Rub the foam into the skin until completely absorbed.

    For the treatment of tinea versicolor.
    Topical dosage (2.5% lotion, Rx-only)
    Adults and Children

    Apply to the affected areas and lather with a small amount of water. Leave on the skin for 10 minutes, then rinse thoroughly. Repeat once daily for 7 days. Additional courses of treatment should be used only for recurrent cases. In the treatment of tinea versicolor, selenium sulfide 2.5% has been shown to have similar efficacy to oral itraconazole, but patient preference was higher for oral itraconazole therapy.

    Topical dosage (Selenos 2.25% shampoo)
    Adults

    Apply to the affected areas and lather with a small amount of water. Leave on the skin for 10 minutes, then rinse thoroughly. Repeat once daily for 7 days.

    Topical dosage (foam)
    Adults

    Apply topically to affected area twice daily. Rub the foam into the skin until completely absorbed.

    For the treatment of psoriasis†.
    Topical dosage (2.5% lotion, Rx-only)
    Adults and Children

    Apply an amount sufficient to cover lesion. Leave on for 15 minutes, then rinse thoroughly. Apply daily for 1 to 3 weeks, then gradually taper. Maintenance treatment 1 to 2 times weekly may be needed. Selenium sulfide 2.5% has been shown effective for various types of psoriatic lesions and associated pruritus on the scalp, trunk, axillae and groin.

    For the adjunctive treatment of tinea capitis†.
    Topical dosage (1% shampoo)
    Adults and Children

    Apply to the affected scalp area and lather with water. Leave on the area for 2 to 3 minutes, then rinse thoroughly. Apply twice per week. Treatment should be continued for at least 6 weeks. The 1% selenium sulfide shampoo (OTC) has been shown to be equally effective as the 2.5% lotion (Rx) when used in combination with oral griseofulvin.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information is available.

    Elderly

    No maximum dosage information is available.

    Adolescents

    No maximum dosage information is available.

    Children

    No maximum dosage information is available.

    Infants

    Safety and efficacy have not been established.

    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.

    ADMINISTRATION

    Topical 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.

    STORAGE

    Anti-Dandruff:
    - Storage information not listed
    Dandrex:
    - Storage information not listed
    Exsel :
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Selenos:
    - Brief exposure up to 104 degrees F does not adversely affect product
    - Do not expose product to temperatures above 77 degrees F
    - Protect from extreme heat
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    SelRx:
    - Avoid excessive heat (above 104 degrees F)
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Selseb:
    - Brief exposure up to 104 degrees F does not adversely affect product
    - Do not expose product to temperatures above 77 degrees F
    - Protect from extreme heat
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Selsun Blue:
    - Storage information not listed
    Tersi Foam:
    - Exposure to temperatures above 120 degrees F may cause bursting
    - Store between 59 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Accidental exposure, ocular exposure

    Selenium sulfide is contraindicated in patients who have previously exhibited sensitivity to any of the components of the lotion, foam, or shampoo. Do not use on inflamed or broken skin. Avoid accidental exposure to genital areas or ocular exposure. To minimize the potential for hair or scalp discoloration, rinse thoroughly after use. Discontinue use if sensitivity reactions occur.

    Children, infants, neonates

    Selenium sulfide, including the non-prescription formulation, should not be used in neonates, infants, or children younger than 2 years of age unless directed by a physician.

    Pregnancy

    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]

    Breast-feeding

    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.

    ADVERSE REACTIONS

    Moderate

    contact dermatitis / Delayed / Incidence not known
    conjunctivitis / Delayed / Incidence not known

    Mild

    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

    DRUG INTERACTIONS

    There are no drug interactions associated with Selenium Sulfide products.

    PREGNANCY AND LACTATION

    Pregnancy

    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.

    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 Route

    When 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.