Selenium sulfide is a topical antiseborrheic and antifungal product. It is labeled for the treatment of dandruff, seborrheic dermatitis, and tinea versicolor. It has also been used in the treatment of psoriasis and as an adjunct to oral antifungals for tinea capitis therapy. Selenium sulfide is available in a 2.5% prescription lotion, a 2.25% prescription foam, a 2.25% prescription shampoo, and a 1% non-prescription shampoo. In a comparative trial of 4 anti-dandruff shampoos, selenium sulfide had significantly greater improvement scores than competitor products.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific 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.
Suppression of lactation occurred in one case following one day of application of selenium sulfide to the upper portion of the body for tinea versicolor. There was a positive rechallenge. Causality is difficult to establish, but selenium has been shown to inhibit DNA synthesis of animal mammary epithelial cells.
Skin irritation (i.e., burning and stinging) is the most frequently reported adverse effect of selenium sulfide; pruritus may also occur. Skin irritation or contact dermatitis may occur in the genital and skin fold area when used for the treatment of tinea versicolor, especially if the product is not rinsed thoroughly. Rarely, severe dermatitis has required discontinuation of therapy; dermatitis may be due to the detergent base present in the selenium sulfide. The odor of selenium sulfide may induce transient nausea or vomiting.
Systemic toxicity may occur if selenium sulfide is ingested or applied to broken lesions on the skin or scalp. Signs and symptoms of toxicity include garlic-like breath odor (halitosis), metallic taste in the mouth, tremor, vomiting, anorexia, sweating and abdominal pain. Symptoms usually subside after discontinuation of the treatment. In one report, these toxic effects occurred in a woman who shampooed her hair with selenium sulfide three times weekly for several months for scalp dermatitis. Urinary selenium and porphyrin levels were found to be elevated.
Conjunctivitis or ocular irritation may occur with ocular exposure to selenium sulfide. Patients should rinse the eyes thoroughly for at least 5 minutes if selenium sulfide gets into the eyes.
Alopecia has occurred with use of selenium sulfide. Alopecia may be a sign of systemic toxicity, although hair loss also occurs frequently with tinea capitis. Topical administration of selenium sulfide has no negative effect on the hair roots and alopecia would not be an expected or usual adverse effect of selenium sulfide.
Hair discoloration due to selenium sulfide is usually associated with inadequate rinsing following application, and has been reversible upon discontinuation of treatment. Hyperpigmentation of the scalp, oily scalp or dry scalp may occur with the use of selenium sulfide. Discoloration of the scalp area may persist despite discontinuation of the treatment. Several case reports have noted hair and scalp color changes in African-American individuals as well as blondes or those with bleached hair.
Selenium sulfide used for several months for treatment of tinea versicolor resulted in brown pigmentation of the distal one-half of the nail bed in one case report. Three months after discontinuation of the selenium sulfide, the nail discoloration faded. The sulfur component of the selenium sulfide may have caused the brown pigment.
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.
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.
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. The manufacturer of selenium sulfide foam recommends use in pregnant women only if necessary.
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.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Malassezia furfur, Malassezia sp., Microsporum audouinii, Microsporum canis, Microsporum sp., Trichophyton schoenleinii, Trichophyton sp., Trichophyton tonsurans
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
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 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.
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.
Maximum Dosage Limits:
-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.
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 Selenium Sulfide products.
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.
Selenium sulfide is applied topically as a lotion, foam, or shampoo.
-Route-Specific Pharmacokinetics
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.