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Selenium Sulfide (Topical)


VA CLASSIFICATION
Primary: DE400

Commonly used brand name(s): Exsel Lotion Shampoo; Glo-Sel; Head & Shoulders Intensive Treatment 2 in 1 (Persistent Dandruff Shampoo plus Conditioner in One) Formula Dandruff Lotion Shampoo; Head & Shoulders Intensive Treatment Conditioning Formula Dandruff Lotion Shampoo; Head & Shoulders Intensive Treatment Regular Formula Dandruff Lotion Shampoo; Selsun; Selsun Blue; Selsun Blue Dry Formula; Selsun Blue Extra Conditioning Formula; Selsun Blue Extra Medicated Formula; Selsun Blue Oily Formula; Selsun Blue Regular Formula; Versel Lotion.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiseborrheic—

Indications

Accepted

Dandruff (treatment) or{01}{18}{20}{22}
Dermatitis, seborrheic, of scalp{01}{18}{20}{23} (treatment)—Selenium sulfide is indicated for the treatment of dandruff or seborrheic dermatitis of the scalp.

Tinea versicolor (treatment)—Selenium sulfide is indicated for the treatment of tinea versicolor. {01} {16} {17} {20} {23}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    143.08 {21}

Mechanism of action/Effect:

Selenium sulfide may act by an antimitotic action, resulting in a reduction in the turnover of epidermal cells. {20} It also has local irritant, antibacterial, and mild antifungal activity, which may contribute to its effectiveness.


Precautions to Consider

Carcinogenicity

No carcinogenic effects were found after dermal applications of 0.625 and 1.25% selenium sulfide solutions were used on mice over an 88-week period. {20}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. However, problems in humans have not been documented when selenium sulfide is used on the scalp. {20}

It is recommended that selenium sulfide not be used for the treatment of tinea versicolor in pregnant women. {20}

Studies have not been done in animals.

FDA Pregnancy Category C (for tinea versicolor). {20}

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Infants—Appropriate studies on the relationship of age to the effects of selenium sulfide have not been performed in infants. Safety and efficacy have not been established. {20}

Children—Appropriate studies on the relationship of age to the effects of selenium sulfide have not been performed in children. However, pediatrics-specific problems that would limit the usefulness of this medication are not expected.


Geriatrics


Appropriate studies on the relationship of age to the effects of selenium sulfide have not been performed in the geriatric population. However, geriatrics-specific problems that would limit the usefulness of this medication in the elderly are not expected.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Inflammation or exudation of skin, acute (an increase in absorption may occur){20}
Sensitivity to selenium sulfide{20}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare
    
Skin irritation{20}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Unusual dryness or oiliness of hair or scalp{20}

Incidence less frequent
    
Increase in normal hair loss{20}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
To decrease absorption—Institute emesis and gastric lavage if accidently ingested. {20}

Supportive care—Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Selenium Sulfide (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to selenium sulfide

Pregnancy—Not using medication for the treatment of tinea versicolor

Proper use of this medication
» Importance of not using more of the 2.5% strength medication than the amount recommended {20}

For best results, using the 1% strength medication at least 2 times a week or as directed by your doctor {18}

Proper administration of the medication for dandruff or seborrheic dermatitis
Before using—Wetting hair and scalp with lukewarm water

Applying enough to scalp (approximately 1 or 2 teaspoonfuls) to work up lather

Allowing lather to remain on scalp for 2 to 3 minutes, then rinsing

Applying medication again and rinsing thoroughly

If using on light or blond, gray, or chemically treated (bleached, tinted, permanent-waved) hair, rinsing hair well for at least 5 minutes after using medication to lessen chance of hair discoloration

After treatment, washing your hands thoroughly

Proper administration of the medication for tinea versicolor
Applying medication to affected areas of body, except face and genitals

Working up lather using a small amount of water

Allowing medication to remain on skin for 10 minutes

Rinsing body well to remove all medication
» Not using medication if blistered, raw, or oozing areas are present on scalp or body

» Avoiding contact with the eyes; flushing thoroughly with water if medication accidentally gets in eyes {18}

» Proper dosing
Missed dose: Using as soon as possible; not using if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if condition does not get better after regular use, or if it gets worse {18}


Side/adverse effects
Signs of potential side effects, especially skin irritation


General Dosing Information
Selenium sulfide should not be used when acute inflammation or exudate is present, because an increase in absorption may occur. {20}

Discoloration of the hair may occur following use of selenium sulfide, especially if used on hair that is light, blond, or gray or on hair that has been chemically treated (i.e., bleached, tinted, or permanent-waved). The discoloration may be minimized or avoided by thoroughly rinsing the hair for at least 5 minutes after treatment. {12} {20}


Topical Dosage Forms

SELENIUM SULFIDE LOTION USP

Usual adult and adolescent dose
Dandruff or
Seborrheic dermatitis
Topical, to the scalp as a 1% lotion, two times a week; {18} {22} or topical, to the scalp as a 2.5% lotion, two times a week for two weeks and then at less frequent intervals of once a week or once every two or more weeks. {20} {23}

Note: The medication should not be used more frequently than required to maintain control. {20}


Tinea versicolor
Topical, to the body as a 2.5% lotion, once a day for seven days. {16} {17} {20} {23}

Note: The lotion should be applied to all affected areas, except for the face and genitals, and left on for 10 minutes. Then the medication should be thoroughly rinsed off. {16} {17} {20}



Usual pediatric dose
Dandruff or
Seborrheic dermatitis or
Tinea versicolor
Infants: Safety and efficacy {20} have not been established.

Children: See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


1% (OTC) [Head & Shoulders Intensive Treatment Conditioning Formula Dandruff Lotion Shampoo{12}] [Head & Shoulders Intensive Treatment Regular Formula Dandruff Lotion Shampoo{12}] [Head & Shoulders Intensive Treatment 2 in 1 (Persistent Dandruff Shampoo plus Conditioner in One) Formula Dandruff Lotion Shampoo{12}] [Selsun Blue Dry Formula{13}{22}] [Selsun Blue Extra Conditioning Formula{13}{22}] [Selsun Blue Extra Medicated Formula{13}{22}] [Selsun Blue Oily Formula{13}{22}] [Selsun Blue Regular Formula{13}{22}][Generic]


2.5% (Rx) [Exsel Lotion Shampoo{14}] [Glo-Sel{19}] [Selsun{20}{23}][Generic]

Canada—


1% (OTC) [Selsun Blue{16}] [Selsun Blue Extra Conditioning Formula{16}]


2.5% (OTC) [Selsun{16}] [Versel Lotion{17}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • For external use only. {18}



Revised: 07/26/1993



References
  1. Selsun and Selsun Blue package insert (Abbott—Canada) and Versel package insert (TCD—Canada), CPS 1987: 790, 927.
                      1. Head & Shoulders Intensive Treatment package insert (Proctor & Gamble—US), Rec 3/12/92.
                      1. Selsun Blue package insert (Ross—US), PDR for nonprescription drugs 1991: 681.
                      1. Exsel Lotion Shampoo package insert (Herbert—US), PDR 1992: 1082.
                        1. Selsun and Selsun Blue 1% and 2.5% package insert (Abbott—Canada), CPS 1991.
                        1. Versel Lotion 2.5% package insert (TCD—Canada), CPS 1991.
                        1. Department of Health and Human Services. Food and Drug Administration. 21 CFR Parts 310 and 358. Dandruff, seborrheic dermatitis, and psoriasis drug products for over-the-counter human use; final rule. Federal Register 1991 Dec 4 Wed; 56(233): 63554-69.
                        1. Glo-Sel 2.5% package insert (Syosset—US), Red Book 1991.
                        1. Selsun Lotion 2.5% package insert (Ross—US), PDR 1992: 1977.
                        1. The United States pharmacopeia. The national formulary. USP 22nd revision (January 1, 1990). NF 17th ed (January 1, 1990). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1990.
                        1. Selsun Blue regular formula package insert (Ross—US), PDR for nonprescription drugs 1993: 685.
                        1. Selsun (Ross—US), PDR 1993: 2068.
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