Selenium sulfide

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Selenium sulfide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Selenium sulfide is a antiseborrheic and dermatological agent that is FDA approved for the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.

Dsoding Information

  • See application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the suspension may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases. The preparation should not be applied more frequently than required to maintain control.
  • For treatment of tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse the body thoroughly. Repeat this procedure once a day for seven days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Selenium sulfide in adult patients.

Non–Guideline-Supported Use

  • Tinea capitis-Adjunct

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Selenium sulfide in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Selenium sulfide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Selenium sulfide in pediatric patients.

Contraindications

  • This product should not be used by patients allergic to any of its components.

Warnings

  • For External Use Only. Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area as it may cause irritation and burning.
  • KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

PRECAUTIONS

General
  • Should not be used when acute inflammation or exudation is present as increased absorption may occur.

Adverse Reactions

Clinical Trials Experience

  • In decreasing order of severity: skin irritation, occasional reports of increase in amount of normal hair loss, discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Selenium sulfide in the drug label.

Drug Interactions

There is limited information regarding Drug Interaction of Selenium sulfide in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE IS CLASSIFIED AS PREGNANCY CATEGORY "C". Animal reproduction studies have not been conducted with Selenium Sulfide Topical Suspension USP, 2.5% (Lotion). It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) should not be used for the treatment of tinea versicolor in pregnant women.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Selenium sulfide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Selenium sulfide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Selenium sulfide with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Selenium sulfide with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Selenium sulfide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Selenium sulfide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Selenium sulfide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Selenium sulfide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Selenium sulfide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Selenium sulfide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Selenium sulfide in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of Selenium sulfide in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Selenium sulfide in the drug label.

Overdosage

Accidental Oral Ingestion
  • Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Topical Suspension USP, 2.5% (Lotion); however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion.

Pharmacology

There is limited information regarding Selenium sulfide Pharmacology in the drug label.

Mechanism of Action

  • Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, thus reducing corneocyte production.

Structure

  • A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS2 and has a molecular weight of 143.09.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Selenium sulfide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Selenium sulfide in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Selenium sulfide in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Selenium sulfide in the drug label.

How Supplied

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is available as follows:

4 fl oz plastic bottle (NDC 45802-040-64).

Storage

  • Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
  • For lot number and expiration date see label or bottom of container.

Images

Drug Images

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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)

For External Use Only

Shake Well Before Use

Rx Only

Peel Here

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

  • Application to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued. May be irritating to mucous membranes of the eyes and contact with this area should be avoided.
  • When applied to the body for treatment of tinea versicolor, Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.

APPLICATION INSTRUCTIONS=

Keep tightly capped. SHAKE WELL BEFORE USING.

Product may damage jewelry; remove jewelry before use.

For treatment of dandruff and seborrheic dermatitis of the scalp:

1. Massage about 1 or 2 teaspoonsful of suspension into wet scalp.

2. Allow to remain on scalp for 2 to 3 minutes.

3. Rinse scalp thoroughly.

4. Repeat application and rinse thoroughly.

5. After treatment, wash hands well.

6. Repeat treatments as directed by physician.

For treatment of tinea versicolor:

1. Apply to affected areas and lather with a small amount of water.

2. Allow to remain on skin for 10 minutes.

3. Rinse body thoroughly.

4. Repeat this procedure once a day for seven days.

Precautions with Alcohol

  • Alcohol-Selenium sulfide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Dandrex®
  • Selsun Blue Medicated Treatment®
  • Selseb®
  • Selenos®
  • Tersi Foam®

Look-Alike Drug Names

There is limited information regarding Selenium sulfide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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