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Selenium Sulfide

RxNorm 706548· SELENIUM SULFIDE· TOPICAL

Laser Pharmaceuticals, LLC

Indications and usage

INDICATIONS & USAGE: A liquid antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.

Dosage and administration

DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USING For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Should not be applied more frequently than necessary to maintain control. For tinea versicolor: Wet skin and apply to affected areas. Massage gently into skin working to a full lather. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days or as directed by a physician.

Warnings

WARNINGS: For external use only. Not for ophthalmic use. DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS. If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. If accidental contact occurs, rinse thoroughly with water. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Contraindications

CONTRAINDICATIONS: Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.

Pregnancy

USE IN PREGNANCY: CATEGORY C Animal reproduction studies have not been conducted with this medication. It is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.

Nursing mothers

NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • drug ineffective124
  • pruritus61
  • hair colour changes55
  • no adverse event51
  • alopecia40
  • pain38
  • condition aggravated36
  • nausea32
  • fatigue31
  • hair texture abnormal31
  • product odour abnormal30
  • rash27
  • anxiety26
  • off label use24
  • headache23
  • vomiting23

Adverse reactions (label)

ADVERSE REACTIONS: In decreasing order of severity: skin irritation; occasional reports of increase in 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.