Selenium

Frequency Not Defined

Irritability

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

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.

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.

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

www.perrigo.com

Rev 01-17

:2J526 RC B5

(se LEE nee um)

Nutritional supplement:

Oral:

Recommended daily allowance (RDA):

Adults: 55 mcg/day

Pregnancy: 60 mcg/day

Lactation: 70 mcg/day

IV in TPN solutions:

Metabolically stable: 20-40 mcg/day

Deficiency from prolonged TPN support: 100 mcg/day

Refer to adult dosing.

Dolutegravir: Selenium may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral selenium. Consider therapy modification

Eltrombopag: Selenium may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any selenium-containing product. Consider therapy modification

Disease-related concerns:

• Gastrointestinal dysfunction: Use with caution in patients with GI impairment.

• Renal impairment: Use with caution in patients with renal impairment.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register, 2002). See manufacturer’s labeling.

Applies to selenium sulfide topical: compounding powder, topical foam, topical lotion, topical shampoo

Dermatologic

Dermatologic side effects including skin irritation, increased hair loss, and discoloration of hair have been reported.[Ref]

Discoloration of hair can be avoided or minimized by thoroughly rinsing hair after treatment.[Ref]

Some side effects of selenium sulfide topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.