Capex

Generic name: fluocinolone topical
Brand names: Capex, Synalar
Drug class: Topical steroids

Medically reviewed by  A Ras MD.

What is Capex?

Capex Shampoo is a prescription medicine used on the scalp to treat a skin condition called seborrheic dermatitis. It is not known if Capex Shampoo is safe and effective in children and infants.

Description

Capex® Shampoo 0.01% is supplied as a shampoo formulation with a 12 mg fluocinolone acetonide capsule which is emptied into the shampoo base by the pharmacist at the time of dispensing. After mixing, Capex® Shampoo contains fluocinolone acetonide(6α,9-Difluoro-11β,16α, 17,21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16,17-acetal with acetone), a synthetic fluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agents.

Chemically, Capex® Shampoo mixture is C24H30F2O6. It has the following structural formula:

Fluocinolone acetonide in Capex® Shampoo has the molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light and melts at 270°F with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each fluocinolone capsule contains 12 mg of fluocinolone acetonide, 548 mg of dibasic calcium phosphate dihydrate USP, and 240 mg of talc USP. The shampoo base contains aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, and fragrances, with D&C Yellow #10 and FD&C Blue #1 as coloring.

What is the most important information I should know about Capex?

Capex Shampoo is for use on the skin only. Do not get Capex Shampoo in your eyes.

Who should not use Capex?

Do not use Capex Shampoo if you are allergic to any of its ingredients. See the end of this guide for a complete list of ingredients in Capex Shampoo.

What should I tell my healthcare provider before taking Capex?

Before using Capex Shampoo, tell your doctor about all of your medical conditions, including if you:

• have a scalp infection. You may need medicine to treat the scalp infection before you use Capex Shampoo.
• are pregnant or plan to become pregnant. It is not known if Capex shampoo can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Capex Shampoo passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed you baby if you use Capex Shampoo.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Do not use other products containing a corticosteroid medicine with Capex Shampoo without talking to your doctor first.

How should I use Capex?

• When you receive your Capex Shampoo, it will already be mixed in a bottle by your pharmacist.
• Use Capex Shampoo exactly as your doctor tells you to use it.
• Your doctor should tell you how much Capex Shampoo to use and where to apply it.
• Capex Shampoo is for use on your scalp only (topical).
• Shake the Capex Shampoo bottle well before using.
• Do not apply more than 1 ounce of Capex Shampoo to your scalp, 1 time each day.
• Work Capex Shampoo into a lather.
• Leave Capex Shampoo on your scalp for at least 5 minutes.
• Rinse your hair and scalp well with water.
• Avoid getting Capex Shampoo in your eyes. If you get Capex Shampoo in your eyes, rinse your eyes well with water.
• Do not bandage or cover your head after using Capex Shampoo unless your doctor tells you to.
• Tell your doctor if you develop irritation where you apply Capex Shampoo, or if your seborrheic dermatitis is not getting better with Capex Shampoo.

What are the possible side effects of Capex?

Capex Shampoo can pass through your skin.

The side effects of corticosteroids medicines used on the skin (topical) include:

• dry, itchy, and reddened skin
• burning or stinging at application site
• inflamed hair follicle
• acne
• thinning of skin
• loss of skin color

These are not all the possible side effects of Capex Shampoo. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Capex

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Capex Shampoo for a condition for which it was not prescribed. Do not give Capex Shampoo to other people, even if they have the same symptoms you have. It may harm them. You can also ask your doctor or pharmacist for information about Capex Shampoo that is written for health professionals.

How should I store Capex?

• Store Capex Shampoo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the Capex Shampoo bottle tightly closed.
• Throw away (discard) your Capex Shampoo bottle after 2 months, even if there is still medicine left in the bottle.

Keep Capex Shampoo and all medicines out of the reach of children.

What are the ingredients in Capex?

Active ingredient: fluocinolone acetonide

Inactive ingredients: aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, dibasic calcium phosphate dihydrate, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, talc, fragrances, D&C Yellow 10, and FD&C Blue 1 as coloring.

Label

PACKAGE LABEL

• ATTN PHARMACIST: Empty contents of enclosed capsule into shampoo bottle.
• Rx only
• NDC 0299-5500-04
• Capex®
  (fluocinolone acetonide)
  topical shampoo
• SHAMPOO (as dispensed)
• 0.01%
• For Topical Use Only
  Shake Well Before Use
  Discard Contents After Two Months
• 4 fl oz
• GALDERMA
• ATTN PHARMACIST: Empty contents of enclosed capsule into shampoo bottle.
• Usual Dose: Apply no more than approximately one ounce of shampoo on affected area, let stand for 5 minutes, then rinse thoroughly with water.
• See package insert for full prescribing information.
• Marketed by:
  GALDERMA LABORATORIES, L.P.
  Fort Worth, Texas 76177 USA

 

SRC: NLM .