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Clobex Shampoo

Package insert / prescribing information
Generic name: clobetasol propionate
Dosage form: shampoo
Drug class: Topical steroids

Medically reviewed by  A Ras MD.

What is Clobex Shampoo?

Clobex Shampoo is a prescription corticosteroid medicine used to treat adults with moderate to severe forms of scalp psoriasis. Clobex Shampoo is for use on the scalp only (topical). Clobex Shampoo should be used for the shortest amount of time needed to treat your scalp psoriasis.

You should not use Clobex Shampoo for longer than 4 weeks in a row. You should not use more than 50 mL (1.75 fluid ounces) of Clobex Shampoo in one week.

You should not use Clobex Shampoo on your face, underarms (armpits) or groin areas. Avoid getting Clobex Shampoo in your eyes or on your lips.

Clobex Shampoo should not be used in children under 18 years of age.

Description

CLOBEX® (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β -methylpregna-1, 4-diene-3, 20-dione 17-propionate.

It has the following structural formula:

 

Clobex Shampoo

 

Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

Each mL of CLOBEX® (clobetasol propionate) Shampoo,0.05%, contains clobetasol propionate, 0.05%, in a shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.

What is the most important information I should know about Clobex Shampoo?

Clobex Shampoo is for use on the scalp only. Do not get Clobex Shampoo near or in your eyes, mouth or vagina.

What should I tell my healthcare provider before taking Clobex Shampoo?

Before you use Clobex Shampoo, tell your doctor if you:

  • have a scalp infection. You may need medicine to treat the scalp infection before you use Clobex Shampoo.
  • have any open sores or cuts on your scalp
  • plan to have surgery
  • have acne vulgaris, rosacea, or a rash around your mouth (perioral dermatitis)
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Clobex Shampoo can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if Clobex Shampoo passes into your breast milk.

Talk to your doctor about the best way to feed your baby if you use Clobex Shampoo.

Tell your doctor about all the medicines you take, including prescription and non-prescription 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. You should not use other products that contain corticosteroids while you are using Clobex Shampoo. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist if you get a new medicine.

How should I use Clobex Shampoo?

How should I use Clobex Shampoo?

  • Use Clobex Shampoo exactly as your doctor tells you to use it.
  • Your doctor should tell you how much Clobex Shampoo to use and where to apply it.
  • Clobex Shampoo is for use on your scalp only (topical).
  • Apply Clobex Shampoo on affected areas of your scalp one time each day.
  • Use only enough Clobex Shampoo to cover the affected areas of your scalp.
  • Do not use Clobex Shampoo on your face, groin, or underarms. Avoid getting Clobex Shampoo in your eyes or on your lips.
  • Do not wet your hair before using Clobex Shampoo.
  • If Clobex Shampoo gets on any part of your body other than your scalp, rinse the area well with water.
  • You should not bandage or cover your head with a shower cap, bathing cap, or a towel, while Clobex Shampoo is on your scalp, unless your doctor tells you to.
  • Tell your doctor if your scalp condition is not getting better after 4 weeks of using Clobex Shampoo. You should not use Clobex Shampoo for more than 4 weeks unless your doctor tells you to.

See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to use Clobex Shampoo.

What are the possible side effects of Clobex Shampoo?

Clobex Shampoo can pass through your skin. Too much Clobex Shampoo passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

The most common side effects of Clobex Shampoo include:

  • burning or stinging at the site of application
  • itching
  • swelling
  • inflamed hair follicle
  • acne
  • dry, itchy and reddened skin
  • hair loss
  • rash or hives
  • thinning of the skin
  • widening of small blood vessels in the skin

If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clobex Shampoo.
Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Clobex 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.

You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

General information about the safe and effective use of Clobex Shampoo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clobex Shampoo for a condition for which it was not prescribed. Do not give Clobex Shampoo to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Clobex Shampoo. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clobex Shampoo that is written for health professionals.

How should I store Clobex Shampoo?

  • Store Clobex Shampoo at room temperature between 68˚F to 77˚F (20˚C to 25˚C).
  • Keep the Clobex Shampoo bottle tightly closed.

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

What are the ingredients in Clobex Shampoo?

Active ingredient: clobetasol propionate

Inactive ingredients (shampoo base): alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate and sodium laureth sulfate.

SRC: NLM .

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