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Clobex Shampoo (Clobetasol Propionate Topical) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week (see DOSAGE and ADMINISTRATION).

Patients should be instructed to use CLOBEX™ Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results (see PRECAUTIONS).

Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS, Pediatric Use).

There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.

DOSAGE AND ADMINISTRATION

CLOBEX™ Shampoo should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying CLOBEX™ Shampoo. Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after four weeks of treatment with CLOBEX™ Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

CLOBEX™ Shampoo should not be used with occlusive dressings unless directed by a physician.

HOW SUPPLIED

CLOBEX™ Shampoo is supplied in 4 fl.oz. (118 mL) bottles. NDC 0299-3847-04

Storage: Keep tightly closed. Store at controlled room temperature 68°F to 77°F (20°C-25°C).

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

www.clobex.com

325060-0104

Revised: January, 2004

PATIENT INFORMATION

For External Use Only

Not for Ophthalmic (Eye) Use

CLOBEX™

(clobetasol propionate) Shampoo, 0.05%

Read the Patient Information that comes with CLOBEX™ Shampoo before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

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

What is CLOBEX™ Shampoo?

CLOBEX™ Shampoo is a medicine called a topical (skin use only) corticosteroid. It is used for a short time to treat forms of scalp psoriasis. CLOBEX™ Shampoo is a super-high potent (very strong) topical corticosteroid. It is very important that you use CLOBEX™ Shampoo only as directed in order to avoid serious side effects.

Who should not use CLOBEX™ Shampoo?

Do not use CLOBEX™ Shampoo if you are allergic to any of its ingredients, or to any other corticosteroid. The active ingredient is clobetasol propionate. See the end of this leaflet for a complete list of ingredients in CLOBEX™ Shampoo. Ask your doctor or pharmacist if you need a list of other corticosteroids.

CLOBEX™ Shampoo is not recommended for use by patients under 18 years of age. Children have smaller body sizes and have a higher chance of side effects.

What should I tell my doctor before using CLOBEX™ Shampoo?

Tell your doctor:

  • if you are pregnant, think you are pregnant, plan to be pregnant. Talk with your doctor before using CLOBEX™ Shampoo or if you are already using CLOBEX™ Shampoo. It is not known if CLOBEX™ Shampoo can harm your unborn baby.
  • if you are breastfeeding. It is not known if CLOBEX™ Shampoo passes into your milk, and if it can harm your baby.
  • if you think you have an infection on your scalp. You may need another medicine to treat the scalp infection before you use CLOBEX™ Shampoo.

Tell your doctor about all the other medicines and skin products you use, including prescription and non-prescription medicines, vitamins, herbal supplements, and cosmetics. Some medicines and products can cause serious side effects if used while you are using CLOBEX™ Shampoo.

How should I use CLOBEX™ Shampoo?

  • Use CLOBEX™ Shampoo exactly as prescribed by your doctor. CLOBEX™ Shampoo is for use on your scalp only.
  • Apply CLOBEX™ Shampoo on affected areas of the scalp once a day. Use only enough to cover the affected areas of your scalp. Do not use CLOBEX™ Shampoo on your face, groin, armpits, lips, or in your eyes.
  • Do not wet your hair before using CLOBEX™ Shampoo. Move the hair away from the scalp so that one of the affected areas is exposed. Apply a small amount of the shampoo directly onto the affected area by gently squeezing the bottle. Gently, rub CLOBEX™ Shampoo into the affected area. Repeat for other affected areas on your scalp.
  • Do not cover your head with a shower cap or bathing cap while CLOBEX™ Shampoo is on your scalp.
  • Leave CLOBEX™ Shampoo in place for 15 minutes before adding water, lathering and rinsing hair and scalp completely. No other shampoos are necessary. However, you can use a non-medicated shampoo on your hair after using CLOBEX™ Shampoo if you want to.
  • Wash your hands after applying CLOBEX™ Shampoo. Wash any other part of your body that came into contact with CLOBEX™ Shampoo such as your neck and shoulders.
  • If you forget to apply CLOBEX™ Shampoo at the scheduled time, use it as soon as you remember. Then go back to your regular schedule. If it is about time for your next dose, apply just that 1 dose, and continue with your regular schedule. Do not make up the missed dose. If you miss several doses, tell your doctor.
  • Do not use more than 50 grams (50 mL or 1.75 fluid ounces) of CLOBEX™ Shampoo per week.

What should I avoid while using CLOBEX™ Shampoo?

Do not do the following while using CLOBEX™ Shampoo:

  • Do not get CLOBEX™ Shampoo on your lips or in or near your eyes because this might cause side effects. If you do, use a lot of water to rinse the CLOBEX™ Shampoo off your face, lips, or out of your eyes. If your eyes keep stinging after rinsing them well with water, contact your doctor right away.
  • Do not apply CLOBEX™ Shampoo to your face, groin or armpits.
  • Do not get CLOBEX™ Shampoo in your mouth. If you or a child accidentally swallows CLOBEX™ Shampoo, call your Poison Control center or local emergency room right away.
  • Do not cover your head with a shower or bathing cap while CLOBEX™ Shampoo is on your scalp.
  • Do not use CLOBEX™ Shampoo any longer than 4 weeks (28 days) for moderate to severe scalp psoriasis.
  • Do not use more than 50 mL (1.75 fluid ounces) of CLOBEX™ Shampoo per week.

What should I do if I miss an application of CLOBEX™ Shampoo?

If you forget to apply CLOBEX™ Shampoo at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at the time of your next application, apply only one dose and continue with your regular schedule. If you miss several doses, tell your doctor.

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 shut down your adrenal glands. This may happen if you use too much CLOBEX™ Shampoo or if you use it for too long, but it can happen with correct use. If your adrenal glands shut down, they may not start working right away after you stop using CLOBEX™ Shampoo. Shutting down of the adrenal glands can cause nausea, vomiting, fever, low blood pressure, heart attack and even death because your body cannot adequately respond to stress or illness.

Your doctor may do special blood and urine tests to check your adrenal gland function while you are using CLOBEX™ Shampoo.

The most common side effects with CLOBEX™ Shampoo include burning or itching at the site of application. Other possible side effects include thinning of the skin and 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:

  • are going to have surgery
  • get sick or don't feel right. Call your doctor right away.
  • have irritation of the treated skin area that does not go away
  • have any unusual effects that you do not understand
  • have affected areas that do not seem to be healing after 4 weeks of using CLOBEX™ Shampoo.

These are not all the possible side effects of CLOBEX™ Shampoo. For more information, ask your doctor or pharmacist.

How should I store CLOBEX™ Shampoo?

  • Store CLOBEX™ Shampoo at room temperature between 68°F to 77°F (20°C-25°C).
  • Keep the bottle tightly closed at all times.
  • Do not use CLOBEX™ Shampoo after the expiration date shown on bottle.
  • Keep CLOBEX™ Shampoo and all medicines out of the reach of children.

General information about CLOBEX™ Shampoo

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. 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 you have. It may harm them. This 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.

What are the ingredients in CLOBEX™ Shampoo?

Active ingredient: clobetasol propionate

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

Rx only

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

www.clobex.com

325060-0104

Revised: January 2004

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