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. Patients using topical corticosteroids should receive the following
information and instructions:
This medication is to be used as directed by the physician and should not be used longer
than the prescribed time period. It is for external use only. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for which it was prescribed.
The scalp area should not be covered while the medication is on the scalp (e.g., shower cap,
bathing cap) so as to be occlusive unless directed by the physician.
Patients should report any signs of local or systemic adverse reactions to their physician.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no
improvement is seen within 4 weeks, contact the physician.
Patients should wash their hands after applying the medication.
Patients should inform their physician(s) that they are using CLOBEX® Shampoo if surgery
is contemplated.
Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of CLOBEX®
Shampoo.
Directions:
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.
Side Effects: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.
Warnings: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.
