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Important Safety Information for Clobex ® (clobetasol propionate) Lotion, %
Clobex ® (clobetasol propionate) Lotion, %, is not recommended for anyone younger than 18 years of age.

Clobex ® Lotion is indicated to treat steroid-responsive dermatoses. Treatment of steroid responsive dermatoses (eczema, dermatitis) should be limited to 2 weeks. Use only as directed by your physician, and do not apply to your face, underarms, or groin and avoid contact with your eyes and lips.

The total dosage should not exceed 50 g (50 mL or fl oz) per week. You should use Clobex ® Lotion only for the minimum period necessary to achieve desired results. In clinical trials, patients reported burning/stinging, skin dryness, irritation, redness, itching, skin thinning and widening of blood vessels. Because too much Lotion passing through your skin may affect your adrenal glands, do not use more than prescribed and stop using the product if you experience nausea, vomiting, fever or low blood pressure, and call you doctor. If you are pregnant, trying to get pregnant or nursing, speak to your doctor before using Clobex ® Lotion.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit /medwatch , or call 1-800-FDA-1088 (1-800-332-1088).

Fluticasone propionate is a synthetic (man-made) corticosteroid that is used on the skin (topically). The naturally-occurring corticosteroid is cortisol or hydrocortisone produced by the adrenal gland. Corticosteroids have potent anti-inflammatory actions and also suppress the immune response. Similar drugs include betamethasone dipropionate (Diprolene), clobetasol propionate (Temovate), halobetasol propionate (Ultravate), betamethasone dipropionate (Diprosone), desoximetasone (Topicort), halcinonide (Halog), amcinonide (Cyclocort), triamcinolone acetonide (Kenalog), fluocinolone acetonide (Synalar), hydrocortisone butyrate (Locoid), hydrocortisone valerate (Westcort), and mometasone furoate (Elocon). The FDA approved topical fluticasone propionate in December, 1990.

Ritonavir : Fluticasone Propionate: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see CLINICAL PHARMACOLOGY ]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression.

Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma , surgery, or infection (particularly gastroenteritis ) or other conditions associated with severe electrolyte loss. Although ARMONAIR RESPICLICK may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid that is necessary for coping with these emergencies.

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Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma , surgery, or infection (particularly gastroenteritis ) or other conditions associated with severe electrolyte loss. Although ARMONAIR RESPICLICK may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid that is necessary for coping with these emergencies.

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