Drug: Clobex Lotion
CLOBEX® (clobetasol propionate) Lotion, 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. Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4diene-3, 20-dione 17-propionate, with the empirical formula C25H32CIFO5, a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure: Clobetasol propionate is a white to practically-white crystalline powder insoluble in water. Each gram of CLOBEX® (clobetasol propionate) Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a vehicle base composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.
Source: http://www.rxlist.com
In controlled clinical trials with CLOBEX® (clobetasol propionate) Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia. The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with CLOBEX® (clobetasol propionate) Lotion, 0.05% at 1.0% or greater was: Adverse Reaction Incidence Skin Atrophy 4.20% Telangiectasia 3.20% Discomfort Skin 1.30% Skin Dry 1.00% Other local adverse events occurred at rates less than 1.0%. Similar rates of local adverse reactions were reported in the comparator (clobetasol propionate cream, 0.05%). Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. Read the Clobex Lotion (clobetasol propionate lotion) Side Effects Center for a complete guide to possible side effectsLearn More »
Source: http://www.rxlist.com
CLOBEX® Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE.) CLOBEX® Lotion, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to:
- 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses,
- and up to 2 additional weeks in very localized lesions of moderate to severe plaque psoriasis (no more than 10% body surface area) that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® (clobetasol propionate) Lotion 0.05%.
Source: http://www.rxlist.com
No information provided. Last reviewed on RxList: 8/30/2012
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
CLOBEX® (clobetasol propionate) Lotion, 0.05% is a super-high potent corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 2 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl.oz.) per week. For the treatment of moderate to severe plaque psoriasis, localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment with CLOBEX® (clobetasol propionate) Lotion, 0.05% may be treated for up to 2 additional weeks. Any additional benefits of extending treatment should be weighed against the risk of HPA axis suppression before prescribing for more than 2 weeks. Patients should be instructed to use CLOBEX® (clobetasol propionate) Lotion, 0.05% for the minimum amount of time 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).
Source: http://www.rxlist.com
CLOBEX® (clobetasol propionate) Lotion, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation. Last reviewed on RxList: 8/30/2012
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Topically applied CLOBEX® (clobetasol propionate) Lotion, 0.05% can be absorbed in sufficient amount to produce systemic effects. (See PRECAUTIONS).
Source: http://www.rxlist.com
CLOBEX® Lotion, 0.05% is supplied in the following sizes: 2 fl. oz./59 mL NDC 0299-3848-02 high density polyethylene bottles.
4 fl. oz./118 mL NDC 0299-3848-04 high density polyethylene bottles. Store at controlled room temperature 68° to 77°F (20°-25°C). Protect from freezing. Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA. Revised: August, 2012 Last reviewed on RxList: 8/30/2012
This monograph has been modified to include the generic and brand name in many instances.
4 fl. oz./118 mL NDC 0299-3848-04 high density polyethylene bottles. Store at controlled room temperature 68° to 77°F (20°-25°C). Protect from freezing. Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA. Revised: August, 2012 Last reviewed on RxList: 8/30/2012
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
General Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Conditions which increase systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression (see laboratory tests below). If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. The effect of CLOBEX® Lotion, 0.05% on HPA axis function was compared to clobetasol propionate cream 0.05% (Temovate E® Emollient, 0.05%) in adults in two studies, one for psoriasis and one for atopic dermatitis. In total, 8 of 10 evaluable patients with moderate to severe plaque psoriasis experienced adrenal suppression following 4 weeks of CLOBEX® Lotion, 0.05% therapy (treatment beyond 4 consecutive weeks is not recommended in moderate to severe plaque psoriasis). In follow-up testing, 1 of 2 patients remained suppressed after 8 days. In this comparative study, for clobetasol propionate cream, 0.05% there were 3 of 10 evaluable patients with HPA axis suppression. Furthermore, 5 of 9 evaluable patients with moderate to severe atopic dermatitis experienced adrenal suppression following 2 weeks of CLOBEX® Lotion, 0.05% therapy (treatment beyond 2 consecutive weeks is not recommended in moderate to severe atopic dermatitis). Of the 3 patients that had follow-up testing, one patient failed to recover adrenal function 7 days post-treatment. For patients treated with clobetasol propionate cream, 0.05%, 4 of 9 evaluable patients experienced adrenal suppression following 2 weeks of treatment. Of the 2 patients that had follow-up testing, both recovered adrenal function 7 days post-treatment. The proportion of subjects suppressed may be underestimated because the adrenal glands were stimulated weekly with cosyntropin in these studies. The potential increase in systemic exposure does not correlate with any proven benefit, but may lead to an increased potential for hypothalamic-pituitary-adrenal (HPA) axis suppression. Patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Patients should be instructed to use CLOBEX® Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results (See INDICATIONS AND USAGE). If irritation develops, CLOBEX® Lotion, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX® Lotion, 0.05% should be discontinued until the infection has been adequately controlled. CLOBEX® Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. Information for Patients Patients using topical corticosteroids should receive the following information and instructions:
This monograph has been modified to include the generic and brand name in many instances.
- This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
- This medication should not be used for any disorder other than that for which it was prescribed.
- The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
- Patients should wash their hands after applying the medication.
- Patients should report any signs of local or systemic adverse reactions to the physician.
- Patients should inform their physicians that they are using CLOBEX® (clobetasol propionate) Lotion, 0.05% if surgery is contemplated.
- This medication is for external use only. It should not be used on the face, underarms, or groin area, and avoid contact with the eyes and lips.
- As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
- Patients should be informed to not use more than 50 g (50 mL or 1.75 fl.oz.) per week of CLOBEX® Lotion, 0.05%.
- Cosyntropin stimulation test
- AM plasma cortisol test
- Urinary free cortisol test
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Search Symptoms, Conditions,
and Medications
Powered by: WebHealthNetwork
Medications Related to Vaccine
Aggregated Health News & Articles
Join Millions
Sign Up For One Of Our
Newsletters
Drug Database Online
Welcome to Vaccine Health Center an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically Clobex Lotion. Find what medications you are taking today.