CLOBEX - clobetasol propionate lotion
Galderma Laboratories, L.P.
1 INDICATIONS AND USAGE
CLOBEX Lotion, 0.05% is a super-high potent topical 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. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week.
Patients should be instructed to use CLOBEX Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2) ].
Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].
1.2 Limitations of Use
CLOBEX Lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. CLOBEX Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
2 DOSAGE AND ADMINISTRATION
CLOBEX Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.
CLOBEX Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely.
The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
CLOBEX Lotion, 0.05% contains a 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 localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX Lotion, 0.05%.
Unless directed by physician, CLOBEX Lotion, 0.05% should not be used with occlusive dressings.
CLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical 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-11?, 17-dihydroxy-16? -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25 H32 CIFO5 , and a molecular weight of 466.98 (CAS Registry Number 25122-46-7).
Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX Lotion, 0.05% contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Like other topical corticosteroids CLOBEX Lotion, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
Information for Patients
Inform the patient using toical corticosteroids to adhere to the following instructions:
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.
Do not use other corticosteroid-containing products while using CLOBEX (clobetasol propionate) Lotion, 0.05%.
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%.