ESAPHARMA LEMONVATE: Clobetasol propionate gel 0.05%

ESAPHARMA LEMONVATE: Clobetasol propionate gel 0.05%

Clobetasol propionate gel 0.05%

ESAPHARMA LEMONVATE contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Each gram of the 0.05% gel for topical administration, contains clobetasol propionate 0.5mg in a base of propylene glycol, carbomer, titanium dioxide, sodium hydroxide, lemon fragrance, E102 and purified water.

Indications and usage

Clobetasol propionate gel is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved.

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Contraindications

Clobetasol propionate gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Preparations

Clobetasol propionate is a topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2g per day. ESAPHARMA LEMONVATE should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin or axillae.

Pediatric use

Safety and effectiveness of ESAPHARMA LEMONVATE in children and infants have not been established; therefore, use in children under 12 years of age is not recommended. Because of higher ratio of skin surface area to body mass, children are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Adverse reactions

In a controlled trial with ESAPHARMA LEMONVATE, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients). In larger controlled clinical trials with other clobetasol propionate formulations, the most frequent reported adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy and telangiectasia (all less that 2%). Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as clobetasol propionate gel. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae and miliaria.

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Overdosage

Following topically applied ESAPHARMA LEMONVATE, clobetasol propionate can be absorbed in sufficient amounts to produce systemic effects.

Dosage and administration

Apply a thin layer of ESAPHARMA LEMONVATE to the affected areas twice daily, or according to the Physician’s prescription, and rub in gently and completely

The active ingredient of ESAPHARMA LEMONVATE, i.e. clobetasol propionate, is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50g per week should not be used. ESAPHARMA LEMONVATE should not be used with occlusive dressings.

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