What is Clobetasoli propionas used for?

CLARELUX is indicated in adults and adolescents aged 12 years and older for the short-term treatment of steroid-responsive dermatoses of the scalp, such as psoriasis, that have not responded satisfactorily to treatment with less potent steroids.

What pharmaceutical form is Clobetasoli propionas available in?

Clobetasoli propionas: Roztwór na skórę 0,5 mg/ml

What are the side effects of Clobetasoli propionas?

Summary of the safety profile As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive body areas may produce adrenocortical suppression. This is usually transient provided the weekly dose in adults does not exceed 50 g. Prolonged and intensive treatment with potent corticosteroids may cause local cutaneous changes such as skin atrophy, ecchymoses secondary to skin atrophy, skin fragility, telangiectasia (particularly on the face), and striae affecting the

Who should NOT take Clobetasoli propionas?

CLARELUX is contraindicated in patients with: hypersensitivity to clobetasol propionate, to other corticosteroids, or to any of the excipients listed in section 6.1; ulcerated lesions or burns; rosacea; acne vulgaris; perioral dermatitis; perianal and genital pruritus. The use of CLARELUX is contraindicated for the treatment of primary infected skin lesions caused by parasitic, viral, fungal, or bacterial infection. CLARELUX: must not be used on the face; is contraindicated in children younger t

Can Clobetasoli propionas be used during pregnancy?

Pregnancy Administration of corticosteroids to pregnant animals may cause abnormal fetal development (see section 5.3). There are no adequate and well-controlled studies of clobetasol propionate in pregnant women. Epidemiological studies in pregnant women receiving oral corticosteroids have shown a low or no risk of an association with cleft palate. Limited evidence suggests a small risk of low birth weight with the use of large amounts of potent/very potent topical corticosteroids, such as clob

Who manufactures Clobetasoli propionas?

GlaxoSmithKline Trading Services Limited

What ATC class does Clobetasoli propionas belong to?

Clobetasoli propionas: ATC D07AD01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Clobetasoli propionas

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: corticosteroids, very potent (group IV). ATC code: D07AD01. Mechanism of action Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the anti-inflammatory effect of topical steroids in the treatment of corticosteroid-responsive dermatoses is generally unclear. Corticosteroids are thought to act through induction of phospholipase A2 inhibitory proteins, collectively termed lipocortins. These proteins are believed to control the biosynthesis of potent inflammatory mediators 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. Pharmacodynamic effects A vasoconstrictor study has shown that CLARELUX has potency comparable to other clobetasol propionate–containing products based on the skin-blanching test. Clinical efficacy and safety The efficacy and safety of 0.05% clobetasol propionate (CP) foam were demonstrated in a double-blind, placebo- and active-controlled (CP solution) study: 188 adult subjects with moderate-to-severe scalp psoriasis were treated for 2 weeks. The products were applied twice daily to the entire affected scalp area. After 2 weeks of treatment, pruritus, scaling, erythema, and plaque thickness were assessed. In 74% of subjects using the CP foam, signs and symptoms cleared or almost cleared, compared with 6–10% in the placebo group and 61% in the CP solution group. All signs and symptoms of the disease improved significantly after 2 weeks of treatment and during the subsequent 2-week treatment-free period. Clinical data in children and adolescents have shown that clobetasol foam is safe and effective for the treatment of mild-to-moderate plaque psoriasis in patients aged 12 years and older. A double-blind, randomised, placebo (vehicle)-controlled study was conducted in 497 patients aged 12 years or older (253 patients received clobetasol foam, 123 patients received vehicle foam, and 121 patients received clobetasol ointment, each for 2 weeks). Approximately 27% of subjects were adolescents. Compared with vehicle foam, clobetasol foam was nearly 4 times more effective in treating mild-to-moderate plaque psoriasis in the overall population (47% vs 12%). Efficacy was similar between adolescents and adults, and the incidence of adverse reactions was comparable between clobetasol foam and vehicle foam in both adult and paediatric subjects aged 12 years.

⚠️ Warnings

Special warnings Hypersensitivity CLARELUX should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients. Local hypersensitivity reactions (see section 4.8) may resemble the condition being treated. If signs of hypersensitivity appear, use of the product should be discontinued immediately. Adrenal suppression In some individuals, particularly children, manifestations of hypercortisolism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis with possible glucocorticoid insufficiency may occur as a result of increased systemic absorption of topical steroids. If any of the above is observed, the product should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid. Abrupt discontinuation may lead to glucocorticoid insufficiency (see section 4.8). Prolonged continuous topical therapy should be avoided, as it may rapidly cause adrenal suppression even without the use of occlusive dressings. Once lesions have resolved, or after a maximum treatment duration of two weeks, switch to intermittent therapy or consider a less potent steroid. Long-term use Cases of osteonecrosis, severe infections (including necrotising fasciitis), and systemic immunosuppression (sometimes leading to reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol in amounts exceeding the recommended dose (see section 4.2). In some cases, patients were concurrently receiving other potent oral/topical corticosteroids or immunosuppressants (e.g. methotrexate, mycophenolate mofetil). If treatment with topical corticosteroids is required for longer than 2 weeks, use of a less potent corticosteroid should be considered. Infections and infestations CLARELUX is not recommended for use on wounds or ulcers. Secondary infection may develop; bacterial infection is favoured by the warmth and moisture produced beneath occlusive dressings, and therefore the skin should be cleansed before a clean dressing is applied. Any spread of infection requires withdrawal of topical corticosteroid therapy and initiation of appropriate antimicrobial treatment. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataract, glaucoma (see "Precautions for use"), or rare diseases such as central serous chorioretinopathy (CSCR), which has been reported after systemic and topical corticosteroid administration. Systemic corticosteroid therapy may be associated with the development of glaucoma and cataract. This risk has also been reported with ophthalmic treatment and with regular application of topical corticosteroids to the eyelids. In addition, cataract and glaucoma have been reported in patients following long-term excessive application of potent topical corticosteroids to the face and/or body. Although the hypertensive effect of topical steroids is usually reversible after treatment is stopped, visual impairment resulting from glaucoma and cataract is irreversible. Precautions for use Increased systemic absorption of topical steroids Increased systemic absorption of topical steroids may result in systemic adverse effects (e.g. adrenal suppression, immunosuppression). Increased systemic absorption of topical steroids may be enhanced by: prolonged exposure; application to a large surface area; use on covered skin areas (e.g. intertriginous areas or under occlusive dressings); use on thin skin (e.g. the face); use on broken skin or under other conditions in which the skin barrier is impaired; increased hydration of the stratum corneum. Unless under medical supervision, CLARELUX should not be used together with occlusive dressings. Rebound phenomenon Long-term use of topical steroids may lead to flare-up of disease after discontinuation of therapy (topical steroid withdrawal reaction). A severe form of disease flare-up may develop in the form of dermatitis with intense redness, stinging, and burning of the skin, which may extend beyond the originally treated areas. This rebound phenomenon is more likely to occur when treating sensitive skin areas such as the face or skin folds, and may be observed after abrupt discontinuation of long-term therapy. This can be minimised by gradual tapering of treatment or by substitution with a less potent corticosteroid. If disease recurs within several days to weeks after successful treatment, a withdrawal reaction should be considered. The medicinal product should be reintroduced with caution, and in such cases specialist consultation is advised or alternative treatment options should be considered. The use of topical corticosteroids may be risky because, following the development of tolerance, a rebound phenomenon (recurrence of symptoms) may occur. In addition, patients may be at risk of developing generalised pustular psoriasis and signs of local or systemic toxicity as a result of impaired skin barrier function. Careful patient monitoring is important. Eye disorders CLARELUX must not be applied to the eyelids (see section 4.3). Patients should wash their hands after each application to prevent ocular contamination with CLARELUX. If CLARELUX comes into contact with the eye, the affected eye should be rinsed with copious amounts of water. Patients on long-term treatment with potent topical steroids should be examined regularly for cataract and glaucoma, particularly those with known risk factors for cataract (e.g. diabetes mellitus, smoking) or glaucoma (e.g. personal or family history of glaucoma). Paediatric population CLARELUX is not recommended for use in children younger than 12 years of age (see section 5.1). Excipients with known effects This medicinal product contains: 2,145 mg of ethanol per application, which may produce a burning sensation on broken skin; 74 mg of propylene glycol (E 1520) per application; cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis); polysorbate 60 (E 435), which may cause allergic reactions.

Clobetasoli propionas

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