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 scalp dermatoses, such as psoriasis, that do not respond satisfactorily to treatment with less potent steroids.

What is the active ingredient in Clobetasoli propionas?

Clobetasoli propionas (Clobetasoli propionas)

What pharmaceutical form is Clobetasoli propionas available in?

Clobetasoli propionas: Maść 0,5 mg/g (na skórę)

Is Clobetasoli propionas OTC or prescription only?

Clobetasoli propionas requires a doctor's prescription.

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 surface areas, may produce adrenocortical suppression. This is usually a transient phenomenon, provided the weekly dose in adults does not exceed 50 g. Long-term, intensive treatment with potent corticosteroids may cause local cutaneous changes, including skin atrophy, ecchymoses secondary to skin atrophy, skin fragility, telangiectasia (particularly on the face), a

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 in 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 under 2 ye

Can Clobetasoli propionas be used during pregnancy?

Pregnancy Administration of corticosteroids to pregnant animals may cause abnormalities of foetal development (see section 5.3). There are no adequate and well-controlled studies of clobetasol propionate administration in pregnant women. Epidemiological studies in pregnant women receiving oral corticosteroids have demonstrated a low or non-existent 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 pot

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

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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 exerts anti-inflammatory, antipruritic, and vasoconstrictive effects. The precise mechanism underlying the anti-inflammatory activity of topical steroids in the treatment of corticosteroid-responsive dermatoses is not fully understood. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, collectively known as lipocortins. These proteins are believed to regulate the biosynthesis of potent inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is liberated from membrane phospholipids by phospholipase A2. Pharmacodynamic effects A vasoconstrictor study demonstrated that CLARELUX has comparable potency to other clobetasol propionate-containing products, as assessed by the skin blanching response. Clinical efficacy and safety The efficacy and safety of 0.05% clobetasol propionate (CP) foam were established in a double-blind, placebo- and active-comparator (CP solution)-controlled study: 188 adult participants 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. Signs and symptoms cleared or almost cleared in 74% of participants using CP foam, 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 continued to improve during the subsequent 2 treatment-free weeks. Clinical data in children and adolescents demonstrated that clobetasol foam is safe and effective for the treatment of mild to moderate plaque-type 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 received vehicle foam, and 121 received clobetasol ointment, each for 2 weeks). Approximately 27% of participants 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 participants 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, discontinue use of the product immediately. Adrenal suppression In some individuals, particularly children, increased systemic absorption of topical steroids may result in features of hypercortisolism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, with possible glucocorticoid insufficiency. If any of the above is observed, the product should be withdrawn gradually by reducing the frequency of application or substituted with a less potent corticosteroid. Abrupt discontinuation of treatment may result in glucocorticoid insufficiency (see section 4.8). Long-term continuous topical therapy should be avoided, as it may rapidly induce 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 use of a less potent steroid. Long-term use Cases of osteonecrosis, severe infections (including necrotising fasciitis), and systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol at doses exceeding the recommended dosage (see section 4.2). In some cases, patients were concurrently using other potent oral/topical corticosteroids or immunosuppressants (e.g. methotrexate, mycophenolate mofetil). If treatment with topical corticosteroids is required for longer than 2 weeks, the 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 warm, moist conditions induced by occlusive dressings, and the skin should therefore be cleansed before a clean dressing is applied. Any spread of infection requires discontinuation 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 both 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 discontinuation of treatment, 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 promoted by: prolonged exposure; application to a large surface area; use on covered areas of skin (e.g. intertriginous areas or under occlusive dressings); use on thin skin (e.g. the face); use on broken skin or in other conditions where 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 a flare of the disease following discontinuation of treatment (topical steroid withdrawal reaction). A severe form of disease flare may develop as dermatitis with intense skin redness, stinging, and burning, which may extend beyond the originally treated areas. This rebound phenomenon is more likely to occur on sensitive sites such as the face or skin folds and may be observed following abrupt discontinuation of long-term treatment. This can be minimised by tapering the treatment gradually and/or substituting with a less potent corticosteroid. If the condition recurs within days to weeks after successful treatment, a withdrawal reaction should be considered. The medicinal product should be reintroduced with caution, and specialist consultation is recommended in such cases, or alternative treatment options should be considered. The use of topical corticosteroids may carry risks, as tolerance may develop and lead to a rebound phenomenon (recurrence of symptoms). In addition, patients may be at risk of developing generalised pustular psoriasis and signs of local or systemic toxicity due to impaired skin barrier function. Careful monitoring of the patient is important. Eye disorders CLARELUX must not be applied to the eyelids (see section 4.3). After each application, patients should wash their hands to avoid contamination of the eyes with CLARELUX. If CLARELUX comes into contact with the eye, the affected eye should be rinsed with plenty of water. Patients on long-term treatment with potent topical steroids must be examined regularly for cataract and glaucoma, particularly those with known risk factors for cataract (e.g. diabetics, smokers) or glaucoma (e.g. a personal or family history of glaucoma). Paediatric population CLARELUX is not recommended for use in children under 12 years of age (see section 5.1). Excipients with known effect This medicinal product contains: 2,145 mg of ethanol per application, which may cause a burning sensation on broken skin; 74 mg of propylene glycol (E1520) per application; cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis); polysorbate 60 (E435), which may cause allergic reactions.

Clobetasoli propionas

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