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 do not respond satisfactorily to 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: Roztwór na skórę 0,5 mg/ml (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 of the product or treatment of extensive skin areas may induce adrenal cortex 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 skin changes, such as skin atrophy, ecchymoses secondary to skin atrophy, skin fragility, telangiectasia (particularly on the face) and striae affe

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, 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 years

Can Clobetasoli propionas be used during pregnancy?

Pregnancy Administration of corticosteroids to pregnant animals may cause abnormal foetal development (see section 5.3). There are no adequate and well-controlled studies of clobetasol propionate use in pregnant women. Epidemiological studies in pregnant women taking oral corticosteroids have shown a low or non-existent risk of 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, suc

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 action of topical steroids in the treatment of corticosteroid-responsive dermatoses is generally unclear. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, collectively known as 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. Pharmacodynamic effects A vasoconstrictor study demonstrated that CLARELUX has potency comparable to other clobetasol propionate–containing preparations as measured by the skin blanching response. 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 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. In 74% of participants using the CP foam, signs and symptoms had 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 following 2 treatment-free weeks. Clinical data in children and adolescents demonstrated that clobetasol foam is safe and effective in 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 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 events 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 manifestations of hypercortisolism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, with the potential for glucocorticoid insufficiency. If any of the above is observed, the product should be withdrawn gradually by reducing the frequency of application or replaced with a less potent corticosteroid. Abrupt discontinuation of treatment may result in glucocorticoid insufficiency (see section 4.8). Prolonged continuous topical therapy should be avoided, as it may rapidly induce adrenal suppression, even without the use of occlusive dressings. Once the 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, serious 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 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 topical corticosteroid treatment must be continued beyond 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 warmth and moisture created under 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 disturbance, referral to an ophthalmologist should be considered to evaluate possible causes, which include cataract, glaucoma (see "Precautions for use") or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported following the use of systemic and topical corticosteroids. Treatment with systemic corticosteroids may be associated with the development of glaucoma and cataract. This risk has also been reported with ocular 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 upon 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. on intertriginous areas or under occlusive dressings); use on thin skin (e.g. the face); use on broken skin or in 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 the disease after treatment is discontinued (topical steroid withdrawal reaction). A severe form of disease flare-up may develop as dermatitis with intense redness, stinging and burning of the skin that may spread beyond the originally treated areas. This rebound phenomenon is more likely to occur with treatment of sensitive skin sites, such as the face or skin folds, and may be observed upon abrupt discontinuation of long-term therapy. This can be minimised by gradual withdrawal of treatment and/or replacement with a less potent corticosteroid. If the disease recurs within several days to weeks following successful treatment, a withdrawal reaction should be considered. The medicinal product should be reintroduced with caution, and specialist consultation or alternative treatment options should be considered in such cases. The use of topical corticosteroids may carry risks, since 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 of local or systemic toxicity due to impaired skin barrier function. Careful patient monitoring is important. Eye disorders CLARELUX must not be applied to the eyelids (see section 4.3). After each application, patients must wash their hands to avoid contaminating the eyes with CLARELUX. If CLARELUX comes into contact with the eye, the affected eye should be rinsed with plenty of water. Patients using potent topical steroids long term must be regularly examined for cataract and glaucoma, particularly those with known risk factors for cataract (e.g. diabetics, smokers) or glaucoma (e.g. 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 product contains: 2,145 mg of ethanol per application, which may cause 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

User Reviews