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CLOBETASOL PROPIONATE is a brand name for Clobetasol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Topical treatment of moderate scalp psoriasis in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
4). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).
Posology Clobetasol propionate 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. 5 ml) per application is sufficient to cover all the scalp. The total dosage should not exceed 50 g per week.
Method of administration For cutaneous use on the scalp only. After application, clobetasol propionate 500 micrograms/g shampoo should be kept in place without covering for 15 minutes. Hands should be washed carefully after application.
After 15 minutes, the product must be thoroughly rinsed with water and/ or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual. The treatment duration should be limited to a maximum of 4 weeks.
As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary. Repeated courses of clobetasol propionate 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.
Special population Elderly The safety and efficacy of clobetasol propionate 500 micrograms/g shampoo in geriatric patients aged 65 years and above have not been established. Renal impairment Clobetasol propionate 500 micrograms/g shampoo has not been studied in patients with renal impairment.
Hepatic impairment Patients with severe liver dysfunction should be treated with special caution and closely monitored for side-effects. Paediatric population The experience in the paediatric population is limited. Clobetasol propionate 500 micrograms/g shampoo is not recommended for use in children and adolescents below 18 years of age.
4).
Summary of the safety profile During clinical development of clobetasol propionate 500 micrograms/g shampoo, in a total of 558 patients receiving clobetasol propionate 500 micrograms/g shampoo, the most commonly reported adverse drug reaction was skin burning sensation.
8%. Most adverse events were rated as mild to moderate and they were not affected by race or gender. 2%). No serious drug-related adverse events were reported during any of the clinical trials. Tabulated list of adverse reactions The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data) and were reported with clobetasol propionate 500 micrograms/g shampoo in clinical studies and post- marketing (see Table 1).
4) Immune System Disorders Uncommon Hypersensitivity Nervous System disorders Uncommon Headache Skin and subcutaneous tissue Common Skin burning sensation, Folliculitis Uncommon Pain of skin Skin discomfort Pruritus Acne Skin oedema Telangiectasia Psoriasis (aggravation) Alopecia Dry skin Urticaria Skin atrophy Skin irritation Skin tightness Allergic contact dermatitis, erythema, rash disorders Not known Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules.
2) and therefore, the risk of appearance of HPA axis suppression is very low compared to non rinsed potent corticosteroids products. Should HPA axis suppression occur, it is likely to be transient with a rapid return to normal values.
Cataract has been reported when corticosteroids where applied to the eyes or eyelids. Immunosuppression and opportunistic infections have been reported in case of prolonged use of potent topical corticosteroids in rare instances. Growth retardation may be observed in children in case of systemic absorption of topical corticosteroids.
Hypersensitivity to corticosteroids can be observed. Therefore, clobetasol propionate, is not recommended in patients who are hypersensitive to other corticosteroids. Long-term continuous therapy with corticosteroids, use of occlusive mobcaps, treatment of large surface areas especially in children can enhance absorption and lead to a higher risk of systemic effects.
In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of HPA axis suppression. Systemic absorption of topical corticosteroids induced by prolonged use especially on large surface areas has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency, manifestations of Cushing's syndrome in some patients.
Such systemic effects resolve when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children. 2). g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered.
Patient with severe diabetes mellitus should be treated with special caution and closely monitored for side-effects. Topical corticosteroids should be used with caution as development of tolerance (tachyphylaxis) may occur as well as local toxicity such as skin atrophy, infection and telangiectasia of the skin.
Clobetasol propionate 500 micrograms/g shampoo is only intended for the treatment of scalp psoriasis and should not be used to treat other skin areas. In particular, Clobetasol propionate 500 micrograms/g shampoo is not recommended for use in the face, intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of adverse events such as atrophic changes, telangiectasia, corticosteroid-induced dermatitis or secondary infection.
1. Clobetasol propionate 500 micrograms/g shampoo must not be applied on skin areas affected by bacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections, ulcerous wounds and specific skin diseases (skin tuberculosis, skin diseases caused by lues).
Clobetasol propionate 500 micrograms/g shampoo must not be applied to the eye and eyelids (risk of glaucoma, risk of cataract). Children under 2 years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Although not observed with clobetasol propionate 500 micrograms/g shampoo, prolonged and/or intensive treatment with potent corticosteroid preparations may cause striae, purpura, and generalised pustular psoriasis. Rebound effects may occur upon discontinuation of treatment.
When applied to the face, very potent corticosteroids can also induce perioral dermatitis or worsen rosacea. There are reports of pigmentation changes, pustular eruptions and hypertrichosis with topical corticosteroids. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalised pustular psoriasis in case of intensive and prolonged topical use.
Clobetasol propionate, is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis. There may be a risk of post-treatment rebound or relapse upon abrupt discontinuation of treatment with clobetasol propionate. Medical supervision should therefore continue in the post-treatment period.
Topical steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area.
It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.
Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered. If clobetasol propionate 500 micrograms/g shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water.
Patients should be instructed to use clobetasol propionate 500 micrograms/g shampoo for the minimum amount of time necessary to achieve the desired results. If signs of local intolerance appear, application should be suspended until they disappear.
If signs of hypersensitivity appear, application should be stopped immediately. In order to avoid interaction with hair colour dying product, such as hair colour changes, clobetasol propionate shampoo should be thoroughly rinsed. 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, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Paediatric population In this age group, growth retardation may also be observed in case of systemic absorption of topical corticosteroids. clobetasol propionate 500 micrograms/g shampoo should not be used in children and adolescents between 2 and 18 years of age.
If clobetasol propionate 500 micrograms/g shampoo is used in children and adolescents below 18 years of age, the treatment should be reviewed weekly.