Dermovate特美膚

Dermovate

clobetasol

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Clobetasol propionate.
Description
Dermovate Cream and Ointment each contain 0.05% w/w clobetasol propionate. The water-miscible cream and the paraffin-based ointment are both white in appearance.
Excipients/Inactive Ingredients: Dermovate Cream: Cetostearyl alcohol, Glyceryl monostearate, Arlacel 165, Beeswax substitute 6621, Propylene glycol, Chlorocresol, Sodium citrate, Citric acid monohydrate, Purified water.
Dermovate Ointment: Propylene glycol, Sorbitan sesquioleate, White soft paraffin.
Indications/Uses
Dermovate is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of steroid responsive dermatoses unresponsive to less potent corticosteroids. These include the following: Psoriasis (excluding widespread plaque psoriasis), recalcitrant dermatoses, lichen planus, discoid lupus erythematosus, other skin conditions which do not respond satisfactorily to less potent steroids.
Dosage/Direction for Use
Adults, Elderly and Children over 1 year: Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs (in the more responsive conditions this may be within a few days), then reduce the frequency of application or change the treatment to a less potent preparation.
Allow adequate time for absorption after each application before applying an emollient.
Repeated short courses of Dermovate may be used to control exacerbations.
In more resistant lesions, especially where there is hyperkeratosis, the effect of Dermovate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion.
If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Treatment should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation should be used.
The maximum weekly dose should not exceed 50gms/week.
Therapy with Dermovate should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of Dermovate.
Recalcitrant dermatoses: Patients who frequently relapse: Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (once daily, twice weekly, without occlusion) may be considered. This has been shown to be helpful in reducing the frequency of relapse.
Application should be continued to all previously affected sites or to known sites of potential relapse. This regimen should be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be re-evaluated on a regular basis.
Paediatric population: Dermovate is contraindicated in children under one year of age.
Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Care should be taken when using Dermovate to ensure the amount applied is the minimum that provides therapeutic benefit.
Duration of treatment for children and infants: Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be used.
Application to the face: Courses should be limited to five days if possible and occlusion should not be used.
Elderly: Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Renal/Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Route of administration: Cutaneous.
Creams are especially appropriate for moist or weeping surfaces.
Ointments are especially appropriate for dry, lichenified or scaly lesions.
Overdosage
Symptoms and signs: Topically applied Dermovate may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur (see Adverse Reactions).
Treatment: In the event of overdose, Dermovate should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated.
Contraindications
Hypersensitivity to the active substance or any of the excipients listed.
The following conditions should not be treated with Dermovate: Untreated cutaneous infections, rosacea, acne vulgaris, pruritus without inflammation, perianal and genital pruritus, perioral dermatitis.
Dermovate is contraindicated in dermatoses in children under one year of age, including dermatitis and nappy eruptions.
Special Precautions
Dermovate should be used with caution in patients with a history of local hypersensitivity to other corticosteroids or to any of the excipients in the preparation.
Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids.
If either of the above are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see Adverse Reactions).
Dermovate Ointment contains propylene glycol which may cause skin irritation.
Dermovate Cream contains: propylene glycol which may cause skin irritation, cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis), chlorocresol which may cause allergic reactions.
Risk factors for increased systemic effects are: Potency and formulation of topical steroid; duration of exposure; application to a large surface area; use on occluded areas of skin (e.g. on intertriginous areas or under occlusive dressings in infants the nappy may act as an occlusive dressing); increasing hydration of the stratum corneum; use on thin skin areas such as the face; use on broken skin or other conditions where the skin barrier may be impaired.
In comparison with adults, children and infants may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects. This is because children have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
Infection risk with occlusion: Bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in Psoriasis: Topical corticosteroids should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.
Concomitant infection: Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
Chronic leg ulcers: Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.
Application to the face: Application to the face is undesirable as this area is more susceptible to atrophic changes. If used on the face, treatment should be limited to only 5 days.
Application to the eyelids: If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. If Dermovate does enter the eye, the affected eye should be bathed in copious amounts of water.
Effects on ability to drive and use machines: There have been no studies to investigate the effect of clobetasol on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical clobetasol.
Use in Children: In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Children are more susceptible to develop atrophic changes with the use of topical corticosteroids.
Duration of treatment for children and infants: Courses should be limited if possible to five days and reviewed weekly. Occlusion should not be used.
Use In Pregnancy & Lactation
Pregnancy: There are limited data from the use of Dermovate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development.
The relevance of this finding to humans has not been established. Administration of Dermovate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
Lactation: The safe use of topical corticosteroids during lactation has not been established. It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of Dermovate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Dermovate should not be applied to the breasts to avoid accidental ingestion by the infant.
Fertility: There are no data in humans to evaluate the effect of topical corticosteroids on fertility Clobetasol administered subcutaneously to rats had no effect upon mating performance; however, fertility was decreased at the highest dose.
Adverse Reactions
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Post-marketing data: Infections and Infestations: Very rare: Opportunistic infection.
Immune System Disorders: Very rare: Hypersensitivity, generalised rash.
Endocrine Disorders: Very rare: Hypothalamic-pituitary adrenal (HPA) axis suppression: Cushingoid features: (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus, local skin burning/skin pain. Uncommon: Skin atrophy*, striae*, telangiectasias*.
Very rare: Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
General Disorders and Administration Site Conditions: Very rare: Application site irritation/pain.
Drug Interactions
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
ATC Classification
D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Cream 0.05% (white, water-miscible) x 30 g. Oint 0.05% (white, paraffin-based) x 30 g.
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