Eumovate

Clobetasone butyrate.

Excipients/Inactive Ingredients: Glycerol, Glycerol monostearate, Cetostearyl alcohol, Beeswax substitute 6621, Arlacel 165, Dimeticone 20, Chlorocresol, Sodium citrate, Citric acid monohydrate, Purified water.

ATC code: D07AB Corticosteroids, moderately potent (group II).
Pharmacology: Pharmacodynamics: Mechanism of action: Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid.
Pharmacodynamic effects: Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.
Pharmacokinetics: Absorption: Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.
Distribution: The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection.
Metabolism: Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver.
Elimination: Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.
Toxicology: Pre-clinical safety data: Carcinogenesis: Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical clobetasone.
Genotoxicity: Clobetasone was not mutagenic in vitro or in vivo.
Fertility: The effect on fertility of topical clobetasone has not been evaluated in animals.
Pregnancy: Topical application of clobetasone to rats at doses of 0.5 or 5 mg/kg/day, and subcutaneous administration to mice at doses ≥3 mg/kg/day or rabbits at doses ≥30 µgs/kg/day during pregnancy resulted in foetal abnormalities including cleft palate.

EUMOVATE cream is moderately potent topical corticosteroids indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.
These include the following: Atopic dermatitis; irritant or allergic contact dermatitis; seborrhoeic dermatitis; nappy rash; photodermatitis; otitis externa; prurigo nodularis; insect bite reactions.
EUMOVATE may be used as maintenance therapy between courses of one of the more potent topical steroids.

Adults, Elderly, Children and Infants: Creams are especially appropriate for moist or weeping surfaces.
Atopic dermatitis (eczema): Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs, 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.
If the condition worsens or does not improve within four weeks, treatment and diagnosis should be re-evaluated.
Therapy with topical corticosteroids 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 topical corticosteroids especially with potent preparations.
Children: Children are more likely to develop local and systemic adverse reactions of topical corticosteroids and, in general, require shorter courses and less potent agents than adults.
Care should be taken when using EUMOVATE to ensure the amount applied is the minimum that provides therapeutic benefit.
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.

Topically applied EUMOVATE 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).
In the event of overdose, EUMOVATE 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 or as recommended by the national poisons centre, where available.

The following conditions should not be treated with Eumovate: Untreated cutaneous infections (e.g. Herpes simplex, chickenpox); rosacea; acne vulgaris; pruritus without inflammation.

EUMOVATE should be used with caution in patients with a history of local hypersensitivity to 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).
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.
Application to the face: Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
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.
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.
Accidental ingestion: For external use only. This and all medication should be kept out of the reach of children. In case of accidental ingestion, professional assistance should be sought or a national poison control centre contacted immediately (see Overdosage).
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of EUMOVATE 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 EUMOVATE.
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 is more likely to occur.

There are limited data from the use of EUMOVATE in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see Pharmacology: Toxicology: Pre-clinical safety data under Actions). The relevance of this finding to humans has not been established. Administration of EUMOVATE 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.
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 EUMOVATE during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation, EUMOVATE should not be applied to the breasts to avoid accidental ingestion by the infant.
There are no data in humans to evaluate the effect of topical corticosteroids on fertility.

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 (e.g. urticaria, local skin burning, rash, pruritus and erythema).
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.
Skin and Subcutaneous Tissue Disorders: Very rare: Allergic contact dermatitis, urticaria, skin atrophy^*, pigmentation changes^*, exacerbation of underlying symptoms, local skin burning, hypertrichosis, rash, pruritus, erythema.
^*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, 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.

Store cream below 30°C.
Shelf-Life: 24 months from manufacturing date.

Topical Corticosteroids

D07AB01 - clobetasone ; Belongs to the class of moderately potent (group II) corticosteroids. Used in the treatment of dermatological diseases.