GSK topical steroid preparations

Mini-Abridged PIs: Steroid Creams/Ointments/Scalp Applications:

BETNOVATE – Abbreviated Prescribing Information: Please refer to full Summary of Product Characteristics (SPC) before prescribing.  Trade name: Betnovate ointment; cream; scalp application 0.1% cutaneous solution. Active Ingredient: Betamethasone Valerate 0.122%  w/w (cream/ointment); 0.1% w/w (scalp application). Pharmaceutical Form: Ointment; aqueous cream; cutaneous solution. Indications:  Eczema in children and adults, including atopic/discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis); seborrhoeic dermatitis; adjunct to systemic steroid therapy in generalised erythroderma. Posology and Method of Administration: Apply a small quantity to the affected area once or twice daily until improvement occurs. In children, courses should be limited to five days and occlusion should not be used. Contraindications: Rosacea, acne vulgaris, pruritus without inflammation, perioral dermatitis, dermatoses in children under 1 year of age, including dermatitis. Special Warnings and Precautions: Long-term continuous therapy should be avoided and used with caution in patients with a history of local hypersensitivity to other corticosteroids. The face especially may exhibit atrophic changes after prolonged treatment. Care is needed to ensure that the preparation does not enter the eye. Careful supervision is important in psoriasis. Appropriate antimicrobial therapy should be used whenever treating infected inflammatory lesions. Spread of infection requires withdrawal of topical corticosteroid therapy. Interactions with other medicaments: Increased systemic exposure is shown when co-administered with drugs that can inhibit CYP3A4. Fertility, Pregnancy and Lactation: No data in humans on fertility; Inadequate evidence and limited safety data on human pregnancy/lactation. Effect on Ability to Drive or Use Machines: No studies. Side Effects: Common (less than 1 in 10): Local skin burning and pruritus. Very Rare (less than 1 in 10,000): Adrenal suppression, hypersensitivity and allergic contact dermatitis. Overdose: Treatment should be clinically managed. Local Presentation: 30g ointment/cream; 100ml scalp application. Marketing Authorisation Holder: Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK (cream/ointment); GlaxoSmithKline Ireland Limited (scalp application). MA Number: MA167/00302 (ointment); MA167/00301 (cream); MA192/00201 (scalp application). Legal category: POM. For further information and full prescribing information contact GlaxoSmithKline (Malta) Ltd: Tel. 21238131. Date of preparation: November 2015.

DERMOVATE – Abbreviated Prescribing Information: Please refer to full Summary of Product Characteristics (SPC) before prescribing.  Trade name: Dermovate ointment; cream; scalp application. Active Ingredient: Clobetasol propionate 0.05375% w/w (ointment); 0.0525% w/w (cream); 0.05% w/w (scalp application). Pharmaceutical Form: Ointment; Cream; Scalp Application. Indications: Short courses for the treatment of more resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant dermatoses, lichen planus, discoid lupus erythematosus, and other skin conditions which do not respond to less active steroids. Posology and Method of Administration: Apply sparingly to the affected area once or twice daily until improvement occurs. If continuous steroid treatment is necessary, a less potent preparation should be used. Contraindications: Rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus; hypersensitivity; dermatoses in children under one year of age, including dermatitis and napkin eruptions. Special Warnings and Precautions: Long-term continuous therapy should be avoided, particularly in infants and children, as adrenal suppression can occur. In children, treatment should be reviewed weekly. If used in childhood or on the face, courses should be limited if possible to five days and occlusion should not be used. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. Care is needed to ensure that the preparation does not enter the eye. Careful supervision is important in psoriasis. Appropriate antimicrobial therapy should be used whenever treating infected inflammatory lesions. Spread of infection requires withdrawal of topical corticosteroid therapy. Interactions with other medicaments: Increased systemic exposure is shown when co-administered with drugs that can inhibit CYP3A4. Fertility, Pregnancy and Lactation: No data in humans on fertility; Safe use during pregnancy and lactation has not been established. Topical steroids should not be used extensively in pregnancy. Effect on Ability to Drive or Use Machines: No studies. Side Effects: Common (less than 1 in 10): Local skin burning and pruritus. Very Rare (less than 1 in 10,000): Adrenal suppression, hypersensitivity and allergic contact dermatitis. Overdose: Treatment should be clinically managed. Local Presentation: 30g ointment/cream; 30ml scalp application. Marketing Authorisation Holder: Glaxo Wellcome UK Ltd trading as Glaxo Laboratories and/or GlaxoSmithKline UK. MA Number: MA 167/00602 (ointment); MA 167/00601 (cream); MA167/00603 (scalp application). Legal category: POM. For further information and full prescribing information contact GlaxoSmithKline (Malta) Ltd: Tel. 21238131. Date of preparation: November 2015.

CUTIVATE – Abbreviated Prescribing Information: Please refer to full Summary of Product Characteristics (SPC) before prescribing.  Trade name: Cutivate 0.005% ointment; 0.05% cream. Active Ingredient: Fluticasone Propionate 0.05% w/w (cream); 0.005% w/w (ointment).

Pharmaceutical Form: Ointment; Cream. Indications: Adults: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as: eczema; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; an adjunct to systemic steroid therapy in generalised erythroderma; insect bite reactions; prickly heat. Children: Children and infants aged three months and over who are unresponsive to lower potency corticosteroids; relief of the inflammatory and pruritic manifestations of atopic dermatitis under the supervision of a specialist. Posology and Method of Administration: Apply a thin film to the affected skin areas twice daily until improvement occurs. In children, if there is no improvement within 7 – 14 days, withdraw treatment. Continuous daily treatment for longer than 4 weeks is not recommended. Contraindications: Rosacea; acne vulgaris; perioral dermatitis; hypersensitivity; perianal and genital pruritus; dermatoses in infants under 3months of age, including dermatitis and nappy rash. Special Warnings and Precautions: Prolonged applications of high doses might lead to adrenal suppression. The face may exhibit atrophic changes after prolonged treatment. Care is needed to ensure that the preparation does not enter the eye. Careful supervision is important in psoriasis. Spread of infection requires withdrawal of topical corticosteroid therapy. Interactions with other medicaments: Increased systemic exposure is shown when co-administered with drugs that can inhibit CYP3A4. Fertility, Pregnancy and Lactation: No data in humans on fertility; Safe use during pregnancy and lactation has not been established. Administration during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or baby. Effect on Ability to Drive or Use Machines: No studies. Side Effects: Common (less than 1 in 10): Pruritus. Uncommon (less than 1 in 100): Local skin burning. Very Rare (less than 1 in 10,000): Adrenal suppression, hypersensitivity and allergic contact dermatitis. Overdose: Treatment should be clinically managed. Local Presentation: 15g ointment/cream. Marketing Authorisation Holder: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK. MA Number: MA167/00502 (ointment); MA167/00501 (cream). Legal category: POM. For further information and full prescribing information contact GlaxoSmithKline (Malta) Ltd: Tel. 21238131. Date of preparation: November 2015.

EUMOVATE – Abbreviated Prescribing Information: Please refer to full Summary of Product Characteristics (SPC) before prescribing.  Trade name: Eumovate cream. Active Ingredient: Clobetasone butyrate 0.05% w/w. Pharmaceutical Form: Cream. Indications: Eczema and dermatitis including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Maintenance therapy between courses of one of the more active topical steroids. Posology and Method of Administration: Apply once ot twice a day until improvement occurs. Contraindications: Rosacea; acne vulgaris; pruritus without inflammation. Special Warnings and Precautions: Hypersensitivity. Long-term administration in infants and children may result in adrenal suppression. Extreme caution is required in dermatoses and treatment should not normally exceed seven days. Appropriate antimicrobial therapy should be used whenever treating infected inflammatory lesions. Spread of infection requires withdrawal of topical corticosteroid therapy. As with all corticosteroids, prolonged application to the face is undesirable. If used in psoriasis, careful patient supervision is important. Care is needed to ensure that the preparation does not enter the eye. Interactions with other medicaments: Increased systemic exposure is shown when coadministered with drugs that can inhibit CYP3A4. Fertility, Pregnancy and Lactation: No data in humans on fertility; Safe use during pregnancy and lactation has not been established. Effect on Ability to Drive or Use Machines: No studies. Side effects: Very Rare (less than 1 in 10,000): Adrenal suppression, hypersensitivity and allergic contact dermatitis. Overdose: Treatment should be clinically managed. Local Presentation: 30g cream. Marketing Authorisation Holder: Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK. MA Number: MA 167/00801 (cream). Legal category: POM. For further information and full prescribing information contact GlaxoSmithKline (Malta) Ltd: Tel. 21238131. Date of preparation: November 2015.

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