Pulse February 2019 issue - Page 19

GENERIC EQUIVALENT TO HAELAN TAPE Fludroxycortide Tape Now In Stock For chronic, localised, recalcitrant dermatoses PIP: 121-2778 Alliance: 8118556 AAH: FLU725E Abridged Prescribing Information Fludroxycortide 4 micrograms per square centimetre Tape Presentation: Transparent, plastic surgical tape impregnated with 4 µg/cm 2 fludroxycortide. Indications: Adjunctive therapy for chronic, localised, recalcitrant dermatoses that may respond to topical corticosteroids and particularly dry, scaling lesions. Posology: Adults and the Elderly: For application to the skin, which should be clean, dry and shorn of hair. In most instances the tape need only remain in place for 12 out of 24 hours. Application: The tape is cut so as to cover the lesion and a quarter inch margin of normal skin. Corners should be rounded off. After removing the lining paper, the tape is applied to the centre of the lesion with gentle pressure and worked to the edges, avoiding excessive tension of the skin. If longer strips of tape are to be applied, the lining paper should be removed progressively. Children: Courses should be limited to five days and tight coverings should not be used. If irritation or infection develops, remove tape and consult a physician. Contra-indications: Chicken pox; vaccinia; tuberculosis of the skin; hypersensitivity to any of the components; facial rosacea; acne vulgaris; perioral dermatitis; perianal and genital pruritus; dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections. Special warnings and precautions for use: Not advocated for acute and weeping dermatoses. Local and systemic toxicity of medium and high potency topical corticosteroids is common, especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary- adrenal (HPA) axis suppression. Long-term continuous therapy should be avoided in all patients irrespective of age. Application under occlusion should be restricted to dermatoses in very limited areas. If used on the face, courses should be limited to five days and occlusion should not be used. In the presence of skin infections, the use of an appropriate antifungal or antibacterial agent should be instituted. For children, administration of topical corticosteroids should be limited to the least amount compatible with an effective therapeutic regimen. Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Pregnancy and Lactation: Use in pregnancy only when there is no safer alternative and when the disease itself carriers risks for mother and child. Caution should be exercised when topical corticosteroids are administered to nursing mothers. Effects on ability to drive and use machines: No expected effects. Undesirable Effects: The following local adverse reactions may occur with the use of occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilatations of superficial blood vessels producing telangiectasia. Transient HPA axis suppression. Cushing’s syndrome. Hyperglycaemia. Glycosuria. Adrenal suppression in children may occur. Local hypersensitivity reactions. Stop treatment immediately if hypersensitivity occurs. Pack size and price: 20 cm £12.49 Legal Category: POM Marketing Authorisation Number: PL 00551/0014 Marketing Authorisation Holder: Typharm Ltd. 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH. Tel: 01603 722480, Fax: 01603 263804. Date of Preparation: September 2017. See Fludroxycortide Tape Summary of Product Characteristics for full prescribing information. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Typharm Limited on 02037 694160. For further information, please contact: Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH, UK, Tel: 01603 722480