You will find a full list in the manufacturer's information leaflet supplied with your medicine. Evidence-based recommendations on tacrolimus (Protopic) and pimecrolimus (Elidel) for people with atopic eczema.. Tacrolimus Accordointment should be applied as a thin layer to affected or commonly affected areas of the skin. Occlusive dressings are not recommended. Tacrolimus (as Tacrolimus monohydrate) 200 microgram; 50: sachet (POM) £71.30 Part VIIIA Category C: £71.30 Mean (SD) EASI total score at end of treatment (week 6), Absolute change from baseline to end of treatment in EASI total score, Table 7 Efficacy of Tacrolimus Accord0.1 % ointment vs the innovator 0.1 % ointment at week 6, Tacrolimus Accord 0.1 % ointment vs the innovator 0.1 % ointment twice daily, Mean % CFB in EASI total score for PP set, Mean % CFB in EASI total score of ITT set. When it is used like this to prevent flares, there should be at least 2-3 days between applications. However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment. Clinical trials have shown tacrolimus (given orally or applied topically) is often an effective treatment for inflammatory skin diseases such as atopic dermatitis and psoriasis. Reporting suspected adverse reactions after authorisation of the medicinal product is important. The ointment is for use on the skin only. Erythema was a common skin irritation adverse reaction. Patients visited the clinic on 09 different occasions for comparative safety and efficacy assessment. Manufacturer's PIL, Protopic® 0.1% Ointment; Leo Laboratories Ltd, The electronic Medicines Compendium. Emollients should not be applied to the same area within 2 hours of applying Tacrolimus Accordointment. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions. Following repeated topical application of the ointment the average half-life of tacrolimus was estimated to be 75 hours for adults and 65 hours for children. It is not known if tacrolimus 0.1% ointment caused this effect. Tacrolimus Accordointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Analysis of the response rate at week 5 showed equivalence between the treatment groups (hydrocortisone 98.3%, tacrolimus ointment 95.4%; 7-11 years: 100% in both arms). How to treat constipation and hard-to-pass stools. Dated June 2018. In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome. The Scottish Medicines Consortium has advised (April 2010) that tacrolimus 0.1 % ointment (Protopic ®) is accepted for restricted use within NHS Scotland for the prevention of flares in patients aged 16 years and over with moderate-to-severe atopic eczema in accordance with the licensed indications; initiation of treatment is restricted to doctors (including general practitioners) with a specialist interest and … Tacrolimus 0.1% ointment (Protopic) is accepted for restricted use within NHS Scotland. There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study. The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period. Embryo/foetal toxicity was observed in rats and rabbits, but only at doses that caused significant toxicity in maternal animals. Continue to use the ointment until your eczema has cleared. The response rate in the 0.1 % tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p<0.001; Table 1). Instruct patients not to smoke or go near naked flames - risk of severe burns. • Tacrolimus ointment may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees. 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