Following a full submission
Tacrolimus 0.1% ointment (Protopic) is accepted for restricted use within NHS Scotland.
Licensed indication under review: the maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in adult patients (16 years) experiencing a high frequency of disease exacerbations (i.e.occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
SMC Restriction: Use is restricted to initiation by doctors with a specialist interest and experience in treating atopic dermatitis using immunomodulatory therapy (this can include General Practitioners).
Twice weekly maintenance therapy with tacrolimus ointment resulted in reduced disease exacerbations when compared to intermittent use only to treat disease exacerbations.
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Medicine details
- Medicine name:
- tacrolimus (Protopic) 0.1% ointment
- SMC ID:
- 609/10
- Indication:
- Moderate to severe atopic dermatitis in adults
- Pharmaceutical company
- Astellas Pharma Ltd
- BNF chapter
- Skin
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 12 April 2010