Tacrolimus (Topical)

Strength is pinned by the product name, so the 'thin layer' instruction is publishable: the SPC states 'Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment' and assigns 0.1% to adults. FLARE TREATMENT, VERBATIM §4.2 (Adults and adolescents, 16 years of age and above): 'Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion. If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted. An attempt should be made to reduce the frequency of application or to use the lower strength Protopic 0.03% ointment if the clinical condition allows. Generally, improvement is seen within one week of starting treatment. If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.' MAINTENANCE, VERBATIM §4.2: 'Patients who are responding to up to 6 weeks treatment using tacrolimus ointment twice daily (lesions cleared, almost cleared or mildly affected) are suitable for maintenance treatment. […] Adult patients should use Protopic 0.1% ointment. Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares. Between applications there should be 2–3 days without Protopic treatment. After 12 months treatment, a review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months. If signs of a flare reoccur, twice daily treatment should be re-initiated.' GENERAL, VERBATIM §4.2: 'Protopic can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis.' and 'Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.' METHOD, VERBATIM §4.2: 'Protopic ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients.' ELDERLY, VERBATIM §4.2: 'Specific studies have not been conducted in older people. However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.' AGE BANDING CAVEAT: the SPC assigns 0.1% to 'Adults and adolescents (16 years of age and above)' and 0.03% to 'Children (2 years of age and above)'; it gives no separate 12–15 year statement beyond that split. maxDose left empty deliberately: no maximum quantity, no maximum treated body-surface area and no maximum course length is stated anywhere in the fetched sections; the nearest statement is the §4.4 principle 'It is recommended to use tacrolimus ointment at the lowest strength and the lowest frequency for the shortest duration necessary as determined by the physician's evaluation of the clinical condition', which is a principle, not a numeric ceiling.

dosePerKg and concentration are null because this is an ointment applied as a thin layer: the SPC gives no per-kilogram, per-gram, per-fingertip-unit or per-body-surface-area quantity, so there is nothing that can drive a weight calculator, and there is no mg/mL strength for an ointment. FLARE TREATMENT, VERBATIM §4.2 (Paediatric population): 'Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment. Treatment should be started twice a day for up to three weeks. Afterwards the frequency of application should be reduced to once a day until clearance of the lesion (see section 4.4). Protopic ointment should not be used in children aged below 2 years until further data are available.' MAINTENANCE, VERBATIM §4.2 (Paediatric population): 'Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment. Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares. Between applications there should be 2–3 days without Protopic treatment. The review of the child`s condition after 12 months treatment should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease.' §4.4, VERBATIM: 'Care should be exercised if applying Protopic to patients with extensive skin involvement over an extended period of time, especially in children' and 'The effect of treatment with Protopic ointment on the developing immune system of children aged below 2 years has not been established.' maxDose left empty deliberately: '0.03% strength only' is a strength/eligibility rule, not a dose ceiling, and no maximum quantity is stated. Verify any under-18 use against a children's formulary and current prescribing references before prescribing.