Posology : מינונים

4.2    Posology and method of administration

Neotigason should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy (see Section 4.6).

The capsules should be taken once daily with meals or with milk.

There is a wide variation in the absorption and rate of metabolism of Neotigason. This necessitates individual adjustment of dosage. For this reason the following dosage recommendations can serve only as a guide.

Adults
Initial daily dose should be 25mg or 30mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. Following assessment of the initial treatment period, titration of the dose upwards or downwards may be necessary to achieve the desired therapeutic response with the minimum of side-effects. The maintenance dose must be based on clinical efficacy and tolerability. In general, a daily dosage of 25 - 50mg taken for a further 6 to 8 weeks achieves optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75mg/day.

In patients with Darier’s disease a starting dose of 10mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur.

Therapy can be discontinued in patients with psoriasis whose lesions have improved sufficiently. Relapses should be treated as described above.

Patients with severe congenital ichthyosis and severe Darier's disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given.

Continuous use beyond 6 months is contraindicated as only limited clinical data are available on patients treated beyond this length of time.

Elderly
Dosage recommendations are the same as for other adults.


Neotigason Capsules 10mg, 25mg, SPC, 02-2020, HH, Notification
Paediatric population
In view of possible severe side-effects associated with long-term treatment, Neotigason is contra-indicated in children unless, in the opinion of the physician, the benefits significantly outweigh the risks.

Neotigason should be used only when all alternative therapies have proved inadequate.
The dosage should be established according to bodyweight. The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35mg/day. The maintenance dose should be kept as low as possible in view of possible long term side-effects.

Combination therapy
Other dermatological therapy, particularly with keratolytics, should normally be stopped before administration of Neotigason. However, the use of topical corticosteroids or bland emollient ointment may be continued if indicated.

When Neotigason is used in combination with other types of therapy, it may be possible, depending on the individual patient's response, to reduce the dosage of Neotigason.

Method of administration
Neotigason capsules are for oral administration.