Posology : מינונים

4.2     Posology and method of administration

Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.

Posology

FIRDAPSE should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day. No single dose should exceed 20 mg.

Tablets are to be taken with food. Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.


If treatment is discontinued, patients may experience some of the symptoms of LEMS.
Renal or hepatic impairment

FIRDAPSE should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function. For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days. If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established. No data are available.

Method of administration

For oral use only.