Posology : מינונים

4.2     Posology and method of administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia.

Posology

Therapy should only be started if a caregiver is available who will regularly monitor drug intake by the patient.
Diagnosis should be made according to current guidelines. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.

Adults:
Dose Titration
The maximum daily dose is 20 mg once daily. In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows: 
Week 1 (day 1-7):
The patient should take 0.5 ml solution (5 mg), equivalent to one pump actuation per day for 7 days.

Week 2 (day 8-14):
The patient should take 1 ml solution (10 mg), equivalent to two pump actuation , per day for 7 days.
Week 3 (day 15-21):
The patient should take 1.5 ml solution (15 mg), equivalent to three pump actuation per day for 7 days.
From Week 4 on:
The patient should take 2 ml solution (20 mg), equivalent to four pump actuation once a day.

Maintenance dose
The recommended maintenance dose is 20 mg per day.

Elderly: On the basis of the clinical studies the recommended dose for patients over the age of 65 years is 20 mg per day (2 ml solution, equivalent to four pump actuation ) as described above.

Renal impairment: In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dosage adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuation ) per day.

Hepatic impairment: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Ebixa is not recommended in patients with severe hepatic impairment.

Paediatric population
No data are available

Method of administration
Ebixa should be taken orally once daily at the same time each day. The solution can be taken with or without food.
The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump.

For detailed instructions on the preparation and handling of the product see section 6.6.