Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
---|---|---|---|
Film Coated Tablets 28 X 20 mg |
|
21040 | 5512 |
Related information
Dosage
Adults:
Dose titration: The maximum daily dose is 20 mg per day. 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. For up-titration other tablet strengths are available.
Week 1 (day 1-7):The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day for 7 days.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
From Week 4 on: The patient should take one 20 mg film-coated tablet per 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 as described above.
Renal impairment: In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dose adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 – 49 ml/min) daily dose should be 10 mg per day. 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 per day.
Hepatic impairment: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose 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 administered orally once a day and should be taken at the same time every day. The film-coated tablets can be taken with or without food.
See prescribing information for full details.
Indications
Moderate-severe to severe Alzheimer’s disease.
Contra-Indications
Hypersensitivity.
Special Precautions
Severe renal impairment, epilepsy, recent myocardial infarction, uncompensated congestive heart failure, uncontrolled hypertension.
Pregnancy and lactation: Should not be used during pregnancy unless clearly necessary. Women should not breast-feed.
Side Effects
Diarrhea, insomnia, dizziness, headache, hallucination.
See prescribing information for full details.
Drug interactions
L-dopa, domaminergic agonists, anticholinergics, barbituates, neuroleptics. Dantrolene, baclofen, amantadine, ketamine, dethromethorphan, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide.
Pregnancy and Lactation
Pregnancy: Should not be used during pregnancy unless clearly necessary. Lactation: Women should not breast-feed.