Ebixa Oral Drops

/ Lundbeck

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.

Moderate-severe Alzheimer’s disease.

Hypersensitivity.

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.

Diarrhea, insomnia, dizziness, headache, hallucination.
See prescribing information for full details.

L-dopa, domaminergic agonists, anticholinergics, barbituates, neuroleptics. Dantrolene, baclofen, amantadine, ketamine, dethromethorphan, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide.

Pregnancy: Should not be used during pregnancy unless clearly necessary. Lactation: Women should not breast-feed.