Amint-10 Dosage/Direction for Use

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Diagnosis should be made according to current guidelines. Memantine hydrochloride should be administered once a day and should be taken at the same time every day. It can be taken with or without food. If a patient misses a single dose of memantine hydrochloride, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride for several days, dosing may need to be resumed at lower doses and retitrated as described as follows.
Alzheimer's disease: The recommended starting dose of Memantine hydrochloride is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses) and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.
Children and adolescents under the age of 18 years: Memantine hydrochloride is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Elderly: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets once a day) as described previously.
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 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 dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Memantine hydrochloride is not recommended in patients with severe hepatic impairment.