Mentra 10

Mentra 10 Dosage/Direction for Use

memantine

Manufacturer:

Cadila Healthcare

Distributor:

Metro Drug

Marketer:

Zydus Healthcare Phils
Full Prescribing Info
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. 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.
Memantine tablets should be administered once a day and should be taken at the same time every day.
Adults: Dose titration.
Treatment Initiation Pack: The recommended starting dose is 5 mg per day, which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows: Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day (pale yellow to yellow, oval shaped) for 7 days.
Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Week 4 (day 22-28): The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong) for 7 days.
The maximum daily dose is 20 mg per day.
Tablet packs of 10 mg and 20 mg and Pump pack of 5 mg/pump actuation: The maximum daily dose is 20 mg 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 half a 10 mg film-coated tablet/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 one 10 mg film-coated tablet/1 mL solution per day (10 mg) equivalent to two pump actuations, per day for 7 days.
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets/1.5 mL solution per day (15 mg) equivalent to three pump actuations, per day for 7 days.
From Week 4 on: The patient should take one 20 mg film-coated tablet/two 10 mg film-coated tablets/2 mL solution per day (20 mg) equivalent to four pump actuations, 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 (one 20 mg film-coated tablet/two 10 mg film-coated tablets/2 mL solution, equivalent to four pump actuations) as described previously.
Children and adolescents under the age of 18 years: Memantine is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
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 actuations) 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 is not recommended in patients with severe hepatic impairment.
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