Denigma

Denigma Dosage/Direction for Use

memantine

Manufacturer:

Kusum

Distributor:

JDS
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.
Adults: Dose titration: 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 5 mg (1/2 tablet) per day for 7 days.
Week 2 (day 8-14): The patient should take 10 mg (1 tablet) per day for 7 days.
Week 3 (day 15-21): The patient should take 15 mg (1 and 1/2 tablet) per day for 7 days.
Week 4 (day 22-28): The patient should take 20 mg (2 tablets) per day for 7 days.
The maximum daily dose is 20 mg 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 previously described.
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. 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 Denigma is not recommended in patients with severe hepatic impairment.
Paediatric population: No data are available.
Method of administration: Denigma should be administered once a day and should be taken at the same time every day. These tablets can be taken with or without food.
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