Osaka, Japan – March 27, 2019 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change applications by the Ministry of Health, Labour and Welfare (MHLW) for DONEPEZIL HYDROCHLORIDE Tablets 3 mg, 5 mg and 10 mg [SAWAI], DONEPEZIL HYDROCHLORIDE OD Tablets 3 mg, 5 mg and 10 mg [SAWAI], and DONEPEZIL HYDROCHLORIDE Fine Granules 0.5 % [SAWAI]*.
This approval expands the indication of DONEPEZIL HYDROCHLORIDE products to include the same uses as their brand equivalents.
* Brand products: Aricept® Tablets 3 mg, 5 mg and 10mg, Aricept® D Tablets 3 mg, 5mg and 10 mg, Aricept® Fine Granules 0.5 %
“Indications and Usage” and “Dosage and Administration” approvals are described below (New approval is underlined);
Indications and Usage
- Suppression of progression of dementia symptoms in dementia of the Alzheimer's type
- Suppression of progression of dementia symptoms in dementia with Lewy bodies
Dosage and Administration
- Suppression of progression of dementia symptoms in dementia of the Alzheimer's type
- The usual initial adult dose for oral use is 3 mg of donepezil hydrochloride once daily. After 1 to 2 weeks the dose is increased to 5 mg. The dosage for patients with severe dementia of the Alzheimer's type is increased to 10 mg after dosing at 5 mg for 4 or more weeks. The dose can be reduced appropriately according to patients' symptoms.
- Suppression of progression of dementia symptoms in dementia with Lewy bodies
- The usual initial adult dose for oral use is 3 mg of donepezil hydrochloride once daily. After 1 to 2 weeks the dose is increased to 5 mg. The dose is increased to 10 mg after dosing at 5 mg for 4 or more weeks. The dose can be reduced to 5 mg according to patients' symptoms.
The products announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.