Drug Catalog - Product Detail
DONEPEZIL TAB 5MG TORR 1000
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13668-0102-10 | TORRENT PHARMACEUTICALS | 1000 | 5MG | TABLET |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24 H 29 NO 3 HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, magnesium stearate, maize starch ( Zea mays ) and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains ferric oxide red and ferric oxide yellow as coloring agents. str
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Donepezil Hydrochloride Tablets Donepezil hydrochloride tablets, USP 5 mg are white to off white, circular, biconvex, film coated tablets debossed with ‘5’ on one side and plain on other side. Bottles of 30 NDC 13668-102-30 Bottles of 90 NDC 13668-102-90 Bottles of 500 NDC 13668-102-05 Bottles of 1000 NDC 13668-102-10 Bottles of 4000 NDC 13668-102-40 100 Unit Dose Tablets NDC 13668-102-74 Donepezil hydrochloride tablets, USP 10 mg are peach colored, circular, biconvex, film coated tablets debossed with ‘10’ on one side and plain on other side. Bottles of 30 NDC 13668-103-30 Bottles of 90 NDC 13668-103-90 Bottles of 500 NDC 13668-103-05 Bottles of 1000 NDC 13668-103-10 Bottles of 2650 NDC 13668-103-26 100 Unit Dose Tablets NDC 13668-103-74 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Donepezil hydrochloride tablets, USP are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1) Donepezil hydrochloride tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Mild to Moderate Alzheimer's Disease: 5 mg to 10 mg once daily (2.1) Moderate to Severe Alzheimer's Disease: 10 mg once daily (2.2) 2.1 Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with mild to moderate Alzheimer's disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. 2.2 Dosing in Moderate to Severe Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablets is 5 mg administered once per day in the evening, just prior to retiring. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. 2.3 Administration Information Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food.