Drug Catalog - Product Detail
DONEPEZIL HCL TB 10MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43547-0276-03 | SOLCO HEALTHCARE | 30 | 10MG | TABLET |
PACKAGE FILES
Generic Name
DONEPEZIL HYDROCHLORIDE
Substance Name
DONEPEZIL HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA200292
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]-1 H -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 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 Tablets, USP, are available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, hydroxypropyl cellulose, magnesium Stearate, microcrystalline cellulose, corn starch, Croscarmellose sodium. Additionally, the 5 mg tablets coating film contains hydroxypropyl methyl cellulose, titanium dioxide, polyethylene glycol, and FD&C blue. The 10 mg tablets coating film contains hydroxypropyl methyl cellulose, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Donepezil Hydrochloride Tablets Supplied as film-coated, round tablets containing 5 mg, or 10 mg of donepezil hydrochloride, USP. The 5 mg tablets are blue, round, film-coated tablets, debossed with ‘HH205' on one side. • Bottles of 30 (NDC# 43547-275-03) • Bottles of 90 (NDC# 43547-275-09) • Bottles of 1000 (NDC# 43547-275-11) The 10 mg tablets are light yellow, round, film-coated tablets, debossed with ‘HH210' on one side. • Bottles of 30 (NDC# 43547-276-03) • Bottles of 90 (NDC# 43547-276-09) • Bottles of 1000 (NDC# 43547-276-11) Storage Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).
Indications & Usage
1 INDICATIONS AND USAGE Donepezil hydrochloride is 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. Donepezil hydrochloride is 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 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Mild to Moderate Alzheimer's disease : 5 mg to 10 mg administered once daily ( 2.1 ) • Moderate to Severe Alzheimer’s Disease : 10 mg administered once daily ( 2.2) 2.1 Dosing in Mild to Moderate Alzheimer's Disease The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride 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 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 should be taken in the evening, just prior to retiring. Donepezil hydrochloride can be taken with or without food.