Drug Catalog - Product Detail
DONEPEZIL HCL TB 23MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0302-30 | DR.REDDY'S LABORATORIES, INC. | 30 | 23MG | TABLET |
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Description
11 DESCRIPTION Donepezil hydrochloride monohydrate USP 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 monohydrate USP is commonly referred to in the pharmacological literature as E2020. It has an molecular formula of C 24 H 29 NO 3 HCl.H 2 O and a molecular weight of 433.95. Donepezil hydrochloride monohydrate USP is a off-white to white crystalline powder and is soluble in chloroform, water and in glacial aceticacid, slightly soluble in alcohol and acetonitrile, practically insoluble in ethyl acetate and n-Hexane. Donepezil hydrochloride tablets, USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride monohydrate USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and methacrylic acid copolymer. The film coating includes iron oxide red, iron oxide yellow and Opadry OY-58900 White contains hypromellose, polyethylene glycol and titanium dioxide.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Donepezil Hydrochloride Tablets Supplied as film-coated, round tablets containing 23 mg of donepezil hydrochloride, USP. Donepezil hydrochloride tablets USP, 23 mg are reddish colored, round, film coated tablet debossed with ‘R’ on one side and ‘23’ on the other side and are supplied in bottles of 30, 90, 500 and 1000. Bottles of 30 NDC 55111-302-30 Bottles of 90 NDC 55111-302-90 Bottles of 500 NDC 55111-302-05 Bottles of 1000 NDC 55111-302-10 Storage: Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Donepezil hydrochloride tablets 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. 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 once daily (2.1) Moderate to Severe Alzheimer’s Disease: 10 mg to 23 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. The maximum recommended dosage of donepezil hydrochloride tablets in patients with moderate to severe Alzheimer’s disease is 23 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. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months. 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. The Donepezil hydrochloride 23 mg tablet should not be split, crushed, or chewed.