Drug Catalog - Product Detail
DONEPEZIL HCL 5MG TB 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42582-0311-30 | BI COASTAL PHARMACEUTICAL | 30 | 5MG | TABLET |
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Description
11 DESCRIPTION Donepezil hydrochloride, USP 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, USP 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, corn starch, microcrystalline cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. chemical structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Donepezil Hydrochloride Tablets, USP Donepezil Hydrochloride Tablets USP, 5 mg are white, round, biconvex film coated tablets debossed with “ ” on one side and “14” on other side. They are supplied as follows: Bottles of 30 NDC 42582-311-30 Bottles of 90 NDC 42582-311-09 Bottles of 500 NDC 42582-311-18 Donepezil Hydrochloride Tablets USP, 10 mg are Pale yellow, round, biconvex film coated tablets debossed with “ ” on one side and “15” on other side. They are supplied as follows: Bottles of 30 NDC 42582-312-30 Bottles of 90 NDC 42582-312-09 Bottles of 500 NDC 42582-312-18 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. image-3 image-4
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 tablets 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
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 tablets 23 mg should not be split, crushed, or chewed.