RVP

Drug Catalog - Product Detail

DONEPEZIL HCL TB 5MG 10X10 UD

NDC Mfr Size Str Form
63304-0128-77 SUN PHARMACEUTICALS 100 5MG TABLET
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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 a molecular formula of C 24 H 29 NO 3 HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is soluble in chloroform, sparingly soluble in water, methanol and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride (monohydrate), USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating contains hypromellose, ferric oxide yellow, polyethylene glycol, talc and titanium dioxide. Complies with USP Organic Impurities, Procedure 2. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Donepezil Hydrochloride Tablets, USP Donepezil hydrochloride tablets, USP, 5 mg are yellow colored, circular, biconvex, film-coated tablets debossed with ‘ RC25 ’ on one side and plain on the other side. They are supplied as follows: NDC 63304-128-20 Bottles of 20 NDC 63304-128-30 Bottles of 30 NDC 63304-128-90 Bottles of 90 NDC 63304-128-10 Bottles of 1000 NDC 63304-128-31 Blister pack of 30 NDC 63304-128-77 Blister pack of 100 Donepezil hydrochloride tablets, USP, 10 mg are yellow colored, circular, biconvex, film-coated tablets debossed with ‘ RC26 ’ on one side and plain on the other side. They are supplied as follows: NDC 63304-129-20 Bottles of 20 NDC 63304-129-30 Bottles of 30 NDC 63304-129-90 Bottles of 90 NDC 63304-129-10 Bottles of 1000 NDC 63304-129-31 Blister pack of 30 NDC 63304-129-77 Blister pack of 100 Storage : Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Donepezil 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. Donepezil 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 Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food. Mild to Moderate Alzheimer’s Disease - 5 mg or 10 mg administered once daily (2.1) Severe Alzheimer’s Disease - 10 mg administered once daily (2.2) A dose of 10 mg once daily can be administered once patients have been on a daily dose of 5 mg for 4 to 6 weeks. (2.3) 2.1 Mild to Moderate Alzheimer’s Disease The dosages of donepezil hydrochloride tablets shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day. The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride tablets might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference. 2.2 Severe Alzheimer’s Disease Donepezil hydrochloride tablets have been shown to be effective in controlled clinical trials at a dose of 10 mg administered once daily. 2.3 Titration The recommended starting dose of donepezil hydrochloride tablets is 5 mg once daily. Evidence from the controlled trials in mild to moderate Alzheimer’s disease indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events compared to the 5 mg dose. In open-label trials using a 6 week titration, the type and frequency of these same adverse events were similar between the 5 mg and 10 mg dose groups. Therefore, because donepezil hydrochloride tablets steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, 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.