Drug Catalog - Product Detail
DONZEPEZIL TABS 5MG 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 31722-0737-30 | CAMBER PHARMACEUTICALS | 30 | 5MG | TABLET |
PACKAGE FILES
Generic Name
DONEPEZIL HYDROCHLORIDE
Substance Name
DONEPEZIL HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203034
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]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP 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 to off white crystalline powder and is soluble in water, methanol and chloroform and sparingly soluble in acetic acid. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. Meets Organic Impurities Test Procedure 2 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 ‘I’ on one side and ‘24’ on the other side. They are supplied as follows Bottles of 30 NDC 31722-737-30 Bottles of 90 NDC 31722-737-90 Bottles of 100 NDC 31722-737-01 Bottles of 500 NDC 31722-737-05 Unit Dose Blister Package 100 (10x10) NDC 31722-737-31 Donepezil hydrochloride tablets, USP 10 mg are yellow round biconvex, film coated tablets debossed with ‘I’ on one side and ‘21’ on the other side. They are supplied as follows Bottles of 30 NDC 31722-738-30 Bottles of 90 NDC 31722-738-90 Bottles of 100 NDC 31722-738-01 Bottles of 500 NDC 31722-738-05 Unit Dose Blister Package 100 (10x10) NDC 31722-738-31 Storage Store at 20° to 25°C (68° 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 tablet, 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 ) 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 tablet is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablet 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 Severe Alzheimer's Disease The recommended starting dosage of donepezil hydrochloride tablet 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 tablet should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablet can be taken with or without food.