DONEPEZIL HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)

可用日期:

Zydus Lifesciences Limited

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data ]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks

產品總結:

Donepezil Hydrochloride Tablets, 23 mg are red-brown, beveled edge, round, film-coated tablets debossed with "521" on one side and plain on the other side and are supplied as follows: NDC 70771-1320-3 in bottle of 30 tablets NDC 70771-1320-9 in bottle of 90 tablets NDC 70771-1320-1 in bottle of 100 tablets NDC 70771-1320-5 in bottle of 500 tablets NDC 70771-1320-0 in bottle of 1000 tablets NDC 70771-1320-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage   Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

授权状态:

Abbreviated New Drug Application

资料单张

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
Cadila Healthcare Limited
----------
PATIENT PACKAGE INSERT
Donepezil Hydrochloride
(doe-NEP-e-zil HYE-droe-KLOR-ide)
Tablets
Read this Patient Information that comes with donepezil hydrochloride
tablets before you start taking it and
each time you get a refill. There may be new information. This leaflet
does not take the place of talking with
your doctor about Alzheimer's disease or treatment for it. If you have
questions, ask the doctor or pharmacist.
What is donepezil hydrochloride?
Donepezil hydrochloride comes as donepezil hydrochloride film-coated
tablets in dosage strength of 5 mg,
10 mg, and 23 mg.
Donepezil hydrochloride is a prescription medicine to treat mild,
moderate and severe Alzheimer's disease.
Donepezil hydrochloride can help with mental function and with doing
daily tasks. Donepezil hydrochloride
does not work the same in all people. Some people may:
•
Seem much better
•
Get better in small ways or stay the same
•
Get worse over time but slower than expected
•
Not change and then get worse as expected
Donepezil hydrochloride does not cure Alzheimer's disease. All
patients with Alzheimer's disease get worse
over time, even if they take donepezil hydrochloride.
Donepezil hydrochloride has not been approved as a treatment for any
medical condition in children.
Who should not take donepezil hydrochloride?
Do not take donepezil hydrochloride if you are allergic to any of the
ingredients in donepezil hydrochloride
or to medicines that contain piperidines. Ask your doctor if you are
not sure. See the end of this leaflet for a
list of ingredients in donepezil hydrochloride.
What should I tell my doctor before taking donepezil hydrochloride?
Tell the doctor about all of your present or past health problems and
conditions.
Include:
•
Any heart problems including problems with irregular, slow, or fast
heartbeats
•
Asthma or lung problems
•
A seizure
•
Stomach ulcers
•
Difficulty passing urine
•
Liver or kidney problem

产品特点

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
DONEPEZIL HYDROCHLORIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1320-1 in bottle of 100 tablets
Donepezil Hydrochloride Tablets, 23 mg
R only
100 tablets
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1320
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL -
UNII:8SSC91326P)
DONEPEZ IL
HYDROCHLORIDE
23 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
STARCH, CORN (UNII: O8232NY3SJ)
x
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PRODUCT CHARACTERISTICS
COLOR
RED (red-brown)
SCORE
no score
SHAPE
ROUND (round)
SIZE
8mm
FLAVOR
IMPRINT CODE
521
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1320-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
03/07/2018
2
NDC:70771-
1320-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
03/07/2018
3
NDC:70771-
1320-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
03/07/2018
4
NDC:70771-
1320-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
03/07/2018
5
NDC:70771-
1320-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
03/07/2018
6
NDC:70771-
1320-4
10 in 1 CARTON
03/07/2018
6
NDC:70771-
1320-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA203162
03/07/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIO