DONEPEZIL HYDROCHLORIDE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Zydus Pharmaceuticals USA Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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 68382-521-06 in bottle of 30 tablets NDC 68382-521-16 in bottle of 90 tablets NDC 68382-521-01 in bottle of 100 tablets NDC 68382-521-05 in bottle of 500 tablets NDC 68382-521-10 in bottle of 1000 tablets NDC 68382-521-77  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.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
Zydus Pharmaceuticals USA Inc.
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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 p

Prekės savybės

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DONEPEZIL HYDROCHLORIDE TABLETS.
DONEPEZIL HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride tablets are 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
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 administered
once daily (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 23 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to donepezil hydrochloride or to piperidine
derivatives (4)
WARNINGS AND PRECAUTIONS
Cholinesterase inhibitors are likely to exaggerate
succinylcholine-type muscle relaxation during
anesthesia (5.1).
Cholinesterase inhibitors may have vagotonic effects on the sinoatrial
and atrioventricular nodes
manifesting as bradycardia or heart block (5.2).
Donepezil hydrochloride can cause vomiting. Patients should be
observed closely at initiation of
treatment and after dose increases (5.3).
Patients should be monitored closely for symptoms of active or occult
gastrointestinal (GI) bleeding,
especially those at increased risk for developing ulcers (5.4).
The use of donepezil hydrochloride in a dose of 23 mg once daily is
associated with weight loss (5.5).
Cholinomimetics may cause bladder outflow obstructions (5.6).
Cholinomimetics are believed to have some potential to cause
generalized convulsions (5.7).
Cholinesterase inhibitors should be prescribed with care to patients
with a history of asthma or
obstructive pulmonary disease (5.8).
ADVERSE REACTIONS
Most common adverse reactions in clinical studie