DONEPEZIL- donepezil hydrochloride tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Camber Pharmaceuticals, Inc.

INN (Միջազգային անվանումը):

DONEPEZIL HYDROCHLORIDE

Կազմը:

DONEPEZIL HYDROCHLORIDE 5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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.

Ապրանքի ամփոփագիր:

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].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

DONEPEZIL - DONEPEZIL HYDROCHLORIDE TABLET
CAMBER PHARMACEUTICALS, 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 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
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 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 studies of donepezil
hydrochloride are nausea, d