DONEPEZIL HYROCHLORIDE 5MG- donepezil hydrochloride tablet, film coated DONEPEZIL HYDROCHLORIDE 10MG- donepezil hydrochloride t

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Bi‐Coastal Pharma International LLC

INN (Tarptautinis Pavadinimas):

DONEPEZIL HYDROCHLORIDE

Sudėtis:

DONEPEZIL HYDROCHLORIDE 5 mg

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 is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Pregnancy Category C There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of 23 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning pro

Produkto santrauka:

Donepezil Hydrochloride Tablets USP, 5 mg are white, round, biconvex film coated tablets debossed with “” on one side and “14” on other side. They are supplied as follows: Bottles of 30             NDC 42582-311-30 Bottles of 90             NDC 42582-311-09 Bottles of 500           NDC 42582-311-18 Donepezil Hydrochloride Tablets USP, 10 mg are Pale yellow, round, biconvex film coated tablets debossed with “” on one side and “15” on other side. They are supplied as follows: Bottles of 30             NDC 42582-312-30 Bottles of 90             NDC 42582-312-09 Bottles of 500           NDC 42582-312-18 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DONEPEZIL HYROCHLORIDE 5MG- DONEPEZIL HYDROCHLORIDE TABLET, FILM
COATED
DONEPEZIL HYDROCHLORIDE 10MG- DONEPEZIL HYDROCHLORIDE TABLET, FILM
COATED
BI COASTAL PHARMA INTERNATIONAL LLC
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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 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)
Moderate to Severe Alzheimer’s Disease: 10 mg to 23 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
dise