DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Zydus Pharmaceuticals USA Inc.

INN (Medzinárodný Name):

DONEPEZIL HYDROCHLORIDE

Zloženie:

DONEPEZIL HYDROCHLORIDE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Donepezil hydrochloride orally disintegrating 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 orally disintegrating 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%

Prehľad produktov:

Donepezil Hydrochloride Orally disintegrating Tablets USP, 5 mg are white to off-white, round-shaped, biconvex, uncoated tablets engraved with 'ZF 14'on one side and plain on other side and are supplied as follows: NDC 68382-346-06 in bottle of 30 tablets NDC 68382-346-16 in bottle of 90 tablets NDC 68382-346-01 in bottle of 100 tablets NDC 68382-346-05 in bottle of 500 tablets NDC 68382-346-10 in bottle of 1000 tablets NDC 68382-346-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, uncoated tablets engraved with 'ZF 15'on one side and plain on other side and are supplied as follows: NDC 68382-347-06 in bottle of 30 tablets NDC 68382-347-16 in bottle of 90 tablets NDC 68382-347-01 in bottle of 100 tablets NDC 68382-347-05 in bottle of 500 tablets NDC 68382-347-10 in bottle of 1000 tablets NDC 68382-347-77 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.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, ORALLY
DISINTEGRATING
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL
HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR DONEPEZIL HYDROCHLORIDE ORALLY
DISINTEGRATING TABLETS.
DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride orally disintegrating 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 once daily (2.2)
DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets (ODT): 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)
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 stu