DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Macleods Pharmaceuticals Limited

INN (আন্তর্জাতিক নাম):

DONEPEZIL HYDROCHLORIDE

রচনা:

DONEPEZIL HYDROCHLORIDE 5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Donepezil hydrochloride orally disintegrating tablets, USP 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. Pregnancy Category C There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride orally disintegrating tablets 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

পণ্য সারাংশ:

Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP. ·          The 5 mg orally disintegrating tablets USP are yellow coloured, circular, flat face beveled edge uncoated tablets debossed with “CL 31” on one side and plain on the other side. Unit Dose Blister Package 30 (10x3)     NDC 33342-029-06 Unit Dose Blister Package 100 (10x10) NDC 33342-029-12 Unit Dose Blister Package 28 (4x7)       NDC 33342-029-60 Container Pack of 30's                            NDC 33342-029-07 ·         The 10 mg orally disintegrating tablets USP are yellow coloured, circular, flat face beveled edge uncoated tablets debossed with “CL 32” on one side and plain on the other side. Unit Dose Blister Package 30 (10x3)     NDC 33342-030-06 Unit Dose Blister Package 100 (10x10) NDC 33342-030-12 Unit Dose Blister Package 28 (4x7)       NDC 33342-030-60 Container Pack of 30's                            NDC 33342-030-07 Storage Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, ORALLY
DISINTEGRATING
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE ORALLY
DISINTEGRATING TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DONEPEZIL HYDROCHLORIDE
ORALLY DISINTEGRATING TABLETS USP.
DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, USP
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
Donepezil hydrochloride orally disintegrating tablets, USP 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 orally disintegrating tablets 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 o