RIVASTIGMINE TRANSDERMAL SYSTEM patch, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

RIVASTIGMINE (UNII: PKI06M3IW0) (RIVASTIGMINE - UNII:PKI06M3IW0)

可用日期:

Alvogen Inc.

INN（国际名称）:

RIVASTIGMINE

组成:

RIVASTIGMINE 4.6 mg

给药途径:

TRANSDERMAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Rivastigmine Transdermal System is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Rivastigmine Transdermal System is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD). Rivastigmine Transdermal System is contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description (11)] . - previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see Warnings and Precautions (5.3)] . Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions (6.2)] . Risk Summary   There are no adequate data on the developmental risks associated with the use of Rivastigmine Transdermal System in pregnant women. In animals, no adverse effects on embryo-

產品總結:

Rivastigmine Transdermal System: 4.6 mg/24 hours Each patch of 4.6 cm2 contains 6.9 mg rivastigmine with in-vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 47781-304-03 Rivastigmine Transdermal System: 9.5 mg/24 hours Each patch of 9.2 cm2 contains 13.8 mg rivastigmine with in-vivo release rate of 9.5 mg/24 hours. Carton of 30………………………NDC 47781-305-03 Rivastigmine Transdermal System: 13.3 mg/24 hours Each patch of 13.8 cm2 contains 20.7 mg rivastigmine with in-vivo release rate of 13.3 mg/24 hours. Carton of 30………………………NDC 47781-405-03 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep Rivastigmine Transdermal System in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely.

授权状态:

Abbreviated New Drug Application

产品特点

RIVASTIGMINE TRANSDERMAL SYSTEM- RIVASTIGMINE TRANSDERMAL
SYSTEM PATCH, EXTENDED RELEASE
ALVOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIVASTIGMINE
TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
RIVASTIGMINE TRANSDERMAL SYSTEM.
RIVASTIGMINE TRANSDERMAL SYSTEM
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Rivastigmine Transdermal System is an acetylcholinesterase inhibitor
indicated for treatment of:
Mild, moderate, and severe dementia of the Alzheimer’s type (AD).
(1.1)
Mild-to-moderate dementia associated with Parkinson’s disease (PD).
(1.2)
DOSAGE AND ADMINISTRATION
Apply patch on intact skin for a 24-hour period; replace with a new
patch every 24 hours. (2.1, 2.4)
Initial Dose: Initiate treatment with 4.6 mg/24 hours Rivastigmine
Transdermal System (2.1)
Dose Titration (2.1): After a minimum of 4 weeks, if tolerated,
increase dose to 9.5 mg/24 hours, which
is the minimum effective dose. Following a minimum additional 4 weeks,
may increase dosage to
maximum dosage of 13.3 mg/24 hours.
Mild-to-Moderate Alzheimer’s Disease and Parkinson’s Disease
Dementia:Rivastigmine Transdermal
System 9.5 mg/24 hours or 13.3 mg/24 hours once daily (2.1)
Severe Alzheimer’s Disease: Rivastigmine Transdermal System 13.3
mg/24 hours once daily. (2.1)
For treatment interruption longer than 3 days, retitrate dosage
starting at 4.6 mg per 24 hours. (2.1)
Consider dose adjustments in patients with (2.2):
Mild-to-moderate hepatic impairment (8.6)
Low (less than 50 kg) body weight (8.7)
DOSAGE FORMS AND STRENGTHS
Patch: 4.6 mg/24 hours or 9.5 mg/24 hours or 13.3 mg/24 hours (3)
CONTRAINDICATIONS
Known hypersensitivity to rivastigmine, other carbamate derivatives,
or other components of the
formulation. (4)
History of application site reactions with rivastigmine transdermal
patch suggestive of allergic contact
dermatitis. (4, 6.2)
WARNINGS AND PRECAUTIONS
Hospitalization and, rarely, death have been reported due