RIVASTIGMINE TRANSDERMAL SYSTEM- rivastigmine patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-fetal d

Product summary:

Rivastigmine Transdermal System: 13.3 mg/24 hours Each patch of 15 cm² contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30 - NDC: 63629-2064-1 Single Patch - NDC: 62629-2064-2 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. CLOSE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIVASTIGMINE TRANSDERMAL SYSTEM- RIVASTIGMINE PATCH, EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
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 to
application of m