RIVASTIGMINE TARTRATE- rivastigmine tartrate capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

RIVASTIGMINE TARTRATE (UNII: 9IY2357JPE) (RIVASTIGMINE - UNII:PKI06M3IW0)

Доступна з:

Apotex Corp.

ІПН (Міжнародна Ім'я):

RIVASTIGMINE TARTRATE

Склад:

RIVASTIGMINE 1.5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type (AD). Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease (PD). Rivastigmine tartrate capsules are contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation [see Description (11)] - a previous history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing [see Warnings and Precautions (5.2)] 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 in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times the maximu

Огляд продуктів:

Rivastigmine tartrate capsules Rivastigmine tartrate capsules, USP 1.5 mg are hard gelatin capsules with yellow opaque body and yellow opaque cap, imprinted “APO R1.5” in black ink with white to off-white fill. They are supplied as follows: Bottles of 30 (NDC 60505-3220-3) Bottles of 60 (NDC 60505-3220-6) Bottles of 100 (NDC 60505-3220-1) Bottles of 500 (NDC 60505-3220-5) Bottles of 1,000 (NDC 60505-3220-8) Rivastigmine tartrate capsules, USP 3 mg are hard gelatin capsules with orange opaque body and orange opaque cap, imprinted “APO R3” in black ink with white to off-white fill. They are supplied as follows: Bottles of 30 (NDC 60505-3221-3) Bottles of 60 (NDC 60505-3221-6) Bottles of 100 (NDC 60505-3221-1) Bottles of 500 (NDC 60505-3221-5) Bottles of 1,000 (NDC 60505-3221-8) Rivastigmine tartrate capsules, USP 4.5 mg are hard gelatin capsules with red opaque body and red opaque cap, imprinted “APO R4.5” in black ink with white to off-white fill. They are supplied as follows: Bottles of 30 (NDC 60505-3222-3) Bottles of 60 (NDC 60505-3222-6) Bottles of 100 (NDC 60505-3222-1) Bottles of 500 (NDC 60505-3222-5) Bottles of 1,000 (NDC 60505-3222-8) Rivastigmine tartrate capsules, USP 6 mg are hard gelatin capsules with orange opaque body and red opaque cap, imprinted “APO R6” in black ink with white to off-white fill. They are supplied as follows: Bottles of 30 (NDC 60505-3223-3) Bottles of 60 (NDC60505-3223-6) Bottles of 100 (NDC 60505-3223-1) Bottles of 500 (NDC 60505-3223-5) Bottles of 1,000 (NDC 60505-3223-8) Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a tight container.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIVASTIGMINE TARTRATE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RIVASTIGMINE TARTRATE CAPSULES.
RIVASTIGMINE TARTRATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated
for treatment of:
Mild to moderate dementia of the Alzheimer’s type (AD) (1.1)
Mild to moderate dementia associated with Parkinson’s disease (PD)
(1.2)
DOSAGE AND ADMINISTRATION
Alzheimer’s Disease (2.1):
Initial Dose: Initiate treatment with 1.5 mg twice a day.
Dose Titration: After a minimum of 2 weeks, if tolerated, increase
dose to 3 mg twice a day and further to 4.5 mg twice a
day and 6 mg twice a day if tolerated with a minimum of 2 weeks at
each dose
Parkinson’s Disease Dementia (PDD) (2.2):
Initial Dose: Initiate treatment with 1.5 mg twice a day.
Dose Titration: After a minimum of 4 weeks, if tolerated, increase
dose to 3 mg twice a day and further to 4.5 mg twice a
day and 6 mg twice a day if tolerated with a minimum of 4 weeks at
each dose.
Rivastigmine tartrate should be taken with meals in divided doses in
the morning and evening. (2.1, 2.2). Rivastigmine
tartrate capsules may be interchanged at equal doses (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 1.5 mg, 3 mg, 4.5 mg, or 6 mg (3.1)
CONTRAINDICATIONS
Known hypersensitivity to rivastigmine, other carbamate derivatives or
other components of the formulation. (4)
History of application site reaction with rivastigmine transdermal
patch suggestive of allergic contact dermatitis, in the
absence of negative allergy testing. (4, 5.2)
WARNINGS AND PRECAUTIONS
Gastrointestinal adverse reactions may include significant nausea,
vomiting, diarrhea, anorexia/decreased appetite, and
weight loss, and may necessitate treatment interruption. Dehydration
may result from prolonged vomiting or diarrhe