RIVASTIGMINE TARTRATE capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Aurobindo Pharma Limited

ИНН (Международная Имя):

RIVASTIGMINE TARTRATE

состав:

RIVASTIGMINE 1.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 tartrate in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2 to 4 t

Обзор продуктов:

Rivastigmine tartrate capsules, USP equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base are available as follows: Rivastigmine Tartrate Capsules USP, 1.5 mg are yellow cap and yellow body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘67’ on body, containing white to off-white granular powder.             Bottles of 60                                 NDC 65862-648-60             Bottles of 500                               NDC 65862-648-05             10 x 10 Unit-dose Capsules          NDC 65862-648-78 Rivastigmine Tartrate Capsules USP, 3 mg are orange cap and orange body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘68’ on body, containing white to off-white granular powder.              Bottles of 60                                 NDC 65862-649-60             Bottles of 500                               NDC 65862-649-05             10 x 10 Unit-dose Capsules          NDC 65862-649-78 Rivastigmine Tartrate Capsules USP, 4.5 mg are red cap and red body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘69’ on body, containing white to off-white granular powder.             Bottles of 60                                 NDC 65862-650-60             Bottles of 500                               NDC 65862-650-05             10 x 10 Unit-dose Capsules          NDC 65862-650-78 Rivastigmine Tartrate Capsules USP, 6 mg are red cap and orange body colored size ‘2’ capsules imprinted in black ink with ‘H’ on cap and ‘70’ on body, containing white to off-white granular powder.             Bottles of 60                                 NDC 65862-651-60             Bottles of 500                               NDC 65862-651-05             10 x 10 Unit-dose Capsules          NDC 65862-651-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a tight container.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

RIVASTIGMINE TARTRATE - RIVASTIGMINE TARTRATE CAPSULE
AUROBINDO PHARMA LIMITED
----------
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 capsules are 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 capsules should be taken with meals in divided
doses in the morning and evening
(2.1, 2.2). Rivastigmine tartrate oral solution and 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