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:

Cadila Pharmaceuticals Limited

ИНН (Международная Имя):

RIVASTIGMINE TARTRATE

состав:

RIVASTIGMINE 1.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Rivastigmine tartrate capsules, USP are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD). Rivastigmine tartrate capsules, USP 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 obs

Обзор продуктов:

Rivastigmine tartrate capsules Rivastigmine tartrate capsules, USP equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base are available as follows: 1.5 mg capsule - white to off white powder filled in size "2" hard gelatin capsules with yellow opaque color cap and yellow opaque color body imprinted "C 91".  Bottles of 60                                       NDC 71209-012-03  Bottles of 500                                     NDC 71209-012-10 3 mg capsule - white to off white powder filled in size "2" hard gelatin capsules with orange opaque color cap and orange opaque color body imprinted "C 92". Bottles of 60                                        NDC 71209-013-03 Bottles of 500                                      NDC 71209-013-10 4.5 mg capsule - white to off white powder filled in size "2" hard gelatin capsules with red opaque color cap and red opaque color body imprinted "C 93". Bottles of 60                                        NDC 71209-014-03 Bottles of 500                                      NDC 71209-014-10 6 mg capsule - white to off white powder filled in size "2" hard gelatin capsules with red opaque color cap and orange opaque color body imprinted "C 94". Bottles of 60                                       NDC 71209-015-03 Bottles of 500                                     NDC 71209-015-10 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tight container.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

RIVASTIGMINE TARTRATE - RIVASTIGMINE TARTRATE CAPSULE
CADILA PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIVASTIGMINE TARTRATE
CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR RIVASTIGMINE
TARTRATE CAPSULES USP.
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 (2.1)
Parkinson's Disease Dementia (PDD) (2.2):
• Initiate treatment with 1.5 mg twice a day
• 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 (2.2)
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. (2.5)
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 necessi