RIVASTIGMINE TARTRATE- rivastigmine tartrate capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Sandoz Inc

INN (Tên quốc tế):

RIVASTIGMINE TARTRATE

Thành phần:

RIVASTIGMINE 1.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Rivastigmine Tartrate Capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Rivastigmine Tartrate Capsules are indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease. Rivastigmine tartrate is 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)] . Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Reproduction studies conducted in pregnant rats and rabbits at oral doses up to 2.3 mg-base/kg/day, or 2 (rat) and 4 (rabbit) times the maximum recommended hu

Tóm tắt sản phẩm:

Rivastigmine Tartrate Capsules   Rivastigmine Tartrate Capsules equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base are available as follows: 1.5 mg capsule – yellow, “SANDOZ 618” is printed in red on the body of the capsule.       Bottles of 60                                     NDC 0781-2614-60 3 mg capsule – orange, “SANDOZ 619” is printed in red on the body of the capsule.       Bottles of 60                                     NDC 0781-2615-60 4.5 mg capsule – red, “SANDOZ 620” is printed in white on the body of the capsule.       Bottles of 60                                     NDC 0781-2616-60 6 mg capsule – orange and red, “SANDOZ 625” is printed in red on the body of the capsule.       Bottles of 60                                     NDC 0781-2617-60 Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Store in a tight container.

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE
SANDOZ INC
----------
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
RECENT MAJOR CHANGES
Dosage and Administration, Dosing in Specific Populations (2.2)
10/2013
Contraindications (4) 10/2013
Warnings and Precautions, Hypersensitivity Reactions of the Skin (5.2)
10/2013
INDICATIONS AND USAGE
Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated
for treatment of:
Mild to moderate dementia of the Alzheimer’s type (1.1)
Mild to moderate dementia associated with Parkinson’s disease (1.2)
DOSAGE AND ADMINISTRATION
Alzheimer’s Disease:
Initiate treatment with 1.5 mg twice a day
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:
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 should be taken with meals in divided doses in
the morning and evening. (2.1) Rivastigmine tartrate
oral solution and rivastigmine tartrate capsules may be interchanged
at equal doses. (2.3)
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, di