RIVASTIGMINE TARTRATE- rivastigmine tartrate capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

rivastigmine tartrate (UNII: 9IY2357JPE) (rivastigmine - UNII:PKI06M3IW0)

Διαθέσιμο από:

Dr. Reddy's Laboratories Limited

INN (Διεθνής Όνομα):

rivastigmine tartrate

Σύνθεση:

rivastigmine 1.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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) ]. 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 times the

Περίληψη προϊόντος:

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 white to off-white powder filled in size ‘2’ hard gelatin capsules with light tan opaque color cap and light tan opaque color body, imprinted ‘RDY” on cap and ‘352’ on body with black ink and are supplied in bottles of 30, 60, 100 and 500.  Bottles of 30 NDC 55111-352-30 Bottles of 60 NDC 55111-352-60 Bottles of 100 NDC 55111-352-01 Bottles of 500 NDC 55111-352-05  Rivastigmine tartrate capsules USP, 3 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with brown opaque color cap and brown opaque color body, imprinted ‘RDY’ on cap and ‘353’ on body with black ink and are supplied in bottles of 30, 60, 100 and 500. Bottles of 30 NDC 55111-353-30 Bottles of 60 NDC 55111-353-60 Bottles of 100 NDC 55111-353-01 Bottles of 500 NDC 55111-353-05 Rivastigmine tartrate capsules USP, 4.5 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with swedish orange opaque color cap and swedish orange opaque color body, imprinted 'RDY' on cap and '354' on body with black ink and are supplied in bottles of 30, 60, 100 and 500.  Bottles of 30 NDC 55111-354-30 Bottles of 60 NDC 55111-354-60 Bottles of 100 NDC 55111-354-01 Bottles of 500 NDC 55111-354-05  Rivastigmine tartrate capsules USP, 6 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with swedish orange opaque color cap and brown opaque color body, imprinted ‘RDY’ on cap and ‘355’ on body with black ink and are supplied in bottles of 30, 60, 100 and 500.  Bottles of 30 NDC 55111-355-30 Bottles of 60 NDC 55111-355-60 Bottles of 100 NDC 55111-355-01 Bottles of 500 NDC 55111-355-05  Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE
DR. REDDY'S LABORATORIES 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 capsule 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 capsule should be taken with meals in divided
doses in the morning and evening (2.1, 2.2).
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 diarrhea
and can be associated with serious