RIVASTIGMINE TARTRATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

RIVASTIGMINE TARTRATE

Composition:

RIVASTIGMINE 1.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral dose

Product summary:

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 – Hard gelatin capsules with orange opaque cap and body printed with WATSON over 3208 on both cap and body in black ink. Capsules are supplied in bottles of 60 (NDC 0591-3208-60). 3 mg -    Hard gelatin capsules with yellow opaque cap and body printed with WATSON over 3209 on both cap and body in black ink. Capsules are supplied in bottles of 60 (NDC 0591-3209-60). 4.5 mg - Hard gelatin capsules with light brown opaque cap and body printed with WATSON over 3210 on both cap and body in black ink. Capsules are supplied in bottles of 60 (NDC 0591-3210-60). 6 mg -    Hard gelatin capsules with light brown opaque cap and orange opaque body printed with WATSON over 3211 on both cap and body in black ink.Capsules are supplied in bottles of 60 (NDC 0591-3211-60). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].  Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE
ACTAVIS PHARMA, INC.
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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 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)
DOSAGE FORMS AND STRENGTHS
Capsules: 1.5 mg, 3 mg, 4.5 mg, or 6 mg (3)
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 outcomes.