RIVASTIGMINE TARTRATE

Rivastigmine shows linear pharmacokinetics up to 3 mg twice a day but is nonlinear at higher doses. Doubling the dose from 3 mg to 6 mg twice a day results in a 3-fold increase in area under the curve (AUC). The elimination half-life is about 1.5 hours, with most elimination as metabolites via the urine.

AbsorptionRivastigmine is rapidly and completely absorbed. Peak plasma concentrations are reached in approximately 1 hour. Absolute bioavailability after a 3-mg dose is about 36%. Administratio...

Mild-to-Moderate Alzheimer’s Disease The effectiveness of rivastigmine tartrate as a treatment for Alzheimer's disease is demonstrated by the results of 2 randomized, double-blind, placebo-controlled clinical investigations ( Study 1 and Study 2 ) in patients with Alzheimer's disease [diagnosed by NINCDS-ADRDA and DSM-IV criteria, Mini-Mental State Examination (MMSE) greater than or equal to 10 and less than or equal to 26, and the Global Deterioration Scale (GDS)]. The mean age of patients participating in rivastigmine tartrate trials was 73 years with a range of 41 to 95. Approximately 59% o...

The following adverse reactions are described below and elsewhere in the labeling: · Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1)] · Allergic Dermatitis [see Warnings and Precautions (5.2)] · Other Adverse Reactions from Increased Cholinergic Activity [see Warnings and Precautions (5.3)] Most common adverse reactions (greater than 5% and 2 times greater than placebo): nausea, vomiting, anorexia, dyspepsia, and asthenia (6.1) To report SUSPECTED ADVERSE REACTIONS, contac...

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 (...

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. (5.1) Discontinue rivastigmine in case of disseminated allergic dermatitis, which may occur after oral or transdermal administration (4, 5.2). In patients with suspected allergic contact dermatitis after transdermal riv...

7 DRUG INTERACTIONS Concomitant use with metoclopramide, beta-blockers, or cholinomimetic and anticholinergic drugs is not recommended (7.1, 7.2, 7.3) 7.1 Metoclopramide Due to the risk of additive extrapyramidal adverse reactions, the concomitant use of metoclopramide and rivastigmine tartrate is not recommended. 7.2 Cholinomimetic and Anticholinergic Medications Rivastigmine tartrate may increas...