리바스티그민타르타르산염

Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: Mild, moderate, and severe dementia of the Alzheimer's type (AD) ( 1.1 ) Mild-to-moderate dementia associated with Parkinson's disease (PD) ( 1.2 ) 1.1 Alzheimer’s Disease Rivastigmine transdermal system is indicated for the treatment of dementia of the Alzheimer's type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. 1.2 Parkinson’s Disease Dementia Rivastigmine transdermal system is indicated for the treatment of mild-to-moderate dementia associated with Parkinson's disease (PDD).

Known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation. ( 4 ) History of application-site reactions with rivastigmine transdermal system suggestive of allergic contact dermatitis. ( 4 , 6.2 ) Rivastigmine transdermal system is contraindicated in patients with: known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description ( 11 )] . previous history of application-site reactions with rivastigmine transdermal system suggestive of allergic contact dermatitis [see Warnings and Precautions ( 5.3 )] . Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions ( 6.2 )] .

Hospitalization and, rarely, death have been reported due to application of multiple transdermal systems at same time. Ensure patients or caregivers receive instruction on proper dosing and administration. ( 5.1 ) 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. ( 5.2 ) Application-site reactions may occur with the transdermal system form of rivastigmine. Discontinue treatment if application-site reactions spread beyond the transdermal system size, if there is evidence of a more intense local reaction (e.g., increasing erythema, edema, papules, vesicles), and if symptoms do not significantly improve within 48 hours after transdermal system removal. ( 5.3 ) 5.1 Medication Errors Resulting in Overdose Medication errors with rivastigmine transdermal system have resulted in serious adverse reactions; some cases have required hospitalization, and rarely, led to death. The majority of medication errors have involved not removing the old transdermal system when putting on a new one and the use of multiple transdermal systems at one time. Instruct patients and their caregivers on important administration instructions for rivastigmine transdermal system [see Dosage and Administration ( 2.4 )] . 5.2 Gastrointestinal Adverse Reactions Rivastigmine …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of rivastigmine in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2-4 times the maximum recommended human dose (MRHD) (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data Oral administration of rivastigmine to pregnant rats and rabbits throughout organogenesis produced no adverse effects …