País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
RIVASTIGMINE TARTRATE (UNII: 9IY2357JPE) (RIVASTIGMINE - UNII:PKI06M3IW0)
Avera McKennan Hospital
RIVASTIGMINE TARTRATE
RIVASTIGMINE 3 mg
PRESCRIPTION DRUG
New Drug Application
EXELON- RIVASTIGMINE TARTRATE CAPSULE AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EXELON SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXELON. EXELON (RIVASTIGMINE TARTRATE) CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE EXELON 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 (PDD) (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 (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. EXELON should be taken with meals in divided doses in the morning and evening. (2.1, 2.2). EXELON Oral Solution and EXELON Capsules may be interchanged at equal doses (2.5) DOSAGE FORMS AND STRENGTHS Capsules: 1.5 mg, 3 mg, 4.5 mg, or 6 mg (3.1) Oral solution: 2 mg/mL (3.2) 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 ou Llegiu el document complet