Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
RIVASTIGMINE TARTRATE (UNII: 9IY2357JPE) (RIVASTIGMINE - UNII:PKI06M3IW0)
McKesson Corporation dba SKY Packaging
RIVASTIGMINE TARTRATE
RIVASTIGMINE 1.5 mg
ORAL
PRESCRIPTION DRUG
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)]
Product: 63739-576 NDC: 63739-576-10 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-577 NDC: 63739-577-10 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-578 NDC: 63739-578-10 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE Product: 63739-579 NDC: 63739-579-10 10 CAPSULE in a BLISTER PACK / 10 in a BOX, UNIT-DOSE
Abbreviated New Drug Application
RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE MCKESSON CORPORATION DBA SKY PACKAGING ---------- 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 associ Прочитать полный документ