País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
RIVASTIGMINE TARTRATE (UNII: 9IY2357JPE) (RIVASTIGMINE - UNII:PKI06M3IW0)
Sandoz Inc
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. Rivastigmine Tartrate Capsules are indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease. Rivastigmine tartrate is 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)] . Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Reproduction studies conducted in pregnant rats and rabbits at oral doses up to 2.3 mg-base/kg/day, or 2 (rat) and 4 (rabbit) times the maximum recommended hu
Rivastigmine Tartrate Capsules Rivastigmine Tartrate Capsules equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base are available as follows: 1.5 mg capsule – yellow, “SANDOZ 618” is printed in red on the body of the capsule. Bottles of 60 NDC 0781-2614-60 3 mg capsule – orange, “SANDOZ 619” is printed in red on the body of the capsule. Bottles of 60 NDC 0781-2615-60 4.5 mg capsule – red, “SANDOZ 620” is printed in white on the body of the capsule. Bottles of 60 NDC 0781-2616-60 6 mg capsule – orange and red, “SANDOZ 625” is printed in red on the body of the capsule. Bottles of 60 NDC 0781-2617-60 Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Store in a tight container.
New Drug Application Authorized Generic
RIVASTIGMINE TARTRATE- RIVASTIGMINE TARTRATE CAPSULE SANDOZ INC ---------- 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 RECENT MAJOR CHANGES Dosage and Administration, Dosing in Specific Populations (2.2) 10/2013 Contraindications (4) 10/2013 Warnings and Precautions, Hypersensitivity Reactions of the Skin (5.2) 10/2013 INDICATIONS AND USAGE Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of: Mild to moderate dementia of the Alzheimer’s type (1.1) Mild to moderate dementia associated with Parkinson’s disease (1.2) DOSAGE AND ADMINISTRATION Alzheimer’s Disease: Initiate treatment with 1.5 mg twice a day 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 (2.1) Parkinson’s Disease Dementia: Initiate treatment with 1.5 mg twice a day 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 (2.2) Rivastigmine tartrate should be taken with meals in divided doses in the morning and evening. (2.1) Rivastigmine tartrate oral solution and rivastigmine tartrate capsules may be interchanged at equal doses. (2.3) DOSAGE FORMS AND STRENGTHS Capsules: 1.5 mg, 3 mg, 4.5 mg, or 6 mg (3.1) 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, di Leia o documento completo