Rivastigmine Tartrate
Generic Name: rivastigmine tartrate
Brand Names:
Rivastigmine Tartrate
11 DESCRIPTION Rivastigmine tartrate USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has a molecular formula of C 14 H 22 N 2 O 2 • C 4 H 6 O 6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt).
Overview
11 DESCRIPTION Rivastigmine tartrate USP is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has a molecular formula of C 14 H 22 N 2 O 2 • C 4 H 6 O 6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt).
Uses
1 INDICATIONS AND USAGE Rivastigmine tartrate capsule 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 (PD) (1.2) 1.1 Alzheimer’s Disease Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD). 1.2 Parkinson’s Disease Dementia Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PD).
Dosage
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 capsule should be taken with meals in divided doses in the morning and evening (2.1 , 2.2) .
Side Effects
6 ADVERSE REACTIONS 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, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
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 increase the cholinergic effects of other cholinomimetic medications and may also interfere with the activity of anticholinergic medications (e.g., oxybutynin, tolterodine). Concomitant use of rivastigmine tartrate with medications having these pharmacologic effects is not recommended unless deemed clinically necessary [see Warnings and Precautions (5.3) ].
Warnings
5 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 rivastigmine use, switch to oral rivastigmine only after negative allergy testing. 4 CONTRAINDICATIONS 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 Pr...
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2 to 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% to 4% and 15% to 20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Rivastigmine tartrate capsules USP, equivalent to 1.5 mg of rivastigmine base are available as follows: Rivastigmine tartrate capsules USP, 1.5 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with light tan opaque color cap and light tan opaque color body, imprinted ‘RDY” on cap and ‘352’ on body with black ink and are supplied in: Uni...
Frequently Asked Questions
What is Rivastigmine Tartrate used for?▼
1 INDICATIONS AND USAGE Rivastigmine tartrate capsule 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 (PD) (1.2) 1.1 Alzheimer’s Disease Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD). 1.2 Parkinson’s Disease Dementia Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PD).
What are the side effects of Rivastigmine Tartrate?▼
6 ADVERSE REACTIONS 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, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Rivastigmine Tartrate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of rivastigmine tartrate in pregnant women. In animals, no adverse effects on embryo-fetal development were observed at oral doses 2 to 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% to 4% and 15% to 20%, respectively.
What are the important warnings for Rivastigmine Tartrate?▼
5 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 rivastigmine use, switch to oral rivastigmine only after negative allergy testing. 4 CONTRAINDICATIONS 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 Pr...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.