Drugplain

Rivastigmine Tartrate 6 mg/1

Rivastigmine Tartrate · CAPSULE · Sun Pharmaceutical Industries, Inc.

2 Recalls on Record
Plain English

Rivastigmine Tartrate is a capsule containing rivastigmine tartrate at 6 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
Rivastigmine Tartrate
Generic Name
Rivastigmine Tartrate
NDC Code (Product)
62756-148
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
6 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA077131
Marketing Start
07/01/2010

Recall History

2 Recalls on Record
Class III03/06/2017

Dr. Reddy's Laboratories, Inc.

Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

TerminatedVoluntary: Firm initiated
Class II08/03/2015

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug interaction52 reports
fall51 reports
anticholinergic syndrome42 reports
confusional state40 reports
death39 reports
drug ineffective30 reports
hallucination30 reports
nausea30 reports
vomiting25 reports
diarrhoea24 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 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) 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 & Administration

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). Rivastigmine tartrate oral solution and Rivastigmine tartrate capsules may be interchanged at equal doses (2.5) 2.1 Dosing in Alzheimer's Disease Rivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening. The recommended dosage of rivastigmine tartrate capsules in Alzheimer’s disease (AD) is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials tha…

Contraindications

4 CONTRAINDICATIONS 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)]. 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)

Drug 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)]. 7.3 Beta-blockers Additive bradycardic effects resulting in syncope may occur when rivastigmine tartrate is used concomitantly with beta-blockers, especially cardioselective beta-blockers (including atenolol). Concomitant use of rivastigmine tartrate with beta-blockers is not recommended.

Adverse Reactions

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 Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Rivastigmine tartrate has been administered to over 5,297 individuals during clinical trials worldwide. Of these, 4,326 patients have been treated for at least 3 months, 3,407 patients have been treated for at least 6 months, 2,150 patients have been treated for 1 year, 1,250 patien…

Frequently Asked Questions

What is Rivastigmine Tartrate used for?

Rivastigmine Tartrate contains Rivastigmine Tartrate. It is a capsule taken oral. Consult your doctor for specific uses.

Is Rivastigmine Tartrate a controlled substance?

Rivastigmine Tartrate is not classified as a controlled substance by the DEA.

What is the generic name for Rivastigmine Tartrate?

The generic name for Rivastigmine Tartrate is Rivastigmine Tartrate. There are 2 other brand versions of Rivastigmine Tartrate.

What is the NDC code for Rivastigmine Tartrate 6 mg/1?

The NDC (National Drug Code) for Rivastigmine Tartrate 6 mg/1 is 62756-148, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

62756-148

Package NDC

62756-148-13

Other Rivastigmine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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