Rivastigmine Transdermal System 9.5 mg/24h

Rivastigmine · PATCH, EXTENDED RELEASE · Breckenridge Pharmaceutical, Inc.

1 Recall on Record

Plain English

Rivastigmine Transdermal System is a patch, extended release containing rivastigmine at 9.5 mg/24h, taken transdermal. Manufactured by Breckenridge Pharmaceutical, Inc..

Key Facts

Brand Name: Rivastigmine Transdermal System
Generic Name: Rivastigmine
NDC Code (Product): 51991-898
Manufacturer: Breckenridge Pharmaceutical, Inc.
Strength: 9.5 mg/24h
Dosage Form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Marketing Status
Application #: ANDA209063
Drug Class: Cholinesterase Inhibitor [EPC]
Marketing Start: 12/19/2019

Recall History

1 Recall on Record

Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

hallucination837 reports

fall771 reports

death621 reports

confusional state554 reports

drug ineffective539 reports

parkinson^s disease386 reports

fatigue358 reports

gait disturbance354 reports

condition aggravated348 reports

off label use345 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Rivastigmine Transdermal System is an acetylcholinesterase inhibitor indicated for treatment of: Mild, moderate, and severe 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 Transdermal System is indicated for the treatment of dementia of the Alzheimer's type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. 1.2 Parkinson's Disease Dementia Rivastigmine Transdermal System is indicated for the treatment of mild-to-moderate dementia associated with Parkinson's disease (PDD).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. ( 2.1 , 2.4 ) Initial Dose : Initiate treatment with 4.6 mg/24 hours Rivastigmine Transdermal System. ( 2.1 ) Dose Titration ( 2.1 ) : After a minimum of 4 weeks, if tolerated, increase dose to 9.5 mg/24 hours, which is the minimum effective dose. Following a minimum additional 4 weeks, may increase dosage to maximum dosage of 13.3 mg/24 hours. Mild-to-Moderate Alzheimer's Disease and Parkinson's Disease Dementia : Rivastigmine Transdermal System 9.5 mg/24 hours or 13.3 mg/24 hours once daily. ( 2.1 ) Severe Alzheimer's Disease : Rivastigmine Transdermal System 13.3 mg/24 hours once daily. ( 2.1 ) For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours. ( 2.1 ) Consider dose adjustments in patients with ( 2.2 ): Mild-to-moderate hepatic impairment ( 8.6 ) Low (less than 50 kg) body weight ( 8.7 ) 2.1 Recommended Dosing Initial Dose Initiate treatment with one 4.6 mg/24 hours Rivastigmine Transdermal System applied to the skin once daily [see Dosage and Administration (2.4) ] . Dose Titration Increase the dose only after a mini…

Contraindications

4 CONTRAINDICATIONS Rivastigmine Transdermal System is contraindicated in patients with: known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description (11) ] . previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see Warnings and Precautions (5.3) ] . 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 reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis. ( 4 , 6.2 )

Drug Interactions

7 DRUG INTERACTIONS Concomitant use with metoclopramide, beta-blockers, or cholinomimetics and anticholinergic medications is not recommended. ( 7.1 , 7.2 , 7.3 ) 7.1 Metoclopramide Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and Rivastigmine Transdermal System is not recommended. 7.2 Cholinomimetic and Anticholinergic Medications Rivastigmine Transdermal System 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 Transdermal System with medications having these pharmacologic effects is not recommended unless deemed clinically necessary [see Warnings and Precautions (5.4) ] . 7.3 Beta-blockers Additive bradycardic effects resulting in syncope may occur when rivastigmine is used concomitantly with beta-blockers, especially cardioselective beta-blockers (including atenolol). Concomitant use is not recommended when signs of bradycardia including syncope are present.

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] . Skin Reactions [see Warnings and Precautions (5.3) ]. Other Adverse Reactions from Increased Cholinergic Activity [see Warnings and Precautions (5.4) ] . Most common adverse reactions (less than 5% and higher than with placebo): Nausea, vomiting, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 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 Transdermal System has been administered to 4516 patients with Alzheimer's disease during clinical trials worldwide. Of these, 3005 patients have been treated for at least 26 weeks, 1771 patients have been treated for at least 52 weeks, 974 patients have been treated for at least 78 weeks, and 2…

Frequently Asked Questions

What is Rivastigmine Transdermal System used for?

Rivastigmine Transdermal System contains Rivastigmine. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.

Is Rivastigmine Transdermal System a controlled substance?

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

What is the generic name for Rivastigmine Transdermal System?

The generic name for Rivastigmine Transdermal System is Rivastigmine. There are 11 other brand versions of Rivastigmine.

What is the NDC code for Rivastigmine Transdermal System 9.5 mg/24h?

The NDC (National Drug Code) for Rivastigmine Transdermal System 9.5 mg/24h is 51991-898, listed by Breckenridge Pharmaceutical, Inc..

Product NDC

51991-898

Package NDC

51991-898-30

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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