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Label Changes for:

Exelon Patch (rivastigmine) transdermal system

February 2015

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

February 2015

WARNINGS AND PRECAUTIONS

Skin Reactions
  • Skin application site reactions may occur with Exelon Patch. These reactions are not in themselves an indication of sensitization. However, use of rivastigmine patch may lead to allergic contact dermatitis
  • There have been isolated postmarketing reports of patients experiencing disseminated allergic dermatitis when administered rivastigmine irrespective of the route of administration (oral or transdermal).

ADVERSE REACTIONS

Postmarketing Experience
  • disseminated allergic dermatitis, and tremor

DRUG INTERACTIONS

Metoclopramide
  • Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and Exelon Patch is not recommended.
Cholinomimetic and Anticholinergic Medications
  • Exelon Patch 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 Exelon PATCH with medications having these pharmacologic effects is not recommended unless deemed clinically necessary.
Beta-blockers
  • Additive bradycardic effects resulting in syncope may occur when Exelon is used concomitantly with betablockers, especially cardioselective beta-blockers (including atenolol). Concomitant use is not recommended when signs of bradycardia including syncope are present.

 

June 2013

CONTRAINDICATIONS

  • previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis.
 
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