Drugplain

Exelon 9.5 mg/24h

rivastigmine · PATCH, EXTENDED RELEASE · Sandoz Inc

No Recall History
Plain English

Exelon is a patch, extended release containing rivastigmine at 9.5 mg/24h, taken transdermal. Manufactured by Sandoz Inc.

Key Facts

Brand Name
Exelon
Generic Name
rivastigmine
NDC Code (Product)
66758-143
Manufacturer
Sandoz Inc
Strength
9.5 mg/24h
Dosage Form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Marketing Status
Application #
NDA022083
Drug Class
Cholinesterase Inhibitor [EPC]
Marketing Start
07/06/2007

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE EXELON PATCH 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 EXELON PATCH 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 EXELON PATCH 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 EXELON PATCH. ( 2.1 ) • Dose Titration: 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. ( 2.1 ) • Mild-to-Moderate Alzheimer’s Disease and Parkinson’s Disease Dementia: EXELON PATCH 9.5 mg/24 hours or 13.3 mg/24 hours once daily. ( 2.1 ) • Severe Alzheimer’s Disease: EXELON PATCH 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 ): o Mild-to-moderate hepatic impairment ( 8.6 ) o Low (less than 50 kg) body weight ( 8.7 ) 2.1 Recommended Dosing Initial Dose Initiate treatment with one 4.6 mg/24 hours EXELON PATCH applied to the skin once daily [see Dosage and Administration (2.4)] . Dose Titration Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous d…

Contraindications

4 CONTRAINDICATIONS EXELON PATCH 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 EXELON PATCH is not recommended. 7.2 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 [see Warnings and Precautions ( 5.5 )] . 7.3 Beta-Blockers Additive bradycardic effects resulting in syncope may occur when EXELON 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 clinically significant 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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 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. EXELON PATCH 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, …

Frequently Asked Questions

What is Exelon used for?

Exelon contains rivastigmine. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.

Is Exelon a controlled substance?

Exelon is not classified as a controlled substance by the DEA.

What is the generic name for Exelon?

The generic name for Exelon is rivastigmine. There are 11 other brand versions of rivastigmine.

What is the NDC code for Exelon 9.5 mg/24h?

The NDC (National Drug Code) for Exelon 9.5 mg/24h is 66758-143, listed by Sandoz Inc.

Product NDC

66758-143

Package NDC

66758-143-31

Other Exelon Dosages

Other Rivastigmine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)