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Rivastigmine: Drug information

Rivastigmine: Drug information
(For additional information see "Rivastigmine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Exelon
Brand Names: Canada
  • APO-Rivastigmine;
  • Exelon;
  • JAMP Rivastigmine;
  • MED-Rivastigmine;
  • MYLAN-Rivastigmine;
  • Rivastigmine Patch 10;
  • Rivastigmine Patch 15;
  • Rivastigmine Patch 5;
  • SANDOZ Rivastigmine
Pharmacologic Category
  • Acetylcholinesterase Inhibitor (Central)
Dosing: Adult
Alzheimer disease, mild to moderate

Alzheimer disease, mild to moderate:

Oral: Initial: 1.5 mg twice daily; may increase by 3 mg daily (1.5 mg/dose) every 2 weeks based on tolerability (maximum recommended dose: 6 mg twice daily).

Low body weight: Careful titration and monitoring should be performed in patients with low body weight. In patients <50 kg, monitor closely for toxicities (eg, excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.

Note: If GI adverse events occur, discontinue treatment for several doses then restart at the same or next lower dosage level; antiemetics have been used to control GI symptoms. If dosing is interrupted for ≤3 days, restart the treatment at the same or lower dose and titrate as previously described. If interrupted for >3 days, reinitiate at 1.5 mg twice daily and titrate as previously described.

Transdermal patch: Initial: 4.6 mg per 24 hours patch applied once daily; after a minimum of 4 weeks, increase as tolerated to 9.5 mg per 24 hours; continue as long as therapeutically beneficial. After a minimum of 4 weeks, may increase as tolerated to a maximum dose of 13.3 mg per 24 hours. Doses >13.3 mg per 24 hours have not been shown to be more effective and are associated with significant increases in adverse events. Recommended effective dose: 9.5 mg per 24 hours or 13.3 mg per 24 hours patch applied once daily; remove old patch and replace with a new patch every 24 hours.

Low body weight: Careful titration and monitoring should be performed in patients with low body weight. In patients <50 kg, monitor closely for toxicities (eg, excessive nausea, vomiting) and consider reducing the maintenance dose to 4.6 mg/24 hour if such toxicities develop.

Note: If dosing is interrupted for ≤3 days, restart treatment with the same or a lower strength patch. If interrupted for >3 days, reinitiate at 4.6 mg/24 hours and titrate (no sooner than every 4 weeks) to lowest effective maintenance dose.

Conversion from oral therapy: If oral daily dose <6 mg, switch to 4.6 mg/24 hours patch; if oral daily dose 6 to 12 mg, switch to 9.5 mg/24 hours patch. Apply patch on the day following last oral dose.

Alzheimer disease, severe

Alzheimer disease, severe: Transdermal patch: Initial: Apply 4.6 mg per 24 hours patch once daily. Increase as tolerated every 4 weeks to a maximum of 13.3 mg per 24 hours. Recommended effective dose: 13.3 mg per 24 hours patch applied once daily; remove old patch and replace with a new patch every 24 hours.

Low body weight: Careful titration and monitoring should be performed in patients with low body weight. In patients <50 kg, monitor closely for toxicities (eg, excessive nausea, vomiting) and consider reducing the maintenance dose to 4.6 mg/24 hours if such toxicities develop.

Note: If dosing is interrupted for ≤3 days, restart treatment with the same or a lower strength patch. If interrupted for >3 days, reinitiate at 4.6 mg/24 hour and titrate (no sooner than every 4 weeks) to lowest effective maintenance dose.

Dementia with Lewy bodies

Dementia with Lewy bodies (off-label use): Oral: Initial: 1.5 mg twice daily; may increase by 3 mg daily (1.5 mg per dose) every 2 weeks based on tolerability up to a maximum of 6 mg twice daily (Ref).

Parkinson disease dementia, mild to moderate

Parkinson disease dementia, mild to moderate:

Oral: Initial: 1.5 mg twice daily; may increase by 3 mg daily (1.5 mg per dose) every 4 weeks based on tolerability (maximum recommended dose: 6 mg twice daily).

Low body weight: Careful titration and monitoring should be performed in patients with low body weight. In patients <50 kg, monitor closely for toxicities (eg, excessive nausea, vomiting) and consider reducing the dose if such toxicities develop.

Note: If GI adverse events occur, discontinue treatment for several doses then restart at the same or next lower dosage level; antiemetics have been used to control GI symptoms. If dosing is interrupted for ≤3 days, restart the treatment at the same or lower dose and titrate as previously described. If interrupted for >3 days, reinitiate at 1.5 mg twice daily and titrate as previously described.

Transdermal patch: Initial: 4.6 mg per 24 hours patch applied once daily; after a minimum of 4 weeks, increase as tolerated to 9.5 mg per 24 hours; continue as long as therapeutically beneficial. After a minimum of 4 weeks, may increase as tolerated to a maximum dose of 13.3 mg per 24 hours. Doses >13.3 mg per 24 hours have not been shown to be more effective and are associated with significant increases in adverse events. Recommended effective dose: 9.5 mg per 24 hours or 13.3 mg per 24 hours patch applied once daily; remove old patch and replace with a new patch every 24 hours.

Low body weight: Careful titration and monitoring should be performed in patients with low body weight. In patients <50 kg, monitor closely for toxicities (eg, excessive nausea, vomiting) and consider reducing the maintenance dose to 4.6 mg/24 hour if such toxicities develop.

Note: If dosing is interrupted for ≤3 days, restart treatment with the same or a lower strength patch. If interrupted for >3 days, reinitiate at 4.6 mg/24 hours and titrate (no sooner than every 4 weeks) to lowest effective maintenance dose.

Vascular dementia, comorbid

Vascular dementia, comorbid (off-label use): Note: For use in patients with suspected comorbid Alzheimer disease, Parkinson disease dementia, or dementia with Lewy bodies (Ref).

Oral: Initial: 1.5 mg twice daily for 4 weeks; may increase dose based on response and tolerability in increments of 3 mg/day (1.5 mg/dose) every 4 weeks up to a maximum of 6 mg twice daily (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Oral: Moderate to severe impairment (CrCl ≤50 mL/minute): There are no dosage adjustments provided in the manufacturer's labeling; patients may only be able to tolerate lower doses. Alternatively, an initial dose of 1.5 mg once daily with slow and cautious titration has been recommended (Ref).

Transdermal: No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Oral:

Mild to moderate impairment (Child-Pugh class A and B): There are no dosage adjustments provided in the manufacturer's labeling; clearance is reduced and patients may require lower doses. Alternatively, an initial dose of 1.5 mg once daily with slow and cautious titration has been recommended (Ref).

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Transdermal:

Mild to moderate impairment (Child-Pugh class A and B): Initial and maximum dose: 4.6 mg/24 hours

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing. Following oral administration, clearance is reduced in patients >60 years of age, but dosage adjustments are not required. Age was not associated with increased exposure in patients treated transdermally.

Adverse Reactions (Significant): Considerations
Cardiac effects

Acetylcholinesterase inhibitors, including rivastigmine, have been associated with cardiac effects, such as conduction abnormalities (eg, bradycardia, atrioventricular block, arrhythmias) and hypertension. Syncope has also been reported (Ref).

Mechanism: Related to the mechanism of action; increased cholinergic activity results in vagotonic effects (Ref).

Onset: Delayed; reported months to years after initiation (Ref).

Risk factors:

• Older adults (Ref)

• History of cardiovascular disease (eg, ischemic heart disease, heart failure) (Ref)

• History of cardiac conduction abnormalities or sick sinus syndrome (Ref)

• History of stroke or transient ischemic attack, diabetes, or syncope (Ref)

• Concurrent antihypertensives (especially beta-blockers), antiarrhythmics, antidepressants, and antipsychotics (Ref)

Dermatologic reactions

Application-site irritation is the most common cutaneous reaction associated with transdermal rivastigmine (Ref). In addition, allergic contact dermatitis may occur following oral and transdermal administration (Ref). Other cutaneous reactions that have been described include angioedema (Ref), skin rash (symmetric drug-related intertriginous and flexural exanthema [SDRIFE]) (Ref) and erythematous maculopapular rash (Ref).

Mechanism: Non–dose-related; immunologic. Delayed hypersensitivity reactions, including rashes (eg, maculopapular) and allergic contact dermatitis are T-cell-mediated (Ref); may be triggered by rivastigmine and/or excipients within the patch (Ref). Sensitization may occur from repeated application in the same area. Transdermal rivastigmine contains polyisobutylene, which is a known contact sensitizer and has been associated with allergic contact dermatitis from stoma bags (Ref). Application-site irritation is caused by direct toxic effect on epidermal keratinocytes, which trigger the innate immune system (Ref). A positive patch test, positive rechallenge with oral drug, and response to desensitization also suggest a possible immunological mechanism (Ref).

Onset: Delayed hypersensitivity reactions: Varied; most reactions occurred within 5 to 15 days (Ref). Application-site irritation may occur within 12 hours of application (Ref).

Risk factors:

• Cross-reactivity between acetylcholinesterase inhibitors is unknown. A potential cross-reaction between transdermal rivastigmine and oral galantamine has been described (Ref).

• Older adults are at an increased risk of irritant contact dermatitis, but not allergic contact dermatitis, due to thinner and more fragile skin (Ref)

• History of eczema may increase risk of irritant contact dermatitis (Ref)

GI effects and weight loss

Dose-related GI effects are the most common adverse reactions associated with rivastigmine. Symptoms may include nausea, vomiting, diarrhea, and abdominal pain (Ref). A systematic review of studies reported more GI effects with oral rivastigmine compared to donepezil (Ref). In another study, oral rivastigmine had the highest rate of GI effects compared to both donepezil and galantamine (Ref). GI effects typically occur with dose titration and are transient and self-limiting; however, dehydration, weight loss, decreased appetite, and/or anorexia may also occur (Ref).

Mechanism: Dose-related; related to mechanism of action. Increased cholinergic activity increases smooth muscle contraction, peristalsis, and sphincter relaxation in the GI tract, leading to GI effects (Ref).

Onset: GI effects: Rapid during dose titration; one study reported GI effects within the first 1 or 2 doses following dose titration (Ref). Weight loss/anorexia: Varied; may occur from the beginning of treatment to any time within the first year of therapy. More research is needed in this area, especially beyond 1 year (Ref).

Risk factors:

• Higher doses

• Rapid dose titration

• Oral versus transdermal formulation (Ref)

• Lack of retitration following prolonged (>3 days) treatment interruption

• Females

• Patients weighing <50 kg

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Gastrointestinal: Abdominal pain (1% to 13%; transdermal: 2%) (table 1), anorexia (≤17%) (table 2), diarrhea (oral: 5% to 19%; transdermal: ≤7%) (table 3), nausea (oral: 23% to 47%; transdermal: 2% to 10%) (table 4), vomiting (oral: 17% to 31%; transdermal: 2% to 9%) (table 5)

Rivastigmine: Adverse Reaction: Abdominal Pain

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

13%

6%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

2%

1%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

1%

1%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

Rivastigmine: Adverse Reaction: Anorexia

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

Comments

17%

3%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

N/A

9%

2%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

Described as "anorexia/decreased appetite"

6%

3%

3 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

362

179

N/A

3%

2%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

Described as "anorexia/decreased appetite"

Rivastigmine: Adverse Reaction: Diarrhea

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

19%

11%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

7%

4%

3 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

362

179

6%

3%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

5%

3%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

5%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

280

N/A

4%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

283

N/A

2%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

241

N/A

<1%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

246

N/A

7%

N/A

13.3 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

355

N/A

5%

N/A

4.6 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

359

N/A

Rivastigmine: Adverse Reaction: Nausea

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

47%

12%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

29%

11%

3 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

362

179

23%

5%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

10%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

280

N/A

7%

5%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

4%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

283

N/A

4%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

241

N/A

2%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

246

N/A

6%

N/A

13.3 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

355

N/A

3%

N/A

4.6 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

359

N/A

Rivastigmine: Adverse Reaction: Vomiting

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

31%

6%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

17%

3%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

17%

2%

3 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

362

179

9%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

280

N/A

6%

3%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

3%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

283

N/A

3%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

241

N/A

2%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

246

N/A

7%

N/A

13.3 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

355

N/A

3%

N/A

4.6 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

359

N/A

Local: Application-site erythema (transdermal: 1% to 13%)

Nervous system: Agitation (transdermal: 1% to 14%), dizziness (oral: 6% to 21%; transdermal: ≤3%), headache (oral: 4% to 17%; transdermal: ≤4%)

1% to 10%:

Cardiovascular: Bradycardia (oral: ≥1%), hypertension (1% to 3%) (table 6), syncope (oral: 3%) (table 7)

Rivastigmine: Adverse Reaction: Hypertension

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

3%

2%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

3%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

280

N/A

2%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

283

N/A

1%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

241

N/A

1%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

246

N/A

Rivastigmine: Adverse Reaction: Syncope

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

3%

2%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

Dermatologic: Diaphoresis (oral: 2% to 4%)

Endocrine & metabolic: Dehydration (2%) (table 8), weight loss (1% to 7%) (table 9)

Rivastigmine: Adverse Reaction: Dehydration

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

2%

1%

3 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

362

179

Rivastigmine: Adverse Reaction: Weight Loss

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

5%

1%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

5%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

241

N/A

3%

<1%

6 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

1,189

868

3%

1%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

3%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

280

N/A

2%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

246

N/A

1%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

283

N/A

7%

N/A

13.3 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

355

N/A

3%

N/A

4.6 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

359

N/A

Gastrointestinal: Decreased appetite (≤9%) (table 10), dyspepsia (oral: 9%), sialorrhea (oral: 1%), upper abdominal pain (≤4%)

Rivastigmine: Adverse Reaction: Decreased Appetite

Drug (Rivastigmine)

Placebo

Dose

Dosage Form

Indication

Number of Patients (Rivastigmine)

Number of Patients (Placebo)

Comments

9%

2%

6 mg twice daily

Oral capsules

Mild-to-moderate Alzheimer disease

294

302

Described as "anorexia/decreased appetite"

8%

5%

3 to 12 mg/day

Oral capsules

Mild-to-moderate Alzheimer disease

362

179

N/A

5%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

280

N/A

N/A

3%

2%

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

291

302

Described as "anorexia/decreased appetite"

2%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

283

N/A

N/A

2%

N/A

13.3 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

241

N/A

N/A

<1%

N/A

9.5 mg per 24 hours

Transdermal patch

Mild-to-moderate Alzheimer disease

246

N/A

N/A

5%

N/A

13.3 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

355

N/A

N/A

1%

N/A

4.6 mg per 24 hours

Transdermal patch

Severe Alzheimer disease

359

N/A

N/A

Genitourinary: Urinary incontinence (transdermal: ≤2%), urinary tract infection (2% to 10%)

Local: Application-site irritation (severe; transdermal: ≤2%), application-site pruritus (transdermal: ≤4%)

Nervous system: Aggressive behavior (1% to 3%), anxiety (1% to 5%), asthenia (2% to 6%), cogwheel rigidity (oral: 1%), confusion (oral: 8%), depression (2% to 6%), drowsiness (oral: 4% to 5%), falling (3% to 8%), fatigue (2% to 9%), hallucination (2% to 5%), insomnia (1% to 9%), malaise (oral: 5%), parkinsonism (oral: 2%), psychomotor agitation (transdermal: 1% to 3%), restlessness (oral: 3%), tremor (oral: 4% to 10%)

Neuromuscular & skeletal: Bradykinesia (oral: 3%), hypokinesia (oral: 1%)

<1%:

Cardiovascular: Atrial fibrillation, atrioventricular block

Nervous system: Dystonia (Diaz 2015)

Postmarketing:

Cardiovascular: Tachycardia

Dermatologic: Allergic dermatitis (including disseminated allergic dermatitis) (Grieco 2011), erythematous maculopapular rash (Makris 2010), skin blister, skin rash (symmetric drug-related intertriginous and flexural exanthema [SDRIFE]) (Allain-Veyrac 2011), Stevens-Johnson syndrome, urticaria

Gastrointestinal: Severe vomiting (with esophageal rupture; following inappropriate reinitiation of dose)

Hepatic: Hepatitis (Mumoli 2009)

Hypersensitivity: Angioedema (Naharci 2018)

Local: Application-site reaction (hypersensitivity reaction)

Nervous system: Nightmares, seizure (Kumlien 2010)

Contraindications

Hypersensitivity to rivastigmine, other carbamate derivatives, or any component of the formulation; history of application-site reactions with rivastigmine patch

Canadian labeling: Additional contraindications (not in US labeling): Severe hepatic impairment; history of severe skin reactions (eg, allergic dermatitis [disseminated], Stevens-Johnson syndrome) with oral or transdermal rivastigmine; history of QT prolongation and/or torsades de pointes, including congenital long QT syndromes; history of cardiac arrhythmias.

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Extrapyramidal effects: May exacerbate or induce extrapyramidal symptoms; worsening of symptoms (eg, tremor) in patients with Parkinson disease has been observed.

Disease-related concerns:

• Peptic ulcer disease: Use with caution in patients at risk of ulcer disease (eg, previous history or NSAID use); may increase gastric acid secretion. Monitor for symptoms of active or occult bleeding.

• Respiratory disease: Use with caution in patients with COPD and/or asthma.

• Seizure disorder: Use with caution in patients with a history of seizure disorder.

• Urinary tract obstruction: Use with caution in patients with bladder outlet obstruction; cholinomimetics may cause or worsen outflow obstructions.

Dosage form specific issues:

• Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI.

Other warnings/precautions:

• Appropriate use: Postmarketing cases of overdose (including rare fatalities) have been reported in association with medication errors/improper use of rivastigmine transdermal patches. No more than 1 patch should be applied daily and existing patch must be removed prior to applying new patch.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 1.5 mg, 3 mg, 4.5 mg, 6 mg

Patch 24 Hour, Transdermal:

Exelon: 4.6 mg/24 hr (1 ea, 30 ea); 9.5 mg/24 hr (1 ea, 30 ea); 13.3 mg/24 hr (1 ea, 30 ea)

Generic: 4.6 mg/24 hr (1 ea, 30 ea); 9.5 mg/24 hr (1 ea, 30 ea); 13.3 mg/24 hr (1 ea, 30 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Rivastigmine Tartrate Oral)

1.5 mg (per each): $0.70 - $4.66

3 mg (per each): $0.70 - $4.66

4.5 mg (per each): $0.70 - $4.66

6 mg (per each): $0.70 - $4.66

Patch, 24-hour (Exelon Transdermal)

4.6 mg/24 hrs (per each): $27.43

9.5 mg/24 hrs (per each): $27.43

13.3 mg/24 hrs (per each): $27.43

Patch, 24-hour (Rivastigmine Transdermal)

4.6 mg/24 hrs (per each): $16.20 - $16.90

9.5 mg/24 hrs (per each): $16.20 - $16.90

13.3 mg/24 hrs (per each): $16.20 - $16.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Exelon: 1.5 mg, 3 mg, 4.5 mg, 6 mg

Generic: 1.5 mg, 3 mg, 4.5 mg, 6 mg

Patch 24 Hour, Transdermal:

Exelon: 4.6 mg/24 hr (30 ea); 9.5 mg/24 hr (30 ea); 13.3 mg/24 hr (30 ea)

Rivastigmine Patch 5: 4.6 mg/24 hr (30 ea)

Rivastigmine Patch 10: 9.5 mg/24 hr (30 ea)

Rivastigmine Patch 15: 13.3 mg/24 hr (30 ea)

Generic: 4.6 mg/24 hr (30 ea); 9.5 mg/24 hr (30 ea)

Solution, Oral:

Exelon: 2 mg/mL (120 mL) [contains sodium benzoate]

Administration: Adult

Oral: Administer with meals (breakfast and dinner). Oral solution [Canadian product], which is available for patients who cannot swallow capsules, can be swallowed directly from syringe or mixed with water, soda, or cold fruit juice. Stir well and drink immediately.

Topical: Apply transdermal patch to upper or lower back (alternatively, may apply to upper arm or chest). Do not use patch if the pouch seal is broken or if the patch is cut, altered, or damaged. Avoid reapplication to same spot of skin for 14 days (eg, may rotate sections of back). Apply to clean, dry, and hairless skin. Patch should be pressed down firmly by applying pressure with the hand over the entire patch for at least 30 seconds, making sure edges stick well. Do not apply to red, irritated, or broken skin. Avoid areas of recent application of lotion or powder. After removal, fold patch to press adhesive surfaces together, place in previously saved pouch, and discard. Avoid eye contact; wash hands after handling patch. Remove old patch and replace with a new patch every 24 hours (at the same time each day). If a dose is missed or if the patch falls off, apply a new patch immediately and replace the following day at the usual application time. Do not use overlays, bandages, or tape to secure a patch that has become loose. Avoid exposing the patch to external sources of heat (eg, sauna, excessive light) for prolonged periods of time. No more than 1 patch should be applied daily and existing patch must be removed prior to applying new patch. Discard any used or unused patches by folding adhesive sides together and dispose of in trash away from children and pets.

Use: Labeled Indications

Alzheimer disease:

Oral: Treatment of mild to moderate dementia of the Alzheimer type.

Transdermal: Treatment of mild, moderate, and severe dementia of the Alzheimer type.

Parkinson disease dementia: Treatment of mild to moderate dementia associated with Parkinson disease.

Use: Off-Label: Adult

Dementia with Lewy bodies; Vascular dementia, comorbid

Medication Safety Issues
Sound-alike/look-alike issues:

Exelon may be confused with Exelan (manufacturer)

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Amifampridine: Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Amifampridine. Amifampridine side effects may also be increased. Amifampridine may enhance the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase inhibitor side effects may also be increased. Risk C: Monitor therapy

Anticholinergic Agents: May diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

Antipsychotic Agents: Rivastigmine may enhance the neurotoxic (central) effect of Antipsychotic Agents. Risk C: Monitor therapy

Benoxinate: Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Benoxinate. Specifically, the effects of benoxinate may be prolonged. Risk C: Monitor therapy

Beta-Blockers: Rivastigmine may enhance the bradycardic effect of Beta-Blockers. Risk X: Avoid combination

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Bromopride: Rivastigmine may enhance the adverse/toxic effect of Bromopride. Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Risk X: Avoid combination

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

Cholinergic Agonists: May enhance the adverse/toxic effect of Rivastigmine. Specifically, cholinergic effects may be enhanced or increased. Rivastigmine may enhance the adverse/toxic effect of Cholinergic Agonists. Management: Use of rivastigmine with a cholinergic agonist is not recommended unless clinically necessary. If the combination is necessary, monitor for increased cholinergic effects. Risk D: Consider therapy modification

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Dipyridamole: May diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Metoclopramide: Rivastigmine may enhance the adverse/toxic effect of Metoclopramide. Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Risk X: Avoid combination

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Acetylcholinesterase Inhibitors may diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Succinylcholine: Acetylcholinesterase Inhibitors may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy

Tobacco (Smoked): May decrease the serum concentration of Rivastigmine. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Food Interactions

Food delays absorption by 90 minutes, lowers Cmax by 30% and increases AUC by 30%. Management: Administer with meals.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Breastfeeding Considerations

It is not known if rivastigmine is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Cognitive function at periodic intervals, symptoms of GI intolerance, decreased weight, signs of cutaneous reactions.

Mechanism of Action

A deficiency of cortical acetylcholine is thought to account for some of the symptoms of Alzheimer disease and Parkinson disease dementia; rivastigmine increases acetylcholine in the central nervous system through reversible inhibition of its hydrolysis by cholinesterase

Pharmacokinetics (Adult Data Unless Noted)

Duration: Anticholinesterase activity (CSF): ~10 hours (6 mg oral dose)

Absorption: Oral: Fasting: Rapid and complete within 1 hour; Transdermal patch: Within 30 to 60 minutes

Distribution: Vd: 1.8 to 2.7 L/kg; penetrates blood-brain barrier (CSF levels are ~40% of plasma levels following oral administration)

Protein binding: 40%

Metabolism: Extensively via cholinesterase-mediated hydrolysis in the brain; metabolite undergoes N-demethylation and/or sulfate conjugation hepatically; CYP minimally involved; linear kinetics at 3 mg twice daily, but nonlinear at higher doses

Bioavailability: Oral: 36%

Half-life elimination: Oral: 1.5 hours; Transdermal patch: ~3 hours (after removal)

Time to peak: Oral: 1 hour; Transdermal patch: 8 to 16 hours following first dose

Excretion: Urine (97% as metabolites); feces (0.4%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function:

Moderate impairment: Mean oral clearance is 64% lower.

Severe impairment: Mean oral clearance is 43% higher for unexplained reasons.

Hepatic function impairment: Mean oral clearance is 60% lower.

Older adult: Mean oral clearance was 30% lower.

Cigarette smoking: Oral clearance increases 23%.

Body weight: Exposure is higher in patients with low body weight (<50 kg) and lower in patients with an increased body weight (>100 kg).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Exelon;
  • (AR) Argentina: Exelon | Luneste | Remizeral | Rivasmina;
  • (AT) Austria: Exelon | Nimvastid | Rivagelan | Rivastigmin 1a pharma | Rivastigmin Genericon | Rivastigmin kappler | Rivastigmin ratiopharm | Rivastigmin sandoz | Rivastigmin Sandoz | Rivastigmin stada | Rivastigmine actavis;
  • (AU) Australia: Exelon | Exelon patch 10 | Exelon Patch 5 | Rivastigmelon;
  • (BD) Bangladesh: Benzenod | Exelon | Rivacap | Rivamer | Vastigro;
  • (BE) Belgium: Exelon | Niddastig | Rivastigmine apotex | Rivastigmine mylan | Rivastigmine Mylan | Rivastigmine sandoz;
  • (BG) Bulgaria: Exelon | Ridaxin;
  • (BR) Brazil: Exelon | Hemitartarato de rivastigmina | Hidrogenotartarato de rivastigmina | Prometax | Rivastelon | Rivastigmina | Tigma | Vastigma | Vivencia;
  • (CH) Switzerland: Exelon | Rivastigmin mepha | Rivastigmin zentiva;
  • (CL) Chile: Exelon | Probrain | Rivazic;
  • (CN) China: Exelon;
  • (CO) Colombia: Astigmin | Exelon | Neuract | Prometax | Rivamer;
  • (CZ) Czech Republic: Evertas | Exelon | Ristidic | Rivastigmin +pharma | Rivastigmin orion | Rivastigmin Ratiopharm | Vastigmex;
  • (DE) Germany: Exelon | Miestigacin | Nimvastid | Prometax | Rivastigmin | Rivastigmin 1a pharma | Rivastigmin Acino | Rivastigmin actavis | Rivastigmin Aurobindo | Rivastigmin Beta | Rivastigmin betapharm | Rivastigmin Biomo | Rivastigmin delorbis | Rivastigmin dura | Rivastigmin Heuman | Rivastigmin heumann | Rivastigmin hexal | Rivastigmin Hormosan | Rivastigmin Neurax | Rivastigmin Neuraxpharm | Rivastigmin Pfizer | Rivastigmin ratiopharm | Rivastigmin stada | Rivastigmin teva | Rivastigmin zentiva | Rivastigmine acino | Rivastigmine aristo | Rivastigmine hexal | Rivendo;
  • (DO) Dominican Republic: Exelom | Exelon;
  • (EC) Ecuador: Exelon | Rivazic;
  • (EE) Estonia: Exelon | Rivastigmin orion;
  • (EG) Egypt: Exelon | Rivamash | Rivamep | Rivastalone | Rivaxel;
  • (ES) Spain: Alzerta | Demelora | Exelon | Nimvastid | Nofleban | Prometax | Rivanex | Rivastigmina Apotex | Rivastigmina apotex | Rivastigmina aristo | Rivastigmina aurobindo | Rivastigmina aurovitas | Rivastigmina Cinfa | Rivastigmina cinfa | Rivastigmina Combix | Rivastigmina farmalider | Rivastigmina Kern | Rivastigmina Kern pharma | Rivastigmina lorien | Rivastigmina mylan | Rivastigmina Normon | Rivastigmina normon | Rivastigmina ortodrol | Rivastigmina ratiopharm | Rivastigmina Sandoz | Rivastigmina stada | Rivastigmina tecnigen | Rivastigmina teva | Rivastigmina travel | Rivastigmina vir | Rivastigmina zentiva;
  • (FI) Finland: Exelon | Nimvastid | Rivastigmin orifarm | Rivastigmin orion | Rivastigmin Ratiopharm | Rivastigmin ratiopharm | Rivastigmin Sandoz | Rivastigmine actavis | Rivastigmine Stada | Rivastor;
  • (FR) France: Exelon | Rivastigmine actavis | Rivastigmine arrow | Rivastigmine Biogaran | Rivastigmine eg | Rivastigmine EG | Rivastigmine mylan | Rivastigmine Mylan | Rivastigmine sandoz | Rivastigmine teva | Rivastigmine viatris | Rivastigmine zentiva | Rivastigmine Zydus;
  • (GB) United Kingdom: Almuriva | Alzest | Eluden | Erastig | Exelon | Kerstipon | Nimvastid | Prometax | Rivastigmine | Rivastigmine actavis | Rivastigmine Rosemont | Rivatev | Somniton | Voleze;
  • (GR) Greece: Alapril | Balaxon | Evertas | Exelon | Immitis | Impalon | Lasium | Mentazac | Rivagmin | Rivanel | Rivaset | Rivastigmine zentiva | Rivastigmine/adelco | Rivastigmine/generics | Rivetal | Vialon;
  • (HK) Hong Kong: Apo Rivastigmine | Exelon | Exelon patch 10 | Exelon Patch 5 | Rivasan;
  • (HR) Croatia: Exelon;
  • (HU) Hungary: Exelon;
  • (ID) Indonesia: Exelon;
  • (IE) Ireland: Exelon | Nimvastid | Rivastigmine | Rivastigmine Mylan;
  • (IL) Israel: Exelon;
  • (IN) India: Exelon | Rivadem | Rivamer | Rivasmine | Rivera;
  • (IS) Iceland: Exelon;
  • (IT) Italy: Demelora | Exelon | Nimvastid | Prometax | Rivastigmina | Rivastigmina Actavis | Rivastigmina doc | Rivastigmina Sandoz | Rivastigmina zentiva;
  • (JO) Jordan: Exelon | Rivaxel | Rivetal | Stegmex;
  • (JP) Japan: Exelon | Rivastach;
  • (KR) Korea, Republic of: Altsustigmine | Ausgmine | Brexell | Demencure | Denuvo | Dimenlis | Dongkoo rivastigmine tartrate | Eusbera | Excel c | Exelon | Exelon patch 10 | Exelon patch 15 | Exelon Patch 5 | Exelriva | Exolon | Huons rivastigmine | Inist rivastigmine | Listamin patch 10 | Listamin patch 5 | Livafiron patch 10 | Livafiron patch 5 | Monsti | Nectimine | Newxelon | Oselon | Rigmin | Riselton | Risti | Rivaderm | Rivaglon | Rivagmine | Rivamensa | Rivameron | Rivamine | Rivaminine | Rivapet | Rivaron | Rivas | Rivaslon | Rivasmin | Rivastigmine bkw | Rivastiren | Rivatimine | Rivawins | Rivaxelon | Rivaxen | Samsung rivastigmine | Samyang biopharm rivastigmine | Sinsin rivastigmine | Stagmin | Stelron | Stigma | Uniriva | Uniselon | Wondron 10 | Wondron 15 | Wondron 5;
  • (KW) Kuwait: Exelon;
  • (LB) Lebanon: Exelon | Rivastigmine arrow;
  • (LT) Lithuania: Evertas | Exelon | Rivastigmin | Rivastigmin ratiopharm | Rivastigmine hexal;
  • (LU) Luxembourg: Exelon;
  • (LV) Latvia: Exelon | Rivastigmin actavis;
  • (MA) Morocco: Exelon;
  • (MX) Mexico: Demsilev | Exelon;
  • (MY) Malaysia: Exelon | Rivadem | Rivamensa;
  • (NL) Netherlands: Demelora | Exelon | Permente | Rivaldo tds | Rivastigmine actavis | Rivastigmine aurobindo | Rivastigmine cf | Rivastigmine Mylan | Rivastigmine mylan | Rivastigmine neuraxpharm | Rivastigmine ratiopharm | Rivastigmine sandoz | Rivastigmine teva;
  • (NO) Norway: Exelon | Orivast | Rivastigmin orion | Rivastigmine Teva;
  • (NZ) New Zealand: Exelon;
  • (PE) Peru: Exelon | Rivamer | Tafcilex-10 | Tafcilex-5;
  • (PH) Philippines: Exelon | Rivadem;
  • (PK) Pakistan: Exelon | Memomax | Ridaxin | Rivagem | Rivamer | Rivastat | Rivastig | Riveme | Rivsaff;
  • (PL) Poland: Evertas | Exelon | Nimvastid | Permente | Prometax | Ristidic | Rivaldo | Rivaldo tds | Rivastigmin orion | Rivastigmin stada | Rivastigmine actavis | Rivastigmine Mylan | Rivastigmine Teva | Rivastigmine teva | Rivaxon | Riveka | Rywastygmina apotex | Rywastygmina neuraxpharm | Signelon | Symelon | Vergesin;
  • (PR) Puerto Rico: Exelon | Rivastigmine | Rivastigmine tartrate | Rivastigmine Transdermal system;
  • (PT) Portugal: Exelon | Prometax | Rivastigmina aurobindo | Rivastigmina Bluepharma | Rivastigmina Ciclum | Rivastigmina generis | Rivastigmina Generis | Rivastigmina Labesfal | Rivastigmina mylan | Rivastigmina pentafarma | Rivastigmina Sandoz | Rivastigmina teva | Rivastigmina toLife | Rivastigmina zentiva;
  • (PY) Paraguay: Exelon;
  • (QA) Qatar: Exelon 10 | Exelon 5;
  • (RO) Romania: Evertas | Exelon | Nimvastid | Ridaxin | Rivastigmina dr. reddy's | Rivastigmina teva | Rivastigmine sandoz;
  • (RU) Russian Federation: Alcenorm | Exelon;
  • (SA) Saudi Arabia: Exelon | Rivetal;
  • (SE) Sweden: Exelon | Nimvastid | Orivast | Prometax | Rigmin | Rivastigmin abacus medicine | Rivastigmin ebb | Rivastigmin orifarm | Rivastigmin orion | Rivastigmin Sandoz | Rivastigmin stada | Rivastigmine actavis | Rivastigmine sandoz | Rivastor;
  • (SG) Singapore: Exelon;
  • (SI) Slovenia: Exelon | Rivastigmin | Rivastigmin teva;
  • (SK) Slovakia: Evertas | Exelon | Ristidic | Rivastigmin +pharma | Rivastigmin orion | Rivastigmine Teva | Vastigmex;
  • (TH) Thailand: Exelon | Rivasta | Trivacin;
  • (TN) Tunisia: Exelon | Rivetal | Vitacholine;
  • (TR) Turkey: Altigmin | Exelon | Ristart | Rivarem | Rivaxel;
  • (TW) Taiwan: Exelon | Revelin | Ristig | Rivast;
  • (UA) Ukraine: Rivastigmin IC | Rivastigmin orion;
  • (UY) Uruguay: Amizeral | Exelon;
  • (VE) Venezuela, Bolivarian Republic of: Exelon | Rivamer;
  • (ZA) South Africa: Exelon | Kyriz
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