Section 03 · Monograph

Rotigotine

Reviewed Nov 2026FDA label

Neupro patchDopamine agonist · patch

Indications

Treatment of signs and symptoms of Parkinson's disease (early-stage monotherapy or advanced-stage combination with levodopa)FDA-labeled
Treatment of moderate-to-severe primary Restless Legs Syndrome (RLS)FDA-labeled

Non-ergoline (non-ergot) dopamine receptor agonist delivered transdermally for continuous 24-hour plasma levels
Precise mechanism in Parkinson's disease thought to relate to stimulation of D3, D2, and D1 dopamine receptors in the caudate-putamen of the brain
Mechanism in RLS is unknown but presumed to involve dopaminergic stimulation within the central nervous system

Early-stage PD: start 2 mg/24 hr once daily; titrate by 2 mg/24 hr at weekly intervals as needed; effective range 4–6 mg/24 hr (max 6 mg/24 hr)
Advanced-stage PD: start 4 mg/24 hr once daily; titrate by 2 mg/24 hr weekly; max 8 mg/24 hr
RLS: start 1 mg/24 hr once daily; titrate by 1 mg/24 hr weekly; max 3 mg/24 hr
Apply once daily to clean, dry, intact skin (abdomen, thigh, hip, flank, shoulder, or upper arm); press firmly in place for ~30 seconds
Rotate application site daily; avoid reapplication to the same site within 14 days
Available strengths: 1, 2, 3, 4, 6, and 8 mg/24-hour patches
Discontinue gradually: reduce PD dose by ≤2 mg/24 hr every other day; reduce RLS dose by 1 mg/24 hr every other day, if possible, to avoid withdrawal-emergent hyperpyrexia/confusion

Known hypersensitivity to rotigotine or any component of the transdermal system
Use caution in patients with sulfite sensitivity (patch contains sodium metabisulfite; risk of anaphylaxis/severe asthma exacerbation, especially in asthmatics)

Dopamine antagonists (e.g., antipsychotics, metoclopramide) may diminish effectiveness of rotigotine
No clinically significant pharmacokinetic interactions identified with cimetidine, levodopa/carbidopa, oral contraceptives, or omeprazole in studies
Additive CNS depressant/sedative effects possible with alcohol or other sedating medications (increased somnolence risk)
Heat application over or near the patch (heating pads, electric blankets, saunas, hot tubs, direct sunlight, heated waterbeds) can increase rotigotine absorption and should be avoided

Nausea, vomiting, application/patch site reactions (erythema, pruritus, edema)
Somnolence and sudden onset of sleep during activities of daily living, including driving
Orthostatic/postural hypotension and syncope
Hallucinations and psychotic-like behavior, particularly in advanced-stage PD and elderly patients
Impulse control disorders: pathological gambling, hypersexuality, compulsive spending, binge eating
Dyskinesia (especially in advanced-stage PD combined with levodopa)
Peripheral edema, dizziness, hyperhidrosis, sleep disturbances, visual disturbances
Laboratory changes: decreased hemoglobin/hematocrit, decreased serum glucose, increased BUN, increased CPK (notably reported in Japanese patients)

Blood pressure and heart rate, particularly supine/standing measurements during initiation and titration
Ongoing assessment for excessive daytime somnolence or sudden sleep episodes; counsel on driving/hazardous activity precautions
Mental status changes, hallucinations, or new/worsening psychotic behavior
Screening for impulse control/compulsive behaviors at each visit
Application site inspection for irritation, and rotate sites as directed
Periodic CBC, glucose, BUN/renal function, and CPK as clinically indicated
Signs/symptoms of withdrawal-emergent hyperpyrexia and confusion if dose is reduced or discontinued

Pregnancy: Animal reproduction studies showed adverse embryofetal effects (increased embryofetal death, delayed ossification, decreased fetal body weight) at doses similar to or below clinical exposure; based on animal data, rotigotine may cause fetal harm — use only if potential benefit justifies potential risk
Lactation: Rotigotine suppresses prolactin secretion and may inhibit lactation; unknown whether rotigotine is present in human milk (excreted in animal milk) — advise patients to notify their provider before breastfeeding