rotigotine transdermal system
- Symptomatic management of idiopathic Parkinson's disease.
- Moderate-to-severe primary restless leg syndrome
Acts as an agonist of dopamine in the CNS, primarily at D2 receptor sites.
- Improvement in symptoms of Parkinson's disease.
- Decreased leg restlessness
Absorption: 46% absorbed from patch over 24 hr.
Protein Binding: 90%
Metabolism and Excretion: Mostly metabolized and excreted in urine as metabolites (71%); 23% excreted in feces.
Half-life: Biphasic: initial half-life 3 hr; terminal half-life 5–7 hr.
TIME/ACTION PROFILE (plasma concentrations)
|Transdermal||1–3 hr||15–18 hr (range 4–27 hr)||24 hr|
- Hypersensitivity to rotigotine or sulfites
Use Cautiously in:
- Severe cardiovascular disease (may ↑ risk of postural hypotension or syncope)
- Severe hepatic impairment
- Major psychotic disorder
- OB: May be excreted in breast milk and pose a risk of adverse effects in the infant; use only if maternal benefits outweigh risk to fetus
- Pedi: Safety not established
Adverse Reactions/Side Effects
CNS: DROWSINESS, insomnia, aggression, agitation, confusion, delirium, delusions, disorientation, dizziness, hallucinations, headache, paranoid ideation, sudden sleep attacks, urges (gambling, sexual)
CV: hypertension, peripheral edema, postural hypotension, syncope, tachycardia
GI: nausea, vomiting, anorexia, dry mouth, dyspepsia
GU: urinary incontinence
Derm: application site reactions, melanoma, pruritus, purpura, sweating
Metabolic: weight gain
MS: leg pain
Neuro: abnormal gait, ataxia, dyskinesia, hypertonia, hypoesthesia, neuralgia, paresthesia
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Transdermal: (Adults) Early-stage– 2 mg/24 hr initially, may ↑ by 2 mg/24 hr weekly, up to 6 mg/24 hr; Advanced-stage– 4mg/24 hr initially, may ↑ by 2 mg/24 hr weekly, up to 8 mg/24 hr.
Restless Legs Syndrome
Transdermal: (Adults) 1 mg/24 hr initially, may ↑ by 1 mg/24 hr weekly, up to 3 mg/24 hr.
Transdermal system: 1 mg/24 hr, 2 mg/24 hr, 3 mg/24 hr, 4 mg/24 hr, 6 mg/24 hr, 8 mg/24 hr
- Assess for allergy to sulfite, may be more common in asthmatics.
- Assess frequently for drowsiness, a common side effect of rotigotine. Episodes of falling asleep during activities that require active participation may occur without warning. Patients may not acknowledge drowsiness unless directly questioned about drowsiness during specific activities. May occur as late as 1 year after initiation of therapy. Assess patient for concomitant medications that have sedating effects. May require discontinuation of therapy.
- Monitor BP, sitting and standing, periodically during therapy, especially during dose escalation. May also cause syncope.
- Assess for application site reactions (erythema, edema, pruritus). If persistent, (more than a few days), increasing in severity, or spreading outside application site, determine risk/benefit ratio. If generalized skin reaction (allergic macular-papular rash) occurs, discontinue rotigotine.
- Assess for hallucinations. May require discontinuation.
- Monitor for weight gain; usually associated with peripheral edema.
- Assess for development of new or increased gambling urges, sexual urges, or other urges during therapy.
- Parkinson's Disease: Assess patient for signs and symptoms of Parkinson's disease (tremor, muscle weakness and rigidity, ataxia) before and throughout therapy.
- Restless Leg Syndrome: Assess sleep patterns and frequency of restless leg disturbances.
Lab Test Considerations: May cause ↓ hemoglobin and serum albumin and glucose levels.
- May cause ↑ BUN and GGT levels.
- Transdermal: Apply once daily to clean, dry, intact skin on abdomen, thigh, hip, flank, shoulder, or upper arm. Hold in place for 20–30 seconds to make sure of good contact, especially around edges. If applied to hairy area, shave area at least 3 days prior to application. Do not apply to areas that could be rubbed by tight clothing, are under a waistband, or to skin folds. Do not apply to skin that is red, irritated, or impaired. Do not apply creams, lotions, ointments, oils, or powders to skin areas where patch will be placed. Wash hands following application to remove any drug and do not touch eyes. Rotate patch site daily; do not use same application site more than once every 14 days. Do not cut or damage patch. Remove patch slowly and carefully to avoid irritation. Fold over so it sticks to itself and discard. Wash application site with soap and water to remove drug or adhesive. May use baby or mineral oil to remove excess residue. Avoid using alcohol or other solvents, may cause skin irritation. If therapy is discontinued, decrease gradually by 2 mg/24 hrs every other day until complete withdrawal.
- Instruct patient on proper method of patch application. Advise patient to wear patch continuously for 24 hrs and to apply system at the same time each day; if patch change is missed, apply as soon as possible and replace at usual time the following day. Patients may bathe, shower or swim with patch on. If patch falls off, apply a new on immediately to a different site and change according to regular schedule. Do not stop therapy without consulting health care professional. withdrawal.
- May cause drowsiness and unexpected episodes of falling asleep. Caution patient to avoid driving and other activities requiring alertness until response to medication is known. Advise patient to notify health care professional if episodes of falling asleep occur.
- Advise patient to notify health care professional if application site reaction occurs.
- Inform patient that rotigotine may cause hallucinations.
- Advise patient to remove rotigotine patch prior to magnetic resonance imaging or cardioversion.
- Caution patient to avoid exposing patch to external heat (heating pad, electric blanket, heat lamp, sauna, hot tub, heated water bed, prolonged direct sunlight).
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications or alcohol.
- Advise patient to notify health care professional if they experience new or increased gambling, sexual or other intense urges during therapy. May require discontinuation.
- Advise patient to have health care professional check their skin for skin cancer regularly due to increase risk of melanoma.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
- Improvement in signs and symptoms of early-stage Parkinson's disease.
- Decrease in restless legs and improved sleep.
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