Rotigotine


Generic Medicine Info
Indications and Dosage
Transdermal
Restless legs syndrome
Adult: For the treatment of moderate to severe primary cases: As patch: Initially, 1 mg/24 hours once daily; may increase in weekly increments of 1 mg/24 hours up to a Max of 3 mg/24 hours based on patient's clinical response and tolerability. Treatment recommendations may vary between countries (refer to specific product guidelines).

Transdermal
Parkinson's disease
Adult: As patch: As monotherapy in early-stage Parkinson's disease: Initially, 2 mg/24 hours once daily; may increase in weekly increments of 2 mg/24 hours up to a Max of 8 mg/24 hours based on patient's clinical response and tolerability. As adjunctive therapy with levodopa in patients with advanced-stage Parkinson's disease: Initially, 4 mg/24 hours once daily; may increase in weekly increments of 2 mg/24 hours up to a Max of 16 mg/24 hours based on patient's clinical response and tolerability. Dosing recommendations may vary between countries (refer to specific product guidelines).
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Special Precautions
Patient with CV disease, cerebrovascular disease, major psychotic disorders. Patients undergoing MRI or cardioversion should remove the patch prior to procedure. Avoid abrupt withdrawal. Severe hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Postural or orthostatic hypotension, syncope; somnolence and episodes of sudden sleep onset; weight gain, fluid retention; abnormal thinking and behaviour (e.g. agitation, aggression, confusion, delirium, delusions, disorientation, hallucinations, paranoid ideation, psychotic-like behaviour); compulsive behaviours and/or loss of impulse control manifested as pathological gambling, increased libido, binge eating; dystonic reactions (e.g. dystonia, abnormal posture, torticollis, pleurothotonus), application site reactions (e.g. localised erythema, oedema, pruritus), increased blood pressure, increased heart rate, dyskinesia; augmentation and rebound (when used in restless legs syndrome); NMS and withdrawal syndrome (after abrupt withdrawal). Rarely, fibrotic complications (e.g. pleural effusion, pleural thickening, pulmonary infiltrates, retroperitoneal fibrosis, pericarditis and/or cardiac valvulopathy).
Ear and labyrinth disorders: Vertigo.
Eye disorders: Visual disturbance.
Gastrointestinal disorders: Nausea, vomiting, dyspepsia, constipation, diarrhoea, xerostomia, abdominal pain.
General disorders and administration site conditions: Asthenia, malaise, peripheral oedema.
Immune system disorders: Hypersensitivity reactions.
Investigations: Decreased weight, serum glucose, haematocrit or haemoglobin; increased BUN.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Headache, dizziness, drowsiness.
Psychiatric disorders: Insomnia, sleep disorder, abnormal dreams, irritability.
Skin and subcutaneous tissue disorders: Hyperhidrosis.
Transdermal: Z (Growth retardation was reported in an infant with pregnancy exposure. Due to limited information, use during pregnancy is generally not recommended.)
Patient Counseling Information
This drug may cause somnolence or sudden sleep episodes, if affected, do not drive or operate machinery. Avoid exposing the application site and surrounding area to direct external heat sources (e.g. heating pads, electric blankets, heated water beds, saunas, heat lamps, hot tubs, direct sunlight).
Monitoring Parameters
Monitor blood pressure. Assess daytime alertness and weight gain.
Overdosage
Symptoms: Nausea, vomiting, hypotension, involuntary movements, confusion, hallucinations and convulsions. Management: Supportive treatment. Remove the patch to decrease the serum concentration of rotigotine. Closely monitor heart rate, heart rhythm and blood pressure.
Drug Interactions
Increased risk of additive effects with other CNS depressants (e.g. sedatives, anxiolytics, antidepressants, antipsychotics, opiate analgesics). May reduce effectiveness with dopamine antagonists (e.g. metoclopramide, phenothiazines, butyrophenones, thioxanthenes).
Food Interaction
Additive effects with alcohol.
Action
Description:
Mechanism of Action: Rotigotine is a non-ergot dopamine receptor agonist. It is believed to stimulate the postsynaptic dopamine D2-type auto receptors within the substantia nigra in the brain. This results in improved dopaminergic transmission in the motor areas of the basal ganglia, particularly in the caudate nucleus and putamen regions.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 15-18 hours.
Distribution: Plasma protein binding: Approx 90%.
Metabolism: Extensively metabolised via conjugation and N-dealkylation into inactive metabolites. Undergoes extensive first-pass metabolism via glucuronidation in the gut wall and liver.
Excretion: Via urine (approx 71% as inactive conjugates and metabolites, <1% as unchanged drug); faeces (approx 23%). Elimination half-life: 5-7 hours (after patch removal).
Chemical Structure

Chemical Structure Image
Rotigotine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 59227, Rotigotine. https://pubchem.ncbi.nlm.nih.gov/compound/Rotigotine. Accessed Nov. 25, 2024.

Storage
Store between 15-30°C.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BC09 - rotigotine ; Belongs to the class of dopamine agonists. Used in the management of Parkinson's disease.
References
Anon. Rotigotine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/11/2024.

Brayfield A, Cadart C (eds). Rotigotine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/11/2024.

Joint Formulary Committee. Rotigotine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/11/2024.

Neupro 2 mg/24 hours, 4 mg/24 hours, 6 mg/24 hours and 8 mg/24 hours Transdermal Patch (UCB Pharma [Thailand] Ltd). MIMS Thailand. http://www.mims.com/thailand. Accessed 04/11/2024.

Neupro 2 mg/24 hours, 4 mg/24 hours, 6 mg/24 hours and 8 mg/24 hours Transdermal Patch (UCB Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/11/2024.

Neupro Patch, Extended Release (UCB, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/11/2024.

Rotigotine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/11/2024.

Disclaimer: This information is independently developed by MIMS based on Rotigotine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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