Rotigotine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : Transdermal As monotherapy in Parkinson’s disease As patch: Initial: 2 mg/24 hr, may increase wkly in increments of 2 mg/24 hr. Max: 8 mg/24 hr. Adjunct to levodopa treatment in Parkinson’s disease As patch: Initial: 4 mg/24 hr, may increase wkly in increments of 2 mg/24 hr. Max: 16 mg/24 hr. Restless leg syndrome As patch: Initial: 1 mg/24 hr, may increase wkly in increments of 1 mg/24 hr. Max: 3 mg/24 hr.
Dosage Details
Transdermal
Monotherapy in Parkinson's disease
Adult: As patch: Initially, 2 mg/24 hr, increased wkly in increments of 2 mg/24 hr, if necessary. Max: 8 mg/24 hr. Reduce daily dose in decrements of 2 mg every other day until complete withdrawal.

Transdermal
Adjunct to levodopa treatment in Parkinson's disease
Adult: As patch: Initially, 4 mg/24 hr, increased wkly in increments of 2 mg/24 hr, if necessary. Max: 16 mg/24 hr. Reduce daily dose in decrements of 2 mg every other day until complete withdrawal.

Transdermal
Restless leg syndrome
Adult: As patch: Initially, 1 mg/24 hr, increased wkly in increments of 1 mg/24 hr, according to response. Max: 3 mg/24 hr. Reduce daily dose in decrements of 1 mg every other day until complete withdrawal. Assess treatment continuation 6 mthly.
Special Precautions
Patient w/ severe CV disease, pre-existing dyskinesia. Avoid abrupt withdrawal. Severe hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Nausea, vomiting, somnolence, dizziness, anorexia, insomnia, hyperhidrosis, headache, fatigue, anxiety, dyspepsia, peripheral oedema, dyskinesia, symptomatic hypotension, syncope, compulsive behaviour, application site reactions.
Patient Counseling Information
This drug may cause somnolence and/or sudden sleep episodes, if affected, do not drive or operate machinery. Remove patch prior to MRI or cardioversion.
MonitoringParameters
Monitor BP, daytime alertness; periodic skin evaluations.
Overdosage
Symptoms: Hypotension, nausea, vomiting, involuntary movements, confusion, hallucinations, convulsions and other signs of central dopaminergic stimulation. Management. General supportive treatment.
Drug Interactions
Decreased effect w/ dopamine antagonists (e.g. phenothiazines, metoclopramide). Additive sedative effect w/ CNS depressants (e.g. benzodiazepines, antipsychotics). May potentiate the dopaminergic adverse reaction of levodopa and may cause and/or exacerbate pre-existing dyskinesia.
Food Interaction
Additive sedative effect w/ alcohol.
Action
Description: Rotigotine is a nonergot-derivative dopamine receptor agonist. The exact mechanism of action is unclear but appears to be related to stimulation of postsynaptic dopamine D2-type auto receptors w/in the substantia nigra in the brain, leading to improved dopaminergic transmission in the motor areas of the basal ganglia.
Pharmacokinetics:
Absorption: Absorbed through the skin. Absolute bioavailability: Approx 37%. Time to peak plasma concentration: 24 hr.
Distribution: Volume of distribution: Approx 84 L/kg. Plasma protein binding: Approx 92%.
Metabolism: Undergoes extensive first-pass metabolism via glucuronidation in the gut wall and liver; also undergoes N-dealkylation and conjugation to form inactive metabolites.
Excretion: Mainly via urine (approx 71%); faeces (approx 23%). Elimination half-life: 5-7 hr.
Chemical Structure

Chemical Structure Image
Rotigotine

Source: National Center for Biotechnology Information. PubChem Database. Rotigotine, CID=59227, https://pubchem.ncbi.nlm.nih.gov/compound/Rotigotine (accessed on Jan. 23, 2020)

Storage
Store between 20-25°C.
ATC Classification
N04BC09 - rotigotine ; Belongs to the class of dopamine agonists. Used in the management of Parkinson's disease.
References
Anon. Rotigotine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/03/2016.

Buckingham R (ed). Rotigotine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/03/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Rotigotine. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 09/03/2016.

Neupro Transdermal System. U.S. FDA. https://www.fda.gov/. Accessed 09/03/2016.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in