Rotigotine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Pregnancy Category (US FDA)

Transdermal: C

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.

Monitoring Parameters

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

Storage

Store between 20-25°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. 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.

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