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ROTIGOTINE


DIR Classification


Classification:Moderate-DIR concern
Severity Score:2

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • WARNINGS AND PRECAUTIONS
  • Hyperpyrexia and Confusion
  • A symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, rhabdomyolysis, and/or autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in anti-Parkinsonian therapy. Therefore, it is recommended that the dose be tapered at the end of NEUPRO treatment [see DOSAGE AND ADMINISTRATION (2.4)].

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
9
42903
Other ADRs
3310
14113969

Odds Ratio = 0.895

Drug Property Information



ATC Code(s):
  • N04BC09 - rotigotine
    • N04BC - Dopamine agonists
    • N04B - DOPAMINERGIC AGENTS
    • N04 - ANTI-PARKINSON DRUGS
    • N - NERVOUS SYSTEM
Active Ingredient:rotigotine
Active Ingredient UNII:87T4T8BO2E
Drugbank ID:DB05271
PubChem Compound:59227
CAS Number:99755-59-6
Dosage Form(s):kit; patch, extended release
Route(s) Of Administrator:transdermal
Daily Dose:
Chemical Structure:
SMILE Code:
CCCN(CCC1=CC=CS1)[C@H]2CCC3=C(C2)C=CC=C3O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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