Parkinson's disease.
Restless legs syndrome (Moderate to Severe).
#仿單變更2021
藥理
Rotigotine is a non-ergoline dopamine receptor agonist. The precise mechanisms of action in the treatment of Parkinson disease and restless legs syndrome are unknown but are thought to be related to rotigotine's ability to stimulate dopamine receptors. In the treatment of Parkinson disease, rotigotine is thought to stimulate dopamine receptors within the caudate-putamen in the brain.
藥動學
Distribution:
Vd: 84 L/kg
Metabolism:
Hepatic; extensive via N-dealkylation and conjugation, catalyzed by multiple CYP isoenzymes, sulfotransferases and 2 UDP-glucuronosyltransferases
Excretion:
Renal: approximately 71%
Dialyzable: no
Elimination Half Life:
3 hours initially, then 5 to 7 hours (biphasic) .
禁忌症
Hypersensitivity to rotigotine or any component of the product.
懷孕分類
C (FDA)B3 (AUS)
哺乳分類
Milk effects are possible.(MDX)
副作用
Common:
Cardiovascular: Orthostatic hypotension (Parkinson disease, 16% to 32%; restless legs syndrome, 8% to 13% ), Peripheral edema (2% to 9% )
Dermatologic: Application site reaction (19% to 43% ), Diaphoresis (1% to 11% )
Gastrointestinal: Loss of appetite (2% to 9% ), Nausea (Parkinson disease, 28% to 48%; restless legs syndrome, 15% to 23% ), Vomiting (Parkinson disease, 10% to 20%; restless legs syndrome, 2% to 4% ), Xerostomia (3% to 7% )
Neurologic: Dizziness (Parkinson disease, 14% to 23%; restless legs syndrome, 5% to 9% ), Dyskinesia (14% ), Headache (10% to 21% ), Sleep disorder (2% to 14% ), Somnolence (5% to 32%; sudden onset of sleep, up to 2% )
Serious:
Cardiovascular: Atrioventricular block, First degree (3% ), Syncope
Psychiatric: Compulsive behavior, Hallucinations (Up to 7% ), Impulse control disorder.
Postmarketing: increased creatine phosphokinase in blood specimen <2021/4/19>