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Ongentys Generic Name & Formulations
Legal Class
Rx
General Description
Opicapone 25mg, 50mg; caps.
Pharmacological Class
COMT inhibitor.
How Supplied
Caps—30
Manufacturer
Generic Availability
NO
Ongentys Indications
Indications
Adjunct to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
Ongentys Dosage and Administration
Adult
Avoid food for 1hr before and at least 1hr after dose. 50mg once daily at bedtime. Hepatic impairment (moderate): 25mg once daily at bedtime; (severe): avoid.
Children
Not established.
Ongentys Contraindications
Contraindications
Concomitant non-selective MAOIs (eg, phenelzine, isocarboxazid, tranylcypromine). Pheochromocytoma. Paraganglioma. Other catecholamine secreting neoplasms.
Ongentys Boxed Warnings
Not Applicable
Ongentys Warnings/Precautions
Warnings/Precautions
Dyskinesias. Pre-existing somnolence or sleep disorders. Monitor for hypotension. Hallucinations, psychotic behaviors, impulse control/compulsive disorders; consider discontinuing if occur. Dopamine dysregulation syndrome. Moderate and severe hepatic impairment: see Adult dose. Severe renal impairment. ESRD: avoid. Pregnancy. Nursing mothers.
Ongentys Pharmacokinetics
See Literature
Ongentys Interactions
Interactions
See Contraindications. Reduce concomitant levodopa dose. Cardiac effects with drugs metabolized by COMT (eg, epinephrine, isoproterenol, norepinephrine, dopamine, dobutamine); caution and monitor. Reduced efficacy with some antipsychotics.
Ongentys Adverse Reactions
Adverse Reactions
Dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, weight decreased; daytime sleepiness, withdrawal-emergent hyperpyrexia and confusion.
Ongentys Clinical Trials
See Literature
Ongentys Note
Not Applicable
Ongentys Patient Counseling
See Literature
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