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Xadago Generic Name & Formulations
Legal Class
Rx
General Description
Safinamide 50mg, 100mg; tabs.
Pharmacological Class
MAO-B inhibitor.
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Xadago Indications
Indications
As adjunct to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
Xadago Dosage and Administration
Adult
Initially 50mg once daily (at same time of day); may increase to 100mg once daily after 2 weeks as tolerated. Moderate hepatic impairment (Child-Pugh B): max 50mg once daily. Taper gradually upon discontinuation.
Children
Not established.
Xadago Contraindications
Contraindications
Severe hepatic impairment (Child-Pugh C). Concomitant other MAOIs including linezolid, opioids (eg, meperidine, methadone, propoxyphene, tramadol), SNRIs, tricyclic, tetracyclic, or triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine and their derivatives, St. John's wort, dextromethorphan.
Xadago Boxed Warnings
Not Applicable
Xadago Warnings/Precautions
Warnings/Precautions
Monitor for new onset or uncontrolled hypertension. Avoid tyramine-rich (>150mg) foods (see full labeling). Dyskinesia: reduce daily dose of levodopa or dopaminergic agent. Consider reducing dose or discontinuing therapy if hallucinations, psychotic disorders, urges/compulsive behaviors develop. Consider discontinuing if excessive daytime sleepiness or if sudden onset of sleep occurs. History of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, active retinopathy; monitor periodically for visual changes. Discontinue if severe hepatic impairment develops. Pregnancy. Nursing mothers.
Xadago Pharmacokinetics
See Literature
Xadago Interactions
Interactions
See Contraindications. Allow at least 14 days after discontinuing safinamide before starting MAOIs, opioids, serotonergics. Possible hypertensive crisis with excess dietary tyramine (see full labeling). Monitor for hypertension and reaction to dietary tyramine if concomitant with isoniazid. Concomitant SSRIs: use lowest effective dose and monitor for serotonin syndrome. Monitor for hypertension if concomitant with sympathomimetics (eg, nasal, oral, ophthalmic, decongestants or cold remedies). May be antagonized by dopamine antagonists (eg, antipsychotics, metoclopramide).
Xadago Adverse Reactions
Adverse Reactions
Dyskinesia, fall, nausea, insomnia; serotonin syndrome, withdrawal-emergent hyperpyrexia and confusion, retinal pathology.
Xadago Clinical Trials
See Literature
Xadago Note
Not Applicable
Xadago Patient Counseling
See Literature
