Rasalect 1 Special Precautions

Cardiovascular: New onset or exacerbation of hypertension (HTN) may occur; if HTN sustained, dose adjustment may be necessary; monitoring recommended.
Hypotension and orthostatic hypotension have been reported; occurs most often in first 2 months of therapy; risk may increase when used as adjunct therapy.
Dermatologic: Increased risk of melanoma in patients with Parkinson disease; monitoring recommended.
Hepatic: Reduce dose in patients with mild hepatic impairment.
Avoid use in patients with moderate or severe hepatic impairment.
Neurologic: Serotonin syndrome has been reported; concomitant use with certain antidepressants not recommended.
Somnolence and falling asleep during activities of daily living may occur without warning, sometimes more than 1 year after treatment initiation; increased risk with preexisting sleep disorders, concomitant sedatives or drugs that increase rasagiline exposure; monitoring recommended; discontinue with significant episodes.
New or worsening dyskinesia may occur when administered with levodopa; levodopa dose adjustment may lesson reaction.
Hyperpyrexia and confusion resembling neuroleptic malignant syndrome has been reported with abrupt withdrawal, rapid dose reduction, or changes in dopaminergic drugs.
Psychiatric: Hallucinations , new or worsening mental stat us changes, and behavioral changes, including psychotic-like behavior, have been reported when starting, with dose increases, and during therapy; dose reduction or therapy withdrawal may be necessary.
Use in major psychotic disorder not recommended due to risk of psychosis exacerbation.
Impaired impulse control or compulsive behaviors has been reported, including urges to gamble or spend money, increased sexual urges, or binge eating; consider dose reduction or therapy withdrawal.
Concomitant use: Foods with high tyramine content (more than 150 mg) should be avoided; increased risk for large blood pressure elevations, including hypertensive emergency, urgency, or crisis.
Antidepressants (eg, SSRIs, selective norepinephrine reuptake inhibitors, or tricyclic, tetracyclic, or triazolopyridine antidepressants) not recommended; allow at least 14 days between rasagiline discontinuation and antidepressant initiation; wait at least 5 weeks after discontinuing antidepressants with long half-life (eg, fluoxetine, particularly high doses or chronic use) before rasagiline initiation.
Ciprofloxacin and other CYP1A2 inhibitors increases rasagiline exposure; dose adjustment recommended.