INDICATIONS AND USAGE（适应症）

AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).

DOSAGE（服用剂量）

General Dosing Recommendations

When AZILECT is prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start AZILECT at the recommended dose of 1 mg administered orally once daily.

In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of AZILECT is 0.5 mg once daily. If the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily. When AZILECT is used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response.

The recommended doses of AZILECT should not be exceeded because of risk of hypertension.

Patients Taking Ciprofloxacin or Other CYP1A2 Inhibitors

Patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should not exceed a dose of AZILECT 0.5 mg once daily.

Patients with Hepatic Impairment

Patients with mild hepatic impairment should not exceed a dose of AZILECT 0.5 mg once daily. AZILECT should not be used in patients with moderate or severe hepatic impairment.

ADVERSE REACTIONS（不良反应）

Hypertension

Serotonin Syndrome

Falling Asleep During Activities of Daily Living and Somnolence

Hypotension / Orthostatic Hypotension

Dyskinesia

Hallucinations / Psychotic-Like Behavior

Impulse Control /Compulsive Behaviors

Withdrawal-Emergent Hyperpyrexia and Confusion

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a40d0e73-3f9f-4b01-979d-402c9cdaeb60/spl-doc?hl=rasagiline

Rasalectinformation