Rasagiline

DRUG INFORMATION

  ADULT
    - Monotherapy: AZILECT 1 mg once daily ( 2.1 ) As adjunct without levodopa: AZILECT
      1 mg once daily ( 2.1 ) As adjunct to levodopa: AZILECT 0.5 mg once daily.
      Source: US FDA label for rasagiline (Azilect), section 'dosage and
      administration', retrieved 2026-08-29
    - 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.
      Source: US FDA label for rasagiline (Azilect), section 'dosage and
      administration', retrieved 2026-08-29
    - 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.
      Source: US FDA label for rasagiline (Azilect), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for rasagiline (Azilect), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - AZILECT should not be used in patients with moderate or severe hepatic impairment
      [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.5 ) and
      Clinical Pharmacology ( 12.3 )] . 8.7 Renal Impairment Dose adjustment of AZILECT
      is not required for patients with mild or moderate renal impairment because
      AZILECT plasma concentrations are not increased in patients with moderate renal
      impairment.
      Source: US FDA label for rasagiline (Azilect), section 'use in specific
      populations', retrieved 2026-08-29
    - Rasagiline has not been studied in patients with severe renal impairment [see
      Clinical Pharmacology ( 12.3 )] .
      Source: US FDA label for rasagiline (Azilect), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Increase dose to 1 mg daily as needed for sufficient clinical response ( 2.1 )
      Patients taking ciprofloxacin or other CYP1A2 inhibitors: AZILECT 0.5 mg once
      daily ( 2.2 , 5.4 ) Patients with mild hepatic impairment: AZILECT 0.5 mg once
      daily.
      Source: US FDA label for rasagiline (Azilect), section 'dosage and
      administration', retrieved 2026-08-29
    - AZILECT should not be used in patients with moderate or severe hepatic impairment
      ( 2.3 , 5.5 ) 2.1 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.
      Source: US FDA label for rasagiline (Azilect), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended doses of AZILECT should not be exceeded because of risk of
      hypertension [see Warnings and Precautions ( 5.1 )]. 2.2 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
      [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.6 ), and Clinical
      Pharmacology ( 12.3 )].
      Source: US FDA label for rasagiline (Azilect), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no adequate data on the developmental risks associated with
      the use of AZILECT in pregnant women.
      Source: US FDA label for rasagiline (Azilect), section 'pregnancy', retrieved
      2026-08-29
    - In animal studies, oral administration of rasagiline to rats during gestation and
      lactation resulted in decreased survival and reduced body weight in the offspring
      at doses similar to those used clinically.
      Source: US FDA label for rasagiline (Azilect), section 'pregnancy', retrieved
      2026-08-29
    - When administered to pregnant animals in combination with levodopa/carbidopa,
      there were increased incidences of fetal skeletal variations in rats and increases
      in embryofetal death and cardiovascular abnormalities in rabbits [see Data] .
      Source: US FDA label for rasagiline (Azilect), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary There are no data on the presence of rasagiline in human milk or the
      effects on the breastfed infant.
      Source: US FDA label for rasagiline (Azilect), section 'nursing mothers',
      retrieved 2026-08-29
    - In rats, rasagiline was shown to inhibit prolactin secretion.
      Source: US FDA label for rasagiline (Azilect), section 'nursing mothers',
      retrieved 2026-08-29
    - The clinical relevance in humans is unknown, and there are no data on the effects
      of rasagiline on prolactin secretion or milk production in humans.
      Source: US FDA label for rasagiline (Azilect), section 'nursing mothers',
      retrieved 2026-08-29