Rotigotine

DRUG INFORMATION

  ADULT
    - Parkinson's disease: Initially, 2 mg/24 hours for early-stage disease or 4 mg/24
      hours for advanced-stage disease.
      Source: US FDA label for rotigotine (Neupro), section 'dosage and administration',
      retrieved 2026-08-29
    - The dose may be increased as needed by 2 mg/24 hours at weekly intervals, up to 6
      mg/24 hours for early-stage disease and up to 8 mg/24 hours for advanced-stage
      disease.
      Source: US FDA label for rotigotine (Neupro), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.1 ) Restless Legs Syndrome: Initially, 1 mg/24 hours, increased as needed by 1
      mg/24 hours at weekly intervals, up to 3 mg/24 hours.
      Source: US FDA label for rotigotine (Neupro), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients for any indication have not been
      established.
      Source: US FDA label for rotigotine (Neupro), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - Monitor for weight gain and fluid retention when treating patients with
      concomitant illnesses such as congestive heart failure or renal insufficiency. 5.9
      Dyskinesia NEUPRO may potentiate the dopaminergic side effects of levodopa and may
      cause or exacerbate pre-existing dyskinesia.
      Source: US FDA label for rotigotine (Neupro), section 'warnings and cautions',
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for rotigotine (Neupro), retrieved
      2026-08-29

  PREGNANCY
    - Risk Summary There are no adequate data on the developmental risk associated with
      the use of NEUPRO in pregnant women.
      Source: US FDA label for rotigotine (Neupro), section 'pregnancy', retrieved
      2026-08-29
    - In animal studies, rotigotine was shown to have adverse effects on embryofetal
      development when administered during pregnancy at doses similar to or lower than
      those used clinically [ see Data ].
      Source: US FDA label for rotigotine (Neupro), section 'pregnancy', retrieved
      2026-08-29
    - In the U.S. general population, the estimated background risk of major birth
      defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and
      15% to 20%, respectively.
      Source: US FDA label for rotigotine (Neupro), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In a study in which rotigotine was administered subcutaneously (0, 0.1, 0.3, or 1
      mg/kg/day) to rats throughout pregnancy and lactation (gestation day 6 through
      postnatal day 21), impaired growth and development during lactation and long-term
      neurobehavioral abnormalities were observed in the offspring at the highest dose
      tested; when those offspring were mated, growth and survival of the next
      generation were adversely affected.
      Source: US FDA label for rotigotine (Neupro), section 'use in specific
      populations', retrieved 2026-08-29
    - The no- effect dose for pre- and postnatal developmental toxicity (0.3 mg/kg/day)
      is less than the MRHD on a mg/m 2 basis. 8.2 Lactation Risk Summary There are no
      data on the presence of rotigotine in human milk, the effects of rotigotine on the
      breastfed infant, or the effects of rotigotine on milk production.
      Source: US FDA label for rotigotine (Neupro), section 'use in specific
      populations', retrieved 2026-08-29
    - However, inhibition of lactation may occur because rotigotine decreases secretion
      of prolactin in humans.
      Source: US FDA label for rotigotine (Neupro), section 'use in specific
      populations', retrieved 2026-08-29