Ropinirole

DRUG INFORMATION

  ADULT
    - Ropinirole extended-release tablets are taken once daily, with or without food;
      tablets must be swallowed whole and not be chewed, crushed, or divided ( 2.1 ) The
      recommended starting dose is 2 mg taken once daily for 1 to 2 weeks, the dose
      should be increased by 2 mg/day at 1 week or longer intervals.
      Source: US FDA label for ropinirole (Ropinirole), section 'dosage and
      administration', retrieved 2026-08-29
    - If a significant interruption in therapy with ropinirole extended-release tablets
      has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s
      Disease The recommended starting dose of ropinirole extended-release tablets is 2
      mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at weekly
      or longer intervals, based on therapeutic response and tolerability.
      Source: US FDA label for ropinirole (Ropinirole), section 'dosage and
      administration', retrieved 2026-08-29
    - In fixed-dose studies designed to characterize the dose response to ropinirole
      extended-release tablets, there was no additional therapeutic benefit shown in
      patients with advanced stage Parkinson’s disease taking daily doses greater than 8
      mg/day, or with early stage Parkinson’s disease taking doses greater than 12
      mg/day [see Clinical Studies ( 14.1 and 14.2 )] .
      Source: US FDA label for ropinirole (Ropinirole), section 'dosage and
      administration', retrieved 2026-08-29

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

  RENAL IMPAIRMENT
    - Renal Impairment No dose adjustment is necessary in patients with moderate renal
      impairment (creatinine clearance of 30 to 50 mL/min).
      Source: US FDA label for ropinirole (Ropinirole), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended maximum total daily dose is 18 mg/day in patients receiving
      regular dialysis.
      Source: US FDA label for ropinirole (Ropinirole), section 'dosage and
      administration', retrieved 2026-08-29
    - Supplemental doses after dialysis are not required.
      Source: US FDA label for ropinirole (Ropinirole), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - The use of ropinirole extended-release tablets in patients with severe renal
      impairment (creatinine clearance <30 mL/min) without regular dialysis has not been
      studied. 8.7 Hepatic Impairment The pharmacokinetics of ropinirole have not been
      studied in patients with hepatic impairment.
      Source: US FDA label for ropinirole (Ropinirole), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no adequate data on the developmental risk associated with
      the use of ropinirole extended-release tablets in pregnant women.
      Source: US FDA label for ropinirole (Ropinirole), section 'pregnancy', retrieved
      2026-08-29
    - In animal studies, ropinirole had adverse effects on development when administered
      to pregnant rats at doses similar to (neurobehavioral impairment) or greater than
      (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s
      disease.
      Source: US FDA label for ropinirole (Ropinirole), section 'pregnancy', retrieved
      2026-08-29
    - Ropinirole doses associated with teratogenicity and embryolethality in pregnant
      rats were associated with maternal toxicity.
      Source: US FDA label for ropinirole (Ropinirole), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary There are no data on the presence of ropinirole in human milk, the
      effects of ropinirole on the breastfed infant, or the effects of ropinirole on
      milk production.
      Source: US FDA label for ropinirole (Ropinirole), section 'nursing mothers',
      retrieved 2026-08-29
    - However, inhibition of lactation is expected because ropinirole inhibits secretion
      of prolactin in humans.
      Source: US FDA label for ropinirole (Ropinirole), section 'nursing mothers',
      retrieved 2026-08-29
    - Ropinirole or metabolites, or both, are present in rat milk.
      Source: US FDA label for ropinirole (Ropinirole), section 'nursing mothers',
      retrieved 2026-08-29