Pramipexol

DRUG INFORMATION

  ADULT
    - Dosing in Patients with Normal Renal Function Initial Treatment Doses should be
      increased gradually from a starting dose of 0.375 mg/day given in three divided
      doses and should not be increased more frequently than every 5 to 7 days.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - In a fixed-dose study in early Parkinson’s disease patients, doses of 3 mg, 4.5
      mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to
      provide any significant benefit beyond that achieved at a daily dose of 1.5
      mg/day.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - The frequency of these events was generally 2-fold greater than placebo for
      pramipexole doses greater than 3 mg/day.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of pramipexole dihydrochloride tablets in pediatric
      patients has not been established.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Dosing in Patients with Renal Impairment The recommended dosing of pramipexole
      dihydrochloride tablets in Parkinson’s disease patients with renal impairment is
      provided in Table 2.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for pramipexole (Pramipexole
      Dihydrochloride), section 'dosage and administration', retrieved 2026-08-29
    - There were no apparent differences in efficacy or safety between older and younger
      patients. 8.6 Renal Impairment The elimination of pramipexole is dependent on
      renal function.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section 'use
      in specific populations', retrieved 2026-08-29
    - Pramipexole clearance is extremely low in dialysis patients, as a negligible
      amount of pramipexole is removed by dialysis.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section 'use
      in specific populations', 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 pramipexole (Pramipexole
      Dihydrochloride), retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no adequate data on the developmental risk associated with
      the use of pramipexole in pregnant women.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - No adverse developmental effects were observed in animal studies in which
      pramipexole was administered to rabbits during pregnancy.
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Effects on embryofetal development could not be adequately assessed in pregnant
      rats; however, postnatal growth was inhibited at clinically relevant exposures
      [see Data].
      Source: US FDA label for pramipexole (Pramipexole Dihydrochloride), section
      'pregnancy', retrieved 2026-08-29

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