Pramipexole

IMPORTANT: doses are stated both as pramipexole BASE and as SALT — confirm which the prescribed product is labelled in. Beyond week 3, if further increase is required, raise the daily dose by 0.54 mg base (0.75 mg salt) at weekly intervals up to the maximum. Efficacy was observed in pivotal studies from a daily dose of 1.1 mg base (1.5 mg salt); the incidence of somnolence increases above 1.5 mg salt per day. In advanced Parkinson's disease, doses above 1.1 mg base (1.5 mg salt) per day can be useful where a reduction in levodopa is intended, and levodopa should be reduced during both escalation and maintenance. Discontinuation: taper by 0.54 mg base (0.75 mg salt) per day until the daily dose is 0.54 mg base (0.75 mg salt), then reduce by 0.264 mg base (0.375 mg salt) per day — abrupt discontinuation risks neuroleptic malignant syndrome or dopamine agonist withdrawal syndrome, and a temporary dose increase may be needed before resuming tapering. Restless legs syndrome: start 0.088 mg base (0.125 mg salt) once daily 2 to 3 hours before bedtime, increasing if needed every 4 to 7 days through 0.18 mg base (0.25 mg salt), 0.35 mg base (0.5 mg salt) to a maximum of 0.54 mg base (0.75 mg salt) per day; review response at 3 months; no tapering is required on stopping as the daily dose does not exceed 0.54 mg base (0.75 mg salt). Hepatic impairment: dose adjustment probably not necessary (about 90% of absorbed drug is renally excreted). Paediatric: safety and efficacy in children under 18 years have not been established — not recommended in Parkinson's disease, restless legs syndrome or Tourette disorder. US labelling covers a once-daily EXTENDED-RELEASE tablet (start 0.375 mg once daily, increase no more often than every 5 to 7 days first to 0.75 mg/day then in 0.75 mg increments to a maximum of 4.5 mg/day) — a different formulation from this UK immediate-release SPC.