Parkinson's disease (PD) and primary Restless Legs Syndrome (RLS)
#仿單變更2021

Pramipexole is a non-ergot dopamine agonist and binds with high selectivity and specificity to the dopamine D2 receptors and has a preferential affinity to D3 receptors; it has full intrinsic activity.

Bioavailability: ＞90 % , time to peak concentration: ∼2 hr.
In humans the protein binding of pramipexole is very low (< 20 %) and the volume of distribution is large (400 L).
Renal excretion of unchanged pramipexole is the major route of elimination and accounts for about 80% of dose.
Elimination half-life: 8-12 hr. Pramipexole is not removed by hemodialysis

Hypersensitivity to pramipexole products

C

Avoided.

abnormal behaviour, abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesias, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, somnolence, weight increase, sudden onset of sleep, withdrawal syndrome<20210115>

Patients with normal to mild renal impairment(ClCr＞60 ml/min), starting dose 0.125 mg ORALLY 3 times per day, MAX 1.5 mg 3 times per day,
Treatment of RLS: initial, 0.125 mg ORALLY once daily 2 - 3 hours before bedtime; May increase by doubling dose every 4 - 7 days to a MAX of 0.5 mg/day; in patients with severe and moderate impairment (ClCr 20~60 mL/min), up-titration every 14 days if needed. The tablet may be taken with food to minimize gastric irritation.

Moderate renal impairment (ClCr 20-50 mL/min) : starting dose 0.125 mg twice daily, MAX 2.25 mg/day
Severe renal impairment (ClCr <20 mL/min): starting dose 0.125 mg once daily, MAX 1.5 mg/day