Classes
DEA Class; Rx
Common Brand Names; Mirapex, Mirapex ER
- Antiparkinson Agents, Dopamine Agonists
Description
Oral non-ergot-derived dopamine agonist
Used for Parkinson’s disease and moderate to severe restless legs syndrome (RLS) in adults
Monitor for hallucinations, psychotic-like behavior, impulse control symptoms, and sleep attacks
Indications
Indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS).
Contraindications
Hypersensitivity
Adverse Effects
Some variations between early Parkinson, advanced Parkinson, and restless legs syndrome
Incidence of some adverse drug reactions (eg, dizziness, accidental injury) but comparable to placebo
- Somnolence
- Dyskinesia
- Hallucinations
- Insomnia
- Dizziness
- Postural hypotension
- Nausea
- Constipation
- Abnormal dreams, thoughts, or vision
- Amnesia
- Confusion
- Paranoia or delusion
- Akathisia
- Asthenia
- Dry mouth
- Urinary frequency
Warnings
May cause sudden daytime “sleep attacks;” inquire about factors that may increase risk of falling asleep, including sleep disorders or taking sedating medications; caution patients about performing tasks requiring mental alertness; discontinue if there is evidence of sleep attacks; if decision is made to continue therapy, advice patient not to perform dangerous activities requiring mental alertness
Orthostatic hypotension may occur, particularly during dose escalation; monitor closely Parkinson patients being treated with dopaminergic agonists, especially during dose escalation
In early Parkinson, dosages higher than 1.5 mg q8hr provided no additional benefit but increased adverse events
Use with caution in renal impairment; dose adjustment may be necessary; do not administer extended release tablets to patients with CrCl<30 mL/min or ESRD requiring hemodialysis
Augmentation or rebound of restless legs syndrome (RLS) may occur with therapy in RLS patients
The elderly may be more prone to adverse effects
Swallow whole; do not chew, crush, or divide extended release tablets
Events reported with dopaminergic therapy include hyperpyrexia and confusion
Pregnancy and Lactation
There are no adequate data on the developmental risk associated with therapy in pregnant women; no adverse developmental effects reported in animal studies in which pramipexole was administered to rabbits during pregnancy; effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures
Lactation: Not known if drug secreted in breast milk; may inhibit milk production; discontinue drug, or do not nurse
Maximum Dosage
4.5 mg/day PO.
4.5 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
How supplied
Pramipexole dihydrochloride
tablet
- 0.125mg
- 0.25mg
- 0.5mg
- 0.75mg
- 1mg
- 1.5mg
tablet, extended release
- 0.375mg
- 0.75mg
- 1.5mg
- 2.25mg
- 3mg
- 3.75mg
- 4.5mg