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Pramipexole

    DEA Class;  Rx

    Common Brand Names; Mirapex, Mirapex ER

    • Antiparkinson Agents, Dopamine Agonists

    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

    Indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS).

    For the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

    Hypersensitivity

    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

    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

    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

    Adults

    4.5 mg/day PO.

    Geriatric

    4.5 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    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