Dosing & Administration

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The recommended starting dose of MIRAPEX is 0.125 mg/day.

Ascending Dosage Schedule of MIRAPEX for RLS⁹

^†If needed

Starter Kit

MIRAPEX tablets should be taken once daily, 2 to 3 hours before bedtime
MIRAPEX may be taken with or without food
Recommended starting dose is 0.125 mg once daily
If needed, dose may be increased every 4 to 7 days
Clinical trials included up to 0.75 mg per day
- There is no evidence in controlled clinical trials that the 0.75 mg dose provides additional benefit beyond the 0.5 mg doses.
In RLS patients with severe and moderate renal impairment (creatinine clearance 20-60 mL/min), the duration between titration steps should be increased to 14 days

Important points about administration of MIRAPEX for the treatment of RLS:

MIRAPEX should be taken 2 to 3 hours before bedtime every night regardless of whether or not a patient is experiencing RLS symptoms
If a patient misses a dose of MIRAPEX, the next dose should not be doubled
MIRAPEX can be taken with or without food. For some patients, taking MIRAPEX with food may lessen the chance of having nausea
MIRAPEX is primarily eliminated by the renal system. Consequently, caution should be exercised in patients with renal insufficiency due to the possibility of impaired drug clearance
Patients should be informed about the potential sedating effects associated with MIRAPEX, including the chance of falling asleep during normal daily activities such as driving an automobile
Patients should be informed about the possibility of additive somnolent effects from MIRAPEX treatment concomitant with alcohol, sedative medication, or medication that can increase plasma levels of pramipexole (eg, cimetidine)
Patients may experience symptomatic postural hypotension while taking MIRAPEX. This is most likely to occur when beginning treatment or during dose escalation. Consequently, patients should be cautioned against standing up rapidly from a seated or prone position
Hallucinations have been reported in patients taking MIRAPEX. While uncommon in patients taking MIRAPEX for RLS, the risk is greater in patients who are taking MIRAPEX for Parkinson's disease

Efficacy of MIRAPEX

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Important Information about MIRAPEX: MIRAPEX is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Hallucinations and postural (orthostatic) hypotension may occur. In clinical trials for RLS, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea (16% vs. 5%), headache (16% vs. 15%), fatigue (9% vs. 7%) and somnolence (6% vs. 3%).

Patients and caregivers should be informed that impulse control disorders and compulsive behaviors have been reported in patients taking dopamine agonists, including MIRAPEX.

This information is intended for U.S. residents only. Products discussed herein may have different labeling in different countries.

Please see full Prescribing Information, including patient information.