Pramipexole

Reviewed on 1/26/2022

What Is Pramipexole and How Does It Work?

Pramipexole is a prescription medication used for the treatment of Parkinson’s disease and restless leg syndrome.

  • Pramipexole is available under the following different brand names: Mirapex, Mirapex ER

What Are Dosages of Pramipexole?

Adult and pediatric dosage

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

Parkinson’s Disease

Adult dosage

  • Immediate release: 0.125 mg orally every 8 hours initially; gradually titrated upward at weekly intervals to a target range of 1.5-4.5 mg/day orally divided every 8 hours
  • Extended-release: 0.375 mg/day orally initially; if necessary, maybe increased every 5-7 days, first to 0.75 mg/day and then by increments of 0.75 mg/day; not to exceed 4.5 mg/day

Restless leg syndrome

Adult dosage

  • 0.125 mg/day orally every 2-3 hr before bedtime initially; may be increased every 4-7 days up to 0.5 mg/day (every 14 days if CrCl 20-60 mL/min)

Dosage Considerations – Should be Given as Follows

  • See “Dosages”

SLIDESHOW

Dementia, Alzheimer's Disease, and Aging Brains See Slideshow

What Are Side Effects Associated with Using Pramipexole?

Common side effects of Pramipexole include:

  • muscle spasm or weakness,
  • drowsiness,
  • dizziness,
  • weakness,
  • confusion,
  • memory problems,
  • dry mouth,
  • nausea,
  • constipation,
  • increased urination,
  • sleep problems (insomnia), and
  • unusual dreams

Serious side effects of Pramipexole include:

  • lightheadedness,
  • hallucinations,
  • extreme drowsiness,
  • falling asleep suddenly, even after feeling alert,
  • tremors, twitching or uncontrollable muscle movements,
  • unexplained muscle pain,
  • muscle tenderness or weakness,
  • vision problems, and
  • involuntary bending forward of the neck, waist or tilting sideways while sitting, standing, and walking

Rare side effects of Pramipexole include:

  • none 
This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

What Other Drugs Interact with Pramipexole?

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

What Are Warnings and Precautions for Pramipexole?

Contraindications

  • Hypersensitivity

Effects of drug abuse

  • None

Short-Term Effects

  • See “What Are Side Effects Associated with Using Pramipexole?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Pramipexole?”

Cautions

  • 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 the 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 every 8 hours 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 less than 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
  • Fibrotic complications reported with use; monitor closely for signs and symptoms of fibrosis; discontinuation of therapy may resolve complications but not in all cases
  • Risk of melanoma increases in Parkinson disease patients; monitor closely and perform a periodic skin examination
  • Pathologic degenerative changes observed in retinas of albino rats during studies; significance in humans unclear
  • May cause or exacerbate dyskinesia; use with caution in patients with pre-existing dyskinesias
  • Symptoms resembling neuroleptic malignant syndrome, including elevated temperature, muscular rigidity, altered consciousness, and autonomic instability reported with rapid dose reduction, discontinuation, or changes in therapy; taper dose to decrease the risk of hyperpyrexia and confusion
  • Risk of new-onset heart failure undergoing FDA evaluation (FDA safety announcement 9/19/2012)

Withdrawal symptoms

  • Gradual discontinuance is required over a period of 1 week or longer; symptoms resembling neuroleptic malignant syndrome may occur on abrupt withdrawal
  • Symptoms including apathy, anxiety, depression, fatigue, insomnia, sweating, and pain reported during taper or after discontinuation of dopamine agonists; these symptoms generally do not respond to levodopa
  • Prior to discontinuation, patients should be informed about potential withdrawal symptoms, and monitored during and after discontinuation; in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at the lowest effective dose may be considered

Psychiatric effects

  • Patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, that increase central dopaminergic tone
  • Patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during treatment or after starting or increasing the dose
  • Other drugs prescribed to improve the symptoms of Parkinson’s disease or RLS can have similar effects on thinking and behavior; this abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, symptoms of mania (e.g., insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, and delirium
  • Risk increases with age; dose reduction or discontinuation may reverse these behaviors but not in all cases

Pregnancy and Lactation

  • There are no adequate data on the developmental risk associated with therapy in pregnant women; no adverse developmental effects were reported in animal studies in which pramipexole was administered to rabbits during pregnancy; effects on embryo-fetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures
  • In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively; background risk of major birth defects and miscarriage for the indicated population is unknown
  • Lactation: Not known if drug secreted in breast milk; may inhibit milk production; discontinue the drug, or do not nurse.

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
References
https://reference.medscape.com/drug/mirapex-mirapex-er-pramipexole-343048#6

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