Mirapex


Also found in: Dictionary.
Related to Mirapex: Restless Leg Syndrome

pramipexole dihydrochloride

Apo-Pramipexole (CA), Mirapex, Mirapex ER, Mirapexin (UK), Novo-Pramipexole (CA), PMS-Pramipexole (CA)

Pharmacologic class: Non-ergot dopamine agonist

Therapeutic class: Antidyskinetic

Pregnancy risk category C

Action

Unknown. May directly stimulate post-synaptic dopamine receptors in corpus striatum (unlike levodopa, which may increase brain's dopamine concentration).

Availability

Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 1.5 mg

Tablets (extended-release): 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, 4.5 mg

Indications and dosages

Idiopathic Parkinson's disease

Adults: Initially, 0.125 mg P.O. t.i.d.; may increase by 0.125 mg q 5 to 7 days over 6 to 7 weeks. Maintenance dosage ranges from 1.5 to 4.5 mg/day in three divided doses. Or, 0.375 mg (extended-release) P.O. daily; may increase no more frequently than every 5 to 7 days, first to 0.75 mg/day and then by 0.75-mg increments up to a maximum recommended dosage of 4.5 mg/day. Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment.

Moderate to severe primary restless leg syndrome

Adults: Initially, 0.125 mg P.O. once daily 2 to 3 hours before bedtime. For patients requiring additional symptomatic relief, increase dosage as needed every 4 to 7 days, up to dosage of 0.5 mg once daily.

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:

• renal impairment

• elderly patients

• pregnant or breastfeeding patients

• children (safety not established).

Administration

• Administer extended-release tablets whole.

• Know that patients may be switched overnight from immediate-release tablets to extended-release tablets at the same daily dose; however, dosage adjustment may be needed in some patients.

• Don't give at same time as other CNS depressants.

• Don't stop therapy abruptly. Taper dosage over 1 week.

Adverse reactions

CNS: headache, dizziness, drowsiness, hallucinations, asthenia, confusion, dyskinesia, insomnia, hypertonia, unsteadiness, sleep attacks, abnormal dreams, amnesia

CV: orthostatic hypotension

EENT: retinal deterioration

GI: nausea, constipation, dyspepsia, dry mouth

GU: urinary frequency, erectile dysfunction

Musculoskeletal: leg cramps

Respiratory: fibrotic complications (such as retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion or thickening)

Skin: rhabdomyolysis (immediate release tablets)

Other: accidental injury, edema

Interactions

Drug-drug. Cimetidine: increased pramipexole blood level

Dopamine antagonists (such as butyro-phenones, metoclopramide, phenothia-zines, thioxanthenes): decreased pramipexole efficacy

Levodopa: increased risk of hallucinations and dyskinesia

Patient monitoring

• Evaluate patient for therapeutic and adverse effects.

• Assess blood pressure; watch for orthostatic hypotension.

• Monitor neurologic status, especially for sleep attacks and extrapyramidal symptoms.

• Watch closely for pulmonary complications.

Patient teaching

• Instruct patient to take drug with food if it causes nausea. Tell him not to take at same time as other CNS depressants.

• Instruct patient to swallow extended-release tablets whole and not to chew, crush, or divide them.

• Advise patient to report respiratory problems, dyskinesia, hallucinations, and sleep attacks.

• Tell patient drug may cause erectile dysfunction. Encourage him to discuss this effect with prescriber.

• Inform patient and family that drug's neurologic and motor effects increase risk of sudden onset of sleep without warning and accidental injury. Teach them ways to prevent injury.

Advise patient and family to contact prescriber if vision changes or unexplained muscle pain, tenderness, or weakness occurs.

• Tell patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure decrease.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

pramipexole

(pra-mi-pex-ole) ,

Mirapex

(trade name),

Mirapex ER

(trade name)

Classification

Therapeutic: antiparkinson agents
Pharmacologic: dopamine agonists
Pregnancy Category: C

Indications

Management of Parkinson’s disease.Restless leg syndrome (immediate-release only).

Action

Stimulates dopamine receptors in the striatum of the brain.

Therapeutic effects

Decreased tremor and rigidity in Parkinson’s disease.
Decreased leg restlessness.

Pharmacokinetics

Absorption: >90% absorbed following oral administration.
Distribution: Widely distributed.
Metabolism and Excretion: 90% excreted unchanged in urine.
Half-life: 8 hr (↑ in geriatric patients and patients with renal impairment).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown2 hr8 hr
PO-ERunknown6 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Renal impairment (↑ dosing interval recommended if CCr <60 mL/min [immediate-release] or CCr <50 mL/min [extended-release]); Obstetric / Lactation / Pediatric: Safety not established; Geriatric: ↑ risk of hallucinations.

Adverse Reactions/Side Effects

Central nervous system

  • sleep attacks (life-threatening)
  • amnesia (most frequent)
  • dizziness (most frequent)
  • drowsiness (most frequent)
  • hallucinations (most frequent)
  • weakness (most frequent)
  • abnormal dreams
  • confusion
  • dyskinesia
  • extrapyramidal syndrome
  • headache
  • insomnia
  • urges (gambling, sexual)

Cardiovascular

  • orthostatic hypotension

Dermatologic

  • melanoma
  • pruritis

Endocrinologic

  • SIADH

Gastrointestinal

  • constipation (most frequent)
  • dry mouth (most frequent)
  • dyspepsia (most frequent)
  • nausea (most frequent)
  • tooth disease

Genitourinary

  • urinary frequency

Musculoskeletal

  • leg cramps

Neurologic

  • hypertonia
  • unsteadiness/falling

Interactions

Drug-Drug interaction

Concurrent levodopa ↑ risk of hallucinations and dyskinesia.Effectiveness may be ↑ by cimetidine.Effectiveness may be ↓ by dopamine antagonists, including butyrophenones, metoclopramide, phenothiazines, or thioxanthenes.

Route/Dosage

When switching from immediate-release to extended-release product, the same total daily dose can be used.

Parkinson's Disease

Oral (Adults) Immediate-release—0.125 mg 3 times daily initially; may be ↑ q 5–7 days (range 1.5–4.5 mg/day in 3 divided doses); Extended-release—0.375 mg once daily; may be ↑ to 0.75 mg once daily in 5–7 days, and then ↑ q 5–7 days by 0.75 mg/day (max dose = 4.5 mg/day).

Renal Impairment

Oral (Adults Immediate-release) CCr 35–59 mL/min—0.125 mg twice daily initially, may be ↑ q 5–7 days up to 1.5 mg twice daily; CCr 15–34 mL/min—0.125 mg daily initially, may be ↑ q 5–7 days up to 1.5 mg daily.

Renal Impairment

Oral (Adults Extended-release) CCr 30–50 mL/min—0.375 mg every other day; may consider ↑ dose to 0.375 mg once daily after 1 wk based on response and tolerability; may ↑ in 0.375 mg increments after 1 wk (max dose = 2.25 mg/day).

Restless Leg Syndrome

Oral (Adults) 0.125 mg daily 1–3 hr before bedtime. May be ↑ at 4–7 day intervals to 0.25 mg daily, then up to 0.5 mg daily.

Renal Impairment

Oral (Adults Immediate-release) CCr 20–60 mL/min—0.125 mg daily 1–3 hr before bedtime. May be ↑ at 14-day intervals to 0.25 mg daily, then up to 0.5 mg daily.

Availability (generic available)

Immediate-release tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 1.5 mg Cost: Generic — 0.125 mg $265.47 / 90, 0.25 mg $277.55 / 90, 0.5 mg $265.47 / 90, 0.75 mg $265.47 / 90, 1 mg $277.55 / 90, 1.5 mg $277.55 / 90
Extended-release tablets: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, 4.5 mg Cost: 0.375 mg $103.92 / 7, 0.75 mg $103.92 / 7, 1.5 mg $103.92 / 7, 2.25 mg $445.40 / 30, 3 mg $445.40 / 30, 3.75 mg $445.40 / 30, 4.5 mg $445.40 / 30

Nursing implications

Nursing assessment

  • Assess patient for confusion or hallucinations. Notify health care professional if these occur.
  • Monitor ECG and BP frequently during dosage adjustment and periodically throughout therapy.
  • Assess patient for drowsiness and sleep attacks. Drowsiness is a common side effect of pramipexole, but sleep attacks or episodes of falling asleep during activities that require active participation may occur without warning. Assess patient for concomitant medications that have sedating effects or may increase serum pramipexole levels (see Interactions). May require discontinuation of therapy.
  • Parkinson's Disease: Assess patient for signs and symptoms of Parkinson’s disease (tremor, muscle weakness and rigidity, ataxia) before and throughout therapy.
  • Restless Leg Syndrome: Assess sleep patterns and frequency of restless leg disturbances.

Potential Nursing Diagnoses

Impaired physical mobility (Indications)
Risk for injury (Indications,  Side Effects)

Implementation

  • Do not confuse Mirapex (pramipexole) with Miralax (polyethylene glycol).
  • An attempt to reduce the dose of levodopa/carbidopa may be made cautiously during pramipexole therapy.
  • Oral: Administer with meals to minimize nausea; usually resolves with continued therapy. Swallow extended-release tablets whole; do not crush, break, or chew.

Patient/Family Teaching

  • Instruct patient to take medication as directed. Take missed doses or immediate-release product as soon as remembered if it is not almost time for next dose. If extended release tablets are missed, skip dose and take next regular dose. Do not double doses. Consult health care professional before reducing dose or discontinuing medication. Advise patient to read the Patient Information sheet before taking and with each Rx refill, changes may occur.
  • May cause drowsiness and unexpected episodes of falling asleep. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Advise patient to notify health care professional if episodes of falling asleep occur.
  • Advise patient to change position slowly to minimize orthostatic hypotension. May occur more frequently during initial therapy.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise patient to have periodic skin exams to check for lesions that may be melanoma.
  • Advise patient to notify health care professional if new or increased gambling, sexual, or other intense urges occur.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding or planning to breast feed.

Evaluation/Desired Outcomes

  • Decreased tremor and rigidity in Parkinson’s disease.
  • Decrease in restless legs and improved sleep.

Mirapex

(mîr′ə-pĕks′)
A trademark for the drug pramipexole.

Mirapex®

Pramipexole, see there.
References in periodicals archive ?
According to IMS Health, the MIRAPEX ER brand and generic had US sales of about USD48.3m MAT for the most recent 12 months ending in June 2015.
In 2008 they took Neupro patch off the market, and they put him on Mirapex and levodopa instead.
Hauser found that PD patients who failed to obtain good symptom control after taking a certain dopamine agonist drug, such as apomorphine (Apokyn), pramipexole (Mirapex), or ropinirole (Requip), achieved much greater symptom relief by taking the commonly prescribed PD drug rasagiline (Azilect).
Influence of dopamine agonist pramipexole (mirapex) on tremor, cognitive and affective impairment in patients with Parkinson's disease.
Ropinirole (Requip) and pramipexole (Mirapex) are FDA-approved to treat moderate to severe RLS.
Current treatments for PD involve dopamine agonists--drugs such as Mirapex (pramipexole) and Requip (ropinirole), which functionally mimic the effects of dopamine in the brain--and Comtan (entacapone) in conjunction with levodopa, the widely-used and effective PD medication that converts to dopamine.
For example, drugs to treat Parkinson's disease, including ropinirole (Requip) and pramipexole (Mirapex), also have FDA approval to treat moderate-to-severe RLS.
The FDA is currently working with Boehringer Ingelheim, which markets pramipexole as Mirapex, to investigate this association further and will provide an update when more information is available.
Parker, a Partner in Venable 's Products" Liability Practice Group, has served on several mass tort litigation trial teams, including breast implants, diesel exhaust, latex gloves, Gelfoam, Mirapex, and Vioxx.
In 2000, he began taking Mirapex, a "dopamine agonist" that stimulates the dopamine receptors in the brain to alleviate the tremors and other symptoms of Parkinson's.
Teva credited its North American results to sales of a generic version of the Parkinson's disease drug Mirapex that was launched during the quarter, along with strong sales of its versions of Adderall XR for attention deficit hyperactivity disorder, the child asthma medication Pulmicort, Accutane for acne, and the colon cancer drug Eloxatin.
In one report, 1,356 of 3,006 fibromyalgia patients had taken at least one dose of a dopamine agonist, and 21 developed compulsive gambling, shopping, or both after taking a mean of 4.5 mg of pramipexole (Mirapex) at bedtime for 14.4 months.