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Pharmacologic class: Non-ergot dopamine agonist
Therapeutic class: Antidyskinetic
Pregnancy risk category C
Unknown. May directly stimulate post-synaptic dopamine receptors in corpus striatum (unlike levodopa, which may increase brain's dopamine concentration).
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.
• Renal impairment
• Hypersensitivity to drug or its components
Use cautiously in:
• renal impairment
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).
• 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.
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
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
• 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.
• 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.
Mirapex ER(trade name)
ClassificationTherapeutic: antiparkinson agents
Pharmacologic: dopamine agonists
Time/action profile (blood levels)
|PO||unknown||2 hr||8 hr|
|PO-ER||unknown||6 hr||24 hr|
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
- extrapyramidal syndrome
- urges (gambling, sexual)
- orthostatic hypotension
- constipation (most frequent)
- dry mouth (most frequent)
- dyspepsia (most frequent)
- nausea (most frequent)
- tooth disease
- urinary frequency
- leg cramps
Drug-Drug interactionConcurrent levodopa ↑ risk of hallucinations and dyskinesia.Effectiveness may be ↑ by cimetidine.Effectiveness may be ↓ by dopamine antagonists, including butyrophenones, metoclopramide, phenothiazines, or thioxanthenes.
Route/DosageWhen switching from immediate-release to extended-release product, the same total daily dose can be used.
Renal ImpairmentOral (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 ImpairmentOral (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
Renal ImpairmentOral (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)
- 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 DiagnosesImpaired physical mobility (Indications)
Risk for injury (Indications, Side Effects)
- 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.
- 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.
- Decreased tremor and rigidity in Parkinson’s disease.
- Decrease in restless legs and improved sleep.