Buy Mirapex Online

Mirapex (pramipexole dihydrochloride)

THERAPEUTIC CLASS

Non-ergot dopamine agonist

DEA CLASS

RX

INDICATIONS

Treatment of Parkinson's disease and moderate to severe primary restless legs syndrome (RLS).

ADULT DOSAGE

Parkinson's Disease

Initial: 0.125mg tid
Titrate: May increase gradually not more frequently than every 5-7 days (eg, Week 2: 0.25mg tid; Week 3: 0.5mg tid; Week 4: 0.75mg tid; Week 5: 1mg tid; Week 6: 1.25mg tid; Week 7: 1.5mg tid)
Maint: 0.5-1.5mg tid in equally divided doses w/ or w/o levodopa

If a significant interruption in therapy has occurred, retitration may be warranted

Restless Legs Syndrome

Primary, Moderate to Severe:
Initial: 0.125mg qd
Titrate: May increase dose every 4-7 days up to 0.5mg/day, if needed

Titration Step 1: 0.125mg qd
Titration Step 2: 0.25mg qd
Titration Step 3: 0.5mg qd
If a significant interruption in therapy has occurred, retitration may be warranted

Administer 2-3 hrs before hs

DOSING CONSIDERATIONS

Renal Impairment
Parkinson's Disease:
Mild (CrCl >50mL/min):
Initial: 0.125mg tid
Max: 1.5mg tid

Moderate (CrCl 30-50mL/min):
Initial: 0.125mg bid
Max: 0.75mg tid

Severe (CrCl 15-<30mL/min):
Initial: 0.125mg qd
Max: 1.5mg qd

Restless Legs Syndrome:
Moderate and Severe Renal Impairment (CrCl 20-60mL/min):
Increase duration between titration steps to 14 days

Discontinuation
Parkinson's Disease:
Taper off at a rate of 0.75mg/day until daily dose has been reduced to 0.75mg, then reduce dose by 0.375mg/day

ADMINISTRATION

Oral route

Take w/ or w/o food

HOW SUPPLIED

Tab: 0.125mg, 0.25mg*, 0.5mg*, 0.75mg, 1mg*, 1.5mg* *scored

WARNINGS/PRECAUTIONS

Falling asleep during activities of daily living and somnolence reported; reassess for drowsiness or sleepiness, and d/c if significant daytime sleepiness or episodes of falling asleep during activities that require active participation develops. May impair mental/physical abilities. May cause orthostatic hypotension; monitor for signs/symptoms, especially during dose escalation. May cause 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 on therapy; consider dose reduction or discontinuation of therapy. Hallucinations and new/worsening mental status and behavioral changes reported; avoid w/ major psychotic disorder. May cause or exacerbate preexisting dyskinesia. Rhabdomyolysis and retinal deterioration reported. Symptom complex resembling the neuroleptic malignant syndrome reported w/ rapid dose reduction, withdrawal of, or changes in dopaminergic therapy; if possible, avoid sudden discontinuation/rapid dose reduction, or taper dose if discontinuing therapy. May cause fibrotic complications (eg, retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, cardiac valvulopathy). Monitor for melanomas frequently and regularly; perform periodic skin examinations. Rebound and augmentation in RLS reported.

ADVERSE REACTIONS

Nausea, dizziness, somnolence, insomnia, constipation, asthenia, hallucinations, anorexia, peripheral edema, amnesia, confusion, headache, diarrhea, dreaming abnormalities, fatigue.

DRUG INTERACTIONS

Sedating medications or alcohol, and medications that increase plasma levels of pramipexole (eg, cimetidine) may increase risk of drowsiness. Dopamine antagonists, (eg, neuroleptics [phenothiazines, butyrophenones, thioxanthenes] or metoclopramide) may diminish effectiveness. May potentiate dopaminergic side effects of levodopa; consider dose reduction of levodopa.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Non-ergot dopamine agonist; not established. In Parkinson's disease, suspected to stimulate dopamine receptors in the striatum.

PHARMACOKINETICS

Absorption: Rapid. Absolute bioavailability (>90%); Tmax=approx 2 hrs. Distribution: Vd=500L; plasma protein binding (15%). Elimination: Urine (90% unchanged); T1/2=8 hrs (healthy), 12 hrs (elderly).

ASSESSMENT

Assess for preexisting dyskinesia, major psychotic disorder, sleep disorders, renal impairment, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for drowsiness or sleepiness, orthostatic hypotension, impulse control/compulsive behaviors, hallucinations, new/worsening mental status and behavioral changes, signs/symptoms of rhabdomyolysis, retinal deterioration, fibrotic complications, melanomas (frequently and regularly), withdrawal symptoms, and other adverse reactions.

PATIENT COUNSELING

Instruct to take as prescribed. If a dose is missed, advise not to double the next dose. Advise that the occurrence of nausea may be reduced if taken w/ food. Instruct not to take both immediate-release pramipexole and extended-release pramipexole. Advise and alert about the potential sedating effects, including somnolence and the possibility of falling asleep while engaged in activities of daily living; instruct not to drive a car or engage in other potentially dangerous activities until the patient has gained sufficient experience w/ pramipexole tabs to gauge whether or not it affects the patient's mental and/or motor performance adversely. Advise to inform physician if taking alcohol or other sedating medications. Inform of the possibility to experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge eating, and/or other intense urges, and of the inability to control these urges. Inform that hallucinations and other psychotic-like behavior may occur. Advise that postural (orthostatic) hypotension may develop w/ or w/o symptoms. Advise to monitor for melanomas frequently and regularly. Instruct to notify physician if pregnant/intending to become pregnant during therapy or breastfeeding/intending to breastfeed.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light.

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