Get advice for managing Multiple Sclerosis: Watch the video.

Pramipexole Dihydrochloride

Pronunciation

Class: Nonergot-derivative Dopamine Receptor Agonists
VA Class: CN500
Chemical Name: (S)-4,5,6,7-Tetrahydro-N6-propyl,2,6-benzothiazolediamine
Molecular Formula: C10H17N3S
CAS Number: 104632-26-0
Brands: Mirapex, Mirapex ER

Warning(s)

Special Alerts:

[Posted 09/19/2012] ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with pramipexole (Mirapex). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether pramipexole increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with pramipexole and will update the public when more information is available.

FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with pramipexole than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with pramipexole use. However, study limitations make it difficult to determine whether excess heart failure was related to pramipexole use or other influencing factors (see FDA Drug Safety Communication Data Summary for a detailed discussion of the studies).

BACKGROUND: Pramipexole is a prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome, in a class of medicines called dopamine agonists.

RECOMMENDATION: At this time, FDA has not concluded that pramipexole increases the risk of heart failure. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing pramipexole. Patients should continue to take their pramipexole as directed and should contact their health care professional if they have any questions or concerns. For more information visit the FDA website at: and .

Introduction

Nonergot-derivative dopamine receptor agonist.1 2 3 6 7 8 9 15 16 17 18 19 25

Uses for Pramipexole Dihydrochloride

Parkinsonian Syndrome

Symptomatic management of idiopathic parkinsonian syndrome.1 2 6 7 8 9 10 13 14 15 16 17 18 19 25 34 35 37

Slideshow: Prescription Drug Addiction - Are You at Risk?

Used as an adjunct to levodopa for the symptomatic management of parkinsonian syndrome in patients with advanced disease.23 24

Also used as monotherapy for the initial symptomatic management of parkinsonian syndrome.23 Most clinicians would use levodopa for initial therapy in individuals >70 years of age (less likely than younger individuals to develop levodopa-related motor complications and because of concerns about cognitive dysfunction), in patients with cognitive impairment, and in those with severe disease.23 A dopamine receptor agonist may be preferred for initial therapy in patients ≤70 years of age.23

Restless Legs Syndrome

Symptomatic management of moderate-to-severe primary restless legs syndrome (Ekbom syndrome).1 26 28 29 30 31 32 33

Pramipexole Dihydrochloride Dosage and Administration

Administration

Oral Administration

Conventional Tablets

Parkinsonian syndrome: Usually administered in 3 equally divided doses daily.1

Restless legs syndrome: Administer once daily 2–3 hours before bedtime.1

May be administered without regard to meals;20 however, taking the drug with food may reduce the occurrence of nausea.1

Extended-release Tablets

Parkinsonian syndrome: Administer once daily.25

Swallow tablet whole; do not chew, crush, or divide.25

May be administered without regard to meals; however, taking the drug with food may reduce the occurrence of nausea.25

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as pramipexole dihydrochloride; dosage expressed in terms of the monohydrated form of this salt.1 25

Initiate at low dosage and titrate slowly based on response and tolerability.1 25 Increases in BP and heart rate observed in healthy individuals when dosage titrated up to 4.5 mg daily more quickly (i.e., every 3 days) than is recommended.1 25

Adults

Parkinsonian Syndrome
Conventional Tablets
Oral

Initiate at a low dosage and increase slowly (at intervals of at least 5–7 days) until the maximum therapeutic response is achieved.1

Table 1. Usual Initial Dosage of Pramipexole Dihydrochloride (as Conventional Tablets) for the Treatment of Parkinsonian Syndrome1

Week of Therapy

Daily Dosage Schedule

Total Daily Dose

1

0.125 mg 3 times daily

0.375 mg daily

2

0.25 mg 3 times daily

0.75 mg daily

3

0.5 mg 3 times daily

1.5 mg daily

4

0.75 mg 3 times daily

2.25 mg daily

5

1 mg 3 times daily

3 mg daily

6

1.25 mg 3 times daily

3.75 mg daily

7

1.5 mg 3 times daily

4.5 mg daily

Continually reevaluate and adjust the dosage according to the needs of the patient in an effort to find a dosage schedule that provides maximum relief of symptoms with minimum adverse effects.1 17

In a fixed-dose study in patients with early parkinsonian syndrome, dosages >1.5 mg daily (i.e., 3, 4.5, or 6 mg daily) were not associated with additional therapeutic benefit.1 As the dosage increased over the range from 1.5 mg to 6 mg daily, the incidence of postural hypotension, nausea, constipation, somnolence, and amnesia increased.1

When pramipexole is used as an adjunct to levodopa, consider reducing the levodopa dosage.1

Discontinue pramipexole therapy gradually over a period of 1 week.1 (See Nervous System and Muscular Effects under Cautions.)

Extended-release Tablets
Oral

Initiate at a low dosage and increase slowly (at intervals of at least 5–7 days) based on response and tolerability assessed after ≥5 days at each dosage level.25

Initially, 0.375 mg once daily; if needed, may increase to 0.75 mg once daily and then increase in 0.75-mg increments up to maximum of 4.5 mg once daily.25

If therapy is interrupted for a substantial period of time, retitration of dosage may be warranted.25

Discontinue pramipexole therapy gradually over a period of 1 week.25 (See Nervous System and Muscular Effects under Cautions.)

Switching from Conventional Tablets to Extended-release Tablets
Oral

Switch patient overnight from conventional tablets to extended-release tablets at the same total daily dosage.25 Because some patients may require dosage adjustment,25 36 monitor patient to determine if dosage adjustment is necessary.25

Restless Legs Syndrome
Oral

Initially, 0.125 mg (as conventional tablets) once daily.1 If relief is inadequate, may increase dosage at intervals of 4–7 days to 0.25 mg daily and then to 0.5 mg daily.1

Was discontinued without gradual reduction in dosage in clinical trials evaluating dosages up to 0.75 mg daily; however, in a 26-week trial, abrupt discontinuance resulted in rebound in symptoms.1 (See Rebound and Augmentation in Restless Legs Syndrome under Cautions.)

Prescribing Limits

Adults

Parkinsonian Syndrome
Extended-release Tablets
Oral

Maximum 4.5 mg once daily.25 Dosages >4.5 mg daily not evaluated in clinical trials.25

Restless Legs Syndrome
Oral

No evidence that 0.75 mg daily provides additional benefit compared with 0.5 mg daily.1

Special Populations

Renal Impairment

Parkinsonian Syndrome

Modify dose and/or frequency of administration in response to the degree of renal impairment.1 17

Conventional Tablets
Oral
Table 2. Recommended Dosage of Pramipexole Dihydrochloride (as Conventional Tablets) for Patients with Renal Impairment115

Clcr

Initial Dosage

Maximum Dosage

≥60 mL/minute

0.125 mg 3 times daily

1.5 mg 3 times daily

35–59 mL/minute

0.125 mg twice daily

1.5 mg twice daily

15–34 mL/minute

0.125 mg once daily

1.5 mg once daily

<15 mL/minute

Not adequately studied; no specific recommendation

Hemodialysis

Not adequately studied; no specific recommendation

Extended-release Tablets
Oral

Clcr >50 mL/minute: Dosage adjustment not required.25

Clcr 30–50 mL/minute: Initiate therapy with every-other-day dosing schedule; carefully assess response and tolerability before increasing to daily dosing after 1 week and before any further dosage titration.25 Increase dosage in 0.375-mg increments at intervals of at least 1 week, up to maximum dosage of 2.25 mg once daily.25

Clcr <30 mL/minute or hemodialysis: Extended-release tablets not studied and not recommended.25

Restless Legs Syndrome
Oral

Clcr 20–60 mL/minute: Increase interval between dosage adjustments to 14 days.1

Geriatric Patients

No dosage adjustments necessary, since therapy is initiated at a low dosage and titrated according to clinical response.1 25

Cautions for Pramipexole Dihydrochloride

Contraindications

  • Known hypersensitivity to pramipexole dihydrochloride or to any ingredient in the formulation.1

Warnings/Precautions

Somnolence

Sudden, irresistible attacks of sleep that resemble narcolepsy have been reported in patients treated with pramipexole.1 20 21 22 25 Episodes of falling asleep while engaged in activities of daily living (e.g., business meetings, telephone calls, driving), which occasionally resulted in accidents, have been reported,1 20 21 22 23 25 in some cases as late as 1 year after initiation of pramipexole therapy.1 20 21 22 25 Some patients perceived no warning signs (e.g., excessive drowsiness) and believed that they were alert immediately prior to the event;1 20 21 22 23 25 many experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history.1 20 21 23 25

Patients with a history of sleep disorders (e.g., somnolence) or those taking multiple drugs known to cause sedation may be at increased risk of experiencing sudden sleep onset.20 Sleep attacks appear to occur more frequently at higher dosages but may occur at any dosage.20

Somnolence is common at dosages >1.5 mg daily.1 20 21 Somnolence reported in 6% of patients with restless legs syndrome receiving dosages of 0.25–0.75 mg daily.1

Patients should not drive or operate other machinery until effects on the individual are known.1 25

Continually reassess patients for drowsiness or sleepiness.1 20 21 22 25 Patients may not acknowledge drowsiness or sleepiness until directly questioned about such adverse effects during specific activities.1 20 21 25 Ask patients about any factors that may increase the risk of somnolence (e.g., concomitant sedating drugs, the presence of sleep disorders, concomitant drugs that increase plasma pramipexole concentrations).1 20 21 25

Pramipexole generally should be discontinued if a patient develops clinically important daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating).1 20 21 25 If the drug is continued, the patient should be advised not to drive and to avoid other potentially dangerous activities.1 20 21 25 Insufficient information to establish that dosage reduction will eliminate episodes of falling asleep while engaged in activities of daily living.1 20 21 25

Impulse Control

Intense urges and compulsive behaviors (e.g., urge to gamble, increased sexual urges, binge eating, uncontrolled spending, other intense urges) and inability to control these urges reported in some patients receiving agents that increase central dopaminergic tone (including pramipexole).1 25 Although causal relationship not established, urges stopped in some cases when dosage was reduced or drug was discontinued.1 25

Consider reducing dosage or discontinuing pramipexole if patient develops such urges.1 25

Hallucinations

Potential for hallucinations, particularly in geriatric patients.1 25

Symptomatic Hypotension

Dopamine agonists appear to impair systemic regulation of BP in patients with parkinsonian syndrome; patients with parkinsonian syndrome appear to have an impaired capacity to respond to an orthostatic challenge.1 25

Use of dopamine agonists in patients with parkinsonian syndrome or restless legs syndrome ordinarily requires careful monitoring for manifestations of orthostatic hypotension, especially during dosage escalation.1 25 Symptomatic orthostatic hypotension occurred in 3 or 1% of patients with parkinsonian syndrome receiving extended-release pramipexole or placebo, respectively, in clinical trials.25 Unexpectedly, the reported incidence of clinically important orthostatic hypotension with pramipexole conventional tablets in patients with parkinsonian syndrome did not differ from that with placebo in clinical trials;1 however, a dose-dependent increase in the incidence of postural hypotension occurs over a pramipexole dihydrochloride dosage range of 1.5–6 mg daily.1

Caution patients about rising rapidly after sitting or lying down, especially if they have been in a seated or recumbent position for prolonged periods and/or if they are just beginning pramipexole therapy.1 25

Rhabdomyolysis

Rhabdomyolysis reported in at least 1 patient with advanced parkinsonian syndrome treated with pramipexole.1 25

Nervous System and Muscular Effects

Although not reported in clinical trials with pramipexole, a symptom complex resembling neuroleptic malignant syndrome (e.g., elevated temperature, muscular rigidity, altered consciousness, autonomic instability) has been reported in association with rapid dosage reduction of, withdrawal of, or changes in antiparkinsonian therapy.1 25

If pramipexole therapy for parkinsonian syndrome is discontinued, gradual dosage reduction over a period of 1 week is recommended; in some studies, however, abrupt discontinuance was uneventful.1 25

Dyskinesia

May potentiate adverse dopaminergic effects of levodopa and may cause or exacerbate preexisting dyskinesias.1 7 8 11 13 25 Reduction of levodopa dosage may ameliorate dyskinesia.1

Fibrotic Effects

Retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, thickening of pleura, pericarditis, and cardiac valvulopathy reported in patients receiving ergot-derivative dopamine receptor agonists (e.g., bromocriptine, pergolide);1 25 presumably related to the ergoline structure of these agents.1 25 Not known whether non-ergot-derived drugs that increase dopaminergic activity (e.g., pramipexole) may induce similar changes.1 25

Possible fibrotic complications (e.g., peritoneal, pleural, or pulmonary fibrosis) reported during postmarketing experience with pramipexole.1 25 Causal relationship not established; the possibility that pramipexole may have a contributory role cannot be excluded.1 25

Ocular Effects

Retinal degeneration reported in albino rats and thinning of outer nuclear layer of the retina reported in pigmented rats receiving pramipexole for 2 years; similar changes not observed in albino mice, monkeys, or minipigs.1 25 Clinical importance in humans not established.1 25

Melanoma

Melanoma observed more frequently in patients with parkinsonian syndrome than in the general population.1 25 Unclear whether increased risk is related to the disease or to other factors (e.g., antiparkinsonian drugs).1 25

Monitor for melanoma on a frequent and regular basis, regardless of the indication for use.1 25 Manufacturer recommends periodic skin examinations performed by appropriately qualified individuals (e.g., dermatologists).1 25

Rebound and Augmentation in Restless Legs Syndrome

Augmentation of symptoms of restless legs syndrome (e.g., earlier onset of symptoms in the evening or afternoon, increase in symptoms, spread of symptoms to involve other extremities) reported; incidence increased with increasing duration of pramipexole treatment.1

Rebound in symptoms following abrupt discontinuance of therapy also reported; worsening of symptoms generally considered mild.1

Incidence, severity, and management of augmentation and/or rebound in patients receiving long-term pramipexole therapy not adequately evaluated.1

Specific Populations

Pregnancy

Category C.1 25

Lactation

Appears to be distributed into milk in rats.1 25 Not known whether pramipexole is distributed into human milk.1 25 Pramipexole inhibits prolactin secretion.1 25 Discontinue nursing or the drug.1 25

Pediatric Use

Safety and efficacy not established in children.1 20 25

Geriatric Use

Geriatric patients are at increased risk for hallucinations.1 25 No other apparent differences in efficacy or safety between geriatric patients and younger adults.1

Renal Impairment

Use with caution.1 25 Clearance is decreased.1 25 Adjust dosage according to degree of renal impairment.1 15 25 (See Renal Impairment under Dosage and Administration.)

Safety and efficacy not evaluated systematically in patients with severe renal impairment or in those undergoing hemodialysis.1 25 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Patients with early parkinsonian syndrome (without levodopa): Nausea,1 25 dizziness,1 25 somnolence,1 25 insomnia,1 asthenia,1 fatigue,25 muscle spasms,25 dry mouth,25 constipation,1 25 hallucinations,1 25 general edema,1 peripheral edema.1 25

Patients with advanced parkinsonian syndrome (with concomitant levodopa): Postural hypotension,1 dyskinesia,1 25 extrapyramidal syndrome,1 insomnia,1 dizziness,1 hallucinations,1 25 accidental injury,1 headache,25 dream abnormalities,1 confusion,1 asthenia,1 nausea,25 anorexia,25 constipation,1 25 somnolence,1 dystonia,1 dry mouth,1 gait abnormalities,1 hypertonia,1 amnesia,1 urinary frequency.1

Patients with restless legs syndrome: Nausea,1 headache,1 fatigue,1 insomnia,1 somnolence,1 abnormal dreams,1 diarrhea,1 nasal congestion,1 influenza,1 pain in extremity.1

Interactions for Pramipexole Dihydrochloride

Does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2E1, 3A4, or 2D6 at usual plasma concentrations; is not appreciably metabolized by CYP isoenzymes.1 25

Drugs Eliminated via Renal Secretion

Drugs that are secreted by the cationic transport system may decrease the oral clearance of pramipexole by about 20%; those secreted by the anionic transport system are likely to have little effect on the oral clearance of pramipexole.1 25

Dopamine Antagonists

Possible pharmacodynamic interaction, resulting in diminished effectiveness of pramipexole.1 25

Specific Drugs

Drug

Interaction

Comments

Amantadine

Possible slight decrease in oral clearance of pramipexole1 25

Antacids

May reduce oral clearance of pramipexole by about 25%25

Anticholinergic agents

Effect on oral clearance of pramipexole is unlikely25

Antipsychotic agents (e.g., phenothiazines, butyrophenones, thioxanthenes)

Dopamine antagonist activity of the antipsychotic agent may diminish effectiveness of pramipexole1 25

Cephalosporins

Effect on oral clearance of pramipexole is unlikely1 25

Chlorpropamide

Effect on oral clearance of pramipexole is unlikely1 25

CNS depressants (e.g., alcohol, antidepressants, antipsychotics, benzodiazepines)

Possible additive sedative effects1 20 21 25

Diltiazem

Diltiazem is secreted by the cationic transport system and may decrease oral clearance of pramipexole1 25

Histamine H2-receptor antagonists

Cimetidine-induced inhibition of renal tubular secretion of organic bases via the cationic transport system increases the AUC and prolongs the half-life of pramipexole1 25

Ranitidine is secreted by the cationic transport system and may decrease oral clearance of pramipexole1 25

H2-receptor antagonists otherwise unlikely to alter oral clearance of pramipexole25

Hydrochlorothiazide

Effect on oral clearance of pramipexole is unlikely1 25

Indomethacin

Effect on oral clearance of pramipexole is unlikely1 25

Levodopa

Additive therapeutic and/or adverse (e.g., dyskinesia) effects; peak plasma levodopa concentration may be higher and occur sooner after administration, but extent of levodopa absorption is not altered1 25

Consider reduction in levodopa dosage when pramipexole is added to levodopa therapy1

Metoclopramide

Dopamine antagonist activity of metoclopramide may diminish effectiveness of pramipexole1 25

Penicillins

Effect on oral clearance of pramipexole is unlikely1 25

Probenecid

No appreciable alteration of pramipexole pharmacokinetics1 25

Prokinetic (propulsive) agents

Effect on oral clearance of pramipexole is unlikely25

Proton-pump inhibitors

Effect on oral clearance of pramipexole is unlikely25

Quinidine and Quinine

Quinidine and quinine are secreted by the cationic transport system and may decrease oral clearance of pramipexole1 25

Selegiline

Alteration of oral clearance of pramipexole is unlikely1 25

Triamterene

Triamterene is secreted by the cationic transport system and may decrease oral clearance of pramipexole1 25

Verapamil

Verapamil is secreted by the cationic transport system and may decrease oral clearance of pramipexole1 25

Pramipexole Dihydrochloride Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentration attained in approximately 2 hours (conventional tablets) or 6 hours (extended-release tablets).1 25 Absolute bioavailability is >90%.1 25

Bioavailability of extended-release tablets relative to conventional tablets is about 100%.25 Equivalent daily dosages of conventional tablets (given 3 times daily) and extended-release tablets (given once daily) result in comparable peak and trough plasma concentrations and systemic exposure over 24 hours.25

Food

Conventional tablets: Food decreases rate but not extent of absorption; time to peak concentration is delayed by about 1 hour.1 12

Extended-release tablets: Food increases peak plasma concentrations by approximately 20% and delays time to peak concentration by approximately 2 hours, but does not affect extent of exposure.25

Distribution

Extent

Widely distributed throughout the body.1 25

Plasma Protein Binding

15%.1 25

Elimination

Metabolism

No metabolites have been identified in plasma or urine.1 25

Elimination Route

Eliminated in urine (90%), almost entirely as unchanged drug.1 25 Renal clearance of pramipexole is approximately 3 times higher than GFR.1 25 Pramipexole is secreted by the renal tubules, probably by the organic cationic transport system.1 25

Half-life

Terminal half-life is about 8 hours in young healthy individuals.1

Special Populations

In individuals >65 years of age, clearance of pramipexole is reduced by approximately 30% and the terminal half-life is about 12 hours.1 25

Pharmacokinetics not evaluated to date in patients with hepatic impairment; however, hepatic impairment would not be expected to have a significant effect on pramipexole elimination, since approximately 90% of a dose is excreted in urine as unchanged drug.1 25

In patients with renal impairment, clearance of pramipexole is about 75% lower in patients with Clcr of approximately 20 mL/minute and about 60% lower in patients with Clcr of approximately 40 mL/minute compared with healthy individuals.1 25

Stability

Storage

Oral

Conventional Tablets

25°C (may be exposed to 15–30°C).1 Protect from light.1

Extended-release Tablets

25°C (may be exposed to 15–30°C).25 Protect from high humidity.25

Actions

  • Exhibits high binding specificity for and intrinsic activity at dopamine D2 receptors in vitro compared with other dopamine receptor agonists (e.g., bromocriptine, pergolide);3 6 7 8 9 18 19 25 has a higher affinity for the D3 subtype13 than for the D2 or D4 subtypes.1 2 9 15 16 19 25

  • In parkinsonian syndrome, appears to act by directly stimulating postsynaptic dopamine receptors in the corpus striatum.1 6 9 15 16 25

  • In restless legs syndrome, mechanism(s) of action is unknown; dopaminergic systems appear to be involved in pathogenesis.1

Advice to Patients

  • Importance of reading the manufacturer's patient information before initiating therapy and each time the drug is dispensed.1 25

  • Importance of taking pramipexole as prescribed.1 25 If a dose is missed, advise not to double the next dose.1 25 If treatment is stopped for any reason, importance of consulting clinician prior to reinitiating therapy.1 25 Advise patients with parkinsonian syndrome of the importance of not discontinuing pramipexole abruptly.1 25

  • Importance of swallowing the extended-release tablets whole; do not chew, crush, or divide.25

  • Importance of not taking both conventional and extended-release tablets of pramipexole concurrently.25

  • Risk of somnolence;1 25 possibility of falling asleep while engaged in activities of daily living.1 20 21 22 23 25 Avoid driving or operating machinery until effects on the individual are known.1 25

  • Potential for orthostatic hypotension (e.g., dizziness, nausea, syncope, sweating), especially during dosage escalation.1 25 Patients should avoid rising rapidly after sitting or lying down, especially if they have been in a seated or recumbent position for prolonged periods and/or if they are just beginning pramipexole therapy.1 25

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs (especially CNS depressants or alcohol), as well as any concomitant illnesses.1 25

  • Importance of asking patients whether they have developed any new or increased urges or compulsive behaviors (e.g., gambling urges, sexual urges, uncontrolled spending, binge eating) while receiving pramipexole and of advising them of the importance of reporting such urges.1 25

  • Risk of hallucinations, particularly in geriatric patients.1 25

  • Pramipexole may be taken with or without food; however, taking the drug with food may reduce the occurrence of nausea.1 25

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 25

  • Importance of informing patients of other important precautionary information.1 25 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pramipexole Dihydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

0.125 mg

Mirapex

Boehringer Ingelheim

0.25 mg

Mirapex (scored)

Boehringer Ingelheim

0.5 mg

Mirapex (scored)

Boehringer Ingelheim

0.75 mg

Mirapex

Boehringer Ingelheim

1 mg

Mirapex (scored)

Boehringer Ingelheim

1.5 mg

Mirapex (scored)

Boehringer Ingelheim

Tablets, extended-release

0.375 mg

Mirapex ER

Boehringer Ingelheim

0.75 mg

Mirapex ER

Boehringer Ingelheim

1.5 mg

Mirapex ER

Boehringer Ingelheim

2.25 mg

Mirapex ER

Boehringer Ingelheim

3 mg

Mirapex ER

Boehringer Ingelheim

3.75 mg

Mirapex ER

Boehringer Ingelheim

4.5 mg

Mirapex ER

Boehringer Ingelheim

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Mirapex 0.125MG Tablets (BOEHRINGER INGELHEIM): 30/$117.99 or 90/$339.97

Mirapex 0.25MG Tablets (BOEHRINGER INGELHEIM): 90/$349.00 or 270/$1,020.97

Mirapex 0.5MG Tablets (BOEHRINGER INGELHEIM): 90/$351.00 or 270/$1,029.96

Mirapex 1MG Tablets (BOEHRINGER INGELHEIM): 90/$350.00 or 270/$1,020.01

Mirapex 1.5MG Tablets (BOEHRINGER INGELHEIM): 90/$350.00 or 270/$989.92

Mirapex ER 0.375MG 24-hr Tablets (BOEHRINGER INGELHEIM): 30/$337.88 or 90/$980.92

Mirapex ER 1.5MG 24-hr Tablets (BOEHRINGER INGELHEIM): 30/$334.61 or 90/$971.21

Mirapex ER 4.5MG 24-hr Tablets (BOEHRINGER INGELHEIM): 30/$334.61 or 90/$971.21

Pramipexole Dihydrochloride 0.125MG Tablets (TORRENT PHARMACEUTICALS): 30/$86.99 or 90/$240.97

Pramipexole Dihydrochloride 0.25MG Tablets (TORRENT PHARMACEUTICALS): 90/$249.99 or 270/$708.96

Pramipexole Dihydrochloride 0.5MG Tablets (TORRENT PHARMACEUTICALS): 90/$251.00 or 270/$732.94

Pramipexole Dihydrochloride 0.75MG Tablets (TORRENT PHARMACEUTICALS): 30/$85.99 or 60/$166.98

Pramipexole Dihydrochloride 1MG Tablets (TEVA PHARMACEUTICALS USA): 90/$240.99 or 270/$680.93

Pramipexole Dihydrochloride 1.5MG Tablets (TORRENT PHARMACEUTICALS): 90/$239.99 or 270/$679.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 24, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Boehringer Ingelheim. Mirapex (pramipexole dihydrochloride) tablets prescribing information. Ridgefield, CT; 2011 May.

2. Parkinson Study Group. Safety and efficacy of pramipexole in early Parkinson disease. JAMA. 1997; 278:125-130. [IDIS 388331] [PubMed 9214527]

3. Schilling JC, Adamus WS, Palluk R. Neuroendocrine and side effect profile of pramipexole, a new dopamine receptor agonist, in humans. Clin Pharmacol Ther. 1992; 51:541-8. [IDIS 297374] [PubMed 1350237]

4. Eli Lilly and Company. Permax (pergolide mesylate) prescribing information (dated 1995 Feb 15). In: Physicians’ desk reference. 51st ed. Montvale, NJ: Medical Economics Company Inc; 1997:571-3.

5. Sandoz. Parlodel SnapTabs (bromocriptine mesylate) prescribing information (dated 1996 Feb). In: Physicians’ desk reference. 51st ed. Montvale, NJ: Medical Economics Company Inc; 1997:2411-3.

6. Hubble JP, Koller WC, Cutler NR et al. Pramipexole in patients with early Parkinson’s disease. Clin Neuropharmacol. 1995; 18:338-47. [PubMed 8665547]

7. Molho ES, Factor SA, Weiner WJ et al. The use of pramipexole, a novel dopamine (DA) agonist, in advanced Parkinson’s disease. J Neural Transm. 1995; 45(Suppl):225-30.

8. Rabey JM. Second generation of dopamine agonists: pros and cons. J Neural Transm. 1995; 45(Suppl):213-24.

9. Goetz CG. New strategies with dopaminergic drugs: modified formulations of levodopa and novel agonists. Exp Neurol. 1997; 144:17-20. [PubMed 9126145]

10. Shannon KM for the Pramipexole Study Group. Pramipexole monotherapy in early Parkinson’s disease: long-term follow-up and interim analysis. Paper presented at XIIth International Symposium on Parkinson’s Disease. London: World Health Organization; 1997 Mar.

11. Oertel WH, Pogarell O. Long-term follow-up of patients with advanced Parkinson’s disease. Paper presented at XIIth International Symposium on Parkinson’s Disease. London: 1997 Mar.

12. Wright CE, Sisson L, Ichhpurani AK et al. Influence of food on the bioavailability of pramipexole. J Neurol. 1997; 244(Suppl 3):S52.

13. Lieberman A, Ranhosky A, Korts D. Clinical evaluation of pramipexole in advanced Parkinson’s disease: results of a double-blind, placebo-controlled, parallel-group study. Neurology. 1997; 49:162-8. [IDIS 388119] [PubMed 9222185]

14. Wright CE, Sisson TL, Ichhpurani AK et al. Pramipexole and levodopa pharmacokinetics following concomitant administration. Neurology. 1997; 48:A185.

15. Wright CE, Sisson L, Ichhpurani AK et al. Influence of renal impairment and hemodialysis on pramipexole pharmacokinetics. Movement Disorders. 1997; 12(Suppl 1):66. [PubMed 8990056]

16. Wright CE, Sisson L, Ichhpurani AK et al. Pramipexole steady-state pharmacokinetics in healthy male and female volunteers. Movement Disorders. 1997; 12(Suppl 1):65.

17. Wright CE, Lasher Sisson T, Ichhpurani AK et al. Influence of age and gender on pramipexole pharmacokinetics. Clin Pharmacol Ther. 1996; 59:184.

18. Albani C, Popescu R, Lacher R et al. Single dose response to pramipexole in patients with Parkinson’s disease. Movement Disorders. 1992; 7(Suppl 1):98.

19. Piercey MF, Hoffmann WE, Smith MW et al. Inhibition of dopamine neuron firing by pramipexole, a dopamine D3 receptor-preferring agonist: comparison to other dopamine receptor agonists. Eur J Pharmacol. 1996; 312:35-44. [PubMed 8891576]

20. Pharmacia & Upjohn, Kalamazoo, MI: Personal communication.

21. Gallen CC. Dear healthcare professional letter regarding pramipexole and reports of sudden sleep onset during daily activities. Kalamazoo, MI: Pharmacia & Upjohn; 1999 Aug.

22. Frucht S, Rogers JD, Greene PE et al. Falling asleep at the wheel: motor vehicle mishaps in persons taking pramipexole and ropinirole. Neurology. 1999; 52:1908-10. [IDIS 430280] [PubMed 10371546]

23. Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson’s disease (2001): treatment guidelines. Neurology. 2001; 56:S1-S88.

24. Anon. Initial treatment of Parkinson’ disease: wait just a minute. Med Lett Drugs Ther. 2001; 43:59-60. [PubMed 11445778]

25. Boehringer Ingelheim. Mirapex ER (pramipexole dihydrochloride) extended-release tablets prescribing information. Ridgefield, CT; 2011 Sep.

26. Gamaldo CE, Earley CJ. Restless legs syndrome: a clinical update. Chest. 2006; 130:1596-604. [PubMed 17099042]

27. Trenkwalder C, Garcia-Borreguero D, Montagna P et al. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry. 2004; 75:92-7. [PubMed 14707315]

28. Earley CJ. Restless legs syndrome. N Engl J Med. 2003; 348:2103-9. [IDIS 497583] [PubMed 12761367]

29. Littner MR, Kushida C, Anderson WM et al. Practice parameters for the dopaminergic treatment of restless legs syndrome and periodic limb movement disorder-An American Academy of Sleep Medicine Report. Sleep. 2004; 27:557-9. [PubMed 15164914]

30. Winkelman JW, Sethi KD, Kushida CA et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology. 2006; 67:1034-9. [PubMed 16931507]

31. Partinen M, Hirvonen K, Jama L et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study--the PRELUDE study. Sleep Med. 2006; 7:407-17. [PubMed 16815748]

32. Trenkwalder C, Stiasny-Kolster K, Kupsch A et al. Controlled withdrawal of pramipexole after 6 months of open-label treatment in patients with restless legs syndrome. Mov Disord. 2006; 21:1404-10. [PubMed 16755554]

33. Oertel WH, Stiasny-Kolster K, Bergtholdt B et al. Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study). Mov Disord. 2007; 22:213-9. [PubMed 17133582]

34. Poewe W, Rascol O, Barone P et al. Extended-release pramipexole in early Parkinson disease: a 33-week randomized controlled trial. Neurology. 2011; 77:759-66. [PubMed 21832218]

35. Schapira AH, Barone P, Hauser RA et al. Extended-release pramipexole in advanced Parkinson disease: a randomized controlled trial. Neurology. 2011; 77:767-74. [PubMed 21832216]

36. Rascol O, Barone P, Hauser RA et al. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010; 25:2326-32. [PubMed 20669265]

37. Hauser RA, Schapira AH, Rascol O et al. Randomized, double-blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease. Mov Disord. 2010; 25:2542-9. [PubMed 20669317]

Learn how medication, diet, and exercise are key to managing Multiple Sclerosis. Click Here

Close
Hide
(web4)