Mirapex
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Questions & Answers
Side Effects & Adverse Reactions
Patients treated with Mirapex® (pramipexole dihydrochloride) tablets have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on MIRAPEX tablets, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment.
Somnolence is a common occurrence in patients receiving MIRAPEX tablets at doses above 1.5 mg/day (0.5 mg TID) for Parkinson’s disease. In controlled clinical trials in RLS, patients treated with MIRAPEX tablets at doses of 0.25-0.75 mg once a day, the incidence of somnolence was 6% compared to an incidence of 3% for placebo-treated patients (see ADVERSE EVENTS, Table 5). Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.
Before initiating treatment with MIRAPEX tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with MIRAPEX tablets such as concomitant sedating medications, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g., cimetidine - see PRECAUTIONS, Drug Interactions). If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), MIRAPEX tablets should ordinarily be discontinued. If a decision is made to continue MIRAPEX tablets, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension, especially during dose escalation. Parkinson's disease patients, in addition, appear to have an impaired capacity to respond to an orthostatic challenge. For these reasons, both Parkinson's disease patients and RLS patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of orthostatic hypotension, especially during dose escalation, and should be informed of this risk (see PRECAUTIONS, Information for Patients).
In clinical trials of pramipexole, however, and despite clear orthostatic effects in normal volunteers, the reported incidence of clinically significant orthostatic hypotension was not greater among those assigned to Mirapex® (pramipexole dihydrochloride) tablets than among those assigned to placebo. This result, especially with the higher doses used in Parkinson’s disease, is clearly unexpected in light of the previous experience with the risks of dopamine agonist therapy.
While this finding could reflect a unique property of pramipexole, it might also be explained by the conditions of the study and the nature of the population enrolled in the clinical trials. Patients were very carefully titrated, and patients with active cardiovascular disease or significant orthostatic hypotension at baseline were excluded. Also, clinical trials in patients with RLS did not incorporate orthostatic challenges with intensive blood pressure monitoring done in close temporal proximity to dosing.
In the three double-blind, placebo-controlled trials in early Parkinson's disease, hallucinations were observed in 9% (35 of 388) of patients receiving MIRAPEX tablets, compared with 2.6% (6 of 235) of patients receiving placebo. In the four double-blind, placebo-controlled trials in advanced Parkinson's disease, where patients received MIRAPEX tablets and concomitant levodopa, hallucinations were observed in 16.5% (43 of 260) of patients receiving MIRAPEX tablets compared with 3.8% (10 of 264) of patients receiving placebo. Hallucinations were of sufficient severity to cause discontinuation of treatment in 3.1% of the early Parkinson's disease patients and 2.7% of the advanced Parkinson's disease patients compared with about 0.4% of placebo patients in both populations.
Age appears to increase the risk of hallucinations attributable to pramipexole. In the early Parkinson's disease patients, the risk of hallucinations was 1.9 times greater than placebo in patients younger than 65 years and 6.8 times greater than placebo in patients older than 65 years. In the advanced Parkinson's disease patients, the risk of hallucinations was 3.5 times greater than placebo in patients younger than 65 years and 5.2 times greater than placebo in patients older than 65 years.
In the RLS clinical program, one pramipexole-treated patient (of 889) reported hallucinations; this patient discontinued treatment and the symptoms resolved.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
The effectiveness of MIRAPEX tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES).
MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with symptoms of RLS.
History
There is currently no drug history available for this drug.
Other Information
MIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S • 2HCl • H2O, and its molecular weight is 302.27.
The structural formula is: 
Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane.
MIRAPEX tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, cornstarch, colloidal silicon dioxide, povidone, and magnesium stearate.
Sources
Mirapex Manufacturers
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Rebel Distributors Corp
![Mirapex (Pramipexole Dihydrochloride) Tablet [Rebel Distributors Corp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mirapex | Rebel Distributors Corp
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Mirapex® (pramipexole dihydrochloride) tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 7 Ascending Dosage Schedule of MIRAPEX tablets for Parkinson's Disease Week Dosage (mg) Total Daily
Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.50 4 0.75 TID 2.25 5 1 TID 3.0 6 1.25 TID 3.75 7 1.5 TID 4.50Maintenance Treatment
Mirapex® (pramipexole dihydrochloride) tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of MIRAPEX tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When MIRAPEX tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 8 Pramipexole Dosage in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose
(mg) Maximum Dose
(mg) Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients)
The use of MIRAPEX tablets has not been adequately studied in this group of patients.Discontinuation of Treatment
It is recommended that MIRAPEX tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
Restless Legs SyndromeThe recommended starting dose of MIRAPEX tablets is 0.125 mg taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days (Table 9). Although the dose of MIRAPEX tablets was increased to 0.75 mg in some patients during long-term open-label treatment, there is no evidence that the 0.75 mg dose provides additional benefit beyond the 0.5 mg dose.
Table 9 Ascending Dosage Schedule of MIRAPEX tablets for RLS Titration Step Duration Dosage (mg) to be taken once daily, 2-3 hours before bedtime *if needed 1 4-7 days 0.125 2* 4-7 days 0.25 3* 4-7 days 0.5Patients with Renal Impairment
The duration between titration steps should be increased to 14 days in RLS patients with severe and moderate renal impairment (creatinine clearance 20-60 mL/min) (see CLINICAL PHARMACOLOGY , Renal Insufficiency).
Discontinuation of Treatment
In clinical trials of patients being treated for RLS with doses up to 0.75 mg once daily, Mirapex® (pramipexole dihydrochloride) tablets were discontinued without a taper.
-
Physicians Total Care, Inc.
Mirapex | Physicians Total Care, Inc.
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Mirapex® (pramipexole dihydrochloride) tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 7 Ascending Dosage Schedule of MIRAPEX tablets for Parkinson's Disease Week Dosage (mg) Total Daily
Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.50 4 0.75 TID 2.25 5 1 TID 3.0 6 1.25 TID 3.75 7 1.5 TID 4.50Maintenance Treatment
Mirapex® (pramipexole dihydrochloride) tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of MIRAPEX tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When MIRAPEX tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 8 Pramipexole Dosage in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose
(mg) Maximum Dose
(mg) Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients)
The use of MIRAPEX tablets has not been adequately studied in this group of patients.Discontinuation of Treatment
It is recommended that MIRAPEX tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
Restless Legs SyndromeThe recommended starting dose of MIRAPEX tablets is 0.125 mg taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days (Table 9). Although the dose of MIRAPEX tablets was increased to 0.75 mg in some patients during long-term open-label treatment, there is no evidence that the 0.75 mg dose provides additional benefit beyond the 0.5 mg dose.
Table 9 Ascending Dosage Schedule of MIRAPEX tablets for RLS Titration Step Duration Dosage (mg) to be taken once daily, 2-3 hours before bedtime *if needed 1 4-7 days 0.125 2* 4-7 days 0.25 3* 4-7 days 0.5Patients with Renal Impairment
The duration between titration steps should be increased to 14 days in RLS patients with severe and moderate renal impairment (creatinine clearance 20-60 mL/min) (see CLINICAL PHARMACOLOGY , Renal Insufficiency).
Discontinuation of Treatment
In clinical trials of patients being treated for RLS with doses up to 0.75 mg once daily, Mirapex® (pramipexole dihydrochloride) tablets were discontinued without a taper.
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Cardinal Health
Mirapex | Cardinal Health
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Mirapex® (pramipexole dihydrochloride) tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 7 Ascending Dosage Schedule of MIRAPEX tablets for Parkinson's Disease Week Dosage (mg) Total Daily
Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.50 4 0.75 TID 2.25 5 1 TID 3.0 6 1.25 TID 3.75 7 1.5 TID 4.50Maintenance Treatment
Mirapex® (pramipexole dihydrochloride) tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of MIRAPEX tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When MIRAPEX tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 8 Pramipexole Dosage in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose
(mg) Maximum Dose
(mg) Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients)
The use of MIRAPEX tablets has not been adequately studied in this group of patients.Discontinuation of Treatment
It is recommended that MIRAPEX tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
Restless Legs SyndromeThe recommended starting dose of MIRAPEX tablets is 0.125 mg taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days (Table 9). Although the dose of MIRAPEX tablets was increased to 0.75 mg in some patients during long-term open-label treatment, there is no evidence that the 0.75 mg dose provides additional benefit beyond the 0.5 mg dose.
Table 9 Ascending Dosage Schedule of MIRAPEX tablets for RLS Titration Step Duration Dosage (mg) to be taken once daily, 2-3 hours before bedtime *if needed 1 4-7 days 0.125 2* 4-7 days 0.25 3* 4-7 days 0.5Patients with Renal Impairment
The duration between titration steps should be increased to 14 days in RLS patients with severe and moderate renal impairment (creatinine clearance 20-60 mL/min) (see CLINICAL PHARMACOLOGY , Renal Insufficiency).
Discontinuation of Treatment
In clinical trials of patients being treated for RLS with doses up to 0.75 mg once daily, Mirapex® (pramipexole dihydrochloride) tablets were discontinued without a taper. In a 26 week placebo-controlled clinical trial, patients reported a worsening of RLS symptom severity as compared to their untreated baseline when MIRAPEX treatment was suddenly withdrawn (see PRECAUTIONS, Events Reported with Dopaminergic Therapy, Rebound and Augmentation in RLS).
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Lake Erie Medical Dba Quality Care Products Llc
Mirapex | Lake Erie Medical Dba Quality Care Products Llc
DOSAGE AND ADMINISTRATIONParkinson's Disease
In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Mirapex® (pramipexole dihydrochloride) tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days.
Mirapex® (pramipexole dihydrochloride) tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of MIRAPEX tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When MIRAPEX tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline
Discontinuation of Treatment
It is recommended that MIRAPEX tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
Restless Legs Syndrome
The recommended starting dose of MIRAPEX tablets is 0.125 mg taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days (Table 9). Although the dose of MIRAPEX tablets was increased to 0.75 mg in some patients during long-term open-label treatment
Patients with Renal Impairment
The duration between titration steps should be increased to 14 days in RLS patients with severe and moderate renal impairment (creatinine clearance 20-60 mL/min) (see CLINICAL PHARMACOLOGY, Renal Insufficiency).
Discontinuation of Treatment
In clinical trials of patients being treated for RLS with doses up to 0.75 mg once daily, Mirapex® (pramipexole dihydrochloride) tablets were discontinued without a taper
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Boehringer Ingelheim Pharmaceuticals, Inc.
Mirapex | Boehringer Ingelheim Pharmaceuticals, Inc.
2.1 General Dosing ConsiderationsMIRAPEX tablets are taken orally, with or without food.
If a significant interruption in therapy with MIRAPEX tablets has occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. MIRAPEX tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Table 1 Ascending Dosage Schedule of MIRAPEX tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 three times a day 0.375 2 0.25 three times a day 0.75 3 0.5 three times a day 1.50 4 0.75 three times a day 2.25 5 1 three times a day 3.0 6 1.25 three times a day 3.75 7 1.5 three times a day 4.50
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1:Maintenance Treatment
MIRAPEX tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of MIRAPEX tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When MIRAPEX tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of MIRAPEX tablets in Parkinson’s disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of MIRAPEX tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment
(creatinine Cl >50 mL/min) 0.125 three times a day 1.5 three times a day Moderate impairment
(creatinine Cl =30 to 50 mL/min) 0.125 twice a day 0.75 three times a day Severe impairment
(creatinine Cl =15 to <30 mL/min) 0.125 once a day 1.5 once a day Very severe impairment
(creatinine Cl <15 mL/min
and hemodialysis patients) The use of MIRAPEX tablets has not been adequately studied in this group of patients.Discontinuation of Treatment
2.3 Dosing for Restless Legs Syndrome
MIRAPEX tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.The recommended starting dose of MIRAPEX tablets is 0.125 mg taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days (Table 3). Although the dose of MIRAPEX tablets was increased to 0.75 mg in some patients during long-term open-label treatment, there is no evidence that the 0.75 mg dose provides additional benefit beyond the 0.5 mg dose.
Table 3 Ascending Dosage Schedule of MIRAPEX tablets for RLS *if needed Titration Step Duration Dose (mg) to be taken once daily, 2-3 hours before bedtime 1 4-7 days 0.125 2* 4-7 days 0.25 3* 4-7 days 0.5Dosing in Patients with Renal Impairment
The duration between titration steps should be increased to 14 days in RLS patients with moderate and severe renal impairment (creatinine clearance 20-60 ml/min) [see Clinical Pharmacology (12.3)].Discontinuation of Treatment
In clinical trials of patients being treated for RLS with doses up to 0.75 mg once daily, MIRAPEX tablets were discontinued without a taper. In a 26 week placebo-controlled clinical trial, patients reported a worsening of RLS symptom severity as compared to their untreated baseline when MIRAPEX treatment was suddenly withdrawn [see Warnings and Precautions (5.9)].
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