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Mirapex

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Mirapex

Indications
Dosage
How Supplied

INDICATIONS

Parkinson's Disease

MIRAPEX tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

Restless Legs Syndrome

MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

DOSAGE AND ADMINISTRATION

General Dosing Considerations

MIRAPEX 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.

Parkinson's Disease

In 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

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 the following table:

Table 1 : 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 1.5
4 0.75 TID 2.25
5 1 TID 3
6 1.25 TID 3.75
7 1.5 TID 4.5

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

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 TID 1.5 TID
Moderate impairment (creatinine Cl =30 to 50 mL/min) 0.125 BID 0.75 TID
Severe impairment (creatinine Cl =15 to < 30 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

MIRAPEX tablets should 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 should be reduced by 0.375 mg per day. 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 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

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 0.5
*if needed
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].

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].

HOW SUPPLIED

Dosage Forms And Strengths

  • 0.125 mg: white, round tablet with “BI” on one side and “83” on the reverse side.
  • 0.25 mg: white, oval, scored tablet with “BI BI” on one side and “84 84” on the reverse side.
  • 0.5 mg: white, oval, scored tablet with “BI BI” on one side and “85 85” on the reverse side.
  • 0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side.
  • 1 mg: white, round, scored tablet with “BI BI” on one side and “90 90” on the reverse side.
  • 1.5 mg: white, round, scored tablet with “BI BI” on one side and “91 91” on the reverse side.

Storage And Handling

MIRAPEX tablets are available as follows:

0.125 mg: white, round, tablet with “BI” on one side and “83” on the reverse side.

Bottles of 90 NDC 0597-0183-90

0.25 mg: white, oval, scored tablet with “BI BI” on one side and “84 84” on the reverse side.

Bottles of 90 NDC 0597-0184-90
Unit dose packages of 100 NDC 0597-0184-61

0.5 mg: white, oval, scored tablet with “BI BI” on one side and “85 85” on the reverse side.

Bottles of 90 NDC 0597-0185-90
Unit dose packages of 100 NDC 0597-0185-61

0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side.

Bottles of 90 NDC 0597-0101-90

1 mg: white, round, scored tablet with “BI BI” on one side and “90 90” on the reverse side.

Bottles of 90 NDC 0597-0190-90
Unit dose packages of 100 NDC 0597-0190-61

1.5 mg: white, round, scored tablet with ld&quo;BI BI” on one side and “91 91” on the reverse side.

Bottles of 90 NDC 0597-0191-90
Unit dose packages of 100 NDC 0597-0191-61

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Protect from light.

Store in a safe place out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Revised: March 2013

Last reviewed on RxList: 3/15/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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