Parkinson's Disease

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).

Restless Legs Syndrome

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.

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 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

Maintenance 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 is 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

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 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

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 tablets were discontinued without a taper.

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

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 “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

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., Ridgefield, CT 06877 USA. Licensed from: Boehringer Ingelheim International GmbH
Trademark under license from: Boehringer Ingelheim International GmbH. Revised: Month XX, 2006. FDA rev date: 11/07/2006

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