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Mirapex Indications, Dosage, Storage, Stability - Pramipexole

Mirapex Indications, Dosage, Storage, Stability - Pramipexole

INDICATIONS

MIRAPEX Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

The effectiveness of MIRAPEX 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 PHARMACOLOGY - CLINICAL STUDIES).

DOSAGE AND ADMINISTRATION

In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. MIRAPEX 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:

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

1.0 tid

3.0

6

1.25 tid

3.75

7

1.5 tid

4.50


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 were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. When MIRAPEX 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.

Patients with Renal Impairment

Pramipexole Dosage in the Renally Impaired

Renal Status

Starting Dose
(mg)
Maximum Dose
(mg)
Normal to mild

impairment

(creatinine

CI > 60mL/min)

0.125 tid

1.5 tid

Moderate

impairment

(creatinine

CI = 35 to 59mL/min)

0.125 bid

1.5 bid

Severe

impairment

(creatinine

CI = 15 to 34 mL/min)

0. 125 qd

1.5 qd

Very severe
impairment
(creatinine CI < 15
mL/min and
hemodialysis patients)
The use of MIRAPEX
has not been adequately
studied in this
group of patients.


Discontinuation of Treatment

It is recommended that MIRAPEX be discontinued over a period of 1week; in some studies, however, abrupt discontinuation was uneventful.

HOW SUPPLIED

MIRAPEX Tablets are available as follows:

0.125mg: white, round tablet with "U" on one side and "2" on the reverse side.
Bottles of 63: NDC 0009-0002-02
0.5 mg: white, oval, scored tablet with “U’ twice on one side and “4” twice on the reverse side.
Bottles of 90: NDC 0009-0004-02
Unit dose packages of 100: NDC 0009-0004-06
1 mg: white, round, scored tablet with “U” twice on one side and “6” twice on the reverse side.
Bottles of 90: NDC 0009-0006-02
Unit dose packages of 100: NDC 0009-0006-06
1.5 mg: white, round, scored tablet with "U" twice on one side and “37” twice on the reverse side.
Bottles of 90: NDC 0009-0037-02
Unit dose packages of 100: NDC 0009-0037-06

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

Caution: Federal law prohibits dispensing without prescription.

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