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Pramipexole

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(CAS:104632-26-0)

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Manufacturer: Pharmacia & Upjohn

Trade Mark: MIRAPEX

Description:

MIRAPEX Tablets contain pramipexole, a dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease .

Chemical Name: ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride mono-hydrate.

Empirical formula: C10H17N3S2HClH2O

Molecular weight: 302.27.

The structural formula is:

Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296C to 301C, 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.

Pramipexole dihydrochloride Tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.

DRUG ABUSE AND DEPENDENCE

Pramipexole is not a controlled substance.

Pramipexole has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. However, in a rat model on cocaine self-administration, pramipexole had little or no effect.

OVERDOSAGE

There is no clinical experience with massive overdosage. One patient, with a 10-year history of schizophrenia, took 11 mg/day of pramipexole for 2 days; this is two to three times the protocol recommended daily dose. No adverse events were reported related to the increased dose. Blood pressure remained stable although pulse rate increased to between 100 and 120 beats/minute. The patient withdrew from the study at the end of week 2 due to lack of efficacy.

There is no known antidote for overdosage of a dopamine agonist. If signs of central nervous system stimulation are present, a phenothiazine or other butyrophenone neuroleptic agent may be indicated; the efficacy of such drugs in reversing the effects of overdosage has not been assessed. Management of overdose may require general supportive measures along with gastric lavage, intravenous fluids, and electrocardiogram monitoring.

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:

Ascending Dosage Schedule of MIRAPEX
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. 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 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 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 has not been adequately studied in this group of patients.

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

HOW SUPPLIED

MIRAPEX Tablets are available as follows:

0.125 mg: white, round tablet with "U" on one side and "2" on the reverse side.

Bottles of 63 NDC 0009-0002-02

0.25 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

0.5 mg: white, oval, scored tablet with "U" twice on one side and "8" twice on the reverse side.

Bottles of 90 NDC 0009-0008-02

Unit dose packages of 100 NDC 0009-0008-03

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