Recommended Topic Related To:

Mirapex ER

"Sept. 19, 2012 -- The FDA is investigating a possible risk of heart failure linked to Mirapex, a drug used to treat Parkinson's disease and restless legs syndrome.

Officials say recent studies suggest a potential raised risk of heart "...

Mirapex ER

Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

General Dosing Considerations

MIRAPEX ER tablets are taken orally once daily, with or without food.

MIRAPEX ER tablets must be swallowed whole and must not be chewed, crushed, or divided.

If a significant interruption in therapy with MIRAPEX ER tablets has occurred, re-titration of therapy may be warranted.

Dosing For Parkinson's Disease

The starting dose is 0.375 mg given once per day. Based on efficacy and tolerability, dosages may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day.

In clinical trials, dosage was initiated at 0.375 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 4.5 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment [see Clinical Studies].

Due to the flexible dose design used in clinical trials, specific dose-response information could not be determined [see Clinical Studies].

MIRAPEX ER 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.

Dosing in Patients with Renal Impairment

The elimination of pramipexole is dependent on renal function [see CLINICAL PHARMACOLOGY]. Patients with mild renal impairment (a creatinine clearance above 50 mL/min) require no reduction in daily dose.

In patients with moderate renal impairment (creatinine clearance between 30 and 50 mL/min), MIRAPEX ER tablets should initially be taken every other day. Caution should be exercised and careful assessment of therapeutic response and tolerability should be made before increasing to daily dosing after one week, and before any additional titration in 0.375 mg increments up to 2.25 mg per day. Dose adjustment should occur no more frequently than at weekly intervals.

MIRAPEX ER tablets have not been studied in patients with severe renal impairment (creatinine clearance < 30 mL/min) or patients on hemodialysis, and are not recommended in these patients.

Switching From Immediate-Release Pramipexole Tablets To MIRAPEX ER

Patients may be switched overnight from immediate-release pramipexole tablets to MIRAPEX ER tablets at the same daily dose. When switching between immediate-release pramipexole tablets and MIRAPEX ER tablets, patients should be monitored to determine if dosage adjustment is necessary.

HOW SUPPLIED

Dosage Forms And Strengths

0.375 mg white to off-white, round, bevel-edged, extended-release tablets debossed with “ER” on one side and “0.375” on the other side

0.75 mg white to off-white, round, bevel-edged, extended-release tablets debossed with “ER” on one side and “0.75” on the other side

1.5 mg white to off-white, oval, extended-release tablets debossed with “ER” on one side and “1.5” on the other side

2.25 mg white to off-white, oval, extended-release tablets debossed with “ER” on one side and “2.25” on the other side 3 mg white to off-white, oval, extended-release tablets debossed with “ER” on one side and “3.0” on the other side

3.75 mg white to off-white, oval, extended-release tablets debossed with “ER” on one side and “3.75” on the other side

4.5 mg white to off-white, oval, extended-release tablets debossed with “ER” on one side and “4.5” on the other side

Storage And Handling

MIRAPEX ER tablets are available as follows:

0. 375 mg: white to off-white, round, bevel-edged, extended-release tablets debossed with “ER” on one side and “0.375” on the other side.

Unit of Use Bottles of 7 NDC 0597-0109-17
Unit of Use Bottles of 30 NDC 0597-0109-30

0.75 mg: white to off-white, round, bevel-edged, extended-release tablets debossed with “ER” on one side and “0.75” on the other side.

Unit of Use Bottles of 7 NDC 0597-0285-17
Unit of Use Bottles of 30 NDC 0597-0285-30

1.5 mg: white to off-white, oval, extended-release tablets debossed with “ER” on one side and “1.5” on the other side.

Unit of Use Bottles of 7 NDC 0597-0113-17
Unit of Use Bottles of 30 NDC 0597-0113-30

2.25 mg: white to off-white, oval, extended-release tablets debossed with “ER” on one side and “2.25” on the other side.

Unit of Use Bottles of 30 NDC 0597-0286-30

3 mg: white to off-white, oval, extended-release tablets debossed with “ER” on one side and “3.0” on the other side.

Unit of Use Bottles of 30 NDC 0597-0115-30

3.75 mg: white to off-white, oval, extended-release tablets debossed with “ER” on one side and “3.75” on the other side.

Unit of Use Bottles of 30 NDC 0597-0287-30

4.5 mg: white to off-white, oval, extended-release tablets debossed with “ER” on one side and “4.5” on the other side.

Unit of Use Bottles of 30 NDC 0597-0116-30

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: May 2014

Last reviewed on RxList: 5/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Mirapex ER - User Reviews

Mirapex ER User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Mirapex ER sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


WebMD Daily

Get breaking medical news.


NIH talks about Ebola on WebMD