لیسکانتین (پریمیدون)
Pramipexole Dihydrochloride Extended-Release Tablets (Mirapex ER)
لیسکانتین (پریمیدون)

نام ژنریک

Primidone

شکل دارویی

اشكال دارويي:


Tablet: 250mg


Suspension: 125, 250 mg/5ml

موارد مصرف

موارد و مقدار مصرف


الف) حالات تونيك - كلونيك (صرع بزرگ) صرع كانوني، صرع ناقص كمپلكس (سايكوموتور).


بزرگسالان و كودكان 8 ساله و بزرگتر: از راه خوراكي، روزهاي اول تا سوم، هر شب mg 125-100، روزهاي چهارم تا ششم mg 125-100، دو بار در روز، روزهاي هفتم تا نهم، mg 125-100 سه بار در روز و در روز دهم مقدار نگهدارنده mg 250 سه بار در روز مصرف مي‌شود. ممكن است تا مقدار g 2 در روز نياز باشد.


كودكان كوچكتر از 8 سال: از راه خوراكي روزهاي اول تا سوم هر شب mg 50، روزهاي چهارم تا ششم، mg 50 دو بار در روز، روزهاي هفتم تا نهم، mg 100 سه بار در روز و در روز دهم مقدار نگهدارنده mg 250 - 125 سه بار در روز مصرف مي‌شود.


ب) لرزش خوش خيم خانوادگي (Benign familial tremor).


بزرگسالان: مقدار mg/day 750 در سه مقدار منقسم مصرف مي‌شود.


مكانيسم اثر


اثر ضد تشنج: پريميدون به عنوان يك داروي مضعف CNS غير اختصاصي به تنهايي يا همراه با ساير داروهاي ضد تشنج براي كنترل حملات تشنجي صرع بزرگ مقاوم و درمان تشنجات كانوني يا سايكوموتور به كار مي‌رود. مكانيسم اثر دارو مشخص نيست. بخشي از فعاليت دارو ممكن است ناشي از فنوباربيتال (متابوليت فعال آن) باشد.

موارد منع مصرف

تداخل دارويي


الكل و ساير داروهاي مضعف CNS، از جمله ضد دردهاي مخدر، موجب افسردگي شديد در بيماراني مي‌شود كه پريميدون مصرف مي‌كنند.


كاربامازپين و فني توئين ممكن است اثرات پريميدون را كاهش داده و تبديل آن به فنوباربيتال را افزايش دهند. براي جلوگيري از بروز مسموميت، غلظت سرمي دارو پيگيري گردد.


استازولاميد ممكن است باعث كاهش سطح پريميدون شود.


پريميدون ممكن است باعث كاهش اثر ضد بارداري‌هاي هورموني شود.


پريميدون ممكن است باعث كاهش اثر متوپرولول و پروپرانولول شود و افزايش دوز بتابلوكر ممكن است ضروري باشد.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي


پريميدون ممكن است موجب بروز اختلال در نتايج آزمونهاي عملكرد كبدي شود (افزايش يا كاهش).


ممكن است باعث كاهش Hgb و هماتوكريت و شمارش پلاكتي شود.


عوارض جانبي


اعصاب مركزي: خواب آلودگي، آتاكسي، اختلالات هيجاني، سرگيجه حقيقي، تحريك پذيري مفرط، خستگي، پارانويا.


پوست: بثورات شبه سرخك.


چشم: دوبيني، نيستاگموس.


دستگاه گوارش: بي اشتهايي، تهوع، استفراغ.


ادراري - تناسلي: ناتواني جنسي، پر ادراري.


خون: آنمي مگالوبلاستيك، ترومبوسيتوپني.


توجه: در صورت بروز علائم حساسيت مفرط يا اختلال عملكرد كبدي، بايد مصرف دارو قطع شود.


مسموميت و درمان


تظاهرات باليني: نشانه‌ها مانند مسموميت با باربيتوراتها است و عبارت‌اند از ضعف تنفسي و CNS، از بين رفتن رفلکس‌ها، كاهش ترشح ادرار، تاكيكاردي، افت فشار خون، كاهش حرارت بدن، اغما (شوك ممكن است بروز كند).


درمان: حمايتي است. در بيماران هوشيار داراي رفلکس حلقي سالم، با شربت ايپكا بيمار وادار به استفراغ شده و به دنبال آن طي 30 دقيقه مقادير مكرر ذغال فعال تجويز مي‌شود. در صورت عدم امكان القاي استفراغ، بايد معده را شستشو داد. قليايي كردن ادرار و ديورز شديد ممكن است دفع دارو را تسريع كند. همودياليز ممكن است ضروري باشد. علائم حياتي و تعادل آب و الكتروليت بيمار پيگيري شود.

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي


پريميدون ممكن است موجب بروز اختلال در نتايج آزمونهاي عملكرد كبدي شود (افزايش يا كاهش).


ممكن است باعث كاهش Hgb و هماتوكريت و شمارش پلاكتي شود.


عوارض جانبي


اعصاب مركزي: خواب آلودگي، آتاكسي، اختلالات هيجاني، سرگيجه حقيقي، تحريك پذيري مفرط، خستگي، پارانويا.


پوست: بثورات شبه سرخك.


چشم: دوبيني، نيستاگموس.


دستگاه گوارش: بي اشتهايي، تهوع، استفراغ.


ادراري - تناسلي: ناتواني جنسي، پر ادراري.


خون: آنمي مگالوبلاستيك، ترومبوسيتوپني.


توجه: در صورت بروز علائم حساسيت مفرط يا اختلال عملكرد كبدي، بايد مصرف دارو قطع شود.


مسموميت و درمان


تظاهرات باليني: نشانه‌ها مانند مسموميت با باربيتوراتها است و عبارت‌اند از ضعف تنفسي و CNS، از بين رفتن رفلکس‌ها، كاهش ترشح ادرار، تاكيكاردي، افت فشار خون، كاهش حرارت بدن، اغما (شوك ممكن است بروز كند).


درمان: حمايتي است. در بيماران هوشيار داراي رفلکس حلقي سالم، با شربت ايپكا بيمار وادار به استفراغ شده و به دنبال آن طي 30 دقيقه مقادير مكرر ذغال فعال تجويز مي‌شود. در صورت عدم امكان القاي استفراغ، بايد معده را شستشو داد. قليايي كردن ادرار و ديورز شديد ممكن است دفع دارو را تسريع كند. همودياليز ممكن است ضروري باشد. علائم حياتي و تعادل آب و الكتروليت بيمار پيگيري شود.

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط شناخته شده به باربيتوراتها، بارداري (خطر ضعف تنفسي و نقص انعقادي در نوزاد وجود دارد) بيماري شديد تنفسي يا آسم مداوم (Status Asthmaticus) (به علت اثرات مضعف تنفسي) ، پورفيري (خطر بروز اثرات جانبي هماتولوژيك وجود دارد)، عيب مشهود كار كبد (به علت خطر افزايش آسيب كبدي).


موارد احتياط: مصرف همزمان با الكل و يا ساير داروهاي مضعف CNS.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: آنالوگ باربيتورات.


طبقه‌بندي درماني: ضد تشنج.


طبقه‌بندي مصرف در بارداري: رده D


نام‌هاي تجاري: Apo - Primidone, Liskantin


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي باربيتوراتها، رعايت موارد زير نيز توصيه مي‌شود:


1 - شمارش كامل سلولهاي خوني و آزمونهاي عملكرد كبد هر شش ماه انجام شود.


2 - قطع ناگهاني مصرف پريميدون ممكن است موجب بروز صرع مداوم شود. مقدار مصرف دارو بايد به تدريج كاهش يابد.


3 - باربيتوراتها انجام فعاليتهاي نيازمند هوشياري، مانند رانندگي، را مختل مي‌سازند.


نكات قابل توصيه به بيمار


1 - دارو را طبق دستور مصرف كنيد.


2 - از مصرف فرآورده‌هاي حاوي الكل و تسكين بخشهاي ديگر خودداري كنيد، زيرا ممكن است موجب بروز ضعف اضافي CNS شود.


3 - در صورت بروز علائم و نشانه‌هاي عوارض جانبي، به پزشك اطلاع دهيد.


4 - قطع مصرف دارو يا تغيير مقدار آن بايد با دستور پزشك انجام شود.


5 - باربيتوراتها ممكن است داروهاي خوراكي جلوگيري كننده از بارداري را بي اثر سازند. بنابراين، از روش ديگر جلوگيري از بارداري استفاده كنيد.


6 - كارت شناسايي پزشكي كه نشانگر بيماري صرع و نام داروهاي مصرفي شماست، به همراه داشته باشيد.


مصرف در سالمندان: مقدار مصرف در بيماران سالخورده بايد كاهش يابد. اين بيماران مبتلا به كاهش عملكرد كليه هستند.


مصرف در كودكان: پريميدون ممكن است موجب تحريك پذيري مفرط كودكان كوچكتر از 6 سال شود.


مصرف در شيردهي: مقادير قابل توجهي از پريميدون در شير ترشح مي‌شود. شيردهي در دوران مصرف دارو توصيه نمي‌شود.

Pramipexole Dihydrochloride Extended-Release Tablets (Mirapex ER)

MIRAPEX ER®
(pramipexole dihydrochloride)

DRUG DESCRIPTION

MIRAPEX ER tablets contain pramipexole, a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S•2HCl•H2O, and its molecular weight is 302.26.

The structural formula is.

MIRAPEX ER® (pramipexole dihydrochloride) Structural Formula Illustration

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

MIRAPEX ER tablets, for oral administration, contain 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, or 4.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients are hypromellose, corn starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate.

What are the possible side effects of pramipexole (Mirapex, Mirapex ER)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking pramipexole and call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • nausea, sweating, feeling light-headed, fainting;
  • hallucinations;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • chest discomfort, dry cough, feeling short of...

Read All Potential Side Effects and See Pictures of Mirapex ER »

What are the precautions when taking pramipexole dihydrochloride extended-release tablets (Mirapex ER)?

See also Side Effects section.

Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (such as irregular heartbeat, heart failure), kidney problems, mental/mood disorders (such as confusion, hallucinations, psychosis, schizophrenia), sleep disorder (such as sleep apnea, narcolepsy).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side...

Read All Potential Precautions of Mirapex ER »

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

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].

When discontinuing therapy with MIRAPEX ER, taper the dose gradually over a period of one week. In some studies with immediate-release pramipexole tablets, however, abrupt discontinuation was uneventful.

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 7NDC 0597-0109-17
Unit of Use Bottles of 30NDC 0597-0109-30 Page 10 of 16

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 7NDC 0597-0285-17
Unit of Use Bottles of 30NDC 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 7NDC 0597-0113-17
Unit of Use Bottles of 30NDC 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 30NDC 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 30NDC 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 30NDC 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 30NDC 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

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.

During the premarketing development of MIRAPEX ER tablets, patients with early Parkinson's disease were treated with MIRAPEX ER tablets, placebo, or immediate-release pramipexole tablets. In addition, a randomized, double-blind, parallel group trial was conducted in 156 early Parkinson's disease patients (Hoehn & Yahr Stages I-III) to assess overnight switching of immediate-release pramipexole tablets to MIRAPEX ER tablets. In this latter study, concomitant treatment with stable doses of levodopa, monoamine oxidase B inhibitor (MAOB-I) drugs, anticholinergics, or amantadine, individually or in combination, was allowed. In a third trial, advanced Parkinson's disease patients received MIRAPEX ER tablets, placebo, or immediate-release pramipexole tablets as adjunctive therapy to levodopa.

Early Parkinson's Disease

The most commonly observed adverse events ( ≥ 5% and more frequent than placebo) after 33 weeks of treatment with MIRAPEX ER tablets in the trial of early Parkinson's disease patients were somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema.

Twenty four of 223 (11%) patients treated with MIRAPEX ER tablets for 33 weeks discontinued treatment due to adverse events compared to 4 of 103 (4%) patients who received placebo and approximately 20 of 213 (9%) patients who received immediate-release pramipexole tablets. The adverse event most commonly causing discontinuation of treatment with MIRAPEX ER tablets was nausea (2%).

Table 1 lists adverse events that occurred with a frequency of at least 2% with MIRAPEX ER and were more frequent than with placebo during 33 weeks of treatment in a double-blind, placebo-controlled study in early Parkinson's disease. In this study, patients did not receive concomitant levodopa; however, levodopa was permitted as rescue medication. Adverse events were usually mild (38%) or moderate (41%) in intensity.

Table 1 : Treatment-Emergent Adverse-Event Incidence in a Double-Blind, Placebo-Controlled 33 Week Trial in Early Parkinson's Disease (Events ≥ 2% of Patients Treated with MIRAPEX ER and greater than with Placebo)

Body System/Adverse Event Placebo
(n=103) %
MIRAPEX ER
(n=223) %
Immediate-Release Pramipexole
(n=213) %
Nervous system disorders
  Somnolence 15 36 33
  Dizziness 7 12 12
  Tremor 1 3 3
  Balance disorder 1 2 0
Gastrointestinal disorders
  Nausea 9 22 24
  Constipation 2 14 12
  Dry mouth 1 5 4
  Vomiting 0 4 4
  Upper abdominal pain 1 3 4
  Dyspepsia 2 3 3
  Abdominal discomfort 0 2 1
General disorders and administration site conditions
  Fatigue 4 6 6
  Peripheral edema 4 5 8
  Asthenia 2 3 1
Musculoskeletal and connective tissue disorders
  Muscle spasms 3 5 3
Psychiatric disorders
  Hallucinations, including visual, auditory and mixed 1 5 6
  Insomnia 3 4 4
  Sleep attacks or sudden onset of sleep 1 3 6
  Sleep disorder 1 2 3
  Depression 0 2 0
Injury, poisoning and procedural complications
  Fall 1 4 4
Vascular disorders
  Orthostatic hypotension 1 3 0
Ear and labyrinth disorders
  Vertigo 1 4 2
Metabolism and nutrition disorders
  Increased appetite 1 3 2
Respiratory, thoracic and mediastinal disorders
  Cough 1 3 3

Because this study used a flexible dose titration design, it was not possible to assess the effects of dose on the incidence of adverse events.

Adverse events can initially occur in either the titration or maintenance phase. Some adverse events developed in MIRAPEX ER-treated patients during the titration phase and persisted ( ≥ 7 days) into the maintenance phase (i.e., MIRAPEX ER % - placebo % = treatment difference ≥ 2%); persistent adverse events were somnolence, nausea, constipation, fatigue, and dry mouth.

A double-blind, randomized, parallel group trial evaluated the tolerability of an overnight switch from immediate-release pramipexole tablets to MIRAPEX ER tablets at the same daily dose in 156 early Parkinson's disease patients with or without levodopa. One of 104 patients switched from immediate-release pramipexole tablets to MIRAPEX ER tablets discontinued due to adverse events (vertigo and nausea).

Advanced Parkinson's Disease

The most commonly observed adverse events ( ≥ 5% and greater frequency than in placebo) during 18 weeks of treatment with MIRAPEX ER tablets in the trial of advanced Parkinson's disease patients with concomitant levodopa were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.

Eight of 164 (5%) patients treated with MIRAPEX ER tablets for 18 weeks discontinued treatment due to adverse events compared to 7 of 178 (4%) patients who received placebo and 8 of 175 (5%) patients who received immediate-release pramipexole tablets. The most common adverse events leading to discontinuation of treatment with MIRAPEX ER tablets were nausea (1%) and hallucination (1%).

Table 2 lists adverse events that occurred with a frequency of at least 2% with MIRAPEX ER and were more frequent than with placebo during 18 weeks of treatment in patients with advanced Parkinson's disease treated with MIRAPEX ER tablets. In this study, MIRAPEX ER tablets, immediate-release pramipexole tablets, or placebo was administered to patients who were also receiving concomitant levodopa. Adverse events were usually mild (32%) or moderate (17%) in intensity.

Table 2 : Treatment-Emergent Adverse-Event Incidence in a Double-Blind, Placebo-Controlled Trial in Advanced Parkinson's Disease* (Events ≥ 2% of Patients Treated with MIRAPEX ER and greater than with Placebo)

Body System/Adverse Event Placebo
n=178 %
MIRAPEX ER
n=164 %
Immediate-Release Pramipexole
n=175 %
Nervous system disorders
  Dyskinesia 8 17 18
  Headache 3 7 4
  Dizziness (postural) 1 2 3
Gastrointestinal disorders
  Nausea 10 11 11
  Constipation   5 7 6
  Salivary hypersecretion 0 2 0
  Diarrhea 1 2 1
Psychiatric disorders
  Hallucinations, including visual, auditory and mixed 2 9 7
  Insomnia 2 4 4
Metabolism and nutrition disorders
  Anorexia 2 5 1
Musculoskeletal and connective tissue disorders
  Back pain 1 2 3
*18-week final analysis

Because this flexible dose study used a titration design, it was not possible to assess the effects of dose on the incidence of adverse events.

Adverse events can initially occur in either the titration or maintenance phase. Some adverse events developed in MIRAPEX ER-treated patients during the titration phase and persisted ( ≥ 7 days) into the maintenance phase (i.e., MIRAPEX ER % - placebo % = treatment difference ≥ 2%); persistent adverse events were dyskinesia and insomnia.

Laboratory Testing

During the development of MIRAPEX ER tablets, no systematic abnormalities on routine laboratory testing were noted. Therefore, no specific guidance is offered regarding routine monitoring; the practitioner retains responsibility for determining how best to monitor the patient in his or her care.

Other adverse events observed during clinical trials of immediate-release pramipexole tablets

Adverse events not listed above but reported on at least two occasions (one occasion if the event was serious) in clinical studies involving 2509 individuals who received pramipexole immediate-release tablets are listed below. The reported events are included without regard to determination of a causal relationship to pramipexole immediate-release tablets.

Blood and lymphatic system disorders: anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocythaemia, thrombocytopenia

Cardiac disorders: angina pectoris, arrhythmia supraventricular, atrial fibrillation, atrioventricular block first degree, atrioventricular block second degree, bradycardia, bundle branch block, cardiac arrest, cardiac failure, cardiac failure congestive, cardiomegaly, coronary artery occlusion, cyanosis, extrasystoles, left ventricular failure, myocardial infarction, nodal arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, tachycardia, ventricular fibrillation, ventricular extrasystoles, ventricular hypertrophy

Congenital, familial, and genetic disorders: atrial septal defect, congenital foot malformation, spine malformation

Ear and labyrinth disorders: deafness, ear pain, hearing impaired, hypoacusis, motion sickness, vestibular ataxia

Endocrine disorders: goiter, hyperthyroidism, hypothyroidism

Eye disorders: accommodation abnormalities, amaurosis fugax, blepharitis, blepharospasm, cataract, dacryostenosis acquired, diplopia, dry eye, eye hemorrhage, eye irritation, eye pain, eyelid edema, eyelid ptosis, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorder, scotoma, vision abnormalities, vision blurred, visual acuity reduced, vitreous floaters

Gastrointestinal disorders: abdominal distension, aphthous stomatitis, ascites, cheilitis, colitis, colitis ulcerative, dyspepsia, dysphagia, duodenal ulcer, duodenal ulcer hemorrhage, enteritis, eructation, fecal incontinence, gastric ulcer, gastric ulcer hemorrhage, gastritis, gastrointestinal hemorrhage, gastroesophageal reflux disease, gingivitis, haematemesis, haematochezia, hemorrhoids, hiatus hernia, hyperchlorhydria, ileus, inguinal hernia, intestinal obstruction, irritable bowel syndrome, esophageal spasm, esophageal stenosis, esophagitis, pancreatitis, periodontitis, rectal hemorrhage, reflux esophagitis, tongue edema, tongue ulceration, toothache, umbilical hernia

General disorders: chest discomfort, chills, death, drug withdrawal syndrome, face edema, feeling cold, feeling hot, feeling jittery, fever, gait disturbance, impaired healing, influenza-like illness, irritability, localized edema, edema, malaise, pitting edema, thirst

Hepatobiliary disorders: biliary colic, cholecystitis, cholecystitis chronic, cholelithiasis

Immune system disorders: drug hypersensitivity

Infections and infestations: abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, ear infection, eye infection, folliculitis, fungal infection, furuncle, gangrene, gastroenteritis, gingival infection, herpes simplex, herpes zoster, hordeolum, influenza, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, otitis externa, otitis media, paronychia, pyelonephritis, pyoderma, sepsis, skin infection, tonsillitis, tooth abscess, tooth infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound infection

Injury, poisoning, and procedural complications: accidental falls, drug toxicity epicondylitis, road traffic accident, sunburn, tendon rupture

Metabolism and nutrition disorders: cachexia, decreased appetite, decreased weight, dehydration, diabetes mellitus, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypovitaminosis, increased creatine PK, metabolic alkalosis

Musculoskeletal and connective tissue disorders: bone pain, bursitis, fasciitis, flank pain, intervertebral disc disorder, intervertebral disc protrusion, joint effusion, joint stiffness, joint swelling, monarthritis, muscle rigidity, musculoskeletal stiffness, myasthenia, myopathy, myositis, nuchal rigidity, osteoarthritis, osteonecrosis, osteoporosis, pain in extremity, polymyalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendonitis, tenosynovitis, twitching

Neoplasms benign, malignant, and unspecified: abdominal neoplasm, adenocarcinoma, adenoma benign, basal cell carcinoma, bladder cancer, breast cancer, breast neoplasm, chronic lymphocytic leukemia, colon cancer, colorectal cancer, endometrial cancer, gallbladder cancer, gastric cancer, gastrointestinal neoplasm, hemangioma, hepatic neoplasm, hepatic neoplasm malignant, lip and/or oral cavity cancer, lung neoplasm malignant, lung cancer metastatic, lymphoma, malignant melanoma, melanocytic naevus, metastases to lung, multiple myeloma, oral neoplasm benign, neoplasm, neoplasm malignant, neoplasm prostate, neoplasm skin, neuroma, ovarian cancer, prostate cancer, prostatic adenoma, pseudo lymphoma, renal neoplasm, skin cancer, skin papilloma, squamous cell carcinoma, thyroid neoplasm, uterine leiomyoma

Nervous system disorders: ageusia, akinesia, amnesia, akathisia, anticholinergic syndrome, aphasia, brain edema, carotid artery occlusion, carpal tunnel syndrome, cerebral artery embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive disorder, coma, convulsion, coordination abnormal, dementia, depressed level of consciousness, disturbance in attention, dizziness postural, dysarthria, dysgraphia, dystonia, extrapyramidal syndrome, facial palsy, grand mal convulsion, hemiplegia, hyperaesthesia, hyperkinesia, hyperreflexia, hyporeflexia, hypertonia, hypesthesia, hypotonia, lethargy, loss of consciousness, memory impairment, migraine, muscle contractions involuntary, myoclonus, narcolepsy, neuralgia, neuropathy, nystagmus, parosmia, psychomotor hyperactivity, sciatica, sedation, sensory disturbance, sleep phase rhythm disturbance, sleep talking, stupor, syncope vasovagal, tension headache, thinking abnormalities

Psychiatric disorders: affect lability, aggression, agitation, bradyphrenia, bruxism, suicide, delirium, delusions, delusional disorder persecutory type, disorientation, dissociation, emotional distress, euphoric mood, initial insomnia, libido increased, mania, middle insomnia, mood altered, nightmare, obsessive thoughts, obsessive-compulsive disorder, panic reaction, paranoid reaction, parasomnia, personality disorder, psychotic disorder, restlessness, sleep walking, suicidal ideation

Renal and urinary disorders: chromaturia, dysuria, glycosuria, hematuria, urgency, nephrolithiasis, neurogenic bladder, nocturia, oliguria, pollakiuria, proteinuria, renal artery stenosis, renal colic, renal cyst, renal failure, renal impairment, urinary frequency, urinary incontinence, urinary retention, urinary tract infection

Reproductive system and breast disorders: amenorrhea, breast pain, dysmenorrhea, epididymitis, gynaecomastia, impotence, menopausal symptoms, menorrhagia, metrorrhagia, ovarian cyst, priapism, prostatitis, sexual dysfunction, uterine hemorrhage, vaginal discharge, vaginal hemorrhage

Respiratory, thoracic, and mediastinal disorders: apnea, aspiration, asthma, choking, chronic obstructive pulmonary disease, dry throat, dysphonia, dyspnea exertional, epistaxis, haemoptysis, hiccups, hyperventilation, increased bronchial secretion, laryngospasm, nasal congestion, nasal dryness, nasal polyps, obstructive airways disorder, pharyngolaryngeal pain, pleurisy, pneumonia, pneumonia aspiration, pneumothorax, postnasal drip, productive cough, pulmonary embolism, pulmonary edema, respiratory alkalosis, respiratory distress, respiratory failure, respiratory tract congestion, rhinitis allergic, rhinorrhea, sinus congestion, sleep apnoea syndrome, sneezing, snoring, tachypnea, wheezing

Skin and subcutaneous tissue disorders: acne, alopecia, cold sweat, dermal cyst, dermatitis, dermatitis bullous, dermatitis contact, dry skin, ecchymosis, eczema, erythema, hyperkeratosis, livedo reticularis, night sweats, periorbital edema, petechiae, photosensitivity allergic reaction, psoriasis, purpura, rash erythematous, rash maculo-papular, rash papular, rosacea, seborrhea, seborrheic dermatitis, skin burning sensation, skin discoloration, skin disorders, skin exfoliation, skin hyperpigmentation, skin hypertrophy, skin irritation, skin nodule, skin odor abnormal, skin ulcer, urticaria

Vascular disorders: aneurysm, angiopathy, arteriosclerosis, circulatory collapse, deep vein thrombosis, embolism, hematoma, hot flush, hypertensive crisis, lymphoedema, pallor, phlebitis, Raynaud's phenomenon, shock, thrombophlebitis, thrombosis, varicose vein

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of immediate-release pramipexole tablets, primarily in Parkinson's disease patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to pramipexole tablets. Similar types of events were grouped into a smaller number of standardized categories using the MedDRA terminology: abnormal behavior, abnormal dreams, accidents (including fall), blackouts, compulsive shopping, fatigue, hallucinations (all kinds), headache, hypotension (including postural hypotension), increased eating (including binge eating, compulsive eating, and hyperphagia), libido disorders (including increased and decreased libido, and hypersexuality), pathological gambling, pruritus, syncope, vomiting, and weight increase.

Read the Mirapex ER (pramipexole dihydrochloride extended-release tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No drug interaction studies were conducted with MIRAPEX ER tablets since the potential for drug interactions mainly depends on the active drug substance pramipexole and not the formulation. Data are available for the immediate-release pramipexole tablet formulation [see CLINICAL PHARMACOLOGY].

Dopamine Antagonists

Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of MIRAPEX ER tablets.

Drug/Laboratory Test Interactions

There are no known interactions between pramipexole and laboratory tests.

Drug Abuse And Dependence

Controlled Substance

Pramipexole is not a controlled substance.

Abuse and Dependence

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

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Falling Asleep During Activities of Daily Living

Patients treated with pramipexole have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on pramipexole tablets, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment. In placebo-controlled clinical trials in Parkinson's disease, the sudden onset of sleep or sleep attacks were reported in 8 of 387 (2%) patients treated with MIRAPEX ER tablets compared to 2 of 281 (1%) patients on placebo.

In early Parkinson's disease, somnolence was reported in 36% of 223 patients treated with MIRAPEX ER, median dose 3.0 mg/day, compared to 15% of 103 patients on placebo. In advanced Parkinson's disease, somnolence was reported in 15% of 164 patients treated with MIRAPEX ER tablets, median dose 3 mg/day, compared to 16% of 178 patients on placebo. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with MIRAPEX ER tablets, advise patients of the potential to develop drowsiness, and specifically ask about factors that may increase the risk such as the use of concomitant sedating medications or alcohol, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g., cimetidine) [see CLINICAL PHARMACOLOGY]. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), MIRAPEX ER tablets should ordinarily be discontinued. If a decision is made to continue MIRAPEX ER tablets, advise patients not to drive and to avoid other potentially dangerous activities. While dose reduction reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Symptomatic Orthostatic Hypotension

Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension, especially during dose escalation. Parkinson's disease patients, in addition, appear to have an impaired capacity to respond to an orthostatic challenge. For these reasons, Parkinson's disease patients being treated with dopaminergic agonists, including MIRAPEX ER, ordinarily require careful monitoring for signs and symptoms of orthostatic hypotension, especially during dose escalation, and should be informed of this risk [see PATIENT INFORMATION]. In placebo-controlled clinical trials in Parkinson's disease, symptomatic orthostatic hypotension was reported in 10 of 387 (3%) patients treated with MIRAPEX ER tablets compared to 3 of 281 (1%) patients on placebo. One patient of 387 on MIRAPEX ER tablets discontinued treatment due to hypotension.

Impulse Control/Compulsive Behaviors

Case reports and the results of cross-sectional studies suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including MIRAPEX ER, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with MIRAPEX ER. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking MIRAPEX ER [see PATIENT INFORMATION].

A total of 1056 patients with Parkinson's disease who participated in two MIRAPEX ER placebo-controlled studies of up to 33 weeks duration were specifically asked at each visit about the occurrence of these symptoms. A total of 14 of 387 (4%) treated with MIRAPEX ER tablets, 12 of 388 (3%) treated with immediate-release pramipexole tablets, and 4 of 281 (1%) treated with placebo reported compulsive behaviors, including pathological gambling, hypersexuality, and/or compulsive buying.

Hallucinations

In placebo-controlled clinical trials in Parkinson's disease, hallucinations (visual or auditory or mixed) were reported in 25 of 387 (6%) patients treated with MIRAPEX ER tablets compared to 5 of 281 (2%) patients receiving placebo. Hallucinations led to discontinuation of treatment in 5 of 387 (1%) patients on MIRAPEX ER tablets.

Age appears to increase the risk of hallucinations attributable to pramipexole. In placebo-controlled clinical trials in Parkinson's disease, hallucinations were reported in 15 of 162 (9%) patients ≥ 65 years of age taking MIRAPEX ER tablets compared to 10 of 225 (4%) patients < 65 years of age taking MIRAPEX ER tablets.

Dyskinesia

MIRAPEX ER tablets may potentiate the dopaminergic side effects of levodopa and may cause or exacerbate preexisting dyskinesia.

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. MIRAPEX ER tablets have not been studied in patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min) or on hemodialysis [see DOSAGE AND ADMINISTRATION, Use in Specific Populations, and CLINICAL PHARMACOLOGY].

Rhabdomyolysis

In the clinical development program for immediate-release pramipexole tablets, a single case of rhabdomyolysis occurred in a 49-year-old male with advanced Parkinson's disease. The patient was hospitalized with an elevated CPK (10,631 IU/L). The symptoms resolved with discontinuation of the medication.

Advise patients to contact a physician if they experience any unexplained muscle pain, tenderness, or weakness, as these may be symptoms of rhabdomyolysis.

Retinal Pathology

Human Data

A two-year open-label, randomized, parallel-group safety study of retinal deterioration and vision compared MIRAPEX tablets and immediate-release ropinirole. Two hundred thirty four Parkinson's disease patients (115 on pramipexole, mean dose 3.0 mg/day and 119 on ropinirole, mean dose 9.5 mg/day) were evaluated using a panel of clinical ophthalmological assessments. Of 234 patients who were evaluable, 196 had been treated for two years and 29 were judged to have developed clinical abnormalities that were considered meaningful (19 patients in each treatment arm had received treatment for less than two years). There was no statistical difference in retinal deterioration between the treatment arms; however, the study was only capable of detecting a very large difference between treatments. In addition, because the study did not include an untreated comparison group (placebo treated), it is unknown whether the findings reported in patients treated with either drug are greater than the background rate in an aging population.

Animal Data

Pathologic changes (degeneration and loss of photoreceptor cells) were observed in the retina of albino rats in a 2-year carcinogenicity study. While retinal degeneration was not diagnosed in pigmented rats treated for 2 years, a thinning in the outer nuclear layer of the retina was slightly greater in rats given drug compared with controls. Evaluation of the retinas of albino mice, monkeys, and minipigs did not reveal similar changes. The potential significance of this effect for humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (i.e., disk shedding) may be involved [see Nonclinical Toxicology].

Events Reported with Dopaminergic Therapy

Although the events enumerated below may not have been reported with the use of pramipexole in its development program, they are associated with the use of other dopaminergic drugs. The expected incidence of these events, however, is so low that even if pramipexole caused these events at rates similar to those attributable to other dopaminergic therapies, it would be unlikely that even a single case would have occurred in a cohort of the size exposed to pramipexole in studies to date.

Withdrawal-Emergent Hyperpyrexia and Confusion

Although not reported with pramipexole in the clinical development program, a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in anti-Parkinsonian therapy.

Fibrotic Complications

Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, and cardiac valvulopathy have been reported in patients treated with ergot-derived dopaminergic agents. While these complications may resolve when the drug is discontinued, complete resolution does not always occur.

Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, non-ergot derived dopamine agonists can cause them is unknown.

Cases of possible fibrotic complications, including peritoneal fibrosis, pleural fibrosis, and pulmonary fibrosis have been reported in the postmarketing experience with immediate-release pramipexole tablets. While the evidence is not sufficient to establish a causal relationship between pramipexole and these fibrotic complications, a contribution of pramipexole cannot be completely ruled out.

Melanoma

Epidemiologic studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the observed increased risk was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear.

For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using MIRAPEX ER tablets for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

Patient Counseling Information

See FDA-Approved Patient Labeling

Dosing Instructions

Instruct patients to take MIRAPEX ER tablets only as prescribed. If a dose is missed, advise patients not to double their next dose.

MIRAPEX ER tablets can be taken with or without food. If patients develop nausea, advise that taking MIRAPEX ER tablets with food may reduce the occurrence of nausea.

MIRAPEX ER tablets should be swallowed whole. They should not be chewed, crushed, or divided [see DOSAGE AND ADMINISTRATION].

Pramipexole is the active ingredient that is in both MIRAPEX ER tablets and immediate-release pramipexole tablets. Ensure that patients do not take both immediate-release pramipexole and MIRAPEX ER.

Sedating Effects

Alert patients to the potential sedating effects of MIRAPEX ER tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with MIRAPEX ER tablets to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., conversations or eating) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects, caution should be advised when patients are taking other sedating medications or alcohol in combination with MIRAPEX ER and when taking concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine) [see WARNINGS AND PRECAUTIONS].

Impulse Control Symptoms Including Compulsive Behaviors

Patients and their caregivers should be alerted to the possibility that they may experience intense urges to spend money, intense urges to gamble, increased sexual urges, binge eating and/or other intense urges and the inability to control these urges while taking MIRAPEX ER [see WARNINGS AND PRECAUTIONS].

Hallucinations

Inform patients that hallucinations can occur and that the elderly are at a higher risk than younger patients with Parkinson's disease [see WARNINGS AND PRECAUTIONS].

Postural (Orthostatic) Hypotension

Advise patients that they may develop postural (orthostatic) hypotension, with or without symptoms such as dizziness, nausea, fainting, or blackouts, and sometimes, sweating. Hypotension may occur more frequently during initial therapy. Accordingly, caution patients against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with MIRAPEX ER [see WARNINGS AND PRECAUTIONS].

Pregnancy

Because the teratogenic potential of pramipexole has not been completely established in laboratory animals, and because experience in humans is limited, advise women to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations].

Nursing Mothers

Because of the possibility that pramipexole may be excreted in breast milk, advise women to notify their physicians if they intend to breast-feed or are breast-feeding an infant [see Use In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year carcinogenicity studies with pramipexole have been conducted in mice and rats. Pramipexole was administered in the diet to mice at doses up to 10 mg/kg/day [or approximately 10 times the maximum recommended human dose (MRHD) of 1.5 mg TID on a mg/m² basis]. Pramipexole was administered in the diet to rats at doses up to 8 mg/kg/day. These doses were associated with plasma AUCs up to approximately 12 times that in humans at the MRHD. No significant increases in tumors occurred in either species.

Pramipexole was not mutagenic or clastogenic in a battery of in vitro (bacterial reverse mutation, V79/HGPRT gene mutation, chromosomal aberration in CHO cells) and in vivo (mouse micronucleus) assays.

In rat fertility studies, pramipexole at a dose of 2.5 mg/kg/day (5 times the MRHD on a mg/m² basis) prolonged estrus cycles and inhibited implantation. These effects were associated with reductions in serum levels of prolactin, a hormone necessary for implantation and maintenance of early pregnancy in rats.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. MIRAPEX ER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

When pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day [5 times the maximum recommended human dose (MRHD) on a mg/m² basis]. Administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. The plasma AUC in rats at this dose was 4 times the AUC in humans at the MRHD. These findings are thought to be due to the prolactin-lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance of early pregnancy in rats (but not rabbits or humans). Because of pregnancy disruption and early embryonic loss in these studies, the teratogenic potential of pramipexole could not be adequately evaluated. There was no evidence of adverse effects on embryo-fetal development following administration of up to 10 mg/kg/day to pregnant rabbits during organogenesis (plasma AUC was 70 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with 0.5 mg/kg/day (approximately equivalent to the MRHD on a mg/m² basis) or greater during the latter part of pregnancy and throughout lactation.

Nursing Mothers

A single-dose, radio-labeled study showed that drug-related material was present in rat milk at concentrations three to six times higher than in plasma at equivalent time points.

Studies have shown that pramipexole treatment resulted in an inhibition of prolactin secretion in humans and rats.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from pramipexole, a decision should be made as to whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The pharmacokinetics, safety, and efficacy of MIRAPEX ER tablets in pediatric patients have not been evaluated.

Geriatric Use

Pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. This resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. In a placebo-controlled clinical trial of MIRAPEX ER tablets in early Parkinson's disease, 47% of the 259 patients were ≥ 65 years of age. Among patients receiving MIRAPEX ER tablets, hallucinations were more common in the elderly, occurring in 13% of the patients ≥ 65 years of age compared to 2% of the patients < 65 years of age.

Patients with Renal Impairment

The elimination of pramipexole is dependent upon renal function. Pramipexole clearance is extremely low in dialysis patients, as a negligible amount of pramipexole is removed by dialysis [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is no clinical experience with significant overdosage. One patient took 11 mg/day of pramipexole for 2 days in a clinical trial for an investigational use. Blood pressure remained stable, although pulse rate increased to between 100 and 120 beats/minute. No other adverse events were reported related to the increased dose.

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.

CONTRAINDICATIONS

None.

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Pramipexole is a non-ergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than to D2 or D4 receptor subtypes.

The precise mechanism of action of pramipexole as a treatment for Parkinson's disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that pramipexole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum and the substantia nigra, the site of neurons that send projections to the striatum. The relevance of D3 receptor binding in Parkinson's disease is unknown.

Pharmacodynamics

The effect of pramipexole on the QT interval of the ECG was investigated in a clinical study in 60 healthy male and female volunteers. All subjects initiated treatment with 0.375 mg MIRAPEX ER tablets administered once daily, and were up-titrated every 3 days to 2.25 mg and 4.5 mg daily. No dose- or exposure-related effect on mean QT intervals was observed; however the study did not have a valid assessment of assay sensitivity. The effect of pramipexole on QTc intervals at higher exposures achieved either due to drug interactions (e.g., with cimetidine), renal impairment, or at higher doses has not been systematically evaluated.

Although mean values remained within normal reference ranges throughout the study, supine systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate for subjects treated with pramipexole generally increased during the rapid up-titration phase, by 10 mmHg, 7 mmHg, and 10 bpm higher than placebo, respectively. Higher SBP, DBP, and pulse rates compared to placebo were maintained until the pramipexole doses were tapered; values on the last day of tapering were generally similar to baseline values. Such effects have not been observed in clinical studies with Parkinson's disease patients, who were titrated according to labeled recommendations.

Pharmacokinetics

MIRAPEX ER tablets, like immediate-release pramipexole tablets, display linear pharmacokinetics over the entire clinical dosage range. Slow release of pramipexole from MIRAPEX ER tablets with once-daily administration results in the same daily maximum and minimum pramipexole plasma concentrations (Cmax, Cmin) as three times daily administration of immediate-release pramipexole tablets.

Absorption

The absolute bioavailability of pramipexole is greater than 90%, indicating that it is well absorbed and undergoes little presystemic metabolism.

Increase in systemic exposure of pramipexole following oral administration of 0.375 mg to 4.5 mg of MIRAPEX ER tablets was dose-proportional. For MIRAPEX ER tablets, steady state of exposure is reached within 5 days of continuous dosing.

Relative bioavailability of MIRAPEX ER tablets compared with immediate-release tablets was approximately 100%. In a repeat-dose study in healthy, normal volunteers, MIRAPEX ER tablets 4.5 mg administered once daily was bioequivalent with regard to Cmax and AUC over 24 hours to immediate-release pramipexole tablets 1.5 mg administered three times daily. The average time-to-peak concentration for MIRAPEX ER tablets is 6 hours. Administration of MIRAPEX ER tablets with food (i.e., high-fat meal) did not affect AUC but increased Cmax by approximately 20% and delayed Tmax by approximately 2 hours compared with dosing under fasted conditions; these differences are not considered to be clinically relevant [see DOSAGE AND ADMINISTRATION].

Distribution

Pramipexole is extensively distributed, having a volume of distribution of about 500 L (coefficient of variation [CV] = 20%). It is about 15% bound to plasma proteins. Pramipexole distributes into red blood cells as indicated by an erythrocyte-to-plasma ratio of approximately 2.

Metabolism

Pramipexole is metabolized only to a negligible extent ( < 10%). No specific active metabolite has been identified in human plasma or urine.

Elimination

Urinary excretion is the major route of pramipexole elimination, with 90% of a pramipexole dose recovered in urine, almost all as unchanged drug. The renal clearance of pramipexole is approximately 400 mL/min (CV=25%), approximately three times higher than the glomerular filtration rate. Thus, pramipexole is secreted by the renal tubules, probably by the organic cation transport system.

Pharmacokinetics in Specific Populations

Because therapy with MIRAPEX ER tablets is initiated at a low dose and gradually titrated upward according to clinical tolerability to obtain the optimum therapeutic effect, adjustment of the initial dose based on gender, weight, race, or age is not necessary. However, renal insufficiency causes a large decrease in the ability to eliminate pramipexole. This will necessitate dosage adjustment in patients with moderate to severe renal impairment [see DOSAGE AND ADMINISTRATION].

Gender

Pramipexole clearance is about 30% lower in women than in men, but this difference can be accounted for by differences in body weight. There is no difference in plasma half-life between males and females.

Age

Pramipexole clearance is reduced by approximately 30% in the elderly (aged 65 years or older) compared with young, healthy volunteers (aged less than 40 years). This difference is most likely due to the reduction in renal function with age, since pramipexole clearance is correlated with renal function, as measured by creatinine clearance.

Race

No racial differences in metabolism and elimination have been identified.

Hepatic Impairment

The influence of hepatic insufficiency on pramipexole pharmacokinetics has not been evaluated. Because approximately 90% of the recovered dose is excreted in the urine as unchanged drug, hepatic impairment would not be expected to have a significant effect on pramipexole elimination.

Renal Impairment

Clearance of immediate-release pramipexole was about 75% lower in patients with severe renal impairment (creatinine clearance approximately 20 mL/min) and about 60% lower in patients with moderate impairment (creatinine clearance approximately 40 mL/min) compared with healthy volunteers [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. In patients with varying degrees of renal impairment, pramipexole clearance correlates well with creatinine clearance. Therefore, creatinine clearance can be used as a predictor of the extent of decrease in pramipexole clearance.

Drug Interactions

No specific pharmacokinetic drug interaction trials were conducted with MIRAPEX ER tablets since the potential for drug interactions mainly depends on the active drug substance pramipexole and not the formulation. The following interaction data were obtained using immediate-release pramipexole tablets.

Carbidopa/levodopa: Carbidopa/levodopa did not influence the pharmacokinetics of pramipexole in healthy volunteers (N=10). Pramipexole did not alter the extent of absorption (AUC) or the elimination of carbidopa/levodopa, although it caused an increase in levodopa Cmax by about 40% and a decrease in Tmax from 2.5 to 0.5 hours.

Selegiline: In healthy volunteers (N=11), selegiline did not influence the pharmacokinetics of pramipexole.

Amantadine: Population pharmacokinetic analyses suggest that amantadine may slightly decrease the oral clearance of pramipexole.

Cimetidine: Cimetidine, a known inhibitor of renal tubular secretion of organic bases via the cationic transport system, caused a 50% increase in pramipexole AUC and a 40% increase in half-life (N=12).

Probenecid: Probenecid, a known inhibitor of renal tubular secretion of organic acids via the anionic transporter, did not noticeably influence pramipexole pharmacokinetics (N=12).

Other drugs eliminated via renal secretion: Population pharmacokinetic analysis suggests that co-administration of drugs that are secreted by the cationic transport system (e.g., cimetidine, ranitidine, diltiazem, triamterene, verapamil, quinidine, and quinine) decreases the oral clearance of pramipexole by about 20%, while those secreted by the anionic transport system (e.g., cephalosporins, penicillins, indomethacin, hydrochlorothiazide, and chlorpropamide) are likely to have little effect on the oral clearance of pramipexole.

CYP interactions: Inhibitors of cytochrome P450 enzymes would not be expected to affect pramipexole elimination because pramipexole is not appreciably metabolized by these enzymes in vivo or in vitro. Pramipexole does not inhibit CYP enzymes CYP1A2, CYP2C9, CYP2C19, CYP2E1, and CYP3A4. Inhibition of CYP2D6 was observed with an apparent Ki of 30 μM, indicating that pramipexole will not inhibit CYP enzymes at plasma concentrations observed following the clinical dose of 4.5 mg/day.

Drugs affecting gastrointestinal motility or gastric pH: Population pharmacokinetic analysis suggests that co-administration of antacids (N=6) decreased the oral clearance of pramipexole by about 25%, while H2-blockers (N=5), anticholinergics (N=27), propulsive (N=7), and proton pump inhibitors (N=16) are likely to have little effect on the oral clearance of pramipexole.

Animal Toxicology and/or Pharmacology

Retinal Pathology in Albino Rats

Pathologic changes (degeneration and loss of photoreceptor cells) were observed in the retina of albino rats in the 2-year carcinogenicity study with pramipexole. These findings were first observed during week 76 and were dose-dependent in animals receiving 2 or 8 mg/kg/day (plasma AUCs equal to 2.5 and 12.5 times that in humans at the MRHD of 1.5 mg TID). In a similar study of pigmented rats with 2-years exposure to pramipexole at 2 or 8 mg/kg/day, retinal degeneration was not observed. Animals given drug had thinning in the outer nuclear layer of the retina that was only slightly greater than that seen in control rats.

Investigative studies demonstrated that pramipexole reduced the rate of disk shedding from the photoreceptor rod cells of the retina in albino rats, which was associated with enhanced sensitivity to the damaging effects of light. In a comparative study, degeneration and loss of photoreceptor cells occurred in albino rats after 13 weeks of treatment with 25 mg/kg/day of pramipexole (54 times the highest clinical dose on a mg/m² basis) and constant light (100 lux), but not in pigmented rats exposed to the same dose and higher light intensities (500 lux). Thus, the retina of albino rats is considered to be uniquely sensitive to the damaging effects of pramipexole and light. Similar changes in the retina did not occur in a 2-year carcinogenicity study in albino mice treated with 0.3, 2, or 10 mg/kg/day (0.3, 2.2, and 11 times the highest clinical dose on a mg/m² basis). Evaluation of the retinas of monkeys given 0.1, 0.5, or 2.0 mg/kg/day of pramipexole (0.4, 2.2, and 8.6 times the highest clinical dose on a mg/m² basis) for 12 months and minipigs given 0.3, 1, or 5 mg/kg/day of pramipexole for 13 weeks also detected no changes.

The potential significance of this effect in humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (i.e., disk shedding) may be involved.

Fibro-osseous Proliferative Lesions in Mice

An increased incidence of fibro-osseous proliferative lesions occurred in the femurs of female mice treated for 2 years with 0.3, 2.0, or 10 mg/kg/day (0.3, 2.2, and 11 times the highest clinical dose on a mg/m² basis). Lesions occurred at a lower rate in control animals. Similar lesions were not observed in male mice or rats and monkeys of either sex that were treated chronically with pramipexole. The significance of this lesion to humans is not known.

Clinical Studies

The effectiveness of MIRAPEX ER tablets in the treatment of Parkinson's disease was supported by clinical pharmacokinetic data [see CLINICAL PHARMACOLOGY] and two randomized, double-blind, placebo-controlled, multicenter clinical trials in early and advanced Parkinson's disease. In both randomized studies, the Unified Parkinson's Disease Rating Scale (UPDRS) served as a primary outcome assessment measure. The UPDRS is a four-part multi-item rating scale intended to evaluate mentation (Part I), activities of daily living (Part II), motor performance (Part III), and complications of therapy (Part IV).

Part II of the UPDRS contains 13 questions related to activities of daily living, which are scored from 0 (normal) to 4 (maximal severity) for a maximum (worst) score of 52. Part III of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings in patients with Parkinson's disease (e.g., tremor, rigidity, bradykinesia, postural instability, etc.), scored for different body regions and has a maximum (worst) score of 108.

Early Parkinson's Disease

The effectiveness of MIRAPEX ER tablets in early Parkinson's disease patients (Hoehn & Yahr Stages I-III) who were not on levodopa therapy was established in a randomized, double-blind, placebo-controlled, 3-parallel-group clinical study. Patients were treated with MIRAPEX ER tablets, immediate-release pramipexole tablets, or placebo; those treated with MIRAPEX ER tablets or immediate-release pramipexole tablets had a starting dose of 0.375 mg/day followed by a flexible up-titration, based on efficacy and tolerability, up to 4.5 mg/day. Levodopa was permitted during the study as rescue medication. Stable doses of concomitant MAO-B inhibitors, anticholinergics, or amantadine, individually or in combination, were allowed. The primary efficacy endpoint was the mean change from baseline in the UPDRS Parts II+III score for MIRAPEX ER tablets versus placebo following 18 weeks of treatment.

At 18 weeks of treatment, the mean change from baseline UPDRS Parts II+III score was –8.1 points in patients receiving MIRAPEX ER tablets (n=102) and –5.1 points in patients receiving placebo (n=50), a difference that was statistically significant (p < 0.03). Seven patients treated with placebo (14%) and 3 patients treated with MIRAPEX ER tablets (3%) received levodopa rescue medication. At 18 weeks, the mean dose of MIRAPEX ER was 3 mg/day.

At 33-weeks, the adjusted mean improvement from baseline UPDRS Parts II+III score was –8.6 points in patients receiving MIRAPEX ER tablets (n=213), compared to –3.8 points in patients receiving placebo (n=103).

At 18 and 33 weeks, the mean dose of MIRAPEX ER tablets was approximately 3 mg/day. Twenty-two patients treated with placebo (21%) and 15 patients treated with MIRAPEX ER tablets (7%) received levodopa rescue medication before the final assessment.

No differences in effectiveness based on age or gender were detected. Patients receiving MAOB-I, anticholinergics, or amantadine had responses similar to patients not receiving these drugs.

Advanced Parkinson's Disease

The effectiveness of MIRAPEX ER tablets in advanced Parkinson's disease patients (Hoehn & Yahr Stages II-IV at “on” time) who were on concomitant levodopa therapy (at an optimized dose) and who had motor fluctuations (at least 2 cumulative hours of “off” time per day) was established in a randomized, double-blind, placebo-controlled, 3-parallel-group clinical study. Patients were treated with MIRAPEX ER tablets, immediate-release pramipexole tablets, or placebo; those treated with MIRAPEX ER tablets or immediate-release pramipexole tablets had a starting dose of 0.375 mg/day followed by a flexible up-titration over 7 weeks, based on efficacy and tolerability, up to 4.5 mg/day, followed by a 26 week maintenance period. Levodopa dosage reduction was permitted only in the case of dopaminergic adverse events. The primary efficacy endpoint was the adjusted mean change from baseline in the UPDRS Parts II+III score for MIRAPEX ER tablets versus placebo following 18 weeks of treatment.

At 18 weeks of treatment, the adjusted mean improvement from baseline UPDRS Parts II+III score was –11.0 points in patients receiving MIRAPEX ER tablets (n=161) and –6.1 points in patients receiving placebo (n=174), (p=0.0001). At week 18, the adjusted mean improvement from baseline in “off” time was –2.1 hours for MIRAPEX ER and –1.4 hours for placebo (p=0.0199).

At 33-weeks the adjusted mean improvement from baseline UPDRS Parts II+III score was –11.1 points in patients receiving MIRAPEX ER tablets (n=117) and –6.8 points in patients receiving placebo (n=136) (p=0.0135).

At both 18 and 33 weeks the mean daily dose of MIRAPEX ER was 2.6 mg/day. At week 18, 4 patients (3%) in the placebo group and 14 patients (11%) in the MIRAPEX ER group had decreased their levodopa daily dose compared to baseline due to dopaminergic adverse events. No clinically relevant difference in effectiveness was observed in the sub-group analyses based on gender, age, race (White vs Asian), or concomitant use of antiparkinsonian treatment (MAOB-I, amantadine or anticholinergics).

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Mirapex ER®
[mir'-ah-pex]
(pramipexole dihydrochloride) extended-release tablets

Read the Patient Information that comes with MIRAPEX ER tablets before you start taking it and each time you refill your prescription. The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment.

What is MIRAPEX ER?

MIRAPEX ER tablets are a prescription medicine to treat the signs and symptoms of Parkinson's disease.

MIRAPEX ER tablets have not been studied in children. It is not known if MIRAPEX ER tablets are safe or effective in children.

Please speak to your doctor for more information about why MIRAPEX ER tablets were prescribed for you.

Who should not take MIRAPEX ER?

You should not take MIRAPEX ER tablets if you are allergic (hypersensitive) to the active ingredient (pramipexole) or any of the other ingredients listed at the end of this leaflet.

What should I tell my doctor before taking MIRAPEX ER?

  • Before taking MIRAPEX ER, tell your doctor about all of your medical conditions, including if you
    • feel sleepy during the day, if you use any medications that make you sleepy, or are taking any medication which your doctor informs you may increase the effects of MIRAPEX ER, such as cimetidine.
    • have low blood pressure, or if you feel dizzy or faint, especially when getting up from a lying or sitting position.
    • have trouble controlling your muscles (dyskinesia).
    • have kidney problems.
    • are pregnant or plan to become pregnant. Based on animal data, MIRAPEX ER may harm your unborn baby.
    • are breastfeeding. It is not known if MIRAPEX ER tablets will pass into your breast milk. You and your doctor should decide if you will take MIRAPEX ER tablets or breast-feed. You should not do both.
    • drink alcohol. Alcohol can increase the chance that MIRAPEX ER tablets will make you feel sleepy or fall asleep when you should be awake.
  • Tell your doctor about all the medicines you take, including:
    • any prescription and non-prescription medicines. Especially tell your doctor if you take any other medicines that make you sleepy.
    • any non-prescription medicines, including vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new prescription. MIRAPEX ER tablets and other medicines may interact with each other causing side effects. MIRAPEX ER tablets may affect the way other medicines work, and other medicines may affect how MIRAPEX ER tablets work.

How should I take MIRAPEX ER?

  • Follow your doctor's directions carefully. MIRAPEX ER is taken once daily. Your doctor will tell you how to use MIRAPEX ER tablets.
  • Your doctor may change your dose until you are taking the right amount of medicine to help control your symptoms. Do not take more or less MIRAPEX ER tablets than your doctor tells you to.
  • Swallow tablets whole. Do not chew, crush, or divide MIRAPEX ER tablets.
  • MIRAPEX ER tablets can be taken with or without food. Taking MIRAPEX ER tablets with food may lower your chances of getting nausea.
  • If you miss a dose, do not double your next dose. Skip the dose you missed and take your next regular dose.
  • If you have Parkinson's disease and are stopping MIRAPEX ER tablets, you should stop MIRAPEX ER tablets slowly over 7 days. Do not suddenly stop taking MIRAPEX ER tablets without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness. Be sure to tell your doctor right away if you stop taking MIRAPEX ER tablets for any reason. Do not start taking MIRAPEX ER tablets again before speaking with your doctor.

What important safety information should I know about MIRAPEX ER?

Please read this document carefully; many sections contain safety information.

This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition or give the medicine to others.

Pramipexole is the active ingredient that is in both MIRAPEX ER tablets and immediate-release pramipexole tablets. Be sure that you do not take both immediate-release pramipexole (MIRAPEX) and MIRAPEX ER.

  • Falling asleep during normal activities. MIRAPEX ER tablets may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating.
    Some people taking the medicine in MIRAPEX ER tablets have had car accidents because they fell asleep while driving.
    Some patients did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning.
    Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER tablets affect you. Sleepiness caused by MIRAPEX ER may first occur as late as one year after initiation of treatment.
    Tell your doctor right away if you fall asleep while you are doing activities such as talking with people, eating, or driving, or if you feel sleepier than is normal for you.
  • Hallucinations. Hallucinations (unreal visions, sounds, or sensations) can occur in patients taking MIRAPEX ER tablets. The chances of having hallucinations are higher in patients with Parkinson's disease who are elderly (defined in this case as age 65 or older). If you have hallucinations, talk with your healthcare provider.
  • Unusual urges. Some patients taking certain medicines to treat Parkinson's disease, including MIRAPEX ER tablets, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.
  • Melanoma. Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the medicines used to treat Parkinson's disease. MIRAPEX ER tablets are one of the medicines used to treat Parkinson's disease; therefore, patients being treated with MIRAPEX ER tablets should have periodic skin examinations.

What are the possible side effects of MIRAPEX ER?

MIRAPEX ER tablets can cause serious side effects, including:

  • falling asleep during normal daily activities. See “What important safety information should I know about MIRAPEX ER?”
  • low blood pressure when you sit or stand up quickly. You may have dizziness, nausea, fainting, or sweating. Sit and stand up slowly after you have been sitting or lying down for a while.
  • hallucinations. You may see, hear, feel, or taste something that isn't there. You have a higher chance of having hallucinations if you are over 65 years old.
  • unusual urges. See “What important safety information should I know about MIRAPEX ER?”

The most common side effects in people taking MIRAPEX ER tablets for early Parkinson's disease are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).

The most common side effects in people taking MIRAPEX ER tablets who have later stage Parkinson's disease are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.

These are not all the possible side effects of MIRAPEX ER tablets. Tell your doctor if you have any side effect that bothers you.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

What should I avoid while taking MIRAPEX ER?

  • Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER affects you. Sleepiness caused by MIRAPEX ER may first occur as late as one year after initiation of treatment. See “What important safety information should I know about MIRAPEX ER?”
  • Do not drink alcohol while taking MIRAPEX ER tablets. It can increase your chances of feeling sleepy or falling asleep when you should be awake.

How should I store MIRAPEX ER?

  • Store MIRAPEX ER tablets at room temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your tablets.
  • Protect from exposure to high humidity.
  • Keep MIRAPEX ER tablets and all medicines out of the reach of children.

What does MIRAPEX ER look like?

These pictures show what MIRAPEX ER tablets look like. Notice that each strength tablet looks different. Immediately call your pharmacist if you receive a MIRAPEX ER tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.

Appearance of MIRAPEX ER -  Illustration

Tablets not actual size.

Other Information about MIRAPEX ER

This Patient Information leaflet summarizes the most important information about MIRAPEX ER tablets. If you would like more information, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for more information about MIRAPEX ER tablets that is written for healthcare professionals. For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800542-6257 or (TTY) 1-800-459-9906.

What are the ingredients in MIRAPEX ER?

Active Ingredient: pramipexole dihydrochloride monohydrate.

Inactive Ingredients: hypromellose, corn starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate.

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Mirapex ER®
[mir'-ah-pex]
(pramipexole dihydrochloride) extended-release tablets

Read the Patient Information that comes with MIRAPEX ER tablets before you start taking it and each time you refill your prescription. The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment.

What is MIRAPEX ER?

MIRAPEX ER tablets are a prescription medicine to treat the signs and symptoms of Parkinson's disease.

MIRAPEX ER tablets have not been studied in children. It is not known if MIRAPEX ER tablets are safe or effective in children.

Please speak to your doctor for more information about why MIRAPEX ER tablets were prescribed for you.

Who should not take MIRAPEX ER?

You should not take MIRAPEX ER tablets if you are allergic (hypersensitive) to the active ingredient (pramipexole) or any of the other ingredients listed at the end of this leaflet.

What should I tell my doctor before taking MIRAPEX ER?

  • Before taking MIRAPEX ER, tell your doctor about all of your medical conditions, including if you
    • feel sleepy during the day, if you use any medications that make you sleepy, or are taking any medication which your doctor informs you may increase the effects of MIRAPEX ER, such as cimetidine.
    • have low blood pressure, or if you feel dizzy or faint, especially when getting up from a lying or sitting position.
    • have trouble controlling your muscles (dyskinesia).
    • have kidney problems.
    • are pregnant or plan to become pregnant. Based on animal data, MIRAPEX ER may harm your unborn baby.
    • are breastfeeding. It is not known if MIRAPEX ER tablets will pass into your breast milk. You and your doctor should decide if you will take MIRAPEX ER tablets or breast-feed. You should not do both.
    • drink alcohol. Alcohol can increase the chance that MIRAPEX ER tablets will make you feel sleepy or fall asleep when you should be awake.
  • Tell your doctor about all the medicines you take, including:
    • any prescription and non-prescription medicines. Especially tell your doctor if you take any other medicines that make you sleepy.
    • any non-prescription medicines, including vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new prescription. MIRAPEX ER tablets and other medicines may interact with each other causing side effects. MIRAPEX ER tablets may affect the way other medicines work, and other medicines may affect how MIRAPEX ER tablets work.

How should I take MIRAPEX ER?

  • Follow your doctor's directions carefully. MIRAPEX ER is taken once daily. Your doctor will tell you how to use MIRAPEX ER tablets.
  • Your doctor may change your dose until you are taking the right amount of medicine to help control your symptoms. Do not take more or less MIRAPEX ER tablets than your doctor tells you to.
  • Swallow tablets whole. Do not chew, crush, or divide MIRAPEX ER tablets.
  • MIRAPEX ER tablets can be taken with or without food. Taking MIRAPEX ER tablets with food may lower your chances of getting nausea.
  • If you miss a dose, do not double your next dose. Skip the dose you missed and take your next regular dose.
  • If you have Parkinson's disease and are stopping MIRAPEX ER tablets, you should stop MIRAPEX ER tablets slowly over 7 days. Do not suddenly stop taking MIRAPEX ER tablets without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness. Be sure to tell your doctor right away if you stop taking MIRAPEX ER tablets for any reason. Do not start taking MIRAPEX ER tablets again before speaking with your doctor.

What important safety information should I know about MIRAPEX ER?

Please read this document carefully; many sections contain safety information.

This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition or give the medicine to others.

Pramipexole is the active ingredient that is in both MIRAPEX ER tablets and immediate-release pramipexole tablets. Be sure that you do not take both immediate-release pramipexole (MIRAPEX) and MIRAPEX ER.

  • Falling asleep during normal activities. MIRAPEX ER tablets may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating.
    Some people taking the medicine in MIRAPEX ER tablets have had car accidents because they fell asleep while driving.
    Some patients did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning.
    Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER tablets affect you. Sleepiness caused by MIRAPEX ER may first occur as late as one year after initiation of treatment.
    Tell your doctor right away if you fall asleep while you are doing activities such as talking with people, eating, or driving, or if you feel sleepier than is normal for you.
  • Hallucinations. Hallucinations (unreal visions, sounds, or sensations) can occur in patients taking MIRAPEX ER tablets. The chances of having hallucinations are higher in patients with Parkinson's disease who are elderly (defined in this case as age 65 or older). If you have hallucinations, talk with your healthcare provider.
  • Unusual urges. Some patients taking certain medicines to treat Parkinson's disease, including MIRAPEX ER tablets, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.
  • Melanoma. Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the medicines used to treat Parkinson's disease. MIRAPEX ER tablets are one of the medicines used to treat Parkinson's disease; therefore, patients being treated with MIRAPEX ER tablets should have periodic skin examinations.

What are the possible side effects of MIRAPEX ER?

MIRAPEX ER tablets can cause serious side effects, including:

  • falling asleep during normal daily activities. See “What important safety information should I know about MIRAPEX ER?”
  • low blood pressure when you sit or stand up quickly. You may have dizziness, nausea, fainting, or sweating. Sit and stand up slowly after you have been sitting or lying down for a while.
  • hallucinations. You may see, hear, feel, or taste something that isn't there. You have a higher chance of having hallucinations if you are over 65 years old.
  • unusual urges. See “What important safety information should I know about MIRAPEX ER?”

The most common side effects in people taking MIRAPEX ER tablets for early Parkinson's disease are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).

The most common side effects in people taking MIRAPEX ER tablets who have later stage Parkinson's disease are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.

These are not all the possible side effects of MIRAPEX ER tablets. Tell your doctor if you have any side effect that bothers you.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

What should I avoid while taking MIRAPEX ER?

  • Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER affects you. Sleepiness caused by MIRAPEX ER may first occur as late as one year after initiation of treatment. See “What important safety information should I know about MIRAPEX ER?”
  • Do not drink alcohol while taking MIRAPEX ER tablets. It can increase your chances of feeling sleepy or falling asleep when you should be awake.

How should I store MIRAPEX ER?

  • Store MIRAPEX ER tablets at room temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your tablets.
  • Protect from exposure to high humidity.
  • Keep MIRAPEX ER tablets and all medicines out of the reach of children.

What does MIRAPEX ER look like?

These pictures show what MIRAPEX ER tablets look like. Notice that each strength tablet looks different. Immediately call your pharmacist if you receive a MIRAPEX ER tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.

Appearance of MIRAPEX ER -  Illustration

Tablets not actual size.

Other Information about MIRAPEX ER

This Patient Information leaflet summarizes the most important information about MIRAPEX ER tablets. If you would like more information, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for more information about MIRAPEX ER tablets that is written for healthcare professionals. For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800542-6257 or (TTY) 1-800-459-9906.

What are the ingredients in MIRAPEX ER?

Active Ingredient: pramipexole dihydrochloride monohydrate.

Inactive Ingredients: hypromellose, corn starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate.

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Mirapex ER Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PRAMIPEXOLE EXTENDED-RELEASE - ORAL

(PRAM-i-PEX-ole)

COMMON BRAND NAME(S): Mirapex

USES: Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome").

Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking pramipexole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Take this medication by mouth with or without food, as directed by your doctor. Taking this medication with food may reduce nausea. To decrease the risk of side effects (such as drowsiness, low blood pressure) when you first start taking pramipexole, your doctor will slowly increase your dosage until the best dose for you is reached. Take this medication as prescribed.

The dosage is based on your medical condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. Do not increase your dose or take it more often than directed.

If you stop taking this medication for several days, you may need to increase your dose slowly back to your previous dosage. Talk with your doctor about how to restart the medication. Do not stop taking this medication without your doctor's approval. Although very unlikely, if you suddenly stop taking this drug, a serious reaction may occur including fever, muscle stiffness, and confusion. Report any such reactions to your doctor immediately. If your doctor directs you to stop regular treatment with this drug, gradually reducing the dosage as directed will help prevent such reactions.

It may take a few weeks for full effects of this medication to be noticed. Tell your doctor if your symptoms do not improve or if they worsen.

Disclaimer

Mirapex ER Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Nausea, vomiting, dizziness, drowsiness, trouble sleeping, constipation, headache, cough, or dry mouth may occur. If these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, depression, hallucinations), muscle cramps/spasm.

Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of the ankles/feet, chest pain, trouble breathing, compulsive behaviors (such as pathological gambling), muscle pain/weakness, unusual tiredness, change in amount of urine, vision changes.

Some people taking pramipexole have reported falling asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur any time during treatment with pramipexole, including up to 1 year after starting the medication. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy. You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, sweating, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Mirapex ER (pramipexole dihydrochloride extended-release tablets) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also Side Effects section.

Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (such as irregular heartbeat, heart failure), kidney problems, mental/mood disorders (such as confusion, hallucinations, psychosis, schizophrenia), sleep disorder (such as sleep apnea, narcolepsy).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects such as dizziness and hallucinations while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. It may also affect milk production. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Disclaimer

Mirapex ER Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: antipsychotics (such as chlorpromazine, haloperidol, thiothixene), cimetidine, metoclopramide.

If you are taking levodopa or a carbidopa/levodopa combination, your doctor may direct you to decrease your levodopa dose after you start taking pramipexole.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (such as diphenhydramine), anti-seizure drugs (such as carbamazepine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (such as allergy, cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). If you are taking this drug to treat Parkinson's disease, tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

MISSED DOSE: If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2010. Copyright(c) 2010 First Databank, Inc.

Mirapex ER Patient Information Including Side Effects

Brand Names: Mirapex, Mirapex ER

Generic Name: pramipexole (Pronunciation: pram i PEX ole)

What is pramipexole (Mirapex ER)?

Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Pramipexole is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Pramipexole is also used to treat restless legs syndrome (RLS).

Pramipexole may also be used for purposes not listed in this medication guide.

Mirapex 0.125 mg

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Mirapex 0.25 mg

oval, white, imprinted with 4 4, U U

Mirapex 0.5 mg

oval, white, imprinted with U U, 8 8

Mirapex 0.75 mg

oval, white, imprinted with BI, 101

Mirapex 1 mg

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Mirapex 1.5 mg

round, white, imprinted with 37 37, U U

Pramipexole 0.125 mg-BAR

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Pramipexole 0.25 mg-BAR

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Pramipexole 0.5 mg-BAR

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Pramipexole 0.75 mg-TEV

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Pramipexole 1 mg-BAR

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Pramipexole 1.5 mg-BAR

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What are the possible side effects of pramipexole (Mirapex ER)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking pramipexole and call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • nausea, sweating, feeling light-headed, fainting;
  • hallucinations;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • chest discomfort, dry cough, feeling short of breath;
  • feeling weak or tired, loss of appetite, rapid weight loss;
  • fast or uneven heartbeats; or
  • tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Less serious side effects may include:

  • dry mouth, stomach pain, vomiting, constipation;
  • headache, dizziness, spinning sensation;
  • mild drowsiness;
  • swelling in your hands or feet;
  • appetite or weight changes;
  • blurred vision;
  • sleep problems (insomnia), unusual dreams;
  • amnesia, forgetfulness, thinking problems; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Mirapex ER (pramipexole dihydrochloride extended-release tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pramipexole (Mirapex ER)?

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking pramipexole.

If you are taking this medication for rest leg syndrome (RLS), tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pramipexole. Tell your doctor if you regularly use any of these other medicines.

Drinking alcohol can increase certain side effects of pramipexole.

Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

Side Effects Centers

Mirapex ER Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking pramipexole (Mirapex ER)?

You should not use pramipexole if you are allergic to it.

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

To make sure you can safely take pramipexole, tell your doctor if you have any of these other conditions:

  • low blood pressure;
  • kidney disease; or
  • tremors (dyskinesia) or uncontrolled muscle movements.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking pramipexole. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking pramipexole.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

How should I take pramipexole (Mirapex ER)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

The dose and timing of pramipexole in treating Parkinson's disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label.

Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture and heat.

Side Effects Centers

Mirapex ER Patient Information including If I Miss a Dose

What happens if I miss a dose (Mirapex ER)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Mirapex ER)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pramipexole (Mirapex ER)?

Pramipexole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of pramipexole.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What other drugs will affect pramipexole (Mirapex ER)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pramipexole. Tell your doctor if you regularly use any of these medicines, or any other medicines for Parkinson's disease.

Tell your doctor about all other medicines you use, especially:

  • amantadine (Symmetrel);
  • cimetidine (Tagamet);
  • diltiazem (Cardizem, Cartia, Dilacor, Tiazac);
  • ranitidine (Zantac);
  • quinidine (Quin-G);
  • quinine (Qualaquin);
  • triamterene (Dyrenium);
  • verapamil (Calan, Covera, Isoptin);
  • medicine to prevent or treat nausea and vomiting, such as metoclopramide (Reglan, Metozolv) or promethazine (Pentazine, Phenergan, Anergan, Antinaus); or
  • medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), thiothixene (Navane), thioridazine (Mellaril), and others.

This list is not complete and other drugs may interact with pramipexole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pramipexole.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision date: 8/11/2011.

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