Pramipexole is a selective dopamine receptor agonist used in the therapy of Parkinson’s disease. Pramipexole therapy is associated with a low rate of transient serum enzyme elevations during treatment but has not been implicated in cases of clinically apparent acute liver injury. Pramipexole Dihydrochloride is the hydrochloride salt of pramipexole, a benzothiazole derivative. As a non-ergot dopamine agonist, pramipexole binds to D2 and D3 dopamine receptors in the striatum and substantia nigra of the brain. Compared to other dopamine agonists, the use of this agent may be associated with fewer dyskinetic side effects in treated subjects.
Pramipexole is a member of the class of benzothiazoles that is 4,5,6,7-tetrahydro-1,3-benzothiazole in which the hydrogens at the 2 and 6-pro-S-positions are substituted by amino and propylamine groups, respectively. It has a role as an antiparkinson drug, a dopamine agonist, an antidyskinesia agent, and a radical scavenger. It is a member of benzothiazoles and a diamine. It is a conjugate base of pramipexole(2+).
Pramipexole is a drug used to treat the symptoms of Parkinson’s Disease (PD). It is a non-ergot dopamine agonist drug that is efficacious in treating various Parkinson’s symptoms such as tremors, rigidity, and bradykinesia (slow movement). It was first approved by the FDA in 1997. Parkinson’s Disease is one of the most common neurodegenerative disorders and causes a high level of disability in patients, leading to increased difficulty in performing activities of daily living due to symptoms that progress over time. The prevalence of Parkinson’s Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016. This increase may be attributed to an aging population along with other contributing factors. In addition to the above FDA approval for Parkinson’s Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS). RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs.
Mechanism of Action
The exact mechanism of action of pramipexole as a treatment for Parkinson’s disease is unknown at this time. It is thought, however, that the ability of pramipexole to cause stimulation of the dopamine receptors in the striatum of the brain, a region that receives a vast array of neurological input and is responsible for a wide variety of functions, may be involved. Studies performed in animals show that pramipexole influences striatal neuronal transmission rates following the activation of dopamine receptors. Pramipexole is considered a non-ergot dopamine agonist that shows specificity and strong activity at the D2 subfamily of dopamine receptors in vitro, binding selectively and dopamine D2 receptors and showing a preference for the dopamine D3 receptor subtype rather than other subtypes. The clinical significance of this binding specificity is unknown.
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Our aim was to determine if pramipexole, a D3-preferring agonist, effectively reduced dopamine neuron and fiber loss in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) mouse model when given at intraperitoneal doses corresponding to clinical doses. We also determined whether subchronic treatment with pramipexole regulates dopamine transporter function, thereby reducing intracellular transport of the active metabolite of MPTP, 1-methyl-4-phenylpyridinium (MPP+). Ten 12-month-old C57BL/6 mice were treated with MPTP (or saline) twice per day at 20 mg/kg s.c. (4 injections over 48 h). Mice were pretreated for 3 days and during the 2-day MPTP regimen with pramipexole (0.1 mg/kg/day) or saline. Stereological quantification of dopamine neuron number and optical density measurement of dopamine fiber loss were carried out at 1 week after treatment, using immunostaining for the dopamine transporter (DAT) and tyrosine hydroxylase (TH). Additional wild-type (WT) and D3 receptor knockout (KO) mice were treated for 5 days with pramipexole (0.1 mg/kg/day) or vehicle. The kinetics of (3)H-MPP+ and (3)H-DA uptake (Vmax and Km) were determined 24 hr later; and at 24 hr and 14 days dopamine transporter density was measured by quantitative autoradiography. Pramipexole treatment completely antagonized the neurotoxic effects of MPTP, as measured by substantia nigra and ventral tegmental area TH-immunoreactive cell counts. MPTP– induced loss of striatal innervation, as measured by DAT-immunoreactivity, was partially prevented by pramipexole, but not with regard to TH-IR. Pramipexole also reduced DAT- immunoreactivity in non-MPTP treated mice. Subchronic treatment with pramipexole lowered the Vmax for (3)H-DA and (3)H-MPP+ uptake into striatal synaptosomes of WT mice. Pramipexole treatment lowered Vmax in WT but not D3 KO mice; however, D3 KO mice had lower Vmax for (3)H-DA uptake. There was no change in DAT number in WT with pramipexole treatment or D3 KO mice at 24 hr post-treatment, but there was a reduction in WT-pramipexole treated and not in D3 KO mice at 14 days post-treatment. These results suggest that protection occurs at clinically suitable doses of pramipexole. Protection could be due to a reduced amount of MPP+ taken up into DA terminals via DAT. D3 receptor plays an important role in this regulation of transporter uptake and availability.
Indications
- This drug is indicated for the symptomatic treatment of Parkinson’s disease. This drug can be administered as monotherapy or in conjunction with levodopa. It is also indicated for symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS).
- Sifrol is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or ‘on-off’ fluctuations).
- Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0. 54 mg of base (0. 75 mg of salt).
- Mirapexin is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or ‘on-off’ fluctuations).
- Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0. 54 mg of base (0. 75 mg of salt).
- Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
- Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0. 54 mg of base (0. 75 mg of salt) (see section 4. 2).
- Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or ‘on-off’ fluctuations).
- Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0. 54 mg of base (0. 75 mg of salt) (see section 4. 2).
- Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or ‘on-off’ fluctuations).
- DAQUIRAN tablets are indicated for treatment of the signs and symptoms of advanced idiopathic Parkinson’s disease in combination with levodopa, i. e. over the course of the disease when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
- Restless Legs Syndrome
- Parkinson’s Disease
- Periodic Limb Movement Disorder
- Tardive Dyskinesia
Contraindication
There are no absolute contraindications listed in the product labeling. However, significant warnings and precautions are as below.
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Falling asleep during activities of daily living: Sudden onset of sleep may occur without warning; advise patients to report symptoms.[rx]
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Symptomatic orthostatic hypotension: Monitor during dose escalation.
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Impulse control/compulsive behaviors: Patients may experience compulsive behaviors like gambling, excessive shopping, and hypersexuality.[rx]
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Hallucinations and psychotic-like behavior: May occur; risk increases with age.
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Dyskinesia: May be caused or exacerbated by pramipexole dihydrochloride tablets.
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Postural deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride tablets if postural deformity occurs.
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Special alerts dopamine agonist withdrawal syndrome (DAWS): DAWS may occur after decreasing or discontinuing dopamine agonists and includes symptoms such as panic attacks, insomnia, irritability, anxiety, and depression.[rx]
Dosage
Strengths: 0.125 mg; 0.25 mg; 1 mg; 0.5 mg; 1.5 mg; 0.75 mg; 0.375 mg; 3 mg; 4.5 mg; 2.25 mg; 3.75 mg
Parkinson’s Disease
Immediate-release:
- Initial dose: 0.125 mg orally three times a day
- Titration: Increase gradually in small dose increments no more frequently than ever 5 to 7 days
- Maintenance dose: 1.5 to 4.5 mg per day based on efficacy and tolerability
- Maximum dose: 4.5 mg per day
The following dose titration was used in clinical trials:
- Week 2, 0.25 mg 3 times a day
- Week 3, 0.5 mg 3 times a day
- Week 4, 0.75 mg 3 times a day
- Week 5, 1 mg 3 times a day
- Week 6, 1.25 mg 3 times a day
- Week 7, 1.5 mg 3 times a day.
- When used in combination with levodopa, the levodopa dose was reduced by an average of 27% from baseline providing a concomitant dose of approximately 800 mg per day.
Extended-release:
- Initial dose: 0.375 mg orally once a day
- Titration: Increase gradually no more frequently than every 5 to 7 days, first dose increase should be to 0.75 mg once a day followed by incremental increases of 0.75 mg; assess therapeutic response and tolerability at a minimum of 5 days after each dose increase.
- Maximum dose: 4.5 mg per day
SWITCHING FROM IMMEDIATE-RELEASE TO EXTENDED-RELEASE:
- Patients may be switched overnight from immediate-release tablets to extended-release tablets at the same daily dose; monitor closely to determine if dose adjustments may be necessary.
Restless Legs Syndrome
Immediate-release:
- Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
- Titration: If needed, the dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maximum dose: 0.5 mg orally once a day
Extended-release tablets are not indicated for Restless Legs Syndrome.
- Doses of 0.75 mg once a day were used in clinical trials but were not found to provide additional benefit as compared to the 0.5 mg dose.
Renal Dose Adjustments
Parkinson’s Disease:
Immediate-release:
- Very severe renal impairment (CrCl less than 15 mL/min): Not recommended
- Severe renal impairment (CrCl 15 to less than 30 mL/min): Initial dose: 0.125 mg orally once a day; titrate gradually at intervals of no more frequently than every 5 to 7 days to a maximum dose of 1.5 mg once a day; Maximum dose: 1.5 mg once per day
- Moderate renal impairment (CrCl 30 to 50 mL/min): Initial dose: 0.125 mg orally twice a day; titrate gradually at intervals of no more frequently than every 5 to 7 days to a maximum dose of 0.75 mg 3 times a day; Maximum dose: 2.25 mg per day
- Normal to mild renal impairment (CrCl greater than 50 mL/min): No adjustment recommended
Extended-release:
- Severe renal impairment: Not recommended
- Moderate renal impairment (CrCl 30 to 50 mL/min): Initial dose: 0.375 mg orally every other day; after 1 week, may increase to once a day dosing based on therapeutic response and tolerability; subsequent dose titrations should be in increments of 0.375 mg no more frequently every 7 days; Maximum dose: 2.25 mg per day
- Mild renal impairment (CrCl greater than 50 mL/min): No adjustment recommended
Restless Legs Syndrome
Immediate-release:
- Moderate to severe renal impairment (CrCl 20 to 60 mL/min): Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
Titration: If needed, the dose may be titrated upwards by increments of 0.125 mg every 14 days; Maximum dose: 0.5 mg orally once a day.
Dose Adjustments
- If the patient is receiving levodopa, a reduction in the dosage of levodopa should be considered.
- Patients may be switched overnight from pramipexole immediate-release to pramipexole extended-release at the same daily dose. Dose adjustment may be needed in some patients.
Discontinuation of Treatment:
- Parkinson’s Disease: Taper off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg, then reduce by 0.375 mg per day.
Side Effects
The Most Common
- nausea
- weakness
- dizziness
- loss of balance, falling
- difficulty falling asleep or staying asleep
- difficulty remembering
- abnormal dreams
- heartburn
- constipation
- diarrhea
- dry mouth
- swollen, stiff, or painful joints
- pain in back, arms or legs
- frequent urination or urgent need to urinate
- difficulty urinating or pain when urinating
More Common
- hallucinations (seeing things or hearing voices that do not exist), confusion, aggressive behavior, agitation, abnormal thoughts
- changes in vision
- abnormal body movements and motions that you cannot control
- changes in the way you sit or stand that you cannot control, such as your neck bending forward, bending forward at the waist, or tilting sideways when you sit, stand or walk,
- dark, red or cola-colored urine
- muscle tenderness
- muscle stiffness or aching
- muscle weakness
Rare
- a light-headed feeling, like you might pass out;
- hallucinations (seeing or hearing things that are not real);
- extreme drowsiness, falling asleep suddenly, even after feeling alert;
- tremors, twitching or uncontrollable muscle movements;
- unexplained muscle pain, tenderness, or weakness;
- vision problems; or
- posture changes you cannot control, such as involuntary bending forward of your neck, bending forward at the waist, or tilting sideways when you sit, stand, or walk.
- muscle spasm or muscle weakness;
- drowsiness, dizziness, weakness;
- confusion, memory problems;
- dry mouth;
- nausea, constipation;
- increased urination; or
- sleep problems (insomnia), unusual dreams.
Drug Interactions
There may be an interaction between pramipexole and any of the following:
- alcohol
- aldesleukin
- aliskiren
- alpha agonists (e.g., clonidine, methyldopa)
- alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
- amantadine
- amifostine
- amiodarone
- angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- antihistamines (e.g., cetirizine, chlorpheniramine, diphenhydramine, doxylamine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- apomorphine
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
- bortezomib
- brimonidine
- buprenorphine
- bupropion
- buspirone
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- chloral hydrate
- cimetidine
- conivaptan
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- domperidone
- duloxetine
- efavirenz
- entacapone
- general anesthetics (medications used to put people to sleep before surgery)
- guanfacine
- hydralazine
- iron sucrose
- kava kava
- levodopa
- methylphenidate
- metoclopramide
- minoxidil
- MAO inhibitors (e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- mirtazapine
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
- nabilone
- narcotic medications (e.g., codeine, fentanyl, hydromorphone, morphine)
- nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
- obinutuzumab
- pentoxifylline
- phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
- riociguat
- ropinirole
- rotigotine
- sacubitril
- scopolamine
- seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- tapentadol
- thalidomide
- tolcapone
- tramadol
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- zolpidem
- zopiclone
Pregnancy and Lactation
FDA pregnancy risk category C
Pregnancy
Studies conducted on rats showed that pramipexole could affect fetal development at higher doses. The evidence of teratogenicity remains insufficient. Hence, the advice is to avoid pramipexole during pregnancy. According to the product labeling, there is no adequate data on the developmental risk associated with using pramipexole dihydrochloride tablets in pregnant women.
Breast-feeding
It is not known if pramipexole passes into breast milk. Since the medication reduces the amount of breast milk produced, women who are breastfeeding should not take this medication. According to the package insert, the judgment during breastfeeding and therapy should consider the risk versus benefit to the infant and the benefits of treatment to the mother. Being a dopaminergic agonist, it is contraindicated in lactating mothers since it suppresses lactation. It is around six times more concentrated in milk than in plasma, and hence the risk of transmission to the nursing baby increases. Pramipexole interferes with prolactin secretion in humans, and that may inhibit lactation.[rx]
How should this medicine be used?
Pramipexole comes as a tablet and an extended-release (long-acting) tablet to take by mouth. When pramipexole is used to treat Parkinson’s disease, the regular tablet is usually taken three times a day and the extended-release tablet is usually taken once daily. When pramipexole is used to treat restless legs syndrome, the regular tablet is usually taken once a day, 2 to 3 hours before bedtime. Pramipexole extended-release tablets are not used to treat restless legs syndrome. Pramipexole may be taken with or without food, but taking pramipexole with food may help to prevent nausea that may be caused by the medication. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take pramipexole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release tablets whole; do not split, chew, or crush them.
Your doctor will start you on a low dose of pramipexole and gradually increase your dose. Your doctor will probably not increase your dose more often than once every 4 to 7 days. It may take several weeks before you reach a dose that works for you.
If you are taking pramipexole to treat restless legs syndrome, you should know that as your treatment continues, your symptoms may worsen, may begin earlier in the evening or afternoon, or may occur in the early morning. Call your doctor if your symptoms worsen or if they begin to occur at different times than in the past.
Pramipexole controls the symptoms of Parkinson’s disease and restless legs syndrome but does not cure these conditions. Continue to take pramipexole even if you feel well. Do not stop taking pramipexole without talking to your doctor. If you are taking pramipexole to treat Parkinson’s disease and you suddenly stop taking the medication, you may experience, fever, confusion, muscle stiffness, a lack of interest or concern for usual activities or things you usually care about, anxiety, depression, tiredness, difficulty falling asleep or staying asleep, sweating, or pain. If you are taking pramipexole to treat restless legs syndrome and you suddenly stop taking the medication, your symptoms may become worse than they were before you started taking this medication. Your doctor will probably decrease your dose gradually.
If you stop taking pramipexole for any reason, do not start to take the medication again without talking to your doctor. Your doctor will probably want to increase your dose again gradually.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
Other uses for this medicine
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking pramipexole,
- tell your doctor and pharmacist if you are allergic to pramipexole or any other medications, or any of the ingredients in pramipexole tablets or extended-release tablets. Ask your doctor or pharmacist for a list of the inactive ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; cimetidine (Tagamet); medications for allergies, mental illness, and nausea; metoclopramide (Reglan); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had a mental illness, trouble controlling the movement of your muscles,a sleep disorder other than restless legs syndrome, dizziness, fainting, low blood pressure, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking pramipexole, call your doctor.
- you should know that pramipexole may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy before you suddenly fall asleep. Do not drive a car or operate machinery at the beginning of your treatment until you know how pramipexole will affect you. If you suddenly fall asleep while you are doing something such as watching television or riding in a car, or if you become very drowsy, call your doctor. Do not drive or operate machinery until you talk to your doctor.
- you should know that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic beverages.
- you should know that pramipexole may cause dizziness, lightheadedness, nausea, fainting, or sweating when you get up too quickly from a sitting or lying position. This is more common when you first start taking pramipexole, or when your dose is increased. To avoid this problem, get out of the chair or bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that some people who took medications such as pramipexole to treat Parkinson’s disease or restless legs syndrome developed gambling problems, an increased interest in shopping or sex, overeating problems, or other intense urges or behaviors that were compulsive or unusual for them. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you develop intense urges or have difficulty controlling any of these behaviors. Tell your family members about these risks so that they can call the doctor even if you do not realize that your behavior has become a problem.
- you should know that if you are taking the extended-release tablets, you may notice something that looks like a swollen tablet or swollen pieces of tablet in your stool. If this happens, especially along with a worsening of your Parkinson’s disease symptoms, call your doctor.
Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
Behaviour changes: People taking pramipexole have experienced abnormal behaviour such as compulsive gambling, compulsive shopping, hypersexuality, and binge eating. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately.
Blood pressure: Pramipexole can lower blood pressure for some people. People taking this medication may feel dizzy or lightheaded when rising from a sitting or lying position. Make sure to tell your doctor if you experience this effect. If you have severe heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Drowsiness/sudden onset of sleep: Pramipexole and similar mediations can cause drowsiness and sudden onset of sleep or sleep attacks. Sudden onset of sleep can occur without warning or drowsiness. People taking this medication should avoid driving or operating heavy machinery. If you experience any daytime drowsiness or sudden onset of sleep while taking this medication, contact your doctor immediately.
Hallucinations: People taking this medication should be aware that hallucinations (mainly seeing things that are not really there) can occur and may affect their ability to drive and perform other daily activities. Make sure to tell your doctor if you experience this effect.
Kidney function: Decreased kidney function or kidney disease can cause this medication to build up in the body, causing side effects. People with reduced kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Pramipexole is not recommended for people with end-stage renal disease.
Melanoma: People with Parkinson’s disease may be at increased risk of developing melanoma (a type of skin cancer). It is not known if this increased risk is due to Parkinson’s disease or to the medications used to treat Parkinson’s disease. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.
Neuroleptic malignant syndrome (NMS): As with other medications that have an effect on movement disorders, pramipexole can trigger a potentially fatal set of symptoms known as neuroleptic malignant syndrome (NMS). If you experience symptoms of NMS, such as high fever; muscle stiffness; confusion or loss of consciousness; sweating; or rapid or irregular heartbeat, seek immediate medical attention.
This is more likely to occur if pramipexole is stopped suddenly or the dose is decreased rapidly. If you are considering stopping this medication, talk with your doctor about the appropriate way to reduce pramipexole.
Restless leg syndrome: When this medication is used to treat the symptoms of restless leg syndrome, it may cause a worsening of symptoms in the early morning hours. It may also cause earlier onset of symptoms in the evening or an increase in symptoms. If you experience this, let your doctor know.
Stopping treatment: Do not stop taking this medication without consulting with your doctor. Stopping this medication suddenly can cause symptoms such as fever, rigid muscles, and blood pressure changes. Other symptoms of depressed mood, fatigue, sweating, trouble sleeping, pain and irritability have also been reported. If you and your doctor decide that stopping this medication is best for you, your doctor will gradually reduce your dose over a week.
Suicidal or agitated behavior: People with Parkinson’s disease are at risk of experiencing thoughts and intentions of self-harm or suicide. These feelings may not pass when the symptoms of PD are relieved. If you have depression or bipolar disorder, you may be at an increased risk of feeling agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or wanting to hurt yourself or others. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately.
Children: The safety and effectiveness of using pramipexole have not been established for children.
Seniors: Seniors may be more likely to experience hallucinations (hearing, seeing, or feeling things that are not there) while taking pramipexole.
References
