Generic Name: Pramipexole Brand Name(s): Generics only. No brands available.

Uses

What is Pramipexole used for?

Pramipexole is used alone or with other medications to treat Parkinson’s disease. It can improve your ability to move and 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”).

This medication is also used to treat a certain medical condition (restless leg syndrome – RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep.

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

How should I take Pramipexole?

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 (e.g., 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. Do not increase your dose or take it more often than directed.

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.

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, withdrawal reactions may occur. Such reactions can include fever, muscle stiffness, and confusion. Report any such reactions to your doctor right away. If you have Parkinson’s disease and are stopping regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

The dosage is based on your medical condition and response to treatment.

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

How do I store Pramipexole?

Pramipexole is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Pramipexole in the bathroom or the freezer. There may be different brands of Pramipexole that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Pramipexole down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Pramipexole?

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 (e.g., irregular heartbeat, heart failure), kidney problems, mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), sleep disorder (e.g., sleep apnea, narcolepsy).

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at a greater risk for 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Pramipexole during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Pramipexole. Pramipexole is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Pramipexole?

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

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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 right away if you have any serious side effects, including: fainting, mental/mood changes (e.g., confusion, depression, hallucinations, memory problems), unusual strong urges (such as increased gambling, increased sexual urges), increased difficulty moving/walking, muscle cramps/spasm, restlessness, decreased sexual ability, increased shakiness (tremor)/stiffness, swelling of the ankles/feet.

Get medical help right away if you have any very serious side effects, including: chest pain, fever, unusually fast/slow/irregular heartbeat, muscle pain/weakness, unusual tiredness, signs of kidney problems (such as change in the amount of urine), vision changes.

Some people taking pramipexole have fallen 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 anytime during treatment with pramipexole even if you have used this medication for a long time. 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 of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Pramipexole?

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

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Pramipexole may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Pramipexole?

Pramipexole may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Pramipexole?

Pramipexole may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Pramipexole.

What is the dose of Pramipexole for an adult?

Usual Adult Dose for 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

Comment: 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.

Comments:

-If a significant interruption in therapy occurs, re-titration may be necessary; upon discontinuation, doses should be tapered.

Use: Treatment of Parkinson’s disease

Usual Adult Dose for Restless Legs Syndrome

Immediate-release:

Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime

Titration: If needed, 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

Comments:

-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.

Use: For the treatment of moderate to severe primary Restless Legs Syndrome.

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, dose may be titrated upwards by increments of 0.125 mg every 14 days; Maximum dose: 0.5 mg orally once a day

Liver Dose Adjustments

No adjustment recommended.

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.

-Restless Legs Syndrome: Taper is not needed

Dialysis

Hemodialysis: Not recommended

Other Comments

Administration advice:

Immediate-release:

-Take orally with or without food

-If a dose is missed, advise patients not to double their next dose

Extended-release:

-Take orally with or without food

-Tablets should be swallowed whole; do not chew, crush, or divide

-If a dose is missed, take as soon as possible, but no later than 12 hours after the regularly scheduled time; after 12 hours, the missed dose should be skipped and dosing resumed on regular schedule

Storage requirements:

-Protect from light and high humidity

General:

-If a significant interruption in therapy occurs during treatment of Parkinson’s disease, retitration may be necessary

-In a fixed dose study in early Parkinson’s disease patients, no significant benefit was observed with daily doses of 3 mg, 4.5 mg, or 6 mg compared with 1.5 mg/day; however, the following adverse events increased with increasing dose: postural hypotension, nausea, constipation, somnolence, and amnesia.

-Upon discontinuation, this drug should be gradually tapered; during clinical trials, this drug was not tapered when used to treat restless legs syndrome.

Monitoring:

-Cardiovascular: Monitor for signs and symptoms of orthostatic hypotension, particularly during dose escalation

-Nervous System: Monitor for somnolence and drowsiness

-Dermatologic: Monitor for melanomas; consider periodic skin examinations by dermatologists.

-Psychiatric: Question patients about new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges.

Patient advice:

-This drug frequently causes drowsiness; patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.

-Patients should be instructed to report episodes of sudden onset of sleep, new or worsening dyskinesia, new or worsening compulsive behaviors and/or unusual urges.

-Patients should be instructed to report changes in the size, shape, or color of moles on their skin and should have their skin checked on a regular basis for melanomas.

-Patients should be aware that this drug may cause orthostatic blood pressure changes including fainting and dizziness and advised to avoid standing rapidly after sitting or lying down.

-Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding

What is the dose of Pramipexole for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Pramipexole available?

Pramipexole is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral tablet, extended release.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Pramipexole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 20, 2018 | Last Modified: April 20, 2018

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