Pramipexole ER 3mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for dopamine D2 and D3 receptors. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum and substantia nigra, thereby mimicking the effects of dopamine in the brain.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty passing urine
New or worsening mental, mood, or behavior changes

Some people have experienced sudden, uncontrollable sleepiness, including falling asleep while driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience excessive sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.

Additionally, some people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways while sitting, standing, or walking. These changes can occur several months after starting the medication or after a dose increase. If you notice any changes in your posture, contact your doctor.

Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
* If you are currently taking another medication that contains the same active ingredient as this drug, to avoid potential interactions or duplicate dosing.

This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.

Follow your doctor's instructions for monitoring your blood pressure while taking this medication. Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop taking this medication, follow the tapering schedule recommended by your doctor. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.

Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

If you notice what appears to be a tablet in your stool, consult your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
• CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of pramipexole.

• Cimetidine, Ranitidine, Quinidine, Quinine, Diltiazem, Verapamil, Triamterene, Trimethoprim, Procainamide: May reduce the renal clearance of pramipexole, leading to increased plasma concentrations.
• Levodopa: May increase the incidence of dyskinesia when co-administered with pramipexole.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Somnolence or sudden onset of sleep (sleep attacks)
• Hallucinations (visual, auditory, tactile)
• Delusions or paranoid ideation
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Dyskinesia (involuntary movements)
• Nausea, constipation
• Peripheral edema
• Weight changes

Pramipexole is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pramipexole is excreted into rat milk and is known to inhibit prolactin secretion in humans, which could inhibit lactation. It is generally not recommended for use in breastfeeding mothers due to potential for serious adverse effects in the infant and inhibition of milk production.

The safety and effectiveness of pramipexole in pediatric patients have not been established. It is not approved for use in children.

Pramipexole clearance is reduced in elderly patients due to age-related decline in renal function. Dosage adjustments are often necessary based on renal creatinine clearance. Elderly patients may also be more susceptible to side effects such as hallucinations, orthostatic hypotension, and somnolence.

• Pramipexole ER should be swallowed whole; crushing or chewing can lead to rapid release and potentially higher peak concentrations, increasing side effects.
• Gradual dose titration is crucial to minimize side effects, especially orthostatic hypotension and somnolence.
• Patients should be warned about the potential for sudden sleep attacks, even without prior warning, and advised to avoid driving or operating machinery if this occurs.
• Monitor patients for the development of impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), which can occur with dopamine agonists. Dose reduction or discontinuation may be necessary.
• Hallucinations are a common side effect, especially in elderly patients or those with advanced Parkinson's disease. They can be visual, auditory, or tactile.
• Pramipexole is primarily renally excreted; careful dose adjustment is required in patients with renal impairment.
• When discontinuing pramipexole, especially after high doses, a gradual taper is recommended to avoid withdrawal symptoms (e.g., akinesia, rigidity, anxiety, depression, fatigue, insomnia, sweating, pain).

• Other non-ergot dopamine agonists (e.g., ropinirole, rotigotine)
• Levodopa/carbidopa (e.g., Sinemet, Rytary, Duopa)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone)
• Amantadine
• Anticholinergics (for tremor, e.g., trihexyphenidyl, benztropine)
• Deep Brain Stimulation (DBS) for advanced Parkinson's disease

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.