Pramipexole ER 2.25mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for the D2 subfamily of dopamine receptors, particularly D2 and D3 receptor subtypes. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum, 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 or seek medical attention immediately:

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
Increased 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 urinating
New or worsening mental, mood, or behavior changes

Important Warnings

Some people have experienced sudden, uncontrolled sleep episodes while taking this medication, even when they felt alert beforehand. This can occur up to 1 year after starting the medication. If you fall asleep during activities, such as driving, eating, or talking, do not drive or engage in tasks that require alertness. Contact your doctor immediately if this happens or if you feel extremely sleepy.

Additionally, some people have developed uncontrolled changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when 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)

NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped suddenly or when 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they 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 unusual 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, any of 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 any other medications that contain the same active ingredient as this drug, to avoid potential interactions or duplication of therapy.

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 plan.

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 performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.

Follow your doctor's instructions for monitoring your blood pressure. Do not discontinue this medication without consulting your doctor, as stopping it abruptly 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 drugs that may cause drowsiness, consult with your doctor.

If you notice what appears to be a tablet in your stool, discuss this with 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, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, butyrophenones, thioxanthenes; metoclopramide): May reduce the efficacy of pramipexole.

• Cimetidine, Ranitidine, Quinidine, Quinine, Diltiazem, Verapamil, Triamterene, Trimethoprim: Drugs eliminated by renal tubular secretion may decrease the oral clearance of pramipexole, leading to increased plasma levels.
• Sedatives, Alcohol, other CNS depressants: May potentiate the sedative effects of pramipexole.

• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Excessive daytime sleepiness or sudden onset of sleep
• Hallucinations (visual, auditory)
• Confusion or disorientation
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Dyskinesia (involuntary movements)
• Nausea, constipation
• Peripheral edema

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Pramipexole is excreted in rat milk and is expected to be excreted in human milk. It may inhibit lactation due to its dopamine agonist activity. Given the potential for serious adverse effects in a breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Not indicated for use in pediatric populations.

Elderly patients (≥65 years) have a higher incidence of hallucinations, orthostatic hypotension, and somnolence compared to younger adults. Renal clearance of pramipexole decreases with age, necessitating careful dose titration and monitoring, especially in those with impaired renal function.

• Pramipexole ER should be swallowed whole and not crushed, chewed, or divided, as this can lead to rapid release of the drug and increased side effects.
• Patients should be warned about the potential for sudden onset of sleep during daily activities, even without prior warning or feeling drowsy. This risk is higher with higher doses and in patients also taking other sedating medications or alcohol.
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) can develop or worsen with dopamine agonist therapy. Patients and caregivers should be specifically questioned about these behaviors.
• Orthostatic hypotension is a common side effect, especially during initial titration. Advise patients to rise slowly from a sitting or lying position.
• Hallucinations are more common in elderly patients and those with advanced Parkinson's disease. They can be dose-related and may require dose reduction or discontinuation.
• For patients switching from immediate-release pramipexole to extended-release, the total daily dose should be the same, but the ER formulation is taken once daily.

• Other dopamine agonists (e.g., ropinirole, rotigotine, bromocriptine)
• Levodopa/carbidopa (for Parkinson's disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone)
• Amantadine
• Anticholinergics (for tremor)
• Non-pharmacological treatments for RLS (e.g., lifestyle modifications, iron supplementation if deficient)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.