Pramipexole 0.125mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for the D2 subfamily of dopamine receptors, particularly D3 receptors. It is thought to exert its antiparkinsonian effects by stimulating dopamine receptors in the striatum. For RLS, the mechanism is unknown but presumed to involve dopaminergic system activity.

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

Some people have experienced sudden, uncontrolled sleepiness, including falling asleep while driving, eating, or talking. If this happens to you, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.

In rare cases, people have developed uncontrolled changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways while sitting, standing, or walking. These changes may 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 suddenly 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 unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
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 symptoms you experienced.
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.

This list is not exhaustive, and it is crucial to discuss all 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.

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, 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. 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 medications that may cause drowsiness, consult 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, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.

• Dopamine antagonists (e.g., antipsychotics, metoclopramide): May reduce the efficacy of pramipexole.
• Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May decrease renal clearance of pramipexole, increasing its plasma levels.

• CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate sedative effects of pramipexole.
• Antihypertensives: May increase risk of orthostatic hypotension.

• Dyskinesia (in Parkinson's patients, especially with levodopa co-administration)
• Hallucinations
• Delusions
• Psychosis
• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Excessive daytime sleepiness
• Sudden onset of sleep
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Augmentation (worsening of RLS symptoms with earlier onset or increased severity)
• Rebound (worsening of RLS symptoms after discontinuation)

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

Pramipexole is excreted in rat milk and may inhibit lactation in humans due to its dopamine agonist activity. It is not known if pramipexole is excreted in human milk. 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 for Parkinson's disease or RLS. Use is not recommended.

Elderly patients may have reduced renal clearance of pramipexole, leading to higher plasma concentrations and increased risk of adverse effects (e.g., hallucinations, orthostatic hypotension, somnolence). Dose adjustments are often necessary based on renal function. Half-life is prolonged in elderly.

• Pramipexole is a non-ergot dopamine agonist, which may have a lower risk of fibrotic complications compared to ergot derivatives (e.g., pergolide).
• Titration is crucial for both Parkinson's disease and RLS to minimize side effects, especially orthostatic hypotension and somnolence.
• Patients should be warned about the potential for sudden onset of sleep and impulse control disorders, and advised to report these immediately.
• For RLS, pramipexole should be taken 2-3 hours before bedtime. Be vigilant for augmentation (worsening of RLS symptoms with earlier onset or increased severity) which may require dose adjustment or discontinuation.
• Renal function must be assessed before starting treatment and monitored periodically, especially in the elderly.

• 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
• For RLS: Gabapentin enacarbil, iron supplementation (if iron deficient), opioids (severe cases, last resort).

If your symptoms or health issues persist or worsen, it's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.