Pramipexole 1mg 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 thought 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 behavioral changes

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

Additionally, some individuals have reported 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 abruptly 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 or fast/abnormal heartbeat
Excessive sweating

Other Possible Side Effects

While many people do not experience side effects or only have mild ones, it is essential to be aware of the following potential side effects:

Headache
Constipation, diarrhea, upset stomach, or decreased appetite
Difficulty sleeping
Dizziness, sleepiness, tiredness, or weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
* Flu-like symptoms

If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. 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 with your existing health conditions and other drugs.

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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. If you experience dizziness or lightheadedness, rise slowly from a sitting or lying position to minimize the risk of falling. Be cautious 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, insomnia, sweating, or pain.

While taking this medication, it is recommended that you avoid consuming alcohol. 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 with your doctor to make an informed decision about your treatment.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of pramipexole.
• Sedatives/CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased risk of somnolence and sudden sleep onset.

• Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May decrease the renal clearance of pramipexole, leading to increased plasma levels. Dose reduction of pramipexole may be necessary.
• Levodopa: May increase the risk of dyskinesia when co-administered with pramipexole in Parkinson's disease.

• Dizziness or lightheadedness upon standing (orthostatic hypotension)
• Nausea
• Somnolence or sudden sleep attacks
• Hallucinations or delusions
• Unusual urges or behaviors (e.g., pathological gambling, increased libido, compulsive shopping, binge eating)
• Involuntary movements (dyskinesia)
• Leg discomfort or urge to move legs (RLS symptom control)

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 in rat milk and is known to inhibit prolactin secretion in humans, which may inhibit lactation. It is not known whether 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 Restless Legs Syndrome. Use is generally not recommended.

Elderly patients (≥65 years) have a reduced renal clearance of pramipexole, resulting in a longer elimination half-life. This may lead to higher plasma concentrations and an increased risk of adverse effects, particularly hallucinations, somnolence, and orthostatic hypotension. Dose adjustments based on renal function are crucial.

• Titrate dose slowly to minimize side effects, especially nausea, dizziness, and somnolence.
• Advise patients about the risk of sudden sleep attacks and impulse control disorders; these can occur without warning and may require dose adjustment or discontinuation.
• Monitor for orthostatic hypotension, particularly during dose escalation and in elderly patients.
• Pramipexole can cause or worsen dyskinesia when used with levodopa in Parkinson's disease.
• For RLS, take the dose 2-3 hours before bedtime. If symptoms are severe, consider taking with a small snack to reduce nausea.
• Renal function must be assessed before starting treatment and periodically thereafter, as dose adjustments are critical in renal impairment.

• For Parkinson's Disease: Ropinirole (another dopamine agonist), Rotigotine (dopamine agonist patch), Levodopa/Carbidopa, MAO-B inhibitors (e.g., Selegiline, Rasagiline), COMT inhibitors (e.g., Entacapone), Amantadine.
• For Restless Legs Syndrome: Ropinirole, Rotigotine, Gabapentin enacarbil, Gabapentin, Pregabalin, Opioids (for severe refractory cases).

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 this medication, don't hesitate to discuss them with 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 happened.