Mirapex 1mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for dopamine D2 and D3 receptors, with highest affinity for the D3 receptor. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum and substantia nigra, thereby mimicking the effects of dopamine and improving motor symptoms in Parkinson's disease and reducing the urge to move in Restless Legs Syndrome.

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 urinating
New or worsening mental, mood, or behavioral 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 individuals 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 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

While many people may 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
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
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 have concerns about other 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 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 your full attention, 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 medications that may impair your physical or mental responses, 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 like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
• Drugs eliminated by renal tubular secretion (e.g., cimetidine, ranitidine, diltiazem, verapamil, quinidine, quinine): May decrease pramipexole clearance, leading to increased plasma levels.

• CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of pramipexole.
• Levodopa: May increase the incidence of dyskinesia when co-administered with pramipexole in Parkinson's disease.

• Dizziness or lightheadedness upon standing (orthostatic hypotension)
• Hallucinations (seeing or hearing things that are not there)
• Delusions or paranoid thoughts
• Unusual urges or inability to control impulses (e.g., gambling, shopping, eating, sexual urges)
• Excessive daytime sleepiness or sudden onset of sleep
• Nausea, vomiting, constipation
• Swelling in ankles or feet (peripheral edema)
• Muscle cramps or abnormal movements (dyskinesia)
• Worsening of RLS symptoms or earlier onset (augmentation)

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 may inhibit prolactin secretion in humans, potentially inhibiting lactation. It is not known whether pramipexole is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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 either Parkinson's disease or Restless Legs Syndrome. Use is generally not recommended.

Clearance of pramipexole decreases with age due to reduced renal function. Dose adjustment is necessary in elderly patients with impaired renal function. Elderly patients may be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence.

• Always titrate pramipexole slowly to minimize side effects, especially orthostatic hypotension and nausea.
• Warn patients about the potential for sudden sleep attacks and advise them not to drive or operate heavy machinery if they experience somnolence.
• Educate patients and caregivers about impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and instruct them to report any new or worsening behaviors immediately.
• Monitor for augmentation in RLS patients, which is a worsening of symptoms, earlier onset, or spread to other body parts. This may require dose reduction or discontinuation.
• Pramipexole is primarily renally cleared; significant dose adjustments are required for patients with renal impairment.
• Consider discontinuing pramipexole gradually to avoid withdrawal symptoms, which can resemble neuroleptic malignant syndrome (e.g., fever, rigidity, altered mental status).

• 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), non-pharmacological interventions.

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 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.