Mirapex 1.5mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for the dopamine D2 subfamily of receptors, particularly D2 and D3 receptor subtypes. It is thought to exert its antiparkinsonian effects by stimulating dopamine receptors in the striatum. For RLS, the mechanism is unknown but is 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 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, uncontrolled sleep episodes, even when feeling alert, up to 1 year after starting this medication. If you fall asleep during activities like driving, eating, or talking, do not engage in tasks that require alertness and contact your doctor immediately.

Additionally, some individuals have reported uncontrolled changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when 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, seek medical help right away:
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 may only have mild side effects, it is essential to be aware of the following potential side effects:

Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Drowsiness
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 any other symptoms that concern you, 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. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease, as this may affect the medication's safety and efficacy.
* If you are currently taking another medication that contains the same active ingredient, to avoid potential interactions or duplication of therapy.

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 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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. 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, sleep disturbances, sweating, or pain.

Refrain from consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may cause drowsiness, discuss the potential risks with your doctor.

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks of this medication for both you and your baby.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of pramipexole.
• Cimetidine, diltiazem, quinidine, quinine, ranitidine, verapamil: These drugs inhibit renal tubular secretion and can decrease the oral clearance of pramipexole, leading to increased plasma levels.

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

• Orthostatic hypotension (dizziness, lightheadedness, fainting)
• Hallucinations (visual, auditory, tactile)
• Delusions or confusion
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Excessive daytime sleepiness or sudden sleep attacks
• Nausea, vomiting, constipation
• Peripheral edema
• Dyskinesia (in Parkinson's patients, especially with levodopa)
• Augmentation (in RLS patients: earlier onset of symptoms, increased intensity, spread to other limbs, shorter latency to onset after rest)

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 may inhibit lactation due to its dopamine agonist activity. It is not known whether pramipexole is excreted in human milk. Because of 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 Parkinson's disease or Restless Legs Syndrome. Use is not recommended.

Clearance of pramipexole is reduced in elderly patients due to age-related decline in renal function. Dose adjustment based on renal function is necessary. Elderly patients may be more susceptible to side effects such as hallucinations, orthostatic hypotension, and somnolence.

• Titrate dose slowly to minimize side effects such as nausea, orthostatic hypotension, and somnolence.
• Counsel patients extensively on the risk of sudden sleep attacks and impulse control disorders (e.g., pathological gambling, hypersexuality). These can occur without warning and may require dose reduction or discontinuation.
• Advise patients to stand up slowly to mitigate orthostatic hypotension.
• For RLS, ensure patients understand the risk of augmentation, where symptoms worsen or occur earlier in the day. This may necessitate dose adjustment or switching therapy.
• Pramipexole is primarily renally cleared; always check renal function before initiating and adjust dose accordingly.

• For Parkinson's Disease: Levodopa/carbidopa, other dopamine agonists (e.g., ropinirole, rotigotine), MAO-B inhibitors (e.g., selegiline, rasagiline), COMT inhibitors (e.g., entacapone), amantadine, anticholinergics (e.g., benztropine).
• For Restless Legs Syndrome: Other dopamine agonists (e.g., ropinirole, rotigotine), alpha-2 delta ligands (e.g., gabapentin enacarbil, pregabalin), iron supplementation (if iron deficiency is present), opioids (for severe, refractory cases).

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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.