Mirapex 0.5mg 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 and compensating for dopamine deficiency in Parkinson's disease. For Restless Legs Syndrome, the exact mechanism is unknown but is thought to involve dopaminergic pathways in the central nervous system.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 behavioral changes

Some people have experienced sudden, unexplained sleepiness, even when feeling alert beforehand. This can occur up to 1 year after starting the 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 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): 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 Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. 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 persist:

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 potential 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 overdose.

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.

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 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 your doctor's guidance on how to taper off safely. 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.

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 to discuss potential interactions.

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 benefits and risks of this medication with your doctor to make an informed decision about its use.

• Dopamine Antagonists (e.g., phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the efficacy of pramipexole.
• CNS Depressants (e.g., alcohol, sedatives, hypnotics, opioids): May potentiate the sedative effects of pramipexole.

• Cimetidine: May decrease renal clearance of pramipexole, leading to increased plasma concentrations.
• Amantadine: May increase risk of hallucinations and confusion when co-administered with dopamine agonists.
• Levodopa: May increase the risk of dyskinesia when co-administered with pramipexole in Parkinson's disease patients.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations (visual, auditory, tactile)
• Dyskinesia (involuntary movements)
• Impulse control disorders (pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Nausea, constipation
• Peripheral edema
• Augmentation of RLS symptoms

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 is likely excreted into human milk. It has the potential to inhibit lactation due to its dopamine agonist activity. 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. Use is generally not recommended.

Pramipexole clearance is reduced in elderly patients due to decreased renal function. Dose adjustments are necessary based on renal creatinine clearance. Elderly patients may also be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence.

• Pramipexole should be titrated slowly to minimize side effects, especially orthostatic hypotension and somnolence.
• Patients should be warned about the potential for sudden sleep attacks, even without prior warning or feeling drowsy. Advise caution with driving or operating machinery.
• Monitor for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), which can develop or worsen during treatment. Patients may not recognize these behaviors as abnormal, so inquire directly.
• For Restless Legs Syndrome, ensure patients understand the risk of augmentation (worsening of RLS symptoms with treatment) and report it if it occurs.
• Discontinuation of pramipexole should be gradual to avoid a dopamine agonist withdrawal syndrome, which can include symptoms like apathy, anxiety, depression, fatigue, sweating, and pain.

• Other dopamine agonists (e.g., ropinirole, rotigotine, bromocriptine)
• Levodopa/Carbidopa (for Parkinson's Disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide - for Parkinson's Disease)
• COMT inhibitors (e.g., entacapone, opicapone - for Parkinson's Disease)
• Amantadine (for Parkinson's Disease)
• Gabapentin/Pregabalin (for Restless Legs Syndrome)
• Iron supplementation (if iron deficiency is present for RLS)

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 occurred.