Mirapex 0.25mg Tablets

Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for D2, D3, and D4 dopamine receptors, with highest affinity for D3 receptors. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum and substantia nigra, thereby mimicking the effects of dopamine in the brain.

Serious 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 experience 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
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 sleepiness during activities like driving, eating, or talking, even if they didn't feel sleepy beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately.

Additionally, some 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 can occur several months after starting the medication or after a dose increase. If you experience any changes in 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 Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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, 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.

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, refrain from 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, exercise caution when taking this medication, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to make an informed decision about your treatment.

• Dopamine antagonists (e.g., phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the efficacy of pramipexole.
• Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May decrease renal clearance of pramipexole, leading to increased plasma levels.

• Sedatives, hypnotics, alcohol: Increased risk of somnolence and sudden sleep onset.
• Antihypertensives: Increased risk of orthostatic hypotension.

• Orthostatic dizziness or lightheadedness
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations (visual, auditory)
• Delusions or paranoid ideation
• Compulsive behaviors (e.g., gambling, shopping, eating, sexual urges)
• Nausea, constipation, dry mouth
• Dyskinesia (in Parkinson's patients)
• Peripheral edema

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown developmental toxicity at doses higher than human therapeutic doses.

Pramipexole is known to inhibit prolactin secretion in humans and may inhibit lactation. It is unknown if pramipexole is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, 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. Not recommended for use in children.

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

• Pramipexole is a non-ergot dopamine agonist, which may have a lower risk of fibrotic complications (e.g., pleuropulmonary fibrosis, retroperitoneal fibrosis, cardiac valvulopathy) compared to ergot-derived dopamine agonists.
• Patients should be warned about the potential for sudden sleep attacks, even without prior warning signs of drowsiness. This risk is higher with higher doses and in patients with pre-existing sleep disorders.
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) can emerge or worsen during treatment. Patients and caregivers should be educated to recognize these behaviors.
• Dose titration should be gradual to minimize adverse effects, especially orthostatic hypotension and nausea.
• For RLS, taking the dose 2-3 hours before bedtime is crucial for optimal efficacy.
• Withdrawal symptoms (e.g., akinesia, insomnia, depression, sweating) can occur if the drug is discontinued abruptly, especially after high doses or prolonged treatment. Tapering is recommended.

• 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, opicapone), amantadine, anticholinergics.
• For Restless Legs Syndrome: Other dopamine agonists (e.g., ropinirole, rotigotine), alpha-2 delta ligands (e.g., gabapentin, pregabalin), 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 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.