Pramipexole ER 1.5mg 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.

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 or seek immediate 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
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 passing urine
New or worsening mental, mood, or behavioral changes

Sudden Sleepiness: A Rare but Serious Side Effect

In rare cases, people taking this medication have fallen asleep suddenly during activities like driving, eating, or talking, even if they felt alert 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 if you fall asleep during activities or feel extremely sleepy.

Posture Changes: A Potential Side Effect

Some people have experienced uncontrollable 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): A Rare but Serious Condition

NMS is a severe and 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
Fast or abnormal heartbeat
Excessive sweating

Other Possible Side Effects

While many people taking this medication 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
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 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 another medication that contains 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 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.

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution 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 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.

Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor.

If you notice what appears to be a tablet in your stool, discuss this 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, inform your doctor to discuss the potential benefits and risks to you and your baby.

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

• Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May decrease renal clearance of pramipexole, leading to increased plasma levels.
• Levodopa: May increase dyskinesia when co-administered with pramipexole.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Hallucinations (seeing or hearing things that are not real)
• Delusions (false beliefs)
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Excessive daytime sleepiness or sudden onset of sleep
• Dyskinesia (involuntary movements)
• Nausea, constipation
• Peripheral edema

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. It is not known whether pramipexole is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants (e.g., inhibition of lactation, potential for CNS effects), 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.

The safety and effectiveness of pramipexole in pediatric patients have not been established for Parkinson's disease or Restless Legs Syndrome. Use is generally not recommended.

Elderly patients may have reduced renal clearance of pramipexole, leading to higher plasma concentrations and potentially increased susceptibility to adverse effects (e.g., hallucinations, orthostatic hypotension). Dose adjustment based on renal function is particularly important in this population.

• Pramipexole ER should be swallowed whole; crushing or chewing can lead to rapid release and potentially higher peak plasma concentrations.
• Titrate dose slowly to minimize side effects, especially orthostatic hypotension and somnolence.
• Counsel patients on the risk of sudden sleep attacks and impulse control disorders, and advise them to report these symptoms immediately.
• Renal function must be assessed before initiating treatment and monitored periodically, as dose adjustments are critical in renal impairment.
• Patients should be advised to avoid activities requiring mental alertness (e.g., driving) if they experience somnolence or sudden sleep episodes.
• Withdrawal should be gradual to avoid symptoms of dopamine agonist withdrawal syndrome (e.g., apathy, anxiety, depression, fatigue, pain, sweating).

• Other dopamine agonists (e.g., ropinirole, rotigotine, apomorphine)
• Levodopa/carbidopa
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone)
• Amantadine
• Anticholinergics (for tremor)
• Adenosine A2A receptor antagonists (e.g., istradefylline)
• Non-pharmacological treatments for RLS (e.g., lifestyle modifications, iron supplementation if deficient)

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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.