Pramipexole ER 3.75mg 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 antiparkinsonian effects by stimulating dopamine receptors in the striatum.

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 notice any of the following symptoms, contact your doctor 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 passing urine
New or worsening mental, mood, or behavior changes

Some people have experienced sudden, uncontrollable sleepiness, even during activities like driving, eating, or talking. If this happens to you, do not drive or engage in tasks that require alertness while taking this medication. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.

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 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 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 people do not experience significant side effects, but some may occur. If you notice 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 unusual 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 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 duplicate dosing.

This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor and pharmacist. This includes:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you use
Vitamins you take
* Any health problems you have, to ensure safe use of this medication

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions or adverse effects.

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 be careful 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 medications 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, plan to become pregnant, or are 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.
• Cimetidine: May decrease renal clearance of pramipexole, leading to increased plasma levels.

• CNS depressants (e.g., alcohol, sedatives, hypnotics, opioids): May potentiate the sedative effects of pramipexole.
• Drugs eliminated by renal tubular secretion (e.g., amantadine, zidovudine, cisplatin, quinine, procainamide): May compete for renal tubular transport, potentially increasing plasma levels of pramipexole or the co-administered drug.

• Orthostatic hypotension (dizziness, lightheadedness, fainting)
• Hallucinations (visual, auditory)
• Delusions, paranoia
• Confusion, disorientation
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Dyskinesia (involuntary movements)
• Excessive daytime sleepiness, sudden sleep onset
• Nausea, constipation
• Peripheral edema
• Weight gain

Pramipexole is 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 breast milk in rats. It is known to inhibit prolactin secretion in humans, which could inhibit lactation. Due to the potential for serious adverse reactions in breastfed 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. Not indicated for use in pediatric populations.

Clearance of pramipexole decreases with age due to reduced renal function. Elderly patients may be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence. Dose titration should be done carefully, and renal function should be monitored.

• Pramipexole ER is designed for once-daily dosing and should not be crushed, chewed, or divided. This is crucial for its extended-release properties.
• Patients should be warned about the potential for sudden onset of sleep, even without prior warning signs of drowsiness. This can occur at any time during treatment and may impair driving or operating machinery.
• Educate patients and caregivers about the risk of impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating). These behaviors may emerge or worsen during treatment and may require dose reduction or discontinuation.
• Orthostatic hypotension is a common side effect, especially during initiation and dose titration. Advise patients to rise slowly from a sitting or lying position.
• Hallucinations are more common in elderly patients and those with advanced Parkinson's disease. They may necessitate dose reduction or discontinuation.
• Renal dose adjustments are critical due to pramipexole's primary renal excretion. Failure to adjust can lead to accumulation and increased side effects.

• Other dopamine agonists (e.g., ropinirole, rotigotine)
• Levodopa/carbidopa
• MAO-B inhibitors (e.g., selegiline, rasagiline)
• COMT inhibitors (e.g., entacapone, tolcapone)
• Amantadine
• Anticholinergics (for tremor, less common)

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. 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 emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.