Pramipexole 0.75mg 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 therapeutic effects by stimulating dopamine receptors in the striatum, thereby mimicking the effects of dopamine in the brain.

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 passing urine
New or worsening mental, mood, or behavior changes

Important Warnings

Some people have experienced sudden, uncontrolled sleep episodes, even when feeling alert, up to 1 year after starting this medication. If this happens, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.

Additionally, some individuals have developed 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 posture, contact your doctor.

Neuroleptic Malignant Syndrome (NMS)

NMS is a rare, 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 Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, 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, or decreased appetite
Trouble sleeping
Dizziness, drowsiness, tiredness, or weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms

This is not an exhaustive list of possible 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. This includes:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements
Vitamins you are taking

Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.

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 down 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 the tapering schedule recommended by your doctor. Immediately contact your doctor if you experience any of the following withdrawal symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, insomnia, sweating, or pain.

Refrain from consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription and 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, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks with your doctor to make an informed decision about your treatment.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of pramipexole.
• CNS depressants (e.g., alcohol, sedatives, hypnotics, opioids): May potentiate the sedative effects of pramipexole.

• Cimetidine, diltiazem, quinidine, quinine, ranitidine, verapamil: These drugs are inhibitors of renal tubular secretion and may decrease the renal clearance of pramipexole, leading to increased plasma concentrations.
• Levodopa: May increase the risk of dyskinesia when co-administered with pramipexole in Parkinson's disease.

• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Excessive daytime sleepiness or sudden onset of sleep
• Hallucinations (visual, auditory)
• Confusion or psychotic-like behavior
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Nausea
• Peripheral edema
• Dyskinesia (in Parkinson's disease)
• 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 rat milk and may inhibit prolactin secretion in humans, potentially inhibiting lactation. It is not known whether pramipexole is excreted in human milk. 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. It is not approved for use in children.

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

• Always titrate pramipexole slowly to minimize adverse effects, especially nausea, orthostatic hypotension, and somnolence.
• Counsel patients extensively about 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.
• Monitor for peripheral edema, which can occur with dopamine agonists.
• In Parkinson's disease, pramipexole can be used as monotherapy or as an adjunct to levodopa. When used with levodopa, it may allow for a reduction in levodopa dose and help manage 'wearing-off' phenomena, but may also increase dyskinesia.
• For Restless Legs Syndrome, take the dose 2-3 hours before bedtime. Doses higher than 0.5 mg/day for RLS are generally not recommended due to increased risk of augmentation (worsening of RLS symptoms or earlier onset).
• Discontinuation should be gradual to avoid a dopamine agonist withdrawal syndrome, which can include symptoms like apathy, anxiety, depression, fatigue, pain, and sweating.

• Other dopamine agonists (e.g., ropinirole, rotigotine)
• 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, especially dyskinesia)
• Gabapentin or pregabalin (for Restless Legs Syndrome)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.