Pramipexole 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. For RLS, the exact mechanism is unknown but is thought to involve dopaminergic system activity.

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 behavioral changes

Some people may experience sudden, uncontrollable sleepiness, even if they feel 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 may experience uncontrolled changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when 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 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 if they 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 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 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 with your existing 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.

Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

Monitor your blood pressure as instructed by your healthcare provider. 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 gradual discontinuation plan recommended by your doctor. 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.

Refrain from consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may impair your physical or mental reactions, discuss the potential risks 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, consult your doctor to weigh the benefits and risks of this medication for both 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, opioids): May potentiate sedative effects and increase risk of somnolence and sudden sleep onset.

• Cimetidine, Ranitidine, Diltiazem, Triamterene, Verapamil, Quinidine, Quinine: Drugs eliminated by renal tubular secretion may reduce pramipexole clearance, leading to increased plasma levels.
• Levodopa: May increase the risk of dyskinesia when co-administered with pramipexole in Parkinson's disease.

• Dizziness or lightheadedness (especially upon standing)
• Excessive daytime sleepiness or sudden onset of sleep
• Hallucinations or confusion
• Unusual urges or behaviors (e.g., gambling, shopping, eating, sexual urges)
• Nausea or vomiting
• Dyskinesia (in Parkinson's disease)
• Leg swelling (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 known to inhibit prolactin secretion in humans and may inhibit lactation. It is excreted in rat milk. Due to the potential for serious adverse reactions in nursing 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 recommended for use in children.

Elderly patients (≥65 years) have reduced renal clearance of pramipexole, leading to higher plasma concentrations and a longer elimination half-life. Dose adjustment based on renal function is crucial in this population. Elderly patients may also be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence.

• Titrate dose slowly to minimize side effects, especially orthostatic hypotension and somnolence.
• Counsel patients and caregivers about the risk of impulse control disorders (e.g., pathological gambling, hypersexuality) and sudden sleep attacks.
• Renal function must be assessed before initiating treatment and periodically thereafter, especially in the elderly, as dose adjustments are critical.
• Pramipexole can cause augmentation or rebound in RLS patients, particularly at higher doses or with long-term use. Monitor for worsening symptoms or earlier onset of symptoms.
• Discontinuation should be gradual to avoid withdrawal symptoms (e.g., akinesia, insomnia, anxiety, depression).

• Other dopamine agonists (e.g., ropinirole, rotigotine, bromocriptine)
• Levodopa/carbidopa (for Parkinson's disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone, tolcapone)
• Amantadine
• For RLS: Gabapentin enacarbil, alpha-2 delta ligands (e.g., gabapentin, pregabalin), opioids (severe cases, last resort).

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