Pramipex Er 1.5 Mg Tablet (10 Tab)

PRAMIPEX ER 1.5 MG TABLET

PRAMIPEX ER 1.5 MG TABLET is an extended-release medication manufactured by SUN PHARMA LABORATORIES LTD., primarily used in the management of neurological conditions.

• Name

  • Brand Name: Pramipex ER 1.5 Tablet
  • Common Name: Pramipexole (extended-release)

• Composition

  • Each extended-release tablet contains 1.5 mg of Pramipexole dihydrochloride (equivalent to 1.41 mg pramipexole dihydrochloride). Pramipexole is a non-ergoline dopamine agonist.

• Uses PRAMIPEX ER 1.5 MG TABLET is prescribed for adults to treat:

  • Parkinson's Disease: It helps manage the symptoms of idiopathic Parkinson's disease, including tremors, stiffness, slow movement (bradykinesia), poor muscle control, and muscle rigidity. It works by mimicking the action of dopamine in the brain, which is crucial for controlling body movement.
  • Restless Legs Syndrome (Willis-Ekbom disease): It is used for moderate to severe primary Restless Legs Syndrome (RLS), alleviating the uncomfortable urge to move the legs that often worsens during rest.

• Dosage and Administration

  • Pramipex ER 1.5 MG TABLET is typically taken once daily, at approximately the same time each day.
  • It can be taken with or without food; taking it with food may help reduce nausea.
  • The tablet must be swallowed whole and should not be crushed, chewed, or broken, as this can affect its extended-release properties.
  • Dosage adjustments may be necessary for patients with kidney impairment.
  • Do not stop taking this medication abruptly. Gradual discontinuation under a doctor's supervision is required to avoid withdrawal symptoms such as anxiety, depression, fatigue, sweating, or pain.

• Side Effects

  • Common Side Effects: Sleepiness (somnolence), nausea, constipation, dizziness, fatigue, dry mouth, headache, insomnia, muscle spasms, peripheral edema (leg swelling), decreased appetite, and increased urination.
  • Serious Side Effects: Hallucinations (seeing or hearing things that are not there), confusion, aggressive behavior, agitation, abnormal thoughts, changes in vision, abnormal uncontrolled movements (dyskinesia), sudden onset of sleep, orthostatic hypotension (a sudden drop in blood pressure when standing), and impulse control disorders (e.g., compulsive gambling, binge eating, excessive spending, increased sexual urges). Seek immediate medical attention if these occur.

• Precautions

  • Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding, as the medication may be unsafe during pregnancy and can pass into breast milk or reduce milk production.
  • Alertness: This medicine can cause drowsiness, dizziness, and sudden sleep attacks. Avoid driving or operating heavy machinery until you know how it affects you.
  • Alcohol: Avoid consuming alcohol while taking Pramipex ER, as it can increase drowsiness and dizziness.
  • Orthostatic Hypotension: Rise slowly from a sitting or lying position to minimize the risk of dizziness or fainting due to a sudden drop in blood pressure.
  • Medical Conditions: Use with caution in patients with kidney or liver problems, low blood pressure, mental health conditions, dyskinesia, dystonia, psychosis, or severe heart or blood vessel disease.
  • Children: Not recommended for individuals under 18 years of age.
  • Drug Interactions: Inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements, as interactions can occur with antipsychotics and metoclopramide.

• Storage Store Pramipex ER 1.5 MG TABLET at room temperature, between 68°F to 77°F (20°C to 25°C), protected from moisture, heat, and direct sunlight. Keep it out of reach and sight of children.

PRAMIPEX ER 1.5 MG TABLET (10 TAB) by SUN PHARMA LABORATORIES LTD. contains Pramipexole, an extended-release medication used to treat certain neurological conditions. Below are frequently asked questions about this medicine.

What is Pramipex ER 1.5 mg Tablet used for?

Pramipex ER 1.5 mg Tablet is primarily used to manage the symptoms of idiopathic Parkinson's disease in adults. It is also prescribed for moderate to severe primary Willis-Ekbom disease, commonly known as restless legs syndrome (RLS). In Parkinson's disease, it helps alleviate symptoms such as tremors, stiffness, slowed movement, and poor muscle control, improving overall mobility and daily functioning. For RLS, it helps relieve the uncomfortable urge to move the legs, especially at night, which can improve sleep quality.

How does Pramipex ER 1.5 mg Tablet work?

Pramipex ER 1.5 mg Tablet contains pramipexole, which is a non-ergot dopamine agonist. It works by mimicking the action of dopamine, a natural substance (neurotransmitter) in the brain essential for controlling body movement. Pramipexole selectively binds to and activates dopamine D2 subfamily receptors, particularly D3 receptors, in the brain. This stimulation helps trigger nerve impulses that control body movements, thereby alleviating the symptoms of Parkinson's disease and restless legs syndrome.

What is the usual dosage for Pramipex ER 1.5 mg Tablet?

Pramipex ER 1.5 mg Tablet is an extended-release formulation designed for once-daily dosing. It should be taken by mouth with or without food, usually at approximately the same time each day to maintain consistent medication levels. The tablet must be swallowed whole and should not be crushed, chewed, or broken, as this can affect its extended-release properties and increase the risk of side effects. Dosage is typically initiated at a low dose and gradually increased by your doctor based on your therapeutic response and tolerability. Doses greater than 4.5 mg/day have not been studied for Parkinson's disease.

What are the possible side effects of Pramipex ER 1.5 mg Tablet?

Common side effects can include sleepiness, nausea, dizziness, fatigue, constipation, and dry mouth. Some individuals may experience more serious side effects such as hallucinations (seeing or hearing things that are not real), confusion, muscle spasms, peripheral edema (leg swelling), and orthostatic hypotension (a sudden drop in blood pressure upon standing, leading to dizziness). Pramipexole can also cause impulse control disorders, leading to intense urges such as compulsive gambling, increased sex drive, overeating, or excessive spending. It may also cause sudden onset of sleep during daily activities. If you experience any severe or persistent side effects, you should consult your doctor.

Is Pramipex ER 1.5 mg Tablet safe during pregnancy or breastfeeding?

Pramipex ER 1.5 mg Tablet is generally not recommended during pregnancy due to limited information on its safety in human pregnancy. It is classified as FDA Pregnancy Category C, meaning animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Consult your doctor if you are pregnant or planning a pregnancy. For breastfeeding, Pramipex ER 1.5 mg Tablet is probably unsafe to use as it can pass into breast milk and may reduce breast milk production. If its use is unavoidable, breastfeeding should be stopped.

Can Pramipex ER 1.5 mg Tablet be taken with other medications?

It is crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, supplements, and herbal products. Pramipex ER 1.5 mg Tablet can interact with certain medications. For example, it should generally not be taken with metoclopramide (used for stomach problems) or certain antipsychotics (like haloperidol or chlorpromazine), as these can reduce its effectiveness or increase side effects. Other medications that cause drowsiness or sedation, such as prescription pain medicines, sleep medicines, or certain antihistamines, should be avoided or used with caution as they can enhance the sedative effects of pramipexole. Cimetidine (used for heartburn) can also increase pramipexole levels in the body, so co-administration should be avoided. Dose adjustments of other medications, like levodopa for Parkinson's disease, may be necessary when taking Pramipex ER.

What precautions should be taken while taking Pramipex ER 1.5 mg Tablet?

Several precautions should be observed. Due to the potential for dizziness and drowsiness, including sudden sleep onset, you should avoid driving or operating heavy machinery until you know how the medication affects you. Alcohol consumption should be avoided as it can increase drowsiness and dizziness. If you have kidney problems, dose adjustments may be necessary, and your doctor should be informed. Rise slowly from a sitting or lying position to minimize the risk of orthostatic hypotension. Do not discontinue the medication suddenly without consulting your doctor, as this can lead to withdrawal symptoms like anxiety, depression, fatigue, sweating, or pain, and may worsen your condition. Inform your doctor if you experience new or worsening mental health changes, hallucinations, or impulse control disorders.

What happens if a dose of Pramipex ER 1.5 mg Tablet is missed?

If you miss a dose of Pramipex ER 1.5 mg Tablet, take it as soon as you remember, but only if it is within 12 hours of your regularly scheduled time. If more than 12 hours have passed, skip the missed dose and resume your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

How should Pramipex ER 1.5 mg Tablet be stored?

Pramipex ER 1.5 mg Tablet should be stored below 25°C (or at room temperature, generally between 68°F to 77°F or 20°C to 25°C), away from moisture, heat, and direct sunlight. Keep this medicine out of the reach and sight of children.