Requip 2mg Tablets

Manufacturer GSK Active Ingredient Ropinirole Tablets(roe PIN i role) Pronunciation roe PIN i role
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
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Drug Class
Antiparkinsonian agent; Agent for restless legs syndrome
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Pharmacologic Class
Dopamine agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ropinirole is a medication used to treat Parkinson's disease and restless legs syndrome. It works by acting like a natural chemical in your brain called dopamine, which helps control movement. By boosting dopamine's effects, it can help reduce tremors, stiffness, and problems with movement in Parkinson's, and relieve uncomfortable sensations and urges to move your legs in restless legs syndrome.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. If you need to stop taking this medication, be sure to talk to your doctor first, as you may need to restart at a lower dose and gradually increase it.

For individuals taking this medication for restless leg syndrome, take it 1 to 3 hours before bedtime.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the lid tightly closed and store all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you miss several days of medication, consult your doctor for advice on how to safely restart your treatment.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery if you experience drowsiness or sudden sleep attacks.
  • Be cautious when standing up quickly from a sitting or lying position to avoid dizziness or fainting due to low blood pressure.
  • Avoid alcohol and other sedating medications, as they can increase drowsiness.
  • Report any new or unusual urges or behaviors (e.g., gambling, shopping, sexual urges) to your doctor immediately.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: For Parkinson's Disease: Initial 0.25 mg three times daily. For Restless Legs Syndrome: Initial 0.25 mg once daily, 1-3 hours before bedtime.
Dose Range: 0.25 - 24 mg

Condition-Specific Dosing:

Parkinson's Disease: Initial: 0.25 mg three times daily. Titrate weekly by 0.25 mg/dose up to 1 mg three times daily, then by 0.5 mg/dose up to 3 mg three times daily, then by 1 mg/dose up to 9 mg three times daily. Max: 24 mg/day.
Restless Legs Syndrome: Initial: 0.25 mg once daily, 1-3 hours before bedtime. Titrate weekly by 0.25 mg up to 1 mg, then by 0.5 mg up to 3 mg, then by 0.5 mg up to 4 mg. Max: 4 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: No adjustment needed (CrCl 30-50 mL/min)
Severe: Limited data; consider dose reduction for CrCl < 30 mL/min. Monitor closely for adverse effects.
Dialysis: Not studied; likely similar considerations as severe impairment. Use with caution.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Not studied; use with caution and monitor for adverse effects.

Pharmacology

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Mechanism of Action

Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It is believed to stimulate postsynaptic D2-type receptors in the caudate-putamen in the brain, thereby mimicking the effects of dopamine and alleviating symptoms of Parkinson's disease and restless legs syndrome.
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Pharmacokinetics

Absorption:

Bioavailability: 55%
Tmax: 1-2 hours
FoodEffect: Food does not affect the extent of absorption (AUC) but may delay Tmax by approximately 2.5 hours.

Distribution:

Vd: 7.5 L/kg
ProteinBinding: 30-40%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 6 hours
Clearance: Approximately 47 L/hr (oral clearance)
ExcretionRoute: Urine (primarily as metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Variable, depends on titration; symptomatic relief can be seen within days to weeks of reaching therapeutic dose.
PeakEffect: Peak plasma concentrations reached in 1-2 hours.
DurationOfAction: Approximately 6-8 hours (for immediate release)
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Changes in eyesight
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
Trouble controlling body movements (new or worsening)
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Sudden sleepiness, including falling asleep during activities like driving, eating, or talking, even if you felt alert beforehand. If this happens, do not drive or engage in activities that require alertness, and contact your doctor immediately.

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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
Back pain

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.
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Seek Immediate Medical Attention If You Experience:

  • Excessive daytime sleepiness or falling asleep suddenly without warning
  • Dizziness, lightheadedness, or fainting, especially when standing up
  • Hallucinations (seeing or hearing things that are not there)
  • Unusual urges or behaviors (e.g., increased gambling, shopping, sexual urges, binge eating)
  • Nausea or vomiting that is severe or persistent
  • Uncontrolled, involuntary movements (dyskinesia)
  • Swelling in the legs or ankles
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Before Using This Medicine

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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking another medication that contains the same active ingredient as this drug.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all of your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety of taking this medication.

Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. Your doctor and pharmacist will help you verify that it is safe to take this medication in combination with your other medications and health conditions.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position. Be cautious when climbing stairs.

Stopping the Medication
Do not stop taking this medication without consulting your doctor. Stopping the medication abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow your doctor's instructions. Monitor yourself for signs of withdrawal, such as fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain, and contact your doctor immediately if you experience any of these symptoms.

Lifestyle Changes
If you start or stop smoking, inform your doctor, as your dosage may need to be adjusted.

Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor.

Monitoring Your Condition
Follow your doctor's instructions for monitoring your blood pressure and heart rate.

Neuroleptic Malignant Syndrome (NMS)
NMS 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. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.

Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of taking this medication with you.

Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, notify your doctor.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Dizziness
  • Somnolence (extreme drowsiness)
  • Orthostatic hypotension (low blood pressure upon standing)
  • Sweating
  • Palpitations
  • Chest pain
  • Confusion
  • Agitation
  • Psychotic behavior
  • Hallucinations

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive, including gastric lavage, emesis, and maintaining airway, breathing, and circulation. Dopamine antagonists may be considered if CNS stimulation is present.

Drug Interactions

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Major Interactions

  • Dopamine antagonists (e.g., antipsychotics like phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the efficacy of ropinirole.
  • CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): Can significantly increase ropinirole plasma levels, increasing risk of adverse effects.
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Moderate Interactions

  • Estrogens (e.g., oral contraceptives): Can decrease ropinirole clearance, leading to increased plasma levels. Dose adjustment of ropinirole may be needed.
  • CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of ropinirole.

Monitoring

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Baseline Monitoring

Renal and Hepatic Function

Rationale: To assess baseline organ function and guide potential dose adjustments in severe impairment.

Timing: Prior to initiation

Blood Pressure (sitting and standing)

Rationale: To establish baseline for orthostatic hypotension risk.

Timing: Prior to initiation

Mental Status/Psychiatric History

Rationale: To assess baseline for potential psychiatric adverse effects (e.g., hallucinations, impulse control disorders).

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (sitting and standing)

Frequency: Regularly, especially during dose titration and if symptoms of orthostatic hypotension occur.

Target: Maintain within patient's normal range, monitor for significant drops.

Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant asymptomatic drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.

Somnolence/Sleep Attacks

Frequency: Regularly, especially during dose titration.

Target: Absence of excessive daytime sleepiness or sudden sleep onset.

Action Threshold: Reports of excessive daytime sleepiness, falling asleep during activities of daily living, or sudden sleep attacks.

Psychiatric Symptoms (e.g., hallucinations, delusions, confusion)

Frequency: Regularly, especially in elderly patients or those with pre-existing psychiatric conditions.

Target: Absence of new or worsening psychiatric symptoms.

Action Threshold: Development of new or worsening hallucinations, delusions, confusion, or other psychotic symptoms.

Impulse Control Disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)

Frequency: Regularly, inquire directly with patient and caregivers.

Target: Absence of new or worsening compulsive behaviors.

Action Threshold: Development of new or worsening compulsive behaviors or urges.

Dyskinesia (in Parkinson's Disease)

Frequency: Regularly, especially with concomitant levodopa.

Target: Minimize or control involuntary movements.

Action Threshold: Development or worsening of troublesome dyskinesia.

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Symptom Monitoring

  • Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
  • Excessive daytime sleepiness or sudden sleep attacks
  • Hallucinations, delusions, confusion, or other psychotic symptoms
  • Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
  • Nausea, vomiting, abdominal pain
  • Dyskinesia (involuntary movements)
  • Peripheral edema

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies at high doses.
Second Trimester: Potential for developmental toxicity observed in animal studies at high doses.
Third Trimester: Potential for developmental toxicity observed in animal studies at high doses; may inhibit lactation.
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Lactation

Ropinirole is known to inhibit prolactin secretion and may inhibit lactation. It is excreted into breast milk in animals, and likely in humans. Due to potential for serious adverse reactions in nursing infants and inhibition of lactation, 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.

Infant Risk: Risk of inhibition of lactation; potential for adverse effects in the infant (e.g., somnolence, effects on CNS).
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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Geriatric Use

Elderly patients (over 65 years) may be more susceptible to the adverse effects of ropinirole, particularly hallucinations, orthostatic hypotension, and somnolence. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Titration is crucial: Ropinirole requires slow, gradual dose titration to minimize side effects, especially nausea, dizziness, and somnolence.
  • Warn patients about sudden sleep attacks: Patients may fall asleep without warning during daily activities, even without feeling drowsy. Advise caution with driving or operating machinery.
  • Monitor for impulse control disorders: Patients and caregivers should be educated about the risk of developing compulsive behaviors (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and instructed to report them immediately.
  • Orthostatic hypotension is common: Advise patients to rise slowly from sitting or lying positions.
  • Augmentation in RLS: Long-term use for RLS can sometimes lead to 'augmentation,' where symptoms start earlier in the day, become more severe, or spread to other body parts. This may require dose adjustment or switching therapy.
  • Do not discontinue abruptly: Abrupt withdrawal can lead to a neuroleptic malignant syndrome-like syndrome or withdrawal symptoms (e.g., anxiety, depression, fatigue, sweating, pain).
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Alternative Therapies

  • Other dopamine agonists (e.g., pramipexole, 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 dyskinesia)
  • Gabapentin or pregabalin (for Restless Legs Syndrome)
  • Opioids (for severe, refractory Restless Legs Syndrome)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 2mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.