Ropinirole 2mg Tablets
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Anti-Parkinsonian Agent, Restless Legs Syndrome Agent
Pharmacologic Class
Dopamine Agonist, Non-ergoline
Pregnancy Category
Category C
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
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. For Parkinson's, it helps improve symptoms like stiffness, tremors, and slow movement. For restless legs syndrome, it helps reduce the uncomfortable urge to move your legs.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions precisely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. If you need to stop taking the medication, consult with your doctor first, as you may need to restart with a lower dose and gradually increase it.
For individuals with restless leg syndrome, take the medication 1 to 3 hours before bedtime.
Storing and Disposing of Your Medication
To maintain the effectiveness 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 container tightly closed and out of reach of children and pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can inform you about potential drug take-back programs in your area.
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. Avoid taking two doses at the same time or taking extra doses. If you miss several days of medication, contact your doctor for guidance on how to safely restart your medication regimen.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions precisely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. If you need to stop taking the medication, consult with your doctor first, as you may need to restart with a lower dose and gradually increase it.
For individuals with restless leg syndrome, take the medication 1 to 3 hours before bedtime.
Storing and Disposing of Your Medication
To maintain the effectiveness 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 container tightly closed and out of reach of children and pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can inform you about potential drug take-back programs in your area.
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. Avoid taking two doses at the same time or taking extra doses. If you miss several days of medication, contact your doctor for guidance on how to safely restart your medication regimen.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor.
- May cause drowsiness or sudden sleep attacks; avoid driving or operating machinery until you know how it affects you.
- Avoid alcohol and other sedating medications, as they can worsen drowsiness.
- Change positions slowly, especially when getting up from sitting or lying down, to prevent dizziness or fainting.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor immediately.
- Take with food if nausea occurs.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and requires titration. For Parkinson's Disease: Initial 0.25 mg three times daily, titrated weekly. For Restless Legs Syndrome: Initial 0.25 mg once daily 1-3 hours before bedtime, titrated weekly.
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 (0.75 mg/day) for the first week, then by 0.5 mg/dose (1.5 mg/day) for the second week, then by 1.5 mg/day weekly thereafter. Max: 24 mg/day.
Restless Legs Syndrome:
Initial: 0.25 mg once daily 1-3 hours before bedtime. Titrate weekly: Week 1: 0.25 mg; Week 2: 0.5 mg; Week 3: 1 mg; Week 4: 1.5 mg; Week 5: 2 mg; Week 6: 2.5 mg; Week 7: 3 mg; Week 8: 4 mg. Max: 4 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 30-50 mL/min)
Moderate:
No adjustment needed (CrCl 30-50 mL/min)
Severe:
Consider dose reduction for patients with end-stage renal disease (CrCl <30 mL/min) on hemodialysis. Max dose 3 mg/day for RLS, 18 mg/day for PD.
Dialysis:
Supplemental doses are not needed after hemodialysis. Max dose 3 mg/day for RLS, 18 mg/day for PD.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution. Consider dose reduction and careful titration.
Severe:
Use with caution. Consider dose reduction and careful titration.
Pharmacology
Mechanism of Action
Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It is believed to exert its effects by stimulating postsynaptic D2-type dopamine receptors in the caudate-putamen in the brain.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50%
Tmax:
1-2 hours
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be prolonged by 2.5 hours and Cmax reduced by 25% when taken with a high-fat meal.
Distribution:
Vd:
7.5 L/kg
ProteinBinding:
Approximately 40%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6 hours
Clearance:
Approximately 47 L/hr
ExcretionRoute:
Mainly renal (approximately 60% as metabolites)
Unchanged:
Less than 10% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for acute effects, but clinical benefit requires titration)
PeakEffect:
1-2 hours (after a single dose)
DurationOfAction:
Approximately 6-8 hours (for immediate-release)
Safety & Warnings
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 notice 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, unexplained sleepiness, including:
+ Falling asleep during activities like driving, eating, or talking
+ Feeling extremely sleepy or alert before falling asleep
+ If you experience sudden sleepiness, do not drive or engage in activities that require alertness while taking this medication. Contact your doctor immediately.
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
Back pain
Reporting Side Effects
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.
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 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, unexplained sleepiness, including:
+ Falling asleep during activities like driving, eating, or talking
+ Feeling extremely sleepy or alert before falling asleep
+ If you experience sudden sleepiness, do not drive or engage in activities that require alertness while taking this medication. Contact your doctor immediately.
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
Back pain
Reporting Side Effects
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.
Seek Immediate Medical Attention If You Experience:
- Sudden onset of sleep during daily activities (even without warning)
- Severe dizziness or fainting spells
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, compulsive shopping, binge eating)
- Worsening of Parkinson's symptoms or new uncontrolled movements (dyskinesia)
- Worsening of restless legs syndrome symptoms or symptoms occurring earlier in the day (augmentation)
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.
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 your safety, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
Your doctor and pharmacist need this information to verify that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting 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.
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 your safety, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
Your doctor and pharmacist need this information to verify that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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, rise 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 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. 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 the dose is lowered. Seek medical attention immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.
Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, inform your doctor.
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, rise 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 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. 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 the dose is lowered. Seek medical attention immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.
Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, inform your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Somnolence
- Orthostatic hypotension
- Sweating
- Palpitations
- Chest pain
- Confusion
- Agitation
- Psychosis
- Hallucinations
- Dyskinesia
What to Do:
Call 911 or your local emergency number immediately. For advice, call a poison control center at 1-800-222-1222. Supportive care is recommended. Gastric lavage may be considered. There is no known antidote.
Drug Interactions
Major Interactions
- Ciprofloxacin (CYP1A2 inhibitor - may increase ropinirole levels)
- Fluvoxamine (CYP1A2 inhibitor - may increase ropinirole levels)
- Other CYP1A2 inhibitors (e.g., enoxacin, norfloxacin)
Moderate Interactions
- Estrogens (e.g., oral contraceptives - may reduce ropinirole clearance)
- Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide - may reduce efficacy of ropinirole)
- Alcohol (may increase CNS depression)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood pressure (orthostatic)
Rationale: To assess for orthostatic hypotension, a common side effect of dopamine agonists.
Timing: Before initiation and during titration.
Renal function (CrCl)
Rationale: To guide dose adjustments in severe renal impairment.
Timing: Before initiation.
Hepatic function (LFTs)
Rationale: To assess for potential need for dose adjustment in severe hepatic impairment.
Timing: Before initiation.
Mental status/Psychiatric history
Rationale: To assess for risk of impulse control disorders, hallucinations, or psychosis.
Timing: Before initiation.
Routine Monitoring
Blood pressure (orthostatic)
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal range, minimize symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.
Effectiveness (PD/RLS symptoms)
Frequency: Regularly, at each visit.
Target: Reduction in motor symptoms (PD) or RLS symptoms (e.g., urge to move, discomfort).
Action Threshold: Inadequate symptom control or worsening of symptoms.
Adverse effects (e.g., somnolence, nausea, dyskinesia, impulse control disorders, hallucinations)
Frequency: Regularly, at each visit.
Target: Absence or minimal severity of side effects.
Action Threshold: Development of significant or bothersome side effects, especially impulse control disorders or sudden sleep attacks.
Symptom Monitoring
- Excessive daytime sleepiness or sudden sleep attacks
- Dizziness or lightheadedness (especially upon standing)
- Nausea or vomiting
- Hallucinations or confusion
- Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Uncontrolled, involuntary movements (dyskinesia) in Parkinson's patients
- Worsening of RLS symptoms or augmentation (earlier onset, increased intensity, spread to other body parts)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects on embryo-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.
Lactation
Ropinirole is excreted in rat milk and may inhibit lactation in humans due to its dopamine agonist activity. 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:
Low to moderate risk. Potential for somnolence, feeding difficulties, or effects on CNS in infant. May reduce milk supply.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose titration should be done carefully, and monitoring for adverse effects (e.g., orthostatic hypotension, hallucinations) is important.
Clinical Information
Clinical Pearls
- Always titrate ropinirole slowly to minimize side effects, especially nausea, dizziness, and somnolence.
- Educate patients about the risk of sudden sleep attacks and impulse control disorders (ICDs). Screen for ICDs regularly.
- Orthostatic hypotension is common, especially during initiation and dose increases. Advise patients to rise slowly.
- For RLS, ensure patients understand to take the dose 1-3 hours before bedtime, and to report augmentation (worsening of RLS symptoms or earlier onset).
- Concomitant use with CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine) requires dose adjustment of ropinirole due to increased exposure.
- Withdrawal should be gradual to avoid dopamine agonist withdrawal syndrome (DAWS), which can include anxiety, panic attacks, depression, fatigue, sweating, and pain.
Alternative Therapies
- Pramipexole (Mirapex)
- Rotigotine (Neupro - patch)
- Levodopa/Carbidopa (Sinemet - for Parkinson's)
- Other non-pharmacological treatments for RLS (e.g., exercise, iron supplementation if deficient)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (2mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.