Ropinirole ER 4mg Tablets
It is used to treat Parkinson's disease.
Drug Class
Antiparkinsonian agent
Pharmacologic Class
Non-ergoline dopamine agonist
Pregnancy Category
Category C
FDA Approved
Jun 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropinirole ER is a medication used to treat Parkinson's disease. It works by acting like a natural chemical in your brain called dopamine, which helps control movement. This extended-release form is taken once a day and slowly releases the medicine over time to help improve your symptoms like stiffness, tremors, and difficulty moving.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole. Do not chew, break, or crush it, as this can affect how the medication works.
If you have a health condition like diarrhea, the medication may pass through your body too quickly, and you may see what looks like the tablet in your stool. If this happens, consult your doctor to discuss the best course of action.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. If you need to stop taking the medication, talk to your doctor first, as you may need to restart with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, away from light and moisture. Keep the container tightly closed and store it in a dry place, such as a closet or cupboard. Avoid storing medication in a bathroom, and keep it out of reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local 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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
If you miss several days of medication, consult your doctor for guidance on how to restart your treatment safely.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but be sure to swallow the tablet whole. Do not chew, break, or crush it, as this can affect how the medication works.
If you have a health condition like diarrhea, the medication may pass through your body too quickly, and you may see what looks like the tablet in your stool. If this happens, consult your doctor to discuss the best course of action.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well. If you need to stop taking the medication, talk to your doctor first, as you may need to restart with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, away from light and moisture. Keep the container tightly closed and store it in a dry place, such as a closet or cupboard. Avoid storing medication in a bathroom, and keep it out of reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local 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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
If you miss several days of medication, consult your doctor for guidance on how to restart your treatment safely.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or divide it.
- Take at approximately the same time each day, with or without food.
- Be aware of potential sudden sleep attacks; avoid driving or operating heavy machinery if you experience drowsiness.
- Rise slowly from a sitting or lying position to reduce dizziness from low blood pressure.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor.
- Avoid alcohol as it can increase drowsiness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initial 2 mg once daily for 1 to 2 weeks, then increase by 2 mg increments weekly. Typical maintenance dose is 4-24 mg once daily.
Dose Range:
2 - 24 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial 2 mg once daily for 1 to 2 weeks. Increase by 2 mg increments weekly based on response and tolerability. Max 24 mg/day. Take at approximately the same time each day with or without food.
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:
Not studied; caution advised (CrCl <30 mL/min)
Dialysis:
Not studied; caution advised
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Not studied; caution advised
Pharmacology
Mechanism of Action
Ropinirole is a non-ergoline dopamine agonist that has 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 alleviating the motor symptoms of Parkinson's disease.
Pharmacokinetics
Absorption:
Bioavailability:
55%
Tmax:
6-10 hours (extended-release)
FoodEffect:
No significant effect on AUC or Tmax, but Tmax may be prolonged by 2.5 hours when taken with a high-fat meal.
Distribution:
Vd:
7.5 L/kg
ProteinBinding:
35-40%
CnssPenetration:
Yes
Elimination:
HalfLife:
6 hours (extended-release)
Clearance:
40 L/hr
ExcretionRoute:
Urine (approximately 60% as metabolites, <10% as unchanged drug)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Varies with titration; clinical effect seen over weeks
PeakEffect:
6-10 hours post-dose (extended-release)
DurationOfAction:
24 hours (extended-release)
Safety & Warnings
Side Effects
Serious 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 medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
Difficulty controlling body movements (new or worsening)
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience sudden sleepiness or excessive sleepiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. 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, or vomiting
Dizziness, drowsiness, tiredness, or weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Feeling nervous or excitable
Shakiness
Anxiety
Nose or throat irritation
Back pain
This is not a comprehensive list of all 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 immediately or seek medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
Difficulty controlling body movements (new or worsening)
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience sudden sleepiness or excessive sleepiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. 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, or vomiting
Dizziness, drowsiness, tiredness, or weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Feeling nervous or excitable
Shakiness
Anxiety
Nose or throat irritation
Back pain
This is not a comprehensive list of all 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
- 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)
- Uncontrolled, involuntary movements (dyskinesia)
- Chest pain or irregular heartbeat
- Swelling in the ankles or feet
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 allergic reaction you experienced, including any symptoms that occurred.
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 they 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 with your other medications and health conditions.
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 allergic reaction you experienced, including any symptoms that occurred.
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 they 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 with your other medications and health conditions.
Precautions & Cautions
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. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
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 guidance provided by your doctor. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
If you start or stop smoking, notify your doctor, as this may necessitate an adjustment in your medication dosage. Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
Monitor your blood pressure and heart rate as directed by your doctor. Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating, seek medical attention immediately.
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, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
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 guidance provided by your doctor. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
If you start or stop smoking, notify your doctor, as this may necessitate an adjustment in your medication dosage. Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
Monitor your blood pressure and heart rate as directed by your doctor. Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating, seek medical attention immediately.
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, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Fainting (syncope)
- Sweating
- Chest pain
- Confusion
- Agitation
- Dyskinesia (involuntary movements)
- Orthostatic hypotension
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, antiemetics, and dopamine antagonists if severe.
Drug Interactions
Major Interactions
- CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): May increase ropinirole plasma levels, requiring dose reduction.
- Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of ropinirole.
Moderate Interactions
- Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, leading to increased plasma levels. Dose adjustment of ropinirole may be needed.
- Alcohol: May increase CNS depressant effects and risk of somnolence.
Monitoring
Baseline Monitoring
Blood Pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Before initiation of therapy
Renal and Hepatic Function
Rationale: To identify potential impairment that may affect drug clearance, especially if severe impairment is suspected.
Timing: Before initiation, if clinically indicated
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, minimize orthostatic drop.
Action Threshold: Significant orthostatic drop (>20 mmHg systolic or >10 mmHg diastolic) or symptomatic hypotension; consider dose reduction or discontinuation.
Mental Status/Behavioral Changes
Frequency: At each visit, especially during dose titration.
Target: Absence of hallucinations, delusions, impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating).
Action Threshold: New onset or worsening of psychiatric symptoms or impulse control disorders; consider dose reduction, discontinuation, or referral to psychiatry.
Somnolence/Sleep Attacks
Frequency: At each visit.
Target: Absence of excessive daytime sleepiness or sudden sleep onset.
Action Threshold: Reports of sudden sleep attacks or significant somnolence; advise against driving/operating machinery, consider dose reduction or discontinuation.
Motor Symptoms (Parkinson's Disease)
Frequency: At each visit.
Target: Improvement in motor symptoms (tremor, rigidity, bradykinesia) with acceptable side effects.
Action Threshold: Worsening of symptoms, onset of dyskinesia, or 'on-off' phenomena; adjust dose or consider adjunctive therapy.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Excessive daytime sleepiness or sudden sleep attacks
- Hallucinations (visual, auditory)
- Delusions or paranoia
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Nausea, vomiting
- Dyskinesia (involuntary movements)
- Peripheral edema
- Syncope
Special Patient Groups
Pregnancy
Category C. Animal studies have shown adverse effects on fetal development. Ropinirole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies.
Second Trimester:
Potential for developmental toxicity observed in animal studies.
Third Trimester:
Potential for developmental toxicity observed in animal studies.
Lactation
Not recommended. Ropinirole is excreted into breast milk in rats and may inhibit lactation in humans due to its dopamine agonist activity. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Moderate risk. Potential for adverse effects on the infant (e.g., somnolence, feeding difficulties) and inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is not recommended.
Geriatric Use
Elderly patients may be at increased risk for hallucinations, orthostatic hypotension, and other adverse events. Initiate therapy at the lowest dose and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Ropinirole ER is designed for once-daily dosing and should not be crushed, chewed, or divided. This can lead to rapid release of the drug and increased side effects.
- Patients should be warned about the potential for sudden onset of sleep during daily activities, even without prior warning signs of drowsiness. Advise caution with driving or operating machinery.
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) have been reported in patients treated with dopamine agonists, including ropinirole. Patients and caregivers should be regularly monitored for these behaviors.
- Orthostatic hypotension is a common side effect, especially during dose titration. Advise patients to rise slowly and monitor blood pressure.
- Nausea can be minimized by taking the medication with food, although it can be taken without food.
- Withdrawal symptoms (e.g., apathy, anxiety, depression, fatigue, insomnia, sweating, pain) can occur if ropinirole is discontinued abruptly, especially at high doses. Taper dose gradually over 7 days or longer.
Alternative Therapies
- Other dopamine agonists (e.g., pramipexole, rotigotine)
- Levodopa/carbidopa
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- Anticholinergics (e.g., trihexyphenidyl, benztropine)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$200+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
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 taken, the amount, and the time it happened.