Ropinirole ER 12mg Tablets
It is used to treat Parkinson's disease.
Drug Class
Antiparkinsonian agent, Restless Legs Syndrome agent
Pharmacologic Class
Dopamine agonist
Pregnancy Category
Category C
FDA Approved
Jun 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropinirole extended-release is a medication used to treat Parkinson's disease by acting like a natural brain chemical called dopamine. It helps improve movement and reduce stiffness and tremors. It is taken once a day.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it.
If you have a health condition like diarrhea that causes the medication to move through your body too quickly, you may see what looks like the tablet in your stool. If this happens, consult your doctor.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. If you need to stop taking this medication, talk to your doctor first. You may need to restart at a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep the lid tightly closed and store all medications in a safe place, out of the 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. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses. If you miss several days of medication, contact your doctor for guidance on how to restart your treatment.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it.
If you have a health condition like diarrhea that causes the medication to move through your body too quickly, you may see what looks like the tablet in your stool. If this happens, consult your doctor.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. If you need to stop taking this medication, talk to your doctor first. You may need to restart at a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep the lid tightly closed and store all medications in a safe place, out of the 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. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore 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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses. If you miss several days of medication, contact your doctor for guidance on how to restart your treatment.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or split it.
- Take at approximately the same time each day, with or without food.
- Avoid sudden changes in position (e.g., standing up quickly) to reduce dizziness.
- Be aware of potential for sudden sleep attacks; avoid driving or operating machinery if you experience drowsiness.
- Limit or avoid alcohol consumption as it can increase drowsiness.
- Report any new or unusual urges or behaviors (e.g., gambling, shopping, sexual urges) to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initial dose 2 mg once daily for 1 to 2 weeks, then may increase by 2 mg increments at weekly or longer intervals. The 12 mg dose is a maintenance dose, typically reached after titration. Max dose 24 mg/day.
Dose Range:
2 - 24 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial: 2 mg once daily for 1-2 weeks. Titrate by 2 mg increments at weekly or longer intervals based on response and tolerability. Maintenance: 2 mg to 24 mg once daily. 12 mg is a common maintenance dose.
Restless Legs Syndrome:
Not indicated for RLS at 12mg ER. Max dose for RLS ER is 4 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl 30-50 mL/min).
Moderate:
No dose adjustment required (CrCl 30-50 mL/min).
Severe:
Use with caution in patients with end-stage renal disease (CrCl < 30 mL/min) on hemodialysis. A maximum dose of 18 mg/day is recommended for patients with ESRD receiving hemodialysis.
Dialysis:
Ropinirole is not significantly removed by hemodialysis. A maximum dose of 18 mg/day is recommended for patients with ESRD receiving hemodialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution. Consider slower titration and careful monitoring.
Severe:
Use with caution. No specific dosing recommendations available; consider slower titration and close monitoring for adverse effects.
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 exert its effects by stimulating postsynaptic D2-type dopamine receptors in the caudate-putamen in the brain.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 55% (oral)
Tmax:
6-10 hours (Extended-Release)
FoodEffect:
Food does not affect the rate or extent of absorption of ropinirole extended-release tablets.
Distribution:
Vd:
7.5 L/kg
ProteinBinding:
10-17%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6 hours (Extended-Release)
Clearance:
Approximately 47 L/hr (oral clearance)
ExcretionRoute:
Renal (approximately 60% as metabolites)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Gradual (due to extended-release formulation)
PeakEffect:
Corresponds to Tmax (6-10 hours)
DurationOfAction:
24 hours
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 or seek medical attention immediately:
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
Some people have experienced sudden sleepiness or fallen asleep 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 excessive sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately if this happens or if you feel extremely sleepy.
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 notice any of the following side effects or any other symptoms that bother you or do not go away, 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
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 immediately:
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
Some people have experienced sudden sleepiness or fallen asleep 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 excessive sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately if this happens or if you feel extremely sleepy.
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 notice any of the following side effects or any other symptoms that bother you or do not go away, 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
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
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, compulsive shopping, binge eating)
- Severe dizziness or fainting, especially when standing up
- New or worsening involuntary movements (dyskinesia)
- Swelling in the legs or ankles
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 treatment, disclose all of your medications, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems that may be relevant to your treatment.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. This will help ensure your safety and the effectiveness of your treatment.
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 treatment, disclose all of your medications, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems that may be relevant to your treatment.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. This will help ensure your safety and the effectiveness of your treatment.
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. Additionally, 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.
As directed by your doctor, regularly monitor your blood pressure and heart rate. 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, contact your doctor right away.
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. Additionally, 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.
As directed by your doctor, regularly monitor your blood pressure and heart rate. 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, contact your doctor right away.
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
- Somnolence
- Fatigue
- Abdominal pain
- Agitation
- Chest pain
- Confusion
- Hypotension
- Palpitations
- Psychosis
- Syncope
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Supportive care, including maintaining blood pressure and respiratory support, is recommended. Gastric lavage may be considered if ingestion is recent.
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, phenothiazines, 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 the risk of somnolence and sudden sleep onset.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation
Heart Rate
Rationale: To assess for baseline cardiovascular status.
Timing: Prior to initiation
Renal Function (CrCl)
Rationale: To guide dosing in severe renal impairment.
Timing: Prior to initiation
Hepatic Function (LFTs)
Rationale: To assess for baseline liver impairment.
Timing: Prior to initiation
Mental Status/Psychiatric History
Rationale: To identify risk factors for hallucinations, psychosis, or impulse control disorders.
Timing: Prior to initiation
Routine Monitoring
Efficacy (Parkinson's symptoms)
Frequency: Regularly during titration and maintenance
Target: Improved motor function, reduced 'off' time
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Orthostatic Blood Pressure and Heart Rate
Frequency: Regularly, especially during titration and with dose increases
Target: Stable BP, minimal orthostatic drop
Action Threshold: Symptomatic orthostatic hypotension (dizziness, lightheadedness, falls) or significant BP drop (>20 mmHg systolic, >10 mmHg diastolic) requires dose reduction or discontinuation.
Somnolence/Sudden Sleep Onset
Frequency: Regularly
Target: Alertness during waking hours
Action Threshold: Excessive daytime sleepiness or sudden sleep attacks require dose reduction or discontinuation, and patient counseling on driving/operating machinery.
Hallucinations/Psychotic-like Behavior
Frequency: Regularly
Target: Absence of hallucinations or delusions
Action Threshold: Presence of new or worsening hallucinations/psychosis requires dose reduction or discontinuation.
Impulse Control Disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
Frequency: Regularly, inquire directly
Target: Absence of new or worsening compulsive behaviors
Action Threshold: Development of these behaviors requires dose reduction, discontinuation, or referral to a specialist.
Dyskinesia (in Parkinson's Disease)
Frequency: Regularly, especially with higher doses
Target: Minimal or tolerable involuntary movements
Action Threshold: Troublesome dyskinesia may require dose reduction or adjustment of concomitant Parkinson's medications.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting)
- Excessive daytime sleepiness or sudden sleep attacks
- Hallucinations or confusion
- Unusual urges or behaviors (e.g., gambling, shopping, eating, sexual urges)
- Nausea, vomiting, abdominal pain
- Dyskinesia (involuntary movements)
- Peripheral edema
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.
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
Ropinirole is excreted into human milk and may inhibit lactation 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:
Potential for adverse effects in the breastfed infant (e.g., somnolence, feeding difficulties) and inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
Increased incidence of hallucinations and orthostatic hypotension has been observed in elderly patients. Start with lower doses and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Ropinirole ER is designed for once-daily dosing, providing continuous dopaminergic stimulation, which may help reduce 'off' time fluctuations in Parkinson's disease.
- Patients should be warned about the potential for sudden sleep attacks without warning, even during normal daily activities. Advise caution with driving or operating machinery.
- Impulse control disorders (e.g., pathological gambling, hypersexuality) are a known side effect of dopamine agonists. Screen patients for these behaviors and counsel them and their caregivers.
- Orthostatic hypotension is common, especially during initiation and dose escalation. Advise patients to rise slowly from a sitting or lying position.
- Do not crush, chew, or split the extended-release tablets, as this will alter the release profile and may lead to rapid absorption and increased side effects.
Alternative Therapies
- Other dopamine agonists (e.g., pramipexole, rotigotine)
- Levodopa/carbidopa
- MAO-B inhibitors (e.g., selegiline, rasagiline)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- Anticholinergics (for tremor)
Cost & Coverage
Average Cost:
$100 - $500 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or higher (for brand)
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 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.