Requip 4mg Tablets
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Anti-Parkinson Agent; Agent for Restless Legs Syndrome
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 (RLS). It works by acting like a natural chemical in your brain called dopamine, which helps control movement. In Parkinson's, it helps improve symptoms like shaking, stiffness, and difficulty moving. For RLS, it helps reduce the uncomfortable urge to move your legs, especially at night.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, 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. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking this medication, consult with your doctor first, as you may need to restart with a lower dose and gradually increase it.
For individuals taking this medication for restless leg syndrome, take your dose 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 at all times. Store all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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 your medication, contact your doctor for guidance on how to safely restart your treatment.
To get the most benefit from your medication, 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. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking this medication, consult with your doctor first, as you may need to restart with a lower dose and gradually increase it.
For individuals taking this medication for restless leg syndrome, take your dose 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 at all times. Store all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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 your medication, contact your doctor for guidance on how to safely restart your treatment.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor.
- May cause dizziness or fainting, especially when standing up quickly. Get up slowly from a sitting or lying position.
- May cause drowsiness or sudden sleep attacks. Avoid driving or operating machinery until you know how this medication affects you.
- Avoid alcohol and other medications that cause drowsiness, as these can worsen side effects.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor immediately.
- Report any new or worsening hallucinations or confusion.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Titrated individually based on indication and patient response. For Parkinson's Disease: Initial 0.25 mg three times daily, titrated weekly by 0.25 mg/dose increments up to 1.5 mg three times daily, then by 0.5 mg/dose increments weekly up to 3 mg three times daily, then by 1 mg/dose increments weekly. Max 24 mg/day. For Restless Legs Syndrome: Initial 0.25 mg once daily, 1-3 hours before bedtime. Titrated weekly by 0.25 mg increments up to 1 mg, then by 0.5 mg increments up to 4 mg. Max 4 mg/day.
Dose Range:
0.25 - 24 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial 0.25 mg TID, titrate weekly. Max 24 mg/day.
Restless Legs Syndrome:
Initial 0.25 mg QHS, titrate weekly. 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.
Moderate:
No adjustment needed.
Severe:
For patients with end-stage renal disease (creatinine clearance <30 mL/min) on hemodialysis, a dose adjustment may be considered. Maximum recommended dose is 3 mg/day for RLS and 18 mg/day for PD.
Dialysis:
Supplemental doses are not required after hemodialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Use with caution. Consider dose reduction.
Severe:
Use with caution. Consider dose reduction.
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, thereby mimicking the effects of dopamine and alleviating symptoms of Parkinson's disease and Restless Legs Syndrome.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 55%
Tmax:
1-2 hours (immediate-release)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be prolonged by approximately 2.5 hours.
Distribution:
Vd:
7.5 L/kg
ProteinBinding:
Approximately 40%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6 hours (immediate-release)
Clearance:
Approximately 47 L/hr
ExcretionRoute:
Primarily renal (approximately 60% as metabolites, <10% as unchanged drug)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for acute effects like motor improvement)
PeakEffect:
1-2 hours (immediate-release)
DurationOfAction:
Approximately 6-8 hours (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
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 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
Nausea or 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.
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
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 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
Nausea or 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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting spells
- Sudden onset of sleep during daily activities
- Hallucinations (seeing or hearing things that are not there)
- Confusion or unusual thoughts
- Unusual urges or behaviors (e.g., uncontrollable gambling, increased sexual urges, compulsive shopping, binge eating)
- New or worsening involuntary movements (dyskinesia)
- Swelling in the ankles or feet
- Nausea or vomiting that is severe or persistent
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 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. This will help ensure that it is safe for you to take this medication in combination 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 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 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. This will help ensure that it is safe for you to take this medication in combination with your other medications and health conditions.
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 tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Stopping the Medication
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop the medication, follow your doctor's instructions. Be aware of potential withdrawal symptoms, including 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 this may affect your medication dosage. Before consuming alcohol, marijuana, or other cannabis products, 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)
Be aware of the risk of NMS, a potentially life-threatening condition that may occur if the medication is stopped abruptly or the dose is lowered. Seek medical attention immediately if you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or irregular 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.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of the medication for both you and your baby.
Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, notify 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 tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Stopping the Medication
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop the medication, follow your doctor's instructions. Be aware of potential withdrawal symptoms, including 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 this may affect your medication dosage. Before consuming alcohol, marijuana, or other cannabis products, 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)
Be aware of the risk of NMS, a potentially life-threatening condition that may occur if the medication is stopped abruptly or the dose is lowered. Seek medical attention immediately if you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or irregular 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.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of the medication for both you and your baby.
Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, notify your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Fainting
- Sweating
- Chest pain
- Confusion
- Agitation
- Hallucinations
- Dyskinesia (involuntary movements)
- Orthostatic hypotension
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Ciprofloxacin (CYP1A2 inhibitor - increases ropinirole levels)
- Fluvoxamine (CYP1A2 inhibitor - increases ropinirole levels)
- Other CYP1A2 inhibitors (e.g., enoxacin, mexiletine) - potential for increased ropinirole exposure.
- Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide) - may reduce efficacy of ropinirole.
Monitoring
Baseline Monitoring
Blood Pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Before initiation
Heart Rate
Rationale: To assess for baseline cardiovascular status.
Timing: Before initiation
Mental Status/Psychiatric History
Rationale: To identify pre-existing psychiatric conditions or risk factors for impulse control disorders, hallucinations, or psychosis.
Timing: Before initiation
Renal Function (CrCl)
Rationale: To guide dosing in severe renal impairment.
Timing: Before initiation, if 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 symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant drop (>20 mmHg systolic, >10 mmHg diastolic) upon standing.
Motor Symptoms (Parkinson's Disease)
Frequency: Regularly, at each visit.
Target: Improvement in tremor, rigidity, bradykinesia.
Action Threshold: Worsening symptoms, dyskinesia, or 'wearing off' phenomena.
RLS Symptoms (Restless Legs Syndrome)
Frequency: Regularly, at each visit.
Target: Reduction in urge to move legs, improved sleep quality.
Action Threshold: Augmentation (symptoms occurring earlier in the day, becoming more severe, or spreading to other body parts).
Psychiatric Symptoms (Hallucinations, Delusions, Psychosis)
Frequency: Regularly, at each visit.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence of new or worsening hallucinations, delusions, or psychotic behavior.
Impulse Control Disorders (ICDs)
Frequency: Regularly, at each visit (inquire about new or worsening urges/behaviors).
Target: Absence of new or worsening pathological gambling, hypersexuality, compulsive shopping, binge eating.
Action Threshold: Patient or caregiver reports new or worsening ICDs.
Somnolence/Sleep Attacks
Frequency: Regularly, at each visit (inquire about excessive daytime sleepiness or sudden sleep onset).
Target: Maintain alertness during waking hours.
Action Threshold: Reports of excessive daytime sleepiness or sudden sleep attacks while engaged in activities.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Nausea
- Vomiting
- Dyskinesia (involuntary movements)
- Hallucinations
- Confusion
- Psychosis
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness
- Sudden onset of sleep
- Augmentation (worsening RLS symptoms, earlier onset, increased severity, spread to other body parts)
- Peripheral edema
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on fetal development. There are no adequate and well-controlled studies in pregnant women. Use 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
It is not known whether ropinirole is excreted in human milk. Ropinirole is known to inhibit prolactin secretion in humans and may inhibit lactation. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, 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 serious adverse reactions; inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for either Parkinson's disease or Restless Legs Syndrome.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate slowly due to potential for increased sensitivity to adverse effects (e.g., hallucinations, orthostatic hypotension).
Clinical Information
Clinical Pearls
- Ropinirole is a non-ergoline dopamine agonist, which may have a lower risk of fibrotic complications compared to ergoline derivatives (e.g., pergolide).
- Dose titration is crucial to minimize side effects, especially nausea, dizziness, and somnolence.
- Patients should be warned about the potential for sudden onset of sleep and impulse control disorders, which can occur without warning.
- For RLS, augmentation (worsening of symptoms with treatment) is a known complication, requiring re-evaluation of treatment.
- Withdrawal symptoms (e.g., anxiety, depression, fatigue, sweating, pain) can occur if discontinued abruptly, especially after high doses or long-term use. Taper gradually.
- Smoking can increase the clearance of ropinirole due to CYP1A2 induction, potentially requiring higher doses in smokers.
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)
- Gabapentin (for Restless Legs Syndrome)
- Pregabalin (for Restless Legs Syndrome)
Cost & Coverage
Average Cost:
Price varies widely by pharmacy and dosage. Typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.