Requip 0.25mg Tablets
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Anti-Parkinsonian 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. For Parkinson's, it helps improve symptoms like shaking, stiffness, and difficulty moving. For RLS, it helps reduce the uncomfortable sensations in your legs and the urge to move them, especially at night.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. 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 to feel better. If you need to stop taking the medication, be sure to discuss this with your doctor first, as you may need to restart at a lower dose and gradually increase it.
For individuals taking this medication for restless leg syndrome, it's recommended to take the 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 lid tightly closed and store all medications in a secure location, 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 disposal method or explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you miss several days of medication, consult your doctor for advice on how to restart your treatment.
To get the most benefit from your medication, it's essential to 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. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking the medication, be sure to discuss this with your doctor first, as you may need to restart at a lower dose and gradually increase it.
For individuals taking this medication for restless leg syndrome, it's recommended to take the 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 lid tightly closed and store all medications in a secure location, 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 disposal method or explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you miss several days of medication, consult your doctor for advice on how to restart your treatment.
Lifestyle & Tips
- Take exactly as prescribed, usually with food to reduce nausea.
- Do not stop taking this medication suddenly, as it can lead to serious withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose if needed.
- Be aware that this medication can cause sudden sleep attacks, even during daily activities like driving. Avoid driving or operating machinery if you experience drowsiness or sudden sleep.
- Avoid alcohol and other sedating medications, as they can increase drowsiness.
- Stand up slowly from a sitting or lying position to avoid dizziness or fainting due to low blood pressure.
- Report any new or unusual behaviors, such as increased gambling, shopping, sexual urges, or binge eating, to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and requires slow titration.
Dose Range:
0.25 - 24 mg
Condition-Specific Dosing:
Parkinson's Disease (Immediate-Release):
Initial: 0.25 mg three times daily (TID) for 1 week. Titrate weekly by 0.25 mg/dose (0.75 mg/day) up to 3 mg/day, then by 0.5 mg/dose (1.5 mg/day) up to 9 mg/day, then by 1.5 mg/dose (4.5 mg/day) up to 24 mg/day. Max: 24 mg/day.
Restless Legs Syndrome (Immediate-Release):
Initial: 0.25 mg once daily, 1-3 hours before bedtime, for 2 days. Titrate to 0.5 mg once daily for 5 days, then 1 mg once daily for 7 days. If needed, increase by 0.5 mg/day weekly up to 3 mg/day, then by 1 mg/day weekly up to 4 mg/day. 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 (ESRD) on hemodialysis, a starting dose of 0.25 mg once daily is recommended. Further dose escalation should be based on tolerability and efficacy.
Dialysis:
Supplemental dose after dialysis is not required as ropinirole is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
Use with caution. Consider slower titration and lower maximum dose.
Severe:
Use with caution. Consider slower titration and lower maximum dose. Not studied in severe hepatic impairment.
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, 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
FoodEffect:
Food does not affect the extent of absorption (AUC) but may decrease Cmax by approximately 25% and prolong Tmax by 2.5 hours.
Distribution:
Vd:
Approximately 7.5 L/kg
ProteinBinding:
Approximately 30-40%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6 hours
Clearance:
Approximately 47 L/hr (oral clearance)
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
For RLS, symptom improvement can be seen within hours of the first dose. For Parkinson's, therapeutic effects are observed with gradual dose titration over weeks.
PeakEffect:
Peak plasma concentrations reached in 1-2 hours. Clinical peak effect varies with titration.
DurationOfAction:
Approximately 6-8 hours for immediate-release formulation.
Safety & Warnings
Side Effects
Urgent 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 immediate medical attention:
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 while passing urine
+ Frequent or urgent need to pass urine
+ 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
New or worsening trouble controlling body movements
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Some people have experienced sudden, unexplained sleepiness, even while engaging in activities like driving, eating, or talking. If this happens to you, do not drive or perform tasks that require alertness while taking this medication. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
* Back pain
This list is not exhaustive. If you have questions or concerns about side effects, consult 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 immediate medical attention:
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 while passing urine
+ Frequent or urgent need to pass urine
+ 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
New or worsening trouble controlling body movements
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Some people have experienced sudden, unexplained sleepiness, even while engaging in activities like driving, eating, or talking. If this happens to you, do not drive or perform tasks that require alertness while taking this medication. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
* Back pain
This list is not exhaustive. If you have questions or concerns about side effects, consult 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, especially when standing up
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, uncontrolled shopping, binge eating)
- New or worsening uncontrolled movements (dyskinesia)
- Severe nausea or vomiting
- 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, 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:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
Your doctor and pharmacist need this information to assess the safety of taking this medication with your other medications and health conditions. Never start, stop, or change the dose 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, 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:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
Your doctor and pharmacist need this information to assess the safety of taking this medication with your other medications and health conditions. Never start, stop, or change the dose 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 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 taking this 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.
Smoking and Medication Dosage
If you start or stop smoking, discuss this with your doctor, as your medication dosage may need to be adjusted.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor.
Monitoring Your Condition
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Neuroleptic Malignant Syndrome (NMS)
Be aware of the risk of NMS, a potentially life-threatening condition that may occur when medications like this one are stopped abruptly or when the dosage is lowered. Seek medical attention immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.
Special Considerations for Older Adults
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 potential benefits and risks to 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 activities 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 taking this 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.
Smoking and Medication Dosage
If you start or stop smoking, discuss this with your doctor, as your medication dosage may need to be adjusted.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor.
Monitoring Your Condition
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Neuroleptic Malignant Syndrome (NMS)
Be aware of the risk of NMS, a potentially life-threatening condition that may occur when medications like this one are stopped abruptly or when the dosage is lowered. Seek medical attention immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.
Special Considerations for Older Adults
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 potential benefits and risks to 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, lightheadedness
- Orthostatic hypotension (low blood pressure upon standing)
- Sweating
- Palpitations
- Chest pain
- Confusion
- Agitation
- Hallucinations
- Dyskinesia (uncontrolled movements)
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Management is supportive, including maintaining blood pressure and treating symptoms. Gastric lavage may be considered if ingestion is recent.
Drug Interactions
Major Interactions
- Ciprofloxacin (CYP1A2 inhibitor): May significantly increase ropinirole plasma levels, requiring dose reduction.
- Fluvoxamine (CYP1A2 inhibitor): May significantly 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 may be needed.
- Other CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate sedative effects of ropinirole.
- Antihypertensives: May increase risk of orthostatic hypotension when co-administered with ropinirole.
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 cardiac status.
Timing: Prior to initiation
Mental Status/Psychiatric History
Rationale: To identify predisposition to hallucinations, delusions, or impulse control disorders.
Timing: Prior to initiation
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 asymptomatic drop (e.g., >20 mmHg systolic, >10 mmHg diastolic).
Mental Status/Behavioral Changes
Frequency: At each visit, especially during dose titration.
Target: Absence of new or worsening hallucinations, delusions, confusion, or impulse control disorders.
Action Threshold: New onset or worsening of psychiatric symptoms, compulsive behaviors (e.g., gambling, hypersexuality, binge eating, shopping).
Excessive Daytime Sleepiness/Sleep Attacks
Frequency: At each visit, especially during dose titration.
Target: Absence of sudden onset sleep episodes or excessive somnolence.
Action Threshold: Reports of falling asleep during daily activities, even without warning.
Efficacy (Parkinson's symptoms or RLS symptoms)
Frequency: Regularly during titration and maintenance.
Target: Improvement in motor symptoms (Parkinson's) or reduction in RLS symptoms (frequency, severity, sleep disturbance).
Action Threshold: Lack of efficacy or worsening of symptoms.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Nausea, vomiting, abdominal pain
- Somnolence, sudden sleep attacks
- Hallucinations, delusions, confusion
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Dyskinesia (in Parkinson's patients, especially with levodopa co-administration)
- Peripheral edema
- Worsening of RLS symptoms (augmentation, rebound)
Special Patient Groups
Pregnancy
Ropinirole is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women. It 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. May inhibit lactation.
Lactation
Ropinirole is excreted in rat milk, and it is unknown if it is excreted in human milk. Dopamine agonists are known to inhibit lactation. Therefore, ropinirole should not be used by nursing mothers unless the potential benefits outweigh the potential risks to the infant and the mother's ability to lactate.
Infant Risk:
Potential for adverse effects on the infant (e.g., somnolence, feeding difficulties) and inhibition of lactation in the mother. Risk is considered L3 (Moderately safe, but may inhibit lactation).
Pediatric Use
The safety and effectiveness of ropinirole in pediatric patients have not been established. It is not indicated for use in children.
Geriatric Use
Elderly patients may be more sensitive to the adverse effects of ropinirole, particularly hallucinations, orthostatic hypotension, and somnolence. Start with lower doses and titrate slowly, monitoring closely for adverse reactions.
Clinical Information
Clinical Pearls
- Slow titration is crucial to minimize common side effects like nausea, dizziness, and somnolence.
- Patients should be warned about the potential for sudden sleep attacks and impulse control disorders, and advised to report these immediately.
- Take with food to help reduce nausea.
- For RLS, take 1-3 hours before bedtime. For Parkinson's, take three times daily.
- Do not discontinue abruptly due to risk of withdrawal symptoms (e.g., akinetic crisis, hyperpyrexia, confusion).
Alternative Therapies
- Other dopamine agonists (e.g., pramipexole, rotigotine)
- Levodopa/Carbidopa (for Parkinson's Disease)
- MAO-B inhibitors (e.g., selegiline, rasagiline) (for Parkinson's Disease)
- COMT inhibitors (e.g., entacapone, tolcapone) (for Parkinson's Disease)
- Amantadine (for Parkinson's Disease)
- Gabapentin or Pregabalin (for Restless Legs Syndrome)
- Opioids (for severe RLS, last resort)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 0.25mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 details. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.