Requip 5mg Tablets
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Antiparkinsonian agent, Agent for restless legs syndrome
Pharmacologic Class
Dopamine agonist
Pregnancy Category
Category C
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropinirole is a medication used to treat Parkinson's disease and restless legs syndrome. It works by acting like a natural chemical in your brain called dopamine, which helps control movement. In Parkinson's, it helps improve symptoms like shaking, stiffness, and slow movement. For restless legs, it helps reduce the uncomfortable urge to move your legs.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, 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 the medication as prescribed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking the medication, consult with your doctor first, as you may need to restart with a lower dose and gradually increase it.
For individuals taking this medication for restless leg syndrome, 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 container tightly closed at all times. Store all medications in a secure location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about 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 medication, contact your doctor for guidance on how to safely restart your medication regimen.
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 the medication as prescribed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking the medication, consult with your doctor first, as you may need to restart with a lower dose and gradually increase it.
For individuals taking this medication for restless leg syndrome, 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 container tightly closed at all times. Store all medications in a secure location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about 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 medication, contact your doctor for guidance on how to safely restart your medication regimen.
Lifestyle & Tips
- Take exactly as prescribed; do not stop abruptly without consulting your doctor.
- Be aware of potential dizziness or lightheadedness, especially when standing up quickly. Rise slowly from a sitting or lying position.
- Avoid or limit alcohol consumption, as it can increase drowsiness.
- Do not drive or operate heavy machinery if you experience sudden sleep attacks or excessive drowsiness.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor immediately.
- For RLS, take your dose 1-3 hours before bedtime. If symptoms worsen or occur earlier in the day, inform your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and individual titration. For Parkinson's Disease, initial 0.25 mg three times daily, titrated weekly. For Restless Legs Syndrome, initial 0.25 mg once daily 1-3 hours before bedtime, titrated weekly.
Dose Range:
0.25 - 24 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial: 0.25 mg three times daily for 1 week. Increase by 0.25 mg/dose weekly (0.75 mg/day increase) for 4 weeks. Then, increase by 1.5 mg/day weekly up to 9 mg/day, then by 3 mg/day weekly. Max: 24 mg/day.
Restless Legs Syndrome:
Initial: 0.25 mg once daily 1-3 hours before bedtime for 2 days. Increase to 0.5 mg once daily for 5 days. Then, 1 mg once daily. May increase by 0.5 mg to 1 mg weekly up to 4 mg once daily. Max: 4 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 30-50 mL/min)
Moderate:
No adjustment needed (CrCl 30-50 mL/min)
Severe:
Consider dose reduction for CrCl < 30 mL/min, but specific guidelines are not well-established. Monitor closely.
Dialysis:
Not well studied; generally not recommended or requires careful monitoring due to limited data on removal by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Consider dose reduction and monitor for adverse effects. Clearance may be reduced by 30%.
Severe:
Not studied; generally not recommended due to extensive hepatic metabolism.
Pharmacology
Mechanism of Action
Ropinirole is a non-ergoline dopamine agonist that selectively stimulates D2 and D3 dopamine receptors in the caudate-putamen. The precise mechanism of action in Parkinson's disease is thought to be related to its ability to stimulate postsynaptic D2-type receptors in the brain's striatum. For Restless Legs Syndrome, the mechanism is unknown but is presumed to involve dopaminergic pathways in the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
55%
Tmax:
1-2 hours
FoodEffect:
Food decreases Cmax by approximately 25% and increases Tmax by 2.5 hours, but does not affect AUC.
Distribution:
Vd:
7.5 L/kg
ProteinBinding:
Approximately 37%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6 hours
Clearance:
Approximately 47 L/hour (oral clearance)
ExcretionRoute:
Primarily renal (approximately 60% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Gradual (requires titration for therapeutic effect in PD); within hours for RLS symptom relief.
PeakEffect:
Varies with titration schedule; typically observed after several weeks of stable dosing.
DurationOfAction:
Approximately 6-8 hours for immediate-release formulation.
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
Sudden, unexplained sleepiness, especially during activities like driving, eating, or talking. If this occurs, do not drive or engage in tasks that require alertness while taking this medication. Contact your doctor immediately if you experience excessive sleepiness.
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 is essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
Back pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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
Sudden, unexplained sleepiness, especially during activities like driving, eating, or talking. If this occurs, do not drive or engage in tasks that require alertness while taking this medication. Contact your doctor immediately if you experience excessive sleepiness.
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 is essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
Back pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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
- Hallucinations (seeing or hearing things that are not real)
- Unusual or uncontrollable urges (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Falling asleep suddenly during daily activities (e.g., talking, eating, driving)
- Uncontrolled, involuntary movements (dyskinesia)
- Worsening of restless legs symptoms, or symptoms occurring earlier in the day (augmentation)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, 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 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 and pharmacist to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, 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 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 and pharmacist to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
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 down 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 signs, 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 with your doctor.
Monitoring Your Condition
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or when the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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 this 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 down 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 signs, 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 with your doctor.
Monitoring Your Condition
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or when the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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 this 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 (syncope)
- Sweating
- Confusion
- Hallucinations
- Agitation
- Dyskinesia (involuntary movements)
- Chest pain
- Orthostatic hypotension
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive. Gastric lavage may be considered. Dopamine antagonists may be administered if severe symptoms warrant.
Drug Interactions
Major Interactions
- CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): Can significantly increase ropinirole plasma levels, requiring dose reduction of ropinirole.
- Dopamine antagonists (e.g., antipsychotics like haloperidol, metoclopramide): May reduce the efficacy of ropinirole due to opposing pharmacologic effects.
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 potentiate CNS depressant effects (e.g., somnolence).
Minor Interactions
- Other CNS depressants (e.g., sedatives, hypnotics): Additive CNS depression.
Monitoring
Baseline Monitoring
Blood Pressure (Orthostatic)
Rationale: To assess baseline for potential orthostatic hypotension, a common side effect.
Timing: Before initiation of therapy.
Renal and Hepatic Function
Rationale: To identify potential impairment that may necessitate dose adjustment or careful monitoring.
Timing: Before initiation, especially if suspected impairment.
Routine Monitoring
Blood Pressure (Orthostatic)
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal limits, avoid symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (dizziness, lightheadedness, syncope) or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.
Mental Status and Behavior
Frequency: At each visit, especially during dose titration.
Target: Absence of new or worsening impulse control disorders, hallucinations, confusion, or psychosis.
Action Threshold: Development of new or worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, confusion, or psychotic-like behavior. Requires dose reduction or discontinuation.
Motor Symptoms (PD/RLS)
Frequency: At each visit.
Target: Improvement in Parkinsonian symptoms (tremor, rigidity, bradykinesia) or RLS symptoms (urge to move legs, unpleasant sensations).
Action Threshold: Lack of efficacy, worsening of symptoms, or development of dyskinesia (in PD) or augmentation/rebound (in RLS).
Somnolence/Sleep Attacks
Frequency: At each visit.
Target: Absence of excessive daytime sleepiness or sudden onset of sleep.
Action Threshold: Reports of excessive somnolence or sudden sleep attacks. Requires dose reduction or discontinuation, and patient counseling regarding driving/operating machinery.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing)
- Fainting (syncope)
- Hallucinations (seeing or hearing things that are not there)
- Confusion
- Unusual urges or behaviors (e.g., pathological gambling, increased sexual urges, compulsive shopping, binge eating)
- Excessive daytime sleepiness or sudden sleep attacks
- Nausea, vomiting
- Dyskinesia (uncontrolled, involuntary movements)
- Worsening of RLS symptoms in the evening or earlier in the day (augmentation)
- RLS symptoms returning earlier or more intensely after a dose (rebound)
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 at high doses.
Second Trimester:
Limited human data; animal data suggest potential for adverse effects.
Third Trimester:
Limited human data; animal data suggest potential for adverse effects.
Lactation
Ropinirole is known to inhibit lactation in humans due to its dopamine agonist activity. It is also excreted into breast milk in rats, and likely in humans. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk of adverse effects on the infant is unknown, but potential for central nervous system effects and inhibition of lactation. L3 (Moderately Safe).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for either Parkinson's disease or Restless Legs Syndrome. Use is not recommended.
Geriatric Use
Elderly patients (over 65 years) may be at increased risk for hallucinations, orthostatic hypotension, and somnolence. Start with lower doses and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Ropinirole requires careful, gradual dose titration to minimize side effects, especially nausea, dizziness, and somnolence.
- Patients should be warned about the risk of sudden onset of sleep and impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating). These can occur without warning and may require dose reduction or discontinuation.
- Orthostatic hypotension is a common side effect, particularly during initiation and dose escalation. Advise patients to rise slowly.
- In Restless Legs Syndrome, augmentation (worsening of symptoms in the evening or earlier in the day) and rebound (symptoms returning earlier or more intensely after a dose) can occur, especially at higher doses. Consider dose adjustment or alternative therapies if this occurs.
- Abrupt discontinuation of ropinirole can lead to a withdrawal syndrome resembling neuroleptic malignant syndrome (fever, rigidity, altered consciousness, autonomic instability). Taper dose gradually over 7 days or more.
- Avoid concomitant use with dopamine antagonists (e.g., antipsychotics, metoclopramide) as they can reduce ropinirole's efficacy.
Alternative Therapies
- Other non-ergoline 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, opicapone) (for Parkinson's Disease)
- Amantadine (for Parkinson's Disease)
- Gabapentin enacarbil (for Restless Legs Syndrome)
- Pregabalin (for Restless Legs Syndrome)
Cost & Coverage
Average Cost:
$10 - $100+ per 30 tablets (generic 5mg)
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 information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.