Requip 3mg Tablets

Manufacturer GSK Active Ingredient Ropinirole Tablets(roe PIN i role) Pronunciation roe PIN i role
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
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Drug Class
Antiparkinsonian agent; Agent for restless legs syndrome
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Pharmacologic Class
Dopamine agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1997
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DEA Schedule
Not Controlled

Overview

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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. For Parkinson's, it helps improve symptoms like shaking, stiffness, and difficulty moving. For restless legs syndrome, it helps reduce the uncomfortable urge to move your legs.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions 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 directed 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 it 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 and out of reach of children and pets. Dispose of 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 disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. 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.
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Lifestyle & Tips

  • Avoid driving or operating machinery if you experience drowsiness, dizziness, or sudden sleep attacks.
  • Avoid alcohol and other sedating medications, as they can worsen drowsiness.
  • Rise slowly from a sitting or lying position to minimize dizziness from low blood pressure.
  • Report any new or unusual urges or behaviors (e.g., gambling, shopping, sexual urges, binge eating) to your doctor immediately.
  • Take with food if you experience nausea.

Dosing & Administration

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Adult Dosing

Standard Dose: For Parkinson's Disease: Initial 0.25 mg three times daily. Titrate weekly by 0.25 mg/dose (0.75 mg/day) up to 3 mg/day, then by 0.5-1 mg/dose weekly. For Restless Legs Syndrome: Initial 0.25 mg once daily 1-3 hours before bedtime. Titrate weekly by 0.25 mg up to 1 mg, then by 0.5 mg up to 3 mg.
Dose Range: 0.25 - 24 mg

Condition-Specific Dosing:

Parkinson's Disease: Initial 0.25 mg TID, titrate weekly by 0.25 mg/dose (0.75 mg/day) up to 3 mg/day, then by 0.5-1 mg/dose weekly based on response and tolerability. Max 24 mg/day.
Restless Legs Syndrome: Initial 0.25 mg once daily 1-3 hours before bedtime. Titrate weekly by 0.25 mg up to 1 mg, then by 0.5 mg up to 3 mg. Max 4 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment necessary (CrCl 30-50 mL/min).
Moderate: No dose adjustment necessary (CrCl 30-50 mL/min).
Severe: Consider dose reduction and monitor for adverse effects (CrCl < 30 mL/min).
Dialysis: Not well studied; use with caution and monitor closely. Ropinirole is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; monitor for adverse effects. Pharmacokinetics in severe hepatic impairment have not been studied.

Pharmacology

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Mechanism of Action

Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It is believed to stimulate postsynaptic D2-type receptors in the caudate-putamen in the brain, thereby mimicking the effects of dopamine and alleviating symptoms of Parkinson's disease and restless legs syndrome.
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Pharmacokinetics

Absorption:

Bioavailability: 50%
Tmax: 1-2 hours
FoodEffect: Food decreases Cmax by approximately 20% and increases Tmax by 2.5 hours, but does not affect AUC. Can be taken with or without food.

Distribution:

Vd: 7.5 L/kg
ProteinBinding: 30-40%
CnssPenetration: Yes

Elimination:

HalfLife: 6 hours
Clearance: Not available (primarily hepatic metabolism)
ExcretionRoute: Urine (primarily metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-2 hours
DurationOfAction: Approximately 6-8 hours (immediate-release)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 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, including:
+ Falling asleep during activities like driving, eating, or talking
+ Feeling extremely sleepy or alert right before falling asleep

If you experience sudden sleepiness, do not drive or engage in activities that require alertness while taking this medication. Contact your doctor immediately if you fall asleep during activities or 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 only minor 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:

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.
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Seek Immediate Medical Attention If You Experience:

  • Excessive daytime sleepiness or sudden sleep attacks (falling asleep without warning)
  • Dizziness or lightheadedness, especially when standing up
  • Hallucinations (seeing or hearing things that aren't there)
  • Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, uncontrolled shopping, binge eating)
  • Nausea or vomiting that is severe or persistent
  • Uncontrolled, involuntary movements (dyskinesias)
  • Swelling in the legs or ankles
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
Potential interactions with other medications or health conditions. To ensure your safety, 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.
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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, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.

Stopping the Medication
Do not stop taking this medication without consulting your doctor. Stopping the medication abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow your doctor's instructions. Monitor for signs of withdrawal, such as 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, consult your doctor, as your 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, discuss the potential risks with your doctor.

Monitoring Your Condition
Regularly check your blood pressure and heart rate as directed by your doctor.

Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that may occur when medications like this one are stopped suddenly 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. Your doctor will help you weigh the benefits and risks of taking this medication.

Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, notify your doctor.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Dizziness
  • Somnolence
  • Sweating
  • Chest pain
  • Confusion
  • Postural hypotension
  • Hallucinations
  • Paranoia
  • Hyperkinesia

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is generally supportive, including maintaining vital signs and gastric lavage if appropriate.

Drug Interactions

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Major Interactions

  • Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of ropinirole.
  • CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): Can significantly increase ropinirole plasma concentrations, requiring dose adjustment of ropinirole.
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Moderate Interactions

  • Estrogens (e.g., oral contraceptives): May decrease the clearance of ropinirole, leading to increased plasma levels. Dose adjustment of ropinirole may be needed.
  • Other CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of ropinirole.

Monitoring

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Baseline Monitoring

Blood Pressure (Orthostatic)

Rationale: To assess for baseline orthostatic hypotension risk, a common side effect.

Timing: Prior to initiation

Renal and Hepatic Function

Rationale: To assess for potential impairment that may affect drug clearance, especially in severe cases.

Timing: Prior to initiation (if clinically indicated)

Psychiatric History (especially impulse control disorders)

Rationale: To identify pre-existing risk factors for impulse control disorders.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (Orthostatic)

Frequency: Regularly, especially during dose titration and if symptoms of orthostatic hypotension occur.

Target: Maintain within normal limits, minimize symptomatic drops.

Action Threshold: Symptomatic orthostatic hypotension or significant sustained drops (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.

Mental Status/Behavioral Changes (e.g., impulse control disorders, hallucinations, confusion)

Frequency: At each visit, or as symptoms arise.

Target: Absence of new or worsening behavioral changes.

Action Threshold: Development of new or worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, or confusion.

Somnolence/Sleep Attacks

Frequency: At each visit, or as symptoms arise.

Target: Absence of excessive daytime sleepiness or sudden sleep attacks.

Action Threshold: Reports of excessive daytime sleepiness, falling asleep during daily activities, or sudden sleep attacks.

Motor Symptoms (for PD/RLS)

Frequency: At each visit.

Target: Improvement or control of Parkinsonian symptoms (tremor, rigidity, bradykinesia) or RLS symptoms (urge to move legs, unpleasant sensations).

Action Threshold: Worsening of symptoms, or development of dyskinesias (in PD).

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Symptom Monitoring

  • Orthostatic hypotension (dizziness, lightheadedness upon standing)
  • Nausea, vomiting
  • Somnolence, sudden sleep attacks
  • Hallucinations, confusion, delusions
  • Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
  • Dyskinesias (in Parkinson's disease)
  • Peripheral edema
  • Syncope

Special Patient Groups

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Pregnancy

Ropinirole is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Animal studies have shown developmental toxicity (e.g., decreased fetal body weight, increased fetal death) at doses higher than human therapeutic doses. Risk in humans is unknown.
Second Trimester: Risk in humans is unknown.
Third Trimester: Risk in humans is unknown. Potential for inhibition of lactation.
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Lactation

Ropinirole is expected to inhibit lactation due to its dopamine agonist activity, which suppresses prolactin secretion. It is unknown if ropinirole is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants and the inhibition of lactation, 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: L4 (Possibly Hazardous) - Potential for inhibition of lactation and unknown effects on the infant.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Ropinirole is not recommended for use in children.

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Geriatric Use

Elderly patients may be more sensitive to the effects of ropinirole, particularly orthostatic hypotension, hallucinations, and somnolence. Start with the lowest effective dose and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Patients should be warned about the risk of sudden onset of sleep and somnolence, and advised to avoid driving or operating machinery if these occur.
  • Ropinirole can cause impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating). Patients and caregivers should be educated to monitor for these behaviors.
  • Orthostatic hypotension is a common side effect, especially during initiation and dose titration. Advise patients to rise slowly.
  • Withdrawal of ropinirole should be done gradually to avoid dopamine agonist withdrawal syndrome, which can include symptoms like apathy, anxiety, depression, fatigue, sweating, and pain.
  • Take with food if nausea is a problem.
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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 - for Parkinson's Disease)
  • Amantadine (for Parkinson's Disease)
  • Gabapentin or pregabalin (for Restless Legs Syndrome)
  • Iron supplementation (if iron deficiency is present for RLS)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (generic 3mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.