Ropinirole

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Generic Name: Ropinirole Brand Name(s): Generics only. No brands available.

Uses

What is Ropinirole used for?

Ropinirole is used alone or with other medications to treat Parkinson’s disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move (“on-off syndrome”).

Ropinirole is also used to treat restless legs syndrome (RLS). It may improve your sleep by decreasing the urge to move your legs and decreasing uncomfortable/unpleasant feelings in the legs.

This medication works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

How should I take Ropinirole?

If you are taking this medication for Parkinson’s disease, take this medication by mouth with or without food, usually 3 times a day as directed by your doctor. Taking this medication with food may reduce nausea. To decrease the risk of side effects (e.g., drowsiness, low blood pressure) when you first start taking ropinirole, your doctor will slowly increase your dosage until the best dose for you is reached.

If you are using this medication for RLS, take this medication by mouth, usually once daily with or without food, 1-3 hours before bedtime or as directed by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Take this medication as prescribed. Do not increase your dose or take it more often than directed.

If you stop taking this medication for several days, you may need to increase your dose slowly back to your previous dosage. Talk with your doctor about how to restart the medication.

Do not stop taking this medication without consulting your doctor. If you suddenly stop taking this drug, withdrawal symptoms such as fever, muscle stiffness, and confusion may occur. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details.

If you are taking this medication for RLS, tell your doctor if your symptoms increase or get worse in the early morning, or if you start getting symptoms earlier in the evening or late afternoon. Your doctor may need to change your treatment.

The dosage is based on your medical condition and response to therapy. It may take a few weeks for this medication to take effect. Inform your doctor if your symptoms do not improve or if they worsen.

How do I store Ropinirole?

Ropinirole is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Ropinirole in the bathroom or the freezer. There may be different brands of Ropinirole that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ropinirole down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ropinirole?

Before taking ropinirole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (including irregular heartbeat), mental/mood disorders (e.g., confusion, hallucinations, psychoses, schizophrenia), difficulty walking, kidney problems, liver problems, high or low blood pressure, sleep disorder (e.g., sleep apnea, narcolepsy).

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as hallucinations), nausea, and vomiting.

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ropinirole during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ropinirole. Ropinirole is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ropinirole?

Nausea, vomiting, constipation, dizziness, drowsiness, weakness, unusual sweating, headache, and dry mouth may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, and fainting. This is more likely when you are first starting the medication or when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.

This medication may also raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: difficulty moving or walking, mental/mood changes (e.g., confusion, depression, hallucinations, memory problems, trouble sleeping), muscle cramps/spasms, decreased sexual ability, unusual strong urges (such as increased gambling, increased sexual urges), swelling of the ankles/feet, chest pain, unusually fast/slow/irregular heartbeat, vision changes.

Some people taking ropinirole have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with ropinirole even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ropinirole?

Some products that may interact with this drug are: antipsychotics (e.g., chlorpromazine, haloperidol, thiothixene), metoclopramide.

Other medications can affect the removal of ropinirole from your body, which may affect how ropinirole works. Examples include cimetidine, fluvoxamine, mexiletine, omeprazole, rifampin, among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Cigarette smoking decreases the level of this medication in your bloodstream. Tell your doctor if you smoke or if you have recently stopped smoking.

Ropinirole may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ropinirole?

Ropinirole may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ropinirole?

Ropinirole may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ropinirole.

What is the dose of Ropinirole for an adult?

Usual Adult Dose for Parkinson’s Disease

Immediate-release tablets:

Initial: 0.25 mg orally three times daily

After 1 week, the dose may be titrated up in weekly increments based on individual efficacy and tolerability:

Week 2: give 0.5 mg orally 3 times daily

Week 3: give 0.75 mg orally 3 times daily

Week 4: give 1 mg orally 3 times daily

After week 4, increase by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, then increase by 3 mg/day on a weekly basis up to a maximum daily dose of 24 mg

Maximum Dose: 8 mg orally three times a day

Extended-release tablets:

Initial: 2 mg orally once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals, depending on therapeutic response and tolerability

Maximum dose: 24 mg orally once a day

Patients may switch from immediate-release to extended-release: The initial dose of extended-release tablet should most closely match the total daily dose of immediate-release formulation. Following conversion, adjust dose depending on response and tolerability.

Comments:

-If significant interruption in therapy occurs, retitration may be necessary; upon discontinuation, this drug should be gradually tapered over a 7-day period.

-The extended-release tablet is designed to release medication over a 24-hour period, if rapid gastrointestinal transit occurs, and tablet residue is observed in the stool, there is a risk of incomplete release of medication,

Use: For the treatment of Parkinson’s disease.

Usual Adult Dose for Restless Legs Syndrome

Immediate-release tablets:

Initial: 0.25 mg orally once a day on Day 1 and Day 2

Dose titration: May titrate as follows based on individual efficacy and tolerability:

Days 3 to 7: give 0.5 mg orally once a day

-Week 2: give 1 mg orally once a day

-Week 3: give 1.5 mg orally once a day

-Week 4: give 2 mg orally once a day

-Week 5: give 2.5 mg orally once a day

-Week 6: give 3 mg orally once a day

-Week 7: give 4 mg orally once a day

Maximum Dose: 4 mg orally once a day

Comments:

-Take 1 to 3 hours before bedtime.

-In clinical trials, this drug was not tapered prior to discontinuation.

Use: For the treatment of moderate to severe Restless Legs Syndrome.

Renal Dose Adjustments

Parkinson’s disease:

Moderate renal impairment (CrCl 30 to 50 mL/mi): No dosage adjustment is necessary

Severe renal impairment without regular dialysis: No data available

Restless Leg Syndrome:

Moderate renal impairment (CrCl 30 to 50 mL/min): No dosage adjustment is necessary

Severe renal impairment without regular dialysis: No data available

Liver Dose Adjustments

Dose adjustments may be required; however, no specific guidelines have been suggested. Caution is recommended.

Dose Adjustments

Doses are individually titrated based on efficacy and tolerability.

Parkinson’s disease:

-If this drug is administered as adjunct therapy to levodopa, the concurrent dose of levodopa may be decreased gradually as tolerated; the average dose reduction of levodopa was 31% and 34% with immediate-release and extended-release tablets, respectively.

Drug interruption:

-If significant interruption in therapy occurs, this drug may need to be retitrated.

Drug discontinuation:

-Immediate-release tablets: Reduce the frequency of administration from 3 times a day to 2 times a day for 4 days, then once a day for 3 days, prior to discontinuation.

-Extended-release tablets: Gradually discontinue over a 7-day period

Precautions

Safety and efficacy of the extended-release product have not been established in patients with Restless Legs Syndrome (RLS).

Dialysis

Peritoneal dialysis: Data not available

End stage renal disease (ESRD) on hemodialysis:

Parkinson’s disease, Immediate-release:

-Initial dose: 0.25 mg orally 3 times a day

-Dose titration should be based on tolerability and need for efficacy

-Maximum dose: 6 mg orally 3 times a day

Parkinson’s disease, Extended-release:

-Initial dose: 2 mg orally once a day

-Dose titration should be based on tolerability and need for efficacy

-Maximum dose: 18 mg orally once a day

Restless Leg Syndrome:

-Initial dose: 0.25 mg orally once a day

-Dose titration should be based on tolerability and need for efficacy

-Maximum dose: 3 mg orally once a day

Comments: Supplemental doses after dialysis are not required.

Other Comments

Administration advice:

-May take with or without food

-If a dose is missed, take your next dose as scheduled; do not double your next dose

-Extended-release products should be taken once a day at a similar time each day; they should not be chewed, crushed, or split

-Restless Leg Syndrome: Take once a day 1 to 3 hours before bedtime

General:

-If significant interruption to therapy occurs, this drug should be retitrated.

-Parkinson’s Disease: This product should be tapered before discontinuation.

-Restless Legs Syndrome: This drug was not tapered to discontinuation during clinical trials.

Monitoring:

-Cardiovascular: Monitor for signs and symptoms of orthostatic hypotension, particularly during dose escalation; consider blood pressure monitoring at the start of treatment, especially in patients with significant cardiovascular disease.

-Nervous System: Monitor for somnolence and drowsiness

-Dermatologic: Monitor for melanomas; consider periodic skin examinations by dermatologists.

-Psychiatric: Question patients about new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges.

Patient advice:

-This drug frequently causes drowsiness; patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.

-Patients should be instructed to report episodes of sudden onset of sleep, new or worsening dyskinesia, new or worsening compulsive behaviors and/or unusual urges.

-Patients should be instructed to report changes in the size, shape, or color of moles on their skin and should have their skin checked on a regular basis for melanomas.

-Patients should be aware that this drug may cause orthostatic blood pressure changes including fainting and dizziness and patients should be advised to avoid standing rapidly after sitting or lying down.

-Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding.

What is the dose of Ropinirole for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ropinirole available?

Ropinirole is available in the following dosage forms and strengths:

  • Oral tablet, extended release,
  • Oral tablet,
  • Oral kit.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ropinirole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: April 26, 2018

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