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Ropinirole (Oral route)

Pronunciation:

roe-PIN-i-role

Brand Names:

  • Requip
  • Requip XL

Dosage Forms:

  • Tablet
  • Tablet, Extended Release

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Dopamine Agonist

Uses of This Medicine:

Ropinirole is used alone or with other medicines to treat Parkinson's disease.

It is also used to treat a condition called Restless Legs Syndrome (RLS). RLS is a neurologic disorder that affects sensation and movement in the legs and causes the legs to feel uncomfortable. This results in an overwhelming feeling of wanting to move your legs to make them comfortable.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ropinirole in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ropinirole in the elderly. However, elderly patients are more likely to have age-related liver problems or to develop hallucinations (seeing, hearing, or feeling things that are not there), which may require caution in patients receiving ropinirole.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ciprofloxacin
  • Kava

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Dyskinesia (trouble controlling your muscles) or
  • Hallucinations or
  • Heart or heart rhythm problems or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure) or
  • Mental illness or
  • Postural hypotension (dizziness, lightheadedness, or fainting when getting up from a lying or sitting position)—Ropinirole may make these conditions worse.
  • Kidney problems—May increase chance of side effects.
  • Liver problems—Higher blood levels of ropinirole may result, and cause an increase in side effects.
  • Lung problems resulting from treatment with some other Parkinson's disease medicines—Ropinirole may cause the condition to recur.
  • Sleep disorders or
  • Sleepiness, history of in the past—May cause side effects to be worse.

Proper Use of This Medicine:

Take this medicine every day exactly as ordered by your doctor in order to improve your condition as much as possible. Do not take more of it or less of it, and do not take it more or less often than your doctor ordered.

Read the Patient Information leaflet before you take this medicine and each time you get your prescription refilled.

This medicine may be taken with or without food, or on an empty or full stomach. Taking this medicine with food may reduce nausea.

Swallow the extended-release tablets whole. Do not split, crush, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For Parkinson's disease:
      • Adults—At first, 2 milligrams (mg) once a day for 1 to 2 weeks. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 24 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For Parkinson's disease:
      • Adults—At first, 0.25 milligrams (mg) three times a day. Your doctor will increase your dose as needed and tolerated. However, the dose is usually not more than 24 mg a day.
      • Children—Use and dose must be determined by your doctor.
    • For Restless Legs Syndrome:
      • Adults—At first, 0.25 mg once a day, 1 to 3 hours before bedtime. Your doctor will increase your dose as needed and tolerated. However, the dose is usually not more than 4 mg a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

People taking ropinirole have reported falling asleep without warning during activities of daily living, including driving, which sometimes resulted in accidents. This may happen as late as one year after taking the medicine. Therefore, make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations may occur in some patients. This is more common with elderly patients. If you have hallucinations, check with your doctor.

Since smoking may decrease the treatment effects of this medicine, it is best to avoid smoking while you are using it. If you have any questions about this, check with your doctor.

It is important that your doctor check your skin for melanoma regularly if you have Parkinson's disease. .

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
drowsiness
falling
nausea
seeing, hearing, or feeling things that are not there (hallucinations)
sleepiness or unusual drowsiness
swelling of legs
twisting, twitching, or other unusual body movements
unusual tiredness or weakness
worsening of parkinsonism
Less common
Abdominal pain
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in urine
blurred vision
burning, pain, or difficulty in urinating
chest pain
chills
cold sweats
cough
double vision or other eye or vision problems
fainting
fear or nervousness
feeling of constant movement of self or surroundings
high or low blood pressure
irregular or pounding heartbeat
loss of memory
mental depression
pain
pain in arms or legs
pounding in the ears
rapid weight gain
sensation of spinning
shortness of breath
slow or fast heartbeat
sore throat
sweating
tightness in chest
tingling of hands or feet
tingling, numbness, or prickly feelings
trouble in concentrating
troubled breathing
unusual weight gain or loss
vomiting
wheezing
Rare
Anxiety
buzzing or ringing in the ears
changes in vision
fever
headache
joint pain
loss of bladder control
muscle cramps, pain, or spasms
nasal congestion
runny nose
sneezing
trouble in swallowing
unusual urges

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Agitation
fatigue
grogginess
increase in unusual body movements, especially of the face or mouth
increased coughing
increased sweating
lack or loss of strength
nightmares

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Abnormal dreams
acid or sour stomach
back pain
belching
decrease in sexual desire or performance
difficulty having a bowel movement (stool)
dryness of mouth
flushing
general feeling of discomfort or illness
heartburn or gas
hot flashes
indigestion
loss of appetite
tremor
weight loss
yawning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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