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Requip (Ropinirole Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Parkinson's Disease

REQUIP is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

The effectiveness of REQUIP was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).

Restless Legs Syndrome

REQUIP is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.

DOSAGE AND ADMINISTRATION

General Dosing Considerations for Parkinson's Disease and RLS

REQUIP can be taken with or without food. Patients may be advised that taking REQUIP with food may reduce the occurrence of nausea. However, this has not been established in controlled clinical trials.

If a significant interruption in therapy with REQUIP has occurred, retitration of therapy may be warranted.

Geriatric Use

Pharmacokinetic studies demonstrated a reduced clearance of ropinirole in the elderly (see CLINICAL PHARMACOLOGY). Dose adjustment is not necessary since the dose is individually titrated to clinical response.

Renal Impairment

The pharmacokinetics of ropinirole were not altered in patients with moderate renal impairment (see CLINICAL PHARMACOLOGY). Therefore, no dosage adjustment is necessary in patients with moderate renal impairment. The use of REQUIP in patients with severe renal impairment has not been studied.

Hepatic Impairment

The pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. Since patients with hepatic impairment may have higher plasma levels and lower clearance, REQUIP should be titrated with caution in these patients.

Dosing for Parkinson's Disease

In all clinical studies, dosage was initiated at a subtherapeutic level and gradually titrated to therapeutic response. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of nausea, dizziness, somnolence, and dyskinesia.

The recommended starting dose for Parkinson's disease is 0.25mg 3 times daily. Based on individual patient response, dosage should then be titrated with weekly increments as described in Table5. After week 4, if necessary, daily dosage may be increased by 1.5mg/day on a weekly basis up to a dose of 9mg/day, and then by up to 3mg/day weekly to a total dose of 24mg/day. Doses greater than 24mg/day have not been tested in clinical trials.

Table 5. Ascending-Dose Schedule of REQUIP for Parkinson's Disease

Week

Dosage

Total Daily Dose

1

0.25mg 3 times daily

0.75mg

2

0.5mg 3 times daily

1.5mg

3

0.75mg 3 times daily

2.25mg

4

1mg 3 times daily

3mg

When REQUIP is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. L-dopa dosage reduction was allowed during the advanced Parkinson's disease (with L-dopa) study if dyskinesias or other dopaminergic effects occurred. Overall, reduction of L-dopa dose was sustained in 87% of patients treated with REQUIP and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with REQUIP.

REQUIP for Parkinson's disease patients should be discontinued gradually over a 7-day period. The frequency of administration should be reduced from 3 times daily to twice daily for 4days. For the remaining 3days, the frequency should be reduced to once daily prior to complete withdrawal of REQUIP.

Dosing for Restless Legs Syndrome

In all clinical trials, the dose for REQUIP was initiated at 0.25mg once daily, 1 to 3 hours before bedtime. Patients were titrated based on clinical response and tolerability.

The recommended adult starting dosage for RLS is 0.25mg once daily, 1 to 3 hours before bedtime. After 2days, the dosage can be increased to 0.5mg once daily and to 1mg once daily at the end of the first week of dosing, then as shown in Table6 as needed to achieve efficacy. For RLS, the safety and effectiveness of doses greater than 4mg once daily have not been established.

Table 6. Dose Titration Schedule for RLS

Day/Week

Dosage to be taken once daily, 1 to 3 hours before bedtime

Days 1 and 2

0.25 mg

Days 3-7

0.5 mg

Week 2

1 mg

Week 3

1.5 mg

Week 4

2 mg

Week 5

2.5 mg

Week 6

3 mg

Week 7

4 mg

In clinical trials of patients being treated for RLS with doses up to 4mg once daily, REQUIP was discontinued without a taper.

HOW SUPPLIED

Tablets

Each pentagonal film-coated TILTAB® tablet with beveled edges contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:

0.25mg: white tablets imprinted with "SB" and "4890" in bottles of 100 (NDC 0007-4890-20).

0.5mg: yellow tablets imprinted with "SB" and "4891" in bottles of 100 (NDC 0007-4891-20).

1 mg: green tablets imprinted with "SB" and "4892" in bottles of 100 (NDC 0007-4892-20).

2mg: pale yellowish-pink tablets imprinted with "SB" and "4893" in bottles of 100 (NDC 0007-4893-20).

3mg: pale to moderate reddish-purple tablets, imprinted with "SB" and“4895” in bottles of 100 (NDC 0007-4895-20).

4mg: pale brown tablets imprinted with "SB" and "4896" in bottles of 100 (NDC 0007-4896-20).

5mg: blue tablets imprinted with "SB" and "4894" in bottles of 100 (NDC 0007-4894-20).

STORAGE: Protect from light and moisture. Close container tightly after each use.

Store at controlled room temperature 20-25C (68-77F) [see USP].

GlaxoSmithKline

Research Triangle Park, NC 27709

REQUIP and TILTAB are registered trademarks of GlaxoSmithKline.

SINEMET is a registered trademark of Merck & Co., Inc.

2009, GlaxoSmithKline. All rights reserved.

May 2009

REP:3PI

PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

REQUIP ® (ropinirole tablets)

Read this information completely before you start taking REQUIP. Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about REQUIP. It does not include everything there is to know about your medicine. This information should not take the place of discussions with your doctor about your medical condition or REQUIP.

What is REQUIP?

REQUIP is a prescription medicine to treat moderate-to-severe primary Restless Legs Syndrome. It is sometimes used to treat Parkinson's disease. Having one of these conditions does not mean you have or will develop the other.

What is the most important information I should know about REQUIP?

  • Patients with RLS should take REQUIP differently than patients with Parkinson's disease (see How should I take REQUIP for RLS? for therecommended dosing for RLS).A lower dose of REQUIP is generally needed for patients with RLS, and is taken once daily before bedtime.
  • There are known side effects of REQUIP. If you fall asleep or feel very sleepy while doing normal activities such as driving, faint, feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, you should talk with your doctor (see What are the possible side effects of REQUIP?).
  • Before starting REQUIP, be sure to tell your doctor if you are taking any medicines that make you drowsy.

Unusual urges: Some patients taking REQUIP or REQUIP XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.

Who should not take REQUIP?

You should not take REQUIP if you are allergic to the active ingredient ropinirole or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients.

What should I tell my doctor?

Be sure to tell your doctor if:

  • you are pregnant or plan to become pregnant.
  • you are breastfeeding.
  • you have daytime sleepiness from a sleep disorder other than RLS or have unexpected sleepiness or periods of sleep while taking REQUIP.
  • you are taking any other prescription or over-the-counter medicines. Some of these medicines may increase your chances of getting side effects while taking REQUIP.
  • you start or stop taking other medicines while you are taking REQUIP. This may increase your chances of getting side effects.
  • you start or stop smoking while you are taking REQUIP. Smoking may decrease the treatment effect of REQUIP.
  • you feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
  • you drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking REQUIP.

How should I take REQUIP for RLS?

  • Be sure to take REQUIP exactly as directed by your doctor or healthcare provider.
  • The usual way to take REQUIP is once in the evening, 1 to 3 hours before bedtime.
  • Your doctor will start you on a low dose of REQUIP. Your doctor may change the dose until you are taking the amount of medicine that is right for you to control your symptoms.
  • If you miss your dose, do not double your next dose. Take only your usual dose 1 to 3 hours before your next bedtime.
  • Contact your doctor, if you stop taking REQUIP for any reason. Do not restart without consulting your doctor.
  • You can take REQUIP with or without food. Taking REQUIP with food may decrease the chances of feeling nauseated.

What are the possible side effects of REQUIP?

  • Most people who take REQUIP tolerate it well. The most commonly reported side effects in people taking REQUIP for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You should be careful until you know if REQUIP affects your ability to remain alert while doing normal daily activities, and you should watch for the development of significant daytime sleepiness or episodes of falling asleep. It is possible that you could fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking REQUIP. Your chances of falling asleep while doing normal activities while taking REQUIP are greater if you are taking other medicines that cause drowsiness.
  • When you start taking REQUIP or when you increase your dose, you may feel dizzy, nauseated, sweaty or faint, when first standing up from sitting or lying down. Therefore, do not stand up quickly after sitting or lying down, particularly if you have been sitting or lying down for a long period of time. Take a minute sitting on the edge of the bed or chair before you get up.
  • Hallucinations (unreal sounds, visions, or sensations) have been reported in patients taking REQUIP. These were uncommon in patients taking REQUIP for RLS. The risk is greater in patients with Parkinson's disease who are elderly, taking REQUIP with L-dopa, or taking higher doses of REQUIP than recommended for RLS.

Some patients taking REQUIP get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.

This is not a complete list of side effects and should not take the place of discussions with your healthcare providers. Your doctor or pharmacist can give you a more complete list of possible side effects.

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

Other Information about REQUIP

  • Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the medicines used to treat Parkinson's disease. REQUIP is one of the medicines used to treat Parkinson's disease, therefore, patients being treated with REQUIP should have periodic skin examinations.
  • Take REQUIP exactly as your doctor prescribes it.
  • Do not share REQUIP with other people, even if they have the same symptoms you have.
  • Keep REQUIP out of the reach of children.
  • Store REQUIP at room temperature out of direct sunlight.
  • Keep REQUIP in a tightly closed container.

This leaflet summarizes important information about REQUIP. Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take REQUIP for a condition for which it was not prescribed. For more information, talk with your doctor or pharmacist. They can give you information about REQUIP that is written for healthcare professionals.

PATIENT INFORMATION

REQUIP ® (ropinirole tablets)

If you have Parkinson's disease, read this side

Read this information completely before you start taking REQUIP. Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about REQUIP. It does not include everything there is to know about your medicine. This information should not take the place of discussions with your doctor about your medical condition or REQUIP.

What is REQUIP?

REQUIP is a prescription medicine used to treat Parkinson's disease. It is also used to treat moderate-to-severe primary Restless Legs Syndrome. Having one of these conditions does not mean you have or will develop the other.

What is the most important information I should know about REQUIP?

  • Patients with Parkinson's disease should take REQUIP differently than patients with Restless Legs Syndrome (see How should I take REQUIP for Parkinson's disease?). For Parkinson's disease, a higher dose of REQUIP is generally needed, and is taken more frequently throughout the day.
  • There are known side effects of REQUIP (see What are the possible side effects of REQUIP?).
  • If you fall asleep or feel very sleepy while doing normal activities such as driving, faint, feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, you should talk with your doctor.
  • Hallucinations (unreal visions, sounds, or sensations) have been reported in patients taking REQUIP. The risk is greater in patients with Parkinson's disease who are elderly, taking REQUIP with L-dopa or taking higher doses of REQUIP. If these occur, you should discuss them with your doctor.
  • REQUIP may make some of the side effects of L-dopa worse. REQUIP may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. You should notify your doctor in such a case as dosage adjustments to your anti-Parkinson's medications may be necessary.
  • Before starting REQUIP, be sure to tell your doctor if you are taking any medicines that make you drowsy.

Unusual urges: Some patients taking REQUIP or REQUIP XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.

Who should not take REQUIP?

You should not take REQUIP if you are allergic to the active ingredient ropinirole or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients.

What should I tell my doctor?

Be sure to tell your doctor if:

  • you are pregnant or plan to become pregnant.
  • you are breastfeeding.
  • you have daytime sleepiness from a sleep disorder or have unexpected sleepiness or periods of sleep while taking REQUIP.
  • you are taking any other prescription or over-the-counter medicines. Some of these medicines may increase your chances of getting side effects while taking REQUIP.
  • you start or stop taking other medicines while you are taking REQUIP. This may increase your chances of getting side effects.
  • you start or stop smoking while you are taking REQUIP. Smoking may decrease the treatment effect of REQUIP.
  • you feel dizzy, nauseated, sweaty, or faint when you first stand up from sitting or lying down.
  • you drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking REQUIP.

How should I take REQUIP for Parkinson's disease?

  • Be sure to take your REQUIP exactly as directed by your doctor or healthcare provider.
  • Three times a day is the usual way to take REQUIP for Parkinson's disease.
  • Your doctor will start you on a low dose of REQUIP. Your doctor will change the dose until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach a dose that controls your symptoms.
  • If you miss a dose, do not double your next dose.
  • Contact your doctor, if you stop taking REQUIP for any reason. Do not restart without consulting your doctor.
  • Your doctor may prescribe REQUIP alone or add REQUIP to medicine that you are already taking for Parkinson's disease.
  • You can take REQUIP with or without food. Taking REQUIP with food may decrease the chances of feeling nauseated.

What are the possible side effects of REQUIP?

  • Most people who take REQUIP tolerate it well. The most commonly reported side effects in people taking REQUIP are nausea, headache, dizziness, drowsiness or sleepiness.
  • You should be careful until you know if REQUIP affects your ability to remain alert while doing normal daily activities, and you should watch for the development of significant daytime sleepiness or episodes of falling asleep. It is possible that you could fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking REQUIP. Your chances of falling asleep while doing normal activities while taking REQUIP are greater if you are taking other medicines that cause drowsiness.
  • When you start taking REQUIP or when you increase your dose, you may feel dizzy, nauseated, sweaty or faint, when first standing up from sitting or lying down. Therefore, do not stand up quickly after sitting or lying down, particularly if you have been sitting or lying down for a long period of time. Take a minute sitting on the edge of the bed or chair before you get up.
  • Hallucinations (unreal visions, sounds, or sensations) have been reported in patients taking REQUIP. The risk is greater in patients with Parkinson's disease who are elderly, taking REQUIP with L-dopa, or taking higher amounts of REQUIP.
  • If you are taking L-dopa for Parkinson's disease, REQUIP may make some of the side effects of L-dopa worse. REQUIP may cause uncontrolled sudden movements or make such movements you already have worse or more frequent.

Some patients taking REQUIP get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.

This is not a complete list of side effects and should not take the place of discussions with your healthcare providers. Your doctor or pharmacist can give you a more complete list of possible side effects.

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

Other Information about REQUIP

  • Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the medicines used to treat Parkinson's disease, therefore, patients being treated with REQUIP should have periodic skin examinations.
  • Take REQUIP exactly as your doctor prescribes it.
  • Do not share REQUIP with other people, even if they have the same symptoms you have.
  • Keep REQUIP out of the reach of children.
  • Store REQUIP at room temperature out of direct sunlight.
  • Keep REQUIP in a tightly closed container.

This leaflet summarizes important information about REQUIP. Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take REQUIP for a condition for which it was not prescribed. For more information, talk with your doctor or pharmacist. They can give you information about REQUIP that is written for healthcare professionals.

GlaxoSmithKline

Research Triangle Park, NC 27709

2009, GlaxoSmithKline. All rights reserved.

April 2009

REP:2PIL

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