Ropinirole Hydrochloride (Page 7 of 9)

14.2 Restless Legs Syndrome

The effectiveness of ropinirole hydrochloride in the treatment of RLS was demonstrated in randomized, double-blind, placebo-controlled trials in adults diagnosed with RLS using the International Restless Legs Syndrome Study Group diagnostic criteria. Patients were required to have a history of a minimum of 15 RLS episodes/month during the previous month and a total score of ≥15 on the International RLS Rating Scale (IRLS scale) at baseline. Patients with RLS secondary to other conditions (e.g., pregnancy, renal failure, anemia) were excluded. All trials employed flexible dosing, with patients initiating therapy at 0.25 mg ropinirole once daily. Patients were titrated based on clinical response and tolerability over 7 weeks to a maximum of 4 mg once daily. All doses were taken between 1 and 3 hours before bedtime.

A variety of measures were used to assess the effects of treatment, including the IRLS scale and Clinical Global Impression-Global Improvement (CGI-I) scores. The IRLS scale contains 10 items designed to assess the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood associated with RLS. The range of scores is 0 to 40, with 0 being absence of RLS symptoms and 40 the most severe symptoms. Three of the controlled trials utilized the change from baseline in the IRLS scale at the Week 12 endpoint as the primary efficacy outcome.

Three hundred eighty patients were randomized to receive ropinirole hydrochloride (n = 187) or placebo (n = 193) in a US trial (RLS-1); 284 were randomized to receive either ropinirole hydrochloride (n = 146) or placebo (n = 138) in a multinational trial (excluding US) (RLS-2); and 267 patients were randomized to ropinirole hydrochloride (n = 131) or placebo (n = 136) in a multinational trial (including US) (RLS-3). Across the three trials, the mean duration of RLS was 16 to 22 years (range: 0 to 65 years), mean age was approximately 54 years (range: 18 to 79 years), and approximately 61% were women. The mean dose at Week 12 was approximately 2 mg/day for the three trials.

At baseline, mean total IRLS score was 22.0 for ropinirole hydrochloride and 21.6 for placebo in RLS-1, was 24.4 for ropinirole hydrochloride and 25.2 for placebo in RLS-2, and was 23.6 for ropinirole hydrochloride and 24.8 for placebo in RLS-3. In all three trials, a statistically significant difference between the treatment group receiving ropinirole hydrochloride and the treatment group receiving placebo was observed at Week 12 for both the mean change from baseline in the IRLS scale total score and the percentage of patients rated as responders (much improved or very much improved) on the CGI-I (see Table 9).

Table 9. Mean Change in Total IRLS Score and Percent Responders on CGI-I

Ropinirole Hydrochloride

Placebo

Difference from Placebo

Mean change in total IRLS score at Week 12

RLS-1

-13.5

-9.8

-3.7

RLS-2

-11.0

-8.0

-3.0

RLS-3

-11.2

-8.7

-2.5

Percent responders on CGI-I at Week 12

RLS-1

73.3%

56.5%

16.8%

RLS-2

53.4%

40.9%

12.5%

RLS-3

59.5%

39.6%

19.9%

Long-term maintenance of efficacy in the treatment of RLS was demonstrated in a 36-week trial. Following a 24-week, single-blind treatment phase (flexible dosages of ropinirole of 0.25 to 4 mg once daily), patients who were responders (defined as a decrease of >6 points on the IRLS scale total score relative to baseline) were randomized in double-blind fashion to placebo or continuation of ropinirole hydrochloride for an additional 12 weeks. Relapse was defined as an increase of at least 6 points on the IRLS scale total score to a total score of at least 15, or withdrawal due to lack of efficacy. For patients who were responders at Week 24, the mean dose of ropinirole was 2 mg (range: 0.25 to 4 mg). Patients continued on ropinirole hydrochloride demonstrated a significantly lower relapse rate compared with patients randomized to placebo (32.6% versus 57.8%, P = 0.0156).

16 HOW SUPPLIED/STORAGE AND HANDLING

Each round biconvex film-coated ropinirole tablet, USP, contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:

0.25 mg: white tablets debossed “972” on one side and “HH” on the other side
Bottles of 90 – NDC 51655-360-26
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Dosing Instructions

Instruct patients to take ropinirole tablets only as prescribed. If a dose is missed, advise patients not to double their next dose. Ropinirole tablets can be taken with or without food [see Dosage and Administration ( 2.1)] .

Ropinirole is the active ingredient in ropinirole tablets. Ask your patients if they are taking another medication containing ropinirole.

Hypersensitivity/Allergic Reactions

Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions to immediately contact their healthcare professional [see Contraindications ( 4)] .

Falling Asleep during Activities of Daily Living and Somnolence

Alert patients to the potential sedating effects caused by ropinirole tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with ropinirole tablets to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.

Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with ropinirole tablets or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole [see Warnings and Precautions ( 5.1)] .

Syncope and Hypotension/Orthostatic Hypotension

Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking ropinirole tablets, especially if they are elderly. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Postural/orthostatic symptoms may be related to sitting up or standing. Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with ropinirole tablets [see Warnings and Precautions ( 5.2, 5.3)] .

Hallucinations/Psychotic-like Behavior

Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations), and that other psychotic-like behavior can occur while taking ropinirole tablets. The elderly are at greater risk than younger patients with Parkinson’s disease. This risk is greater in patients who are taking ropinirole tablets with L-dopa or taking higher doses of ropinirole tablets and may also be further increased in patients taking any other drugs that increase dopaminergic tone. Tell patients to report hallucinations or psychotic-like behavior to their healthcare provider promptly should they develop [see Warnings and Precautions ( 5.4)].

Dyskinesia

Inform patients that ropinirole tablets may cause and/or exacerbate pre-existing dyskinesias [see Warnings and Precautions ( 5.5)] .

Impulse Control/Compulsive Behaviors

Advise patients that they may experience impulse control and/or compulsive behaviors while taking one or more of the medications (including ropinirole tablets) that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with ropinirole tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ropinirole tablets [see Warnings and Precautions ( 5.6)] .

Withdrawal-emergent Hyperpyrexia and Confusion

Advise patients to contact their healthcare provider if they wish to discontinue ropinirole tablets or decrease the dose of ropinirole tablets [see Warnings and Precautions ( 5.7)] .

Melanoma

Advise patients with Parkinson’s disease that they have a higher risk of developing melanoma. Advise patients to have their skin examined on a regular basis by a qualified healthcare provider (e.g., dermatologist) when using ropinirole tablets for any indication [see Warnings and Precautions ( 5.8)] .

Augmentation and Rebound

Inform patients with RLS that augmentation and/or rebound may occur after starting treatment with ropinirole tablets [see Warnings and Precautions ( 5.9)] .

Nursing Mothers

Because of the possibility that ropinirole may be excreted in breast milk, 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 [see Use in Specific Populations ( 8.3)] . Advise patients that ropinirole tablets could inhibit lactation because ropinirole inhibits prolactin secretion .

Pregnancy

Because ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects, in animals, and because experience in humans is limited, advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations ( 8.1)] .

See separately provided patient information sheet.

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare U. S., LLC Cranbury, NJ 08512, USA

Revised: 11/2015

07255-05

PATIENT INFORMATION

Ropinirole tablets (roe pin’ i role”), USP

If you have Parkinson’s disease, read this side.

If you have Restless Legs Syndrome (RLS), read the other side.

Important Note: Ropinirole extended-release tablets have not been studied in Restless Legs Syndrome (RLS) and are not approved for the treatment of RLS. However, an immediate-release form of ropinirole is approved for the treatment of moderate to severe primary RLS (see other side of this leaflet).

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

What is the most important information I should know about ropinirole tablets?

Ropinirole tablets can cause serious side effects, including:

  • Hypersensitivity/allergic reactions. You may experience a hypersensitivity/allergic reaction characterized by hives, rash, itching, and/or swelling of the face, lips, mouth, tongue, or throat, which may cause problems in swallowing or breathing. If you experience any of these reactions , you should not take ropinirole tablets again until you talk to a healthcare provider and seek their advice.
  • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole tablets. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking ropinirole tablets are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting ropinirole tablets, be sure to tell your healthcare provider if you take any medicines that make you drowsy.
  • Fainting. Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking ropinirole tablets or your dose is increased. Tell your healthcare provider if you faint or feel dizzy or light-headed.
  • Decrease in blood pressure. Ropinirole tablets can decrease your blood pressure. Decreases in your blood pressure (hypotension) can happen, especially when you start taking ropinirole tablets or when your dose is changed. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down (orthostatic hypotension), this may mean that your blood pressure is decreased. When you change position from lying down or sitting to standing up, you should do it carefully and slowly. Call your healthcare provider if you have any of the symptoms of decreased blood pressure listed above.
  • Changes in heart rate (decrease or increase). Ropinirole tablets can decrease or increase your heart rate.
  • Hallucinations and other psychotic-like behavior. Ropinirole tablets can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. The chances of having hallucinations or these other psychotic-like changes are higher in people with Parkinson’s disease who are taking ropinirole tablets or taking higher doses of these drugs. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider.
  • Uncontrolled sudden movements. Ropinirole tablets may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your healthcare provider if this happens. The doses of your anti-Parkinson’s medicine may need to be changed.
  • Unusual urges. Some patients taking ropinirole tablets get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble, increased sexual urges and behaviors, or an uncontrollable urge to shop, spend money, or eat. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.
  • Increased chance of skin cancer (melanoma). People with Parkinson’s disease may have a higher chance of getting melanoma. It is not known if ropinirole tablets increase your chances of getting melanoma. You and your healthcare provider should check your skin on a regular basis. Tell your healthcare provider right away if you notice any changes in your skin such as a change in the size, shape, or color of moles on your skin.

What are ropinirole tablets?

  • Ropinirole tablets are a short-acting prescription medicine containing ropinirole (usually taken 3 times a day) that is used to treat Parkinson’s disease. It is also used to treat a condition called Restless Legs Syndrome (RLS).

Having one of these conditions does not mean you have or will develop the other condition.

You should not be taking more than 1 medicine containing ropinirole. Tell your healthcare provider if you are taking any other medicine containing ropinirole.

It is not known if ropinirole tablets are safe and effective for use in children younger than 18 years of age.

Who should not take ropinirole tablets?

Do not take ropinirole tablets if you:

  • are allergic to ropinirole or any of the ingredients in ropinirole tablets. See the end of this page for a complete list of the ingredients in ropinirole tablets.

Call your healthcare provider and get help right away if you have any of the following symptoms of an allergic reaction. Symptoms of an allergic reaction may include:

  • hives
  • rash
  • swelling of the face, lips, mouth, tongue, or throat
  • itching

What should I tell my healthcare provider before taking ropinirole tablets?

Before you take ropinirole tablets, tell your healthcare provider if you:

  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • are taking any other prescription or over-the-counter medicines. Some of these medicines may increase your chances of getting side effects while taking ropinirole tablets.
  • start or stop taking other medicines while you are taking ropinirole tablets. This may increase your chances of getting side effects.
  • start or stop smoking while you are taking ropinirole tablets. Smoking may decrease the treatment effect of ropinirole tablets.
  • feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
  • drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking ropinirole tablets.
  • have high or low blood pressure.
  • have or have had heart problems.
  • are pregnant or plan to become pregnant. Ropinirole tablets should only be used during pregnancy if needed.
  • are breastfeeding. It is not known if ropinirole hydrochloride passes into your breast milk. Talk to your healthcare provider to decide whether you will breastfeed or take ropinirole tablets.
  • have any other medical conditions.

How should I take ropinirole tablets for Parkinson’s disease?

  • Take ropinirole tablets exactly as directed by your healthcare provider.
  • Do not suddenly stop taking ropinirole tablets without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness.
  • Before starting ropinirole tablets, you should talk to your healthcare provider about what to do if you miss a dose. If you have missed the previous dose and it is time for your next dose, do not double the dose.
  • Your healthcare provider will start you on a low dose of ropinirole tablets. Your healthcare provider 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 are taking ropinirole tablets:

  • Ropinirole tablets are usually taken 3 times a day for Parkinson’s disease.
  • Contact your healthcare provider if you stop taking ropinirole tablets for any reason. Do not restart without talking with your healthcare provider.
  • Your healthcare provider may prescribe ropinirole tablets alone, or add ropinirole tablets to medicine that you are already taking for Parkinson’s disease.
  • You should not substitute ropinirole tablets for ropinirole extended-release tablets, or ropinirole extended-release tablets for ropinirole tablets without talking with your healthcare provider.
  • You can take ropinirole tablets with or without food.

What are the possible side effects of ropinirole tablets?

Ropinirole tablets can cause serious side effects, including:

  • See “What is the most important information I should know about ropinirole tablets?”

The most common side effects of ropinirole tablets include:

  • fainting
  • sleepiness or drowsiness
  • hallucinations (seeing or hearing things that are not real)
  • dizziness
  • nausea or vomiting
  • uncontrolled sudden movements
  • leg swelling
  • fatigue, tiredness, or weakness
  • confusion
  • headache
  • upset stomach, abdominal pain or discomfort
  • increased sweating

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

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

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

How should I store ropinirole tablets?

  • Store ropinirole tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ropinirole tablets in a tightly closed container and out of direct sunlight.

Keep ropinirole tablets and all medicines out of the reach of children.

General information about the safe and effective use of ropinirole tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take ropinirole tablets for a condition for which it was not prescribed. Do not give ropinirole tablets to other people, even if they have the same symptoms you have. It may harm them.

This side of the patient information leaflet summarizes the most important information about ropinirole tablets for Parkinsons disease. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ropinirole tablets that is written for healthcare professionals. For more information call 1-866-257-2597.

What are the ingredients in ropinirole tablets?

The following ingredients are in ropinirole tablets:

Active ingredient: ropinirole (as ropinirole hydrochloride)

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below:

Strength

Inactive ingredients of the film coat

0.25 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and lecithin (soya).

0.5 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and iron oxide yellow.

1 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and iron oxide yellow.

2 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, lecithin (soya) and iron oxide red.

3 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, carmine and FD&C Blue No. 1 aluminum lake.

4 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, iron oxide yellow and iron oxide red.

5 mg

polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and lecithin (soya).

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare U. S., LLC Cranbury, NJ 08512, USA

Revised: 11/2015

07256-05

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