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ropinirole hcl er 8 mg tablet generic requip xl

Out of Stock Manufacturer ACTAVIS/TEVA 00228366003
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Uses

Parkinsonian Syndrome

Ropinirole hydrochloride is used for the symptomatic management of idiopathic parkinsonian syndrome.

Dopamine receptor agonists (bromocriptine mesylate, pramipexole dihydrochloride, pergolide mesylate, ropinirole hydrochloride) are used as adjuncts to levodopa for the symptomatic management of parkinsonian syndrome in patients with advanced disease. Dopamine receptor agonists also are used as monotherapy for the initial symptomatic management of parkinsonian syndrome. Levodopa currently is the most effective drug for relieving the symptoms of parkinsonian syndrome and traditionally has been considered the drug of choice for the initial symptomatic management of idiopathic parkinsonian syndrome. However, long-term administration of levodopa is associated with motor complications. One strategy to reduce the risk of motor complications and to improve long-term outcome is to initiate symptomatic therapy with a dopamine receptor agonist and to add levodopa as supplemental therapy when dopamine receptor agonist monotherapy no longer provides adequate symptom control. However, clinical studies evaluating this strategy are limited both in number and duration, and it remains to be determined whether initiating therapy with a dopamine receptor agonist rather than levodopa results in a more favorable long-term outcome. Factors to consider when choosing an agent for the initial symptomatic management of idiopathic parkinsonian syndrome include patient age, cognitive status, disease severity, and cost. Most clinicians would use levodopa for initial therapy in individuals older than 70 years of age (since these individuals are less likely than younger individuals to develop levodopa-related motor complications and because of concerns about cognitive dysfunction), in patients with cognitive impairment, and in those with severe disease. A dopamine receptor agonist may be preferred for initial therapy in patients 70 years of age or younger.

Efficacy of ropinirole for the management of parkinsonian syndrome has been established in several placebo-controlled studies of up to 6 months' duration in patients with early (approximately 2 years' duration) parkinsonian syndrome receiving no concomitant levodopa therapy, and in patients with advanced parkinsonian syndrome who were receiving levodopa therapy concomitantly. In these studies, improvement in manifestations of parkinsonian syndrome was assessed principally using the Unified Parkinson's Disease Rating Scale (UPDRS), a 4-part rating scale intended to evaluate mentation, activities of daily living, motor performance, and complications of therapy.

Ropinirole appears to improve activities of daily living as well as motor manifestations of parkinsonian syndrome, such as tremor, rigidity, bradykinesia, and postural stability. In clinical studies in patients with early parkinsonian syndrome, ropinirole was more effective than placebo in reducing the severity of symptoms associated with this disorder. In a study in patients with early parkinsonian syndrome, clinical response (defined as improvement of at least 30% in UPDRS motor score) occurred in 71% of patients receiving ropinirole (mean daily dosage: 7.4 mg) compared with 41% of patients receiving placebo for 12 weeks. In addition, improvement from baseline in the UPDRS motor score averaged 43% in ropinirole-treated patients versus 21% with placebo. In this study, concomitant therapy with amantadine, selegiline, or anticholinergic drugs, but not levodopa or other dopamine receptor agonists, was allowed. In another placebo-controlled study in patients with early parkinsonian syndrome, 47% of patients receiving ropinirole (mean daily dosage: 15.7 mg on an intent-to-treat basis) responded to therapy (defined as improvement of at least 30% in UPDRS motor score) compared with 20% of those receiving placebo; average UPDRS motor score improved by 22-24% with ropinirole therapy and worsened by 3-4% in the placebo group. In this study, addition of levodopa therapy for symptomatic relief was required in 29% of patients treated with placebo versus 11% of those receiving ropinirole.

In placebo-controlled clinical studies in patients with advanced parkinsonian syndrome who were receiving concomitant levodopa therapy, ropinirole reduced the severity of symptoms associated with this disorder and allowed a reduction in levodopa dosage. In patients with advanced parkinsonian syndrome who were experiencing ''on-off'' phenomena (i.e., a deteriorating response to levodopa therapy), ropinirole was more effective than placebo in reducing ''off'' time. In a study in patients with advanced (mean disease duration: 9 years) parkinsonian syndrome, average daily ''off'' time was reduced from a baseline value of 6.4 hours to 4.9 hours following 6 months of therapy with ropinirole, while ''off'' time with placebo averaged 7.3 hours at baseline and 6.4 hours after 6 months. In another study in patients with advanced parkinsonian syndrome not optimally controlled with levodopa therapy, ''off'' time was reduced by at least 30% in 65 versus 39% of patients (on an intent-to-treat basis) treated with ropinirole versus placebo, respectively, for 12 weeks.

A preliminary report of a long-term (approximately 3 years' duration), comparative study in patients with early parkinsonian syndrome receiving ropinirole or bromocriptine (with supplemental levodopa therapy in some patients) indicated clinically important improvements in UPDRS motor score and activities of daily living (ADL) score with either therapy, although functional status (as measured by the ADL score) was more improved in ropinirole-treated patients at the end of the study. Further study is required to establish safety and efficacy of ropinirole during long-term administration and to determine the long-term effect of the drug on disability in parkinsonian syndrome.

Patients receiving a dopamine receptor agonist (e.g., pramipexole, ropinirole) have reported falling asleep while engaged in activities of daily living, including business meetings, telephone calls, and operating a motor vehicle, which occasionally resulted in accidents. Although many of these patients reported somnolence while receiving pramipexole or ropinirole, some perceived no warning signs (e.g., excessive drowsiness) and believed that they were alert immediately prior to the event. Some of these events have been reported as late as 1 year after initiation of therapy with the drug.

Many experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. Therefore, it is recommended that clinicians continually reassess patients for drowsiness or sleepiness especially since some incidents of sudden sleep onset occurred well after the start of dopamine receptor agonist therapy. Clinicians also should be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about such adverse effects during specific activities. In addition, patients should be asked about any factors that may increase the risk of somnolence during ropinirole therapy (e.g., concomitant sedating drugs, the presence of sleep disorders [other than restless legs syndrome], concomitant drugs that increase ropinirole plasma concentrations [e.g., ciprofloxacin]). If a patient develops clinically important daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating), ropinirole generally should be discontinued. If a decision is made to continue the drug, patients should be advised not to drive and to avoid other potentially dangerous activities. The manufacturers state that there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Patients should be informed that hallucinations can occur with ropinirole therapy; geriatric patients are at increased risk for this adverse effect. Patients also should be advised that ropinirole may cause somnolence and that they should not drive a car or operate other complex machinery until they have gained sufficient experience with the drug to determine whether it has adverse effects on their mental and/or motor performance. In addition, the possibility of additive sedative effects should be considered in patients receiving other CNS depressants concomitantly with ropinirole.

Restless Legs Syndrome

Ropinirole is used for the symptomatic management of moderate-to-severe primary restless legs syndrome (Ekbom syndrome). Restless legs syndrome is a sensorimotor disorder characterized by a distressing urge to move the legs accompanied by sensations deep in the limbs that have been described as twitching, pulling, and sometimes painful. These symptoms are present at rest, especially in the evening and at night, and are relieved by movement. Some clinicians consider a dopamine receptor agonist (e.g., ropinirole) the drug of choice for patients with symptoms that occur nightly.

Efficacy of ropinirole for this indication has been established in 3 randomized, placebo-controlled studies in patients with moderate-to-severe restless legs syndrome (score of at least 15 on the International Restless Legs Syndrome [IRLS] scale and a history of symptoms of restless legs syndrome on at least 15 nights per month). Patients were excluded from these studies if they had restless legs syndrome associated with end-stage renal failure, anemia, or pregnancy. Ropinirole was initiated at a dosage of 0.25 mg once daily (given 1-3 hours before bedtime) and increased over 7 weeks to a maximum dosage of 4 mg once daily; the average dosage after 7 weeks of therapy was 2 mg once daily. The primary end point of these studies was the mean change in IRLS score from baseline to week 12. The Clinical Global Impression-Global Improvement (CGI-I) scale was used to assess general improvement. At week 12, the mean improvement in IRLS score in patients receiving ropinirole was greater than that in patients receiving placebo. In addition, 73.3, 53.4, and 59.5% of patients receiving ropinirole in the 3 studies were described as responders (defined as being much improved or very much improved) on the CGI-I scale compared with 56.5, 40.9, and 39.6%, respectively, of patients receiving placebo. Ropinirole therapy was associated with greater improvement in sleep and quality-of-life scores than placebo. Improvement was observed in ropinirole-treated patients as early as week 1. Efficacy has been maintained over 36 weeks in patients who continued to receive ropinirole.

Use of dopamine receptor agonists in patients with restless legs syndrome can result in end-of-dose rebound (i.e., worsening of symptoms in the early morning hours). Long-term use of dopamine receptor agonists in patients with restless legs syndrome has been associated with augmentation of the symptoms of restless legs syndrome; augmentation can take the form of onset of symptoms earlier in the day, increase in symptoms, or extension of symptoms from the legs to the arms or trunk. Because patients with rebound restless legs syndrome or augmentation were excluded from clinical studies that evaluated efficacy of ropinirole and the duration of these studies was not long enough to evaluate the incidence of these events, the incidence and appropriate management of rebound and/or augmentation in patients receiving long-term therapy with ropinirole have not been evaluated in controlled clinical studies.

The reported incidence of somnolence is lower in patients receiving ropinirole for restless legs syndrome (12%) than in those receiving the drug for parkinsonian syndrome (up to 40%).(See Uses: Parkinsonian Syndrome.)

Dosage and Administration

Administration

Ropinirole hydrochloride is administered orally. For the management of parkinsonian syndrome, ropinirole is administered in 3 equally divided doses daily. For the management of restless legs syndrome, ropinirole is administered once daily, 1-3 hours before bedtime. Ropinirole may be administered without regard to meals. Patients in whom ropinirole causes nausea should be advised that taking the drug with food may reduce the occurrence of this adverse effect. If the patient skips a dose of ropinirole, a double dose should not be taken to make up for the missed dose.

Dispensing and Administration Precautions

The US Food and Drug Administration (FDA) alerted healthcare professionals and patients of medication error reports in which patients were given risperidone (Risperdal), an antipsychotic agent, instead of ropinirole hydrochloride (Requip) and vice versa. As of June 2011, the FDA had evaluated 226 wrong drug medication errors associated with confusion between these 2 drugs; all of the reports involved tablet formulations of the drugs. Several of these cases resulted in adverse effects (including confusion, lethargy, ataxia, hallucinations, tiredness, dizziness, tingling, numbness, and altered mental status) and some of the patients who took the wrong drug required hospitalization. The FDA has determined that the factors contributing to the confusion between these 2 products include similarities in both the trade (brand) and generic (nonproprietary) names, similarities in the container labels and carton packaging, illegible handwriting on the prescriptions, and overlapping product characteristics (such as drug strengths, dosage forms, and dosing intervals). It is also possible that the 2 products may be stocked close to one another on pharmacy shelves whether they are alphabetized by brand or generic name. In addition, some generic manufacturers make both products. Healthcare professionals are therefore reminded to clearly print out or spell out the drug name on prescriptions and to make sure their patients know the name of their prescribed drug and the reason they are taking it.

Dosage

The manufacturers state that the safety and efficacy of ropinirole hydrochloride in pediatric patients have not been established.

Dosage of ropinirole hydrochloride is expressed in terms of ropinirole.

Because the dosage of ropinirole is titrated to clinical response, routine dosage adjustment based solely on age is not necessary in geriatric adults.

If ropinirole therapy is interrupted for a substantial period of time, retitration of therapy, beginning at the usual recommended initial dosage, may be warranted.

Parkinsonian Syndrome

For the management of parkinsonian syndrome, therapy with ropinirole is initiated at a low dosage and increased slowly until the maximum therapeutic response is achieved. The usual initial dosage of ropinirole is 0.25 mg 3 times daily (total of 0.75 mg daily) the first week, then 0.5 mg 3 times daily (total of 1.5 mg daily) the second week, 0.75 mg 3 times daily (total of 2.25 mg daily) the third week, and 1 mg 3 times daily (total of 3 mg daily) the fourth week. After the fourth week, the daily dosage may be increased by 1.5 mg daily each week up to 9 mg daily, and then by up to 3 mg daily each week to a total daily dosage of 24 mg. Dosages exceeding 24 mg daily have not been evaluated in clinical trials. As with other dopamine agonists, the dosage of ropinirole must be reevaluated and adjusted according to the needs of the patient in a constant effort to find a dosage schedule that provides maximum relief of symptoms with minimum adverse effects.

In clinical studies in patients with parkinsonian syndrome, ropinirole 0.25-8 mg daily in 3 equally divided doses has been effective and well tolerated when administered with or without concomitant levodopa therapy. Since concomitant therapy with ropinirole and levodopa may result in additive therapeutic and/or adverse (e.g., dyskinesia) effects, a reduction in levodopa dosage should be considered when ropinirole is added to levodopa therapy. In a controlled study in patients with advanced parkinsonian syndrome, the dosage of levodopa initially was reduced by an average of 31% from baseline with concomitant ropinirole therapy.

Although not reported in clinical trials with ropinirole, a symptom complex resembling neuroleptic malignant syndrome (e.g., NMS; elevated temperature, muscular rigidity, altered consciousness, autonomic instability) has been reported in association with rapid dosage reduction of, withdrawal of, or changes in antiparkinsonian therapy. The manufacturers recommend that in patients with parkinsonian syndrome, discontinuance of ropinirole therapy take place gradually over a period of 1 week. Frequency of administration of ropinirole should be reduced from 3 times daily to twice daily for 4 days, then to once daily for the next 3 days, before complete discontinuance of the drug. In clinical trials in patients with restless legs syndrome, ropinirole, given at dosages of up to 4 mg once daily, was discontinued without a taper.

Use of dopamine agonists in patients with parkinsonian syndrome ordinarily requires careful monitoring for manifestations of orthostatic hypotension, especially during dosage escalation, since these drugs appear to impair systemic regulation of blood pressure. Syncope, sometimes associated with bradycardia, has been reported in clinical trials of ropinirole in patients with early (without concomitant levodopa) or advanced (with concomitant levodopa) parkinsonian syndrome; these episodes generally occurred more than 4 weeks after initiation of therapy and in association with a recent increase in ropinirole dosage. Patients with parkinsonian syndrome generally have a reduced capacity to respond to an orthostatic challenge; therefore, the manufacturers state that patients should be cautioned about rising rapidly after sitting or lying down, especially if they have been in a seated or recumbent position for prolonged periods and/or if they are just beginning ropinirole therapy.

Restless Legs Syndrome

For the management of restless legs syndrome, therapy with ropinirole is initiated at a low dosage and increased slowly until the maximum therapeutic response is achieved. The usual initial dosage of ropinirole is 0.25 mg daily for 2 days, then 0.5 mg once daily for 5 days (days 3-7), and then 1 mg daily for 1 week (week 2). After the second week, the daily dosage may be increased by 0.5 mg daily each week up to a dosage of 3 mg daily at week 6, with a final increase to 4 mg daily at week 7.

Dosage in Renal and Hepatic Impairment

Adjustment in ropinirole dosage is not necessary in patients with creatinine clearances of 30-50 mL/minute. The use of ropinirole has not been evaluated in patients with severe renal impairment or in those undergoing hemodialysis, and the manufacturers currently make no specific recommendation for dosage adjustment in such patients. However, because of the large apparent volume of distribution (7.5 L/kg) of ropinirole, removal of substantial amounts of the drug by hemodialysis is unlikely.

Clearance of ropinirole may be reduced, and plasma ropinirole concentrations increased, in patients with hepatic impairment. The manufacturers state that the drug should be used with caution in patients with hepatic impairment but make no specific recommendations for dosage adjustment in such patients.

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