Ropinirole Hydrochloride (Page 3 of 6)

PRECAUTIONS

General


Dyskinesia
Ropinirole Hydrochloride Tablets may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate preexisting dyskinesia in patients treated with L-dopa for Parkinson’s disease. Decreasing the dose of L-dopa may ameliorate this side effect.
Renal Impairment
No dosage adjustment is needed in patients with mild to moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The use of Ropinirole Hydrochloride Tablets 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, Ropinirole Hydrochloride Tablets should be titrated with caution in these patients.
Events Reported With Dopaminergic Therapy

Withdrawal-Emergent Hyperpyrexia and Confusion
Although not reported with Ropinirole Hydrochloride Tablets, a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in anti-Parkinsonian therapy.

Fibrotic Complications
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when the drug is discontinued, complete resolution does not always occur.
Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot-derived dopamine agonists can cause them is unknown.
A small number of reports have been received of possible fibrotic complications, including pleural effusion, pleural fibrosis, interstitial lung disease, and cardiac valvulopathy, in the development program and postmarketing experience for Ropinirole Hydrochloride Tablets. While the evidence is not sufficient to establish a causal relationship between Ropinirole Hydrochloride Tablets and these fibrotic complications, a contribution of Ropinirole Hydrochloride Tablets cannot be completely ruled out in rare cases.

Melanoma
Epidemiologic studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear.
For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using Ropinirole Hydrochloride Tablets for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
Augmentation and Rebound in RLS
Reports in the literature indicate treatment of RLS with dopaminergic medications can result in a worsening of symptoms in the early morning hours, referred to as rebound. Augmentation has also been described during therapy for RLS. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities. The controlled trials of Ropinirole Hydrochloride Tablets in patients with RLS excluded patients with augmentation and rebound and were generally not of sufficient duration to capture these phenomena. The frequency of augmentation and/or rebound after longer use of Ropinirole Hydrochloride Tablets and the appropriate management of these events, have not been evaluated in controlled clinical trials.
Retinal Pathology

Albino Rats
Retinal degeneration was observed in albino rats in the 2-year carcinogenicity study at all doses tested (equivalent to 0.6 to 20 times the maximum recommended human dose on a mg/m2 basis), but was statistically significant at the highest dose (50 mg/kg/day). Additional studies to further evaluate the specific pathology (e.g., loss of photoreceptor cells) have not been performed. Similar changes were not observed in a 2-year carcinogenicity study in albino mice or in rats or monkeys treated for 1 year. The potential significance of this effect in humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (e.g., disk shedding) may be involved.
Human
In order to evaluate the effect of Ropinirole Hydrochloride Tablets in humans, ocular electroretinogram (ERG) assessments were conducted during a 2-year, double-blind, multicenter, flexible dose, L-dopa controlled clinical study of Ropinirole Hydrochloride Tablets in patients with Parkinson’s disease. A total of 156 patients (78 on ropinirole, mean dose 11.9 mg/day and 78 on L-dopa, mean dose 555.2 mg/day) were evaluated for evidence of retinal dysfunction through electroretinograms. There was no clinically meaningful difference between the treatment groups in retinal function over the duration of the study.

Binding to Melanin
Ropinirole Hydrochloride binds to melanin-containing tissues (i.e., eyes, skin) in pigmented rats. After a single dose, long-term retention of drug was demonstrated, with a half-life in the eye of 20 days. It is not known if Ropinirole Hydrochloride accumulates in these tissues over time.

Information for Patients


Physicians should instruct their patients to read the Patient Information leaflet before starting therapy with Ropinirole Hydrochloride Tablets and to reread it upon prescription renewal for new information regarding the use of Ropinirole Hydrochloride Tablets.
Patients should be instructed to take Ropinirole Hydrochloride Tablets only as prescribed. If a dose is missed, patients should be advised not to double their next dose.
Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets with food may reduce the occurrence of nausea. However, this has not been established in controlled clinical trials.
Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. 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). Accordingly, patients should be cautioned against rising 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 Hydrochloride Tablets.
Patients should be alerted to the potential sedating effects associated with Ropinirole Hydrochloride Tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with Ropinirole Hydrochloride Tablets to gauge whether or not it affects their mental and/or motor performance adversely. Patients should be advised that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.
Because of possible additive effects, caution should be advised when patients are taking other sedating medications or alcohol in combination with Ropinirole Hydrochloride Tablets and when taking concomitant medications that increase plasma levels of ropinirole (e.g., ciprofloxacin).
Because of the possible additive sedative effects, caution should also be used when patients are taking alcohol or other CNS depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with Ropinirole Hydrochloride Tablets.
Patients should be informed they may experience hallucinations (unreal visions, sounds, or sensations) while taking Ropinirole Hydrochloride Tablets. These were uncommon in patients taking Ropinirole Hydrochloride Tablets for Restless Legs Syndrome. The risk is greater in patients with Parkinson’s disease; the elderly are at greater risk than younger patients with Parkinson’s disease; and the risk is greater in patients who are taking Ropinirole Hydrochloride Tablets with L-dopa, or taking higher doses of Ropinirole Hydrochloride Tablets.
Impulse Control Symptoms Including Compulsive Behaviors: There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease, including Ropinirole Hydrochloride Tablets. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Ropinirole Hydrochloride Tablets. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Ropinirole Hydrochloride Tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Ropinirole Hydrochloride Tablets.
Because of the possibility that ropinirole may be excreted in breast milk, patients should be advised to notify their physicians if they intend to breastfeed or are breastfeeding an infant.
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, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS: Pregnancy).

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