Ropinirole Hydrochloride (Page 4 of 6)

Drug Interactions


P450 Interaction
In vitro metabolism studies showed that CYP1A2 was the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for substrates or inhibitors of this enzyme when coadministered with ropinirole to alter its clearance. Therefore, if therapy with a drug known to be a potent inhibitor of CYP1A2 is stopped or started during treatment with Ropinirole Hydrochloride Tablets, adjustment of the dose of Ropinirole Hydrochloride Tablets may be required.
L-dopa
Co-administration of carbidopa + L-dopa (SINEMET® 10/100 mg twice daily) with ropinirole (2 mg 3 times daily) had no effect on the steady-state pharmacokinetics of ropinirole (n = 28 patients). Oral administration of Ropinirole Hydrochloride Tablets 2 mg 3 times daily increased mean steady state Cmax of L-dopa by 20%, but its AUC was unaffected (n = 23 patients).
Digoxin
Co-administration of Ropinirole Hydrochloride Tablets (2 mg 3 times daily) with digoxin (0.125 to 0.25 mg once daily) did not alter the steady-state pharmacokinetics of digoxin in 10 patients.
Theophylline
Administration of theophylline (300 mg twice daily, a substrate of CYP1A2) did not alter the steady-state pharmacokinetics of ropinirole (2 mg 3 times daily) in 12 patients with Parkinson’s disease. Ropinirole (2 mg 3 times daily) did not alter the pharmacokinetics of theophylline (5 mg/kg IV) in 12 patients with Parkinson’s disease.
Ciprofloxacin
Co-administration of ciprofloxacin (500 mg twice daily), an inhibitor of CYP1A2, with ropinirole (2 mg 3 times daily) increased ropinirole AUC by 84% on average and Cmax by 60% (n = 12 patients).
Estrogens
Population pharmacokinetic analysis revealed that estrogens (mainly ethinyl estradiol: intake 0.6 to 3 mg over 4-month to 23-year period) reduced the oral clearance of ropinirole by 36% in 16 patients. Dosage adjustment may not be needed for Ropinirole Hydrochloride Tablets in patients on estrogen therapy because patients must be carefully titrated with ropinirole to tolerance or adequate effect. However, if estrogen therapy is stopped or started during treatment with Ropinirole Hydrochloride Tablets, then adjustment of the dose of Ropinirole Hydrochloride Tablets may be required.
Dopamine Antagonists
Since ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may diminish the effectiveness of Ropinirole Hydrochloride Tablets. Patients with major psychotic disorders treated with neuroleptics should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Population analysis showed that commonly administered drugs, e.g., selegiline, amantadine, tricyclic antidepressants, benzodiazepines, ibuprofen, thiazides, antihistamines, and anticholinergics, did not affect the oral clearance of ropinirole.

Carcinogenesis, Mutagenesis, Impairment of Fertility


Two-year carcinogenicity studies were conducted in Charles River CD-1 mice at doses of 5, 15, and 50 mg/kg/day and in Sprague-Dawley rats at doses of 1.5, 15, and 50 mg/kg/day (top doses equivalent to 10 and 20 times, respectively, the maximum recommended human dose of 24 mg/day on a mg/m2 basis). In the male rat, there was a significant increase in testicular Leydig cell adenomas at all doses tested, i.e., ≥1.5 mg/kg (0.6 times the maximum recommended human dose on a mg/m2 basis). This finding is of questionable significance because the endocrine mechanisms believed to be involved in the production of Leydig cell hyperplasia and adenomas in rats are not relevant to humans. In the female mouse, there was an increase in benign uterine endometrial polyps at a dose of 50 mg/kg/day (10 times the maximum recommended human dose on a mg/m2 basis).
Ropinirole was not mutagenic or clastogenic in the in vitro Ames test, the in vitro chromosome aberration test in human lymphocytes, the in vitro mouse lymphoma (L1578Y cells) assay, and the in vivo mouse micronucleus test.
When administered to female rats prior to and during mating and throughout pregnancy, ropinirole caused disruption of implantation at doses of 20 mg/kg/day (8 times the maximum recommended human dose on a mg/m2 basis) or greater. This effect is thought to be due to the prolactin-lowering effect of ropinirole. In humans, chorionic gonadotropin, not prolactin, is essential for implantation. In rat studies using low doses (5 mg/kg) during the prolactin-dependent phase of early pregnancy (gestation days 0 to 8), ropinirole did not affect female fertility at dosages up to 100 mg/kg/day (40 times the maximum recommended human dose on a mg/m2 basis). No effect on male fertility was observed in rats at dosages up to 125 mg/kg/day (50 times the maximum recommended human dose on a mg/m2 basis).

Pregnancy

Pregnancy Category C.
In animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. Ropinirole given to pregnant rats during organogenesis (20 mg/kg on gestation days 6 and 7 followed by 20, 60, 90, 120, or 150 mg/kg on gestation days 8 through 15) resulted in decreased fetal body weight at 60 mg/kg/day, increased fetal death at 90 mg/kg/day, and digital malformations at 150 mg/kg/day (24, 36, and 60 times the maximum recommended human dose on a mg/m2 basis, respectively). The combined administration of ropinirole (10 mg/kg/day, 8 times the maximum recommended human dose on a mg/m2 basis) and L-dopa (250 mg/kg/day) to pregnant rabbits during organogenesis produced a greater incidence and severity of fetal malformations (primarily digit defects) than were seen in the offspring of rabbits treated with L-dopa alone. No indication of an effect on development of the conceptus was observed in rabbits when a maternally toxic dose of ropinirole was administered alone (20 mg/kg/day, 16 times the maximum recommended human dose on a mg/m2 basis). In a perinatal-postnatal study in rats, 10 mg/kg/day (4 times the maximum recommended human dose on a mg/m2 basis) of ropinirole impaired growth and development of nursing offspring and altered neurological development of female offspring.
There are no adequate and well-controlled studies using Ropinirole Hydrochloride Tablets in pregnant women. Ropinirole Hydrochloride Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Nursing Mothers


Ropinirole Hydrochloride Tablets inhibit prolactin secretion in humans and could potentially inhibit lactation.
Studies in rats have shown that Ropinirole Hydrochloride Tablets and/or its metabolite(s) is excreted in breast milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Ropinirole Hydrochloride Tablets, 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.

Pediatric Use


Safety and effectiveness in the pediatric population have not been established.

ADVERSE REACTIONS


Parkinson’s Disease
During the premarketing development of Ropinirole Hydrochloride Tablets, patients received Ropinirole Hydrochloride Tablets either without L-dopa (early Parkinson’s disease studies) or as concomitant therapy with L-dopa (advanced Parkinson’s disease studies). Because these 2 populations may have differential risks for various adverse events, this section will, in general, present adverse event data for these 2 populations separately.
Early Parkinson’s Disease (Without L-dopa)
The most commonly observed adverse events (>5%) in the double-blind, placebo-controlled early Parkinson’s disease trials associated with the use of Ropinirole Hydrochloride Tablets (n = 157) not seen at an equivalent frequency among the placebo-treated patients (n = 147) were, in order of decreasing incidence: nausea, dizziness, somnolence, headache, vomiting, syncope, fatigue, dyspepsia, viral infection, constipation, pain, increased sweating, asthenia, dependent/leg edema, orthostatic symptoms, abdominal pain, pharyngitis, confusion, hallucinations, urinary tract infections, and abnormal vision.
Approximately 24% of 157 patients treated with Ropinirole Hydrochloride Tablets who participated in the double-blind, placebo-controlled early Parkinson’s disease (without L-dopa) trials discontinued treatment due to adverse events compared to 13% of 147 patients who received placebo. The adverse events most commonly causing discontinuation of treatment by patients treated with Ropinirole Hydrochloride Tablets were: nausea (6.4%), dizziness (3.8%), aggravated Parkinson’s disease (1.3%), hallucinations (1.3%), somnolence (1.3%), vomiting (1.3%), and headache (1.3%). Of these, hallucinations appear to be dose-related. While other adverse events leading to discontinuation may be dose-related, the titration design utilized in these trials precluded an adequate assessment of the dose response. For example, in the larger of the 2 trials described in CLINICAL PHARMACOLOGY: Clinical Trials , the difference in the rate of discontinuations emerged only after 10 weeks of treatment, suggesting, although not proving, that the effect could be related to dose.
Adverse Event Incidence in Controlled Clinical Studies
Table 2 lists treatment-emergent adverse events that occurred in ≥2% of patients with early Parkinson’s disease (without L-dopa) treated with Ropinirole Hydrochloride Tablets participating in the double-blind, placebo-controlled studies and were numerically more common in the group treated with Ropinirole Hydrochloride Tablets. In these studies, either Ropinirole Hydrochloride Tablets or placebo was used as early therapy (i.e., without L-dopa).
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied.
Table 2. Treatment-Emergent Adverse Event * Incidence in Double-Blind, Placebo-Controlled Early Parkinson’s Disease (Without L-dopa) Trials (Events ≥2% of Patients Treated With Ropinirole Hydrochloride Tablets and Numerically More Frequent Than the Placebo Group)

Adverse Experience Ropinirole Hydrochloride Tablets(n = 157)(%) Placebo(n = 147)(%)
Autonomic nervous system
Flushing 3 1
Dry mouth 5 3
Increased sweating 6 4
Body as a whole
Asthenia 6 1
Chest pain 4 2
Dependent edema 6 3
Leg edema 7 1
Fatigue 11 4
Malaise 3 1
Pain 8 4
Cardiovascular general
Hypertension 5 3
Hypotension 2 0
Orthostatic symptoms 6 5
Syncope 12 1
Central/peripheral nervous system
Dizziness 40 22
Hyperkinesia 2 1
Hypesthesia 4 2
Vertigo 2 0
Gastrointestinal system
Abdominal pain 6 3
Anorexia 4 1
Dyspepsia 10 5
Flatulence 3 1
Nausea 60 22
Vomiting 12 7
Heart rate/rhythm
Extrasystoles 2 1
Atrial fibrillation 2 0
Palpitation 3 2
Tachycardia 2 0
Metabolic/nutritional
Increased alkaline phosphatase 3 1
Psychiatric
Amnesia 3 1
Impaired concentration 2 0
Confusion 5 1
Hallucination 5 1
Somnolence 40 6
Yawning 3 0
Reproductive male
Impotence 3 1
Resistance mechanism
Viral infection 11 3
Respiratory system
Bronchitis 3 1
Dyspnea 3 0
Pharyngitis 6 4
Rhinitis 4 3
Sinusitis 4 3
Urinary system
Urinary tract infection 5 4
Vascular extracardiac
Peripheral ischemia 3 0
Vision
Eye abnormality 3 1
Abnormal vision 6 3
Xerophthalmia 2 0


* Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.
Other events reported by 1% or more of early Parkinson’s disease (without L-dopa) patients treated with Ropinirole Hydrochloride Tablets, but that were equally or more frequent in the placebo group, were: headache, upper respiratory infection, insomnia, arthralgia, tremor, back pain, anxiety, dyskinesias, aggravated Parkinsonism, depression, falls, myalgia, leg cramps, paresthesias, nervousness, diarrhea, arthritis, hot flushes, weight loss, rash, cough, hyperglycemia, muscle spasm, arthrosis, abnormal dreams, dystonia, increased salivation, bradycardia, gout, basal cell carcinoma, gingivitis, hematuria, and rigors.
Among the treatment-emergent adverse events in patients treated with Ropinirole Hydrochloride Tablets, hallucinations appear to be dose-related.
The incidence of adverse events was not materially different between women and men.
Advanced Parkinson’s Disease (With L-dopa) The most commonly observed adverse events (>5%), in the double-blind, placebo-controlled advanced Parkinson’s disease (with L-dopa) trials associated with the use of Ropinirole Hydrochloride Tablets (n = 208) as an adjunct to L-dopa not seen at an equivalent frequency among the placebo-treated patients (n = 120) were, in order of decreasing incidence: dyskinesias, nausea, dizziness, aggravated Parkinsonism, somnolence, headache, insomnia, injury, hallucinations, falls, abdominal pain, upper respiratory infection, confusion, increased sweating, vomiting, viral infection, increased drug level, arthralgia, tremor, anxiety, urinary tract infection, constipation, dry mouth, pain, hypokinesia, and paresthesia.
Approximately 24% of 208 patients who received Ropinirole Hydrochloride Tablets in the double-blind, placebo-controlled advanced Parkinson’s disease (with L-dopa) trials discontinued treatment due to adverse events compared to 18% of 120 patients who received placebo. The events most commonly (≥1%) causing discontinuation of treatment by patients treated with Ropinirole Hydrochloride Tablets were: dizziness (2.9%), dyskinesias (2.4%), vomiting (2.4%), confusion (2.4%), nausea (1.9%), hallucinations (1.9%), anxiety (1.9%), and increased sweating (1.4%). Of these, hallucinations and dyskinesias appear to be dose-related.
Adverse Event Incidence in Controlled Clinical Studies

Table 3 lists treatment-emergent adverse events that occurred in ≥2% of patients with advanced Parkinson’s disease (with L-dopa) treated with Ropinirole Hydrochloride Tablets who participated in the double-blind, placebo-controlled studies and were numerically more common in the group treated with Ropinirole Hydrochloride Tablets. In these studies, either Ropinirole Hydrochloride Tablets or placebo was used as an adjunct to L-dopa. Adverse events were usually mild or moderate in intensity.
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse events incidence rate in the population studied.Table 3. Treatment-Emergent Adverse Event* Incidence in Double-Blind, Placebo-Controlled Advanced Parkinson’s Disease (With L-dopa) Trials (Events ≥2% of Patients Treated With Ropinirole Hydrochloride Tablets and Numerically More Frequent Than the Placebo Group)

Adverse Experience Ropinirole Hydrochloride Tablets(n = 208)(%) Placebo(n = 120)(%)
Autonomic nervous system
Dry mouth 5 1
Increased sweating 7 2
Body as a whole
Increased drug level 7 3
Pain 5 3
Cardiovascular general
Hypotension 2 1
Syncope 3 2
Central/peripheral nervous system
Dizziness 26 16
Dyskinesia 34 13
Falls 10 7
Headache 17 12
Hypokinesia 5 4
Paresis 3 0
Paresthesia 5 3
Tremor 6 3
Gastrointestinal system
Abdominal pain 9 8
Constipation 6 3
Diarrhea 5 3
Dysphagia 2 1
Flatulence 2 1
Nausea 30 18
Increased saliva 2 1
Vomiting 7 4
Metabolic/nutritional
Weight decrease 2 1
Musculoskeletal system
Arthralgia 7 5
Arthritis 3 1
Psychiatric
Amnesia 5 1
Anxiety 6 3
Confusion 9 2
Abnormal dreaming 3 2
Hallucinations 10 4
Nervousness 5 3
Somnolence 20 8
Red blood cell
Anemia 2 0
Resistance mechanism
Upper respiratory tract infection 9 8
Respiratory system
Dyspnea 3 2
Urinary system
Pyuria 2 1
Urinary incontinence 2 1
Urinary tract infection 6 3
Vision
Diplopia 2 1


* Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.
Other events reported by 1% or more of patients treated with both Ropinirole Hydrochloride Tablets and L-dopa, but equally or more frequent in the placebo/L-dopa group, were: myocardial infarction, orthostatic symptoms, virus infections, asthenia, dyspepsia, myalgia, back pain, depression, leg cramps, fatigue, rhinitis, chest pain, hematuria, vertigo, tinnitus, leg edema, hot flushes, abnormal gait, hyperkinesia, and pharyngitis.
Among the treatment-emergent adverse events in patients treated with Ropinirole Hydrochloride Tablets, hallucinations and dyskinesias appear to be dose-related.
Restless Legs Syndrome
The most commonly observed adverse events (>5%) in the 12-week double-blind, placebo-controlled trials in the treatment of Restless Legs Syndrome with Ropinirole Hydrochloride Tablets (n = 496) and at least twice the rate for placebo-treated patients (n = 500) were, in order of decreasing incidence: nausea, somnolence, vomiting, dizziness, and fatigue (see Table 4). Occurrences of nausea in clinical trials were generally mild to moderate in intensity (see also DOSAGE AND ADMINISTRATION: General Dosing Considerations).
Approximately 5% of 496 patients treated with Ropinirole Hydrochloride Tablets who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse events compared to 4% of 500 patients who received placebo. The adverse events most commonly causing discontinuation of treatment by patients treated with Ropinirole Hydrochloride Tablets were: nausea (1.6%), dizziness (0.8 %), and headache (0.8%).
Adverse Event Incidence in Controlled Clinical Studies

Table 4 lists treatment-emergent adverse events that occurred in ≥2% of patients with RLS treated with Ropinirole Hydrochloride Tablets participating in the 12-week double-blind, placebo-controlled studies and were numerically more common in the group treated with Ropinirole Hydrochloride Tablets.
The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied.
Table 4. Treatment-Emergent Adverse Event Incidence in Double-Blind, Placebo-Controlled RLS Trials (Events ≥2% of Patients Treated With Ropinirole Hydrochloride Tablets and Numerically More Frequent Than the Placebo Group)

Adverse Experience Ropinirole Hydrochloride Tablets(n = 496)(%) Placebo(n =500)(%)
Ear and labyrinth disorders
Vertigo 2 1
Gastrointestinal disorders
Nausea 40 8
Vomiting 11 2
Diarrhea 5 3
Dyspepsia 4 3
Dry mouth 3 2
Abdominal pain upper 3 1
General disorders and administration site conditions
Fatigue 8 4
Edema peripheral 2 1
Infections and infestations
Nasopharyngitis 9 8
Influenza 3 2
Musculoskeletal and connective tissue disorders
Arthralgia 4 3
Muscle cramps 3 2
Pain in extremity 3 2
Nervous system disorders
Somnolence 12 6
Dizziness 11 5
Paresthesia 3 1
Respiratory, thoracic, and mediastinal disorders
Cough 3 2
Nasal congestion 2 1
Skin and subcutaneous tissue disorders
Hyperhidrosis 3 1


Other events reported by 2% or more of patients treated with Ropinirole Hydrochloride Tablets, but equally or more frequent in the placebo group, were headache, insomnia, restless legs syndrome, upper respiratory tract infection, back pain, and sinusitis.
Other Adverse Events Observed During All Phase 2/3 Clinical Trials for Parkinson’s Disease
Ropinirole Hydrochloride Tablets have been administered to 1,599 individuals in clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 1,599 individuals exposed to Ropinirole Hydrochloride Tablets who experienced events of the type cited on at least 1 occasion while receiving Ropinirole Hydrochloride Tablets. All reported events that occurred at least twice (or once for serious or potentially serious events), except those already listed above, trivial events, and terms too vague to be meaningful, are included without regard to determination of a causal relationship to Ropinirole Hydrochloride Tablets, except that events very unlikely to be drug-related have been deleted.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients and infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare events are those occurring in fewer than 1/1,000 patients.
Body as a Whole
Infrequent: Cellulitis, peripheral edema, fever, influenza-like symptoms, enlarged abdomen, precordial chest pain, and generalized edema. Rare: Ascites.
Cardiovascular
Infrequent: Cardiac failure, bradycardia, tachycardia, supraventricular tachycardia, angina pectoris, bundle branch block, cardiac arrest, cardiomegaly, aneurysm, mitral insufficiency. Rare: Ventricular tachycardia.
Central/Peripheral Nervous System
Frequent: Neuralgia. Infrequent: Involuntary muscle contractions, hypertonia, dysphonia, abnormal coordination, extrapyramidal disorder, migraine, choreoathetosis, coma, stupor, aphasia, convulsions, hypotonia, peripheral neuropathy, paralysis. Rare: Grand mal convulsions, hemiparesis, hemiplegia.
Endocrine
Infrequent: Hypothyroidism, gynecomastia, hyperthyroidism. Rare: Goiter, SIADH.
Gastrointestinal
Infrequent: Increased hepatic enzymes, bilirubinemia, cholecystitis, cholelithiasis colitis, dysphagia, periodontitis, fecal incontinence, gastroesophageal reflux, hemorrhoids, toothache, eructation, gastritis, esophagitis, hiccups, diverticulitis, duodenal ulcer, gastric ulcer, melena, duodenitis, gastrointestinal hemorrhage, glossitis, rectal hemorrhage, pancreatitis, stomatitis and ulcerative stomatitis, tongue edema. Rare: Biliary pain, hemorrhagic gastritis, hematemesis, salivary duct obstruction.
Hematologic
Infrequent: Purpura, thrombocytopenia, hematoma, Vitamin B12 deficiency, hypochromic anemia, eosinophilia, leukocytosis, leukopenia, lymphocytosis, lymphopenia, lymphedema.
Metabolic/Nutritional
Frequent: Increased BUN. Infrequent: Hypoglycemia, increased alkaline phosphatase, increased LDH, weight increase, hyperphosphatemia, hyperuricemia, diabetes mellitus, glycosuria, hypokalemia, hypercholesterolemia, hyperkalemia, acidosis, hyponatremia, thirst, increased CPK, dehydration. Rare: Hypochloremia.
Musculoskeletal
Infrequent: Aggravated arthritis, tendonitis, osteoporosis, bursitis, polymyalgia rheumatica, muscle weakness, skeletal pain, torticollis. Rare: Dupuytren’s contracture requiring surgery.
Neoplasm
Infrequent: Malignant breast neoplasm. Rare: Bladder carcinoma, benign brain neoplasm, esophageal carcinoma, malignant laryngeal neoplasm, lipoma, rectal carcinoma, uterine neoplasm.
Psychiatric
Infrequent: Increased libido, agitation, apathy, impaired concentration, depersonalization, paranoid reaction, personality disorder, euphoria, delirium, dementia, delusion, emotional lability, decreased libido, manic reaction, somnambulism, aggressive reaction, neurosis. Rare: Suicide attempt.
Genitourinary
Infrequent: Amenorrhea, vaginal hemorrhage, penile disorder, prostatic disorder, balanoposthitis, epididymitis, perineal pain, dysuria, micturition frequency, albuminuria, nocturia, polyuria, renal calculus. Rare: Breast enlargement, mastitis, uterine hemorrhage, ejaculation disorder, Peyronie’s disease, pyelonephritis, acute renal failure, uremia.
Resistance Mechanism
Infrequent: Herpes zoster, otitis media, sepsis, abscess, herpes simplex, fungal infection, genital moniliasis.
Respiratory
Infrequent: Asthma, epistaxis, laryngitis, pleurisy, pulmonary edema.
Skin/Appendage
Infrequent: Pruritus, dermatitis, eczema, skin ulceration, alopecia, skin hypertrophy, skin discoloration, urticaria, fungal dermatitis, furunculosis, hyperkeratosis, photosensitivity reaction, psoriasis, maculopapular rash, psoriaform rash, seborrhea.
Special Senses
Infrequent: Tinnitus, earache, decreased hearing, abnormal lacrimation, conjunctivitis, blepharitis, glaucoma, abnormal accommodation, blepharospasm, eye pain, photophobia. Rare: Scotoma.
Vascular Extracardiac
Infrequent: Varicose veins, phlebitis, peripheral gangrene. Rare : Limb embolism, pulmonary embolism, gangrene, subarachnoid hemorrhage, deep thrombophlebitis, leg thrombophlebitis, thrombosis.
Falling Asleep During Activities of Daily Living
Patients treated with Ropinirole Hydrochloride Tablets have reported falling asleep while engaged in activities of daily living, including operation of a motor vehicle which sometimes resulted in accidents (see bolded WARNING).
Other Adverse Events Observed During Phase 2/3 Clinical Trials for RLS
Ropinirole Hydrochloride Tablets has been administered to 911 individuals in clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using MedDRA dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 911 individuals exposed to Ropinirole Hydrochloride Tablets who experienced events of the type cited on at least one occasion while receiving Ropinirole Hydrochloride Tablets. All reported events that occurred at least twice (or once for serious or potentially serious events), except those already listed, trivial events, and terms too vague to be meaningful, are included without regard to determination of a causal relationship to Ropinirole Hydrochloride Tablets, except that events very unlikely to be drug-related have been deleted.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients and infrequent adverse events are those occurring in 1/100 to 1/1,000 patients.
Blood and Lymphatic System Disorders
Infrequent: Anemia, lymphadenopathy.
Cardiac Disorders
Frequent: Palpitations. Infrequent: Acute coronary syndrome, angina pectoris, angina unstable, bradycardia, cardiac failure, cardiovascular disorder, coronary artery disease, myocardial infarction, sick sinus syndrome, tachycardia.
Congenital, Familial, and Genetic Disorders
Infrequent: Pigmented nevus.
Ear and Labyrinth Disorders
Infrequent: Ear pain, middle ear effusion, tinnitus.
Endocrine Disorders
Infrequent: Goiter, hypothyroidism.
Eye Disorders
Infrequent: Blepharitis, conjunctival hemorrhage, conjunctivitis, eye irritation, eye pain, keratoconjunctivitis sicca, vision blurred, visual acuity reduced, visual disturbance.
Gastrointestinal Disorders
Frequent: Abdominal pain, constipation, gastroesophageal reflux disease, stomach discomfort, toothache. Infrequent: Abdominal adhesions, abdominal discomfort, abdominal distension, abdominal pain lower, duodenal ulcer, dysphagia, eructation, flatulence, gastric disorder, gastric hemorrhage, gastric polyps, gastric ulcer, gastritis, gastrointestinal pain, hematemesis, hemorrhoids, hiatus hernia, intestinal obstruction, irritable bowel syndrome, loose stools, mouth ulceration, pancreatitis acute, peptic ulcer, rectal hemorrhage, reflux esophagitis.
General Disorders and Administration Site Conditions
Frequent: Asthenia, chest pain, influenza-like illness, rigors. Infrequent: Chest discomfort, feeling cold, feeling hot, hunger, lethargy, malaise, edema, pain, pyrexia.
Hepatobiliary Disorders
Infrequent: Cholecystitis, cholelithiasis, ischemic hepatitis.
Immune System Disorders
Infrequent: Hypersensitivity.
Infections and Infestations
Frequent: Bronchitis, gastroenteritis, gastroenteritis viral, lower respiratory tract infection, rhinitis, tooth abscess, urinary tract infection. Infrequent: Appendicitis, bacterial infection, bladder infection, bronchitis acute, candidiasis, cellulitis, cystitis, diarrhea infectious, diverticulitis, ear infection, folliculitis, fungal infection, gastrointestinal infection, herpes simplex, infected cyst, laryngitis, localized infection, mastitis, otitis externa, otitis media, pharyngitis, pneumonia, postoperative infection, respiratory tract infection, tonsillitis, tooth infection, vaginal candidiasis, vaginal infection, vaginal mycosis, viral infection, viral upper respiratory tract infection, wound infection.
Injury, Poisoning, and Procedural Complications
Infrequent: Concussion, lower limb fracture, post procedural hemorrhage, road traffic accident.
Investigations
Infrequent: Blood cholesterol increased, blood iron decreased, blood pressure increased, blood urine present, hemoglobin decreased, heart rate increased, protein urine present, weight decreased, weight increased.
Metabolism and Nutrition Disorders
Infrequent: Anorexia, decreased appetite, diabetes mellitus non-insulin-dependent, fluid retention, gout, hypercholesterolemia.
Musculoskeletal and Connective Tissue Disorders
Frequent: Muscle spasms, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, tendonitis. Infrequent: Arthritis, aseptic necrosis bone, bone pain, bone spur, bursitis, groin pain, intervertebral disc degeneration, intervertebral disc protrusion, joint stiffness, joint swelling, localized osteoarthritis, monoarthritis, muscle contracture, muscle tightness, muscle twitching, osteoporosis, rotator cuff syndrome, sacroiliitis, synovitis.
Neoplasms Benign, Malignant, and Unspecified
Infrequent: Anaplastic thyroid cancer, angiomyolipoma, basal cell carcinoma, breast cancer, gastric cancer, gastrointestinal stromal tumor, malignant melanoma, prostate cancer, skin papilloma, squamous cell carcinoma, uterine leiomyoma.
Nervous System Disorders
Frequent: Hypoesthesia, migraine. Infrequent: Amnesia, aphasia, ataxia, balance disorder, benign intracranial hypertension, burning sensation, carpal tunnel syndrome, disturbance in attention, dizziness postural, dysgeusia, dyskinesia, head discomfort, hyperesthesia, hypersomnia, lethargy, loss of consciousness, memory impairment, migraine with aura, migraine without aura, neuralgia, sciatica, sedation, sinus headache, sleep apnea syndrome, syncope vasovagal, tension headache, transient ischemic attack, tremor.
Psychiatric Disorders
Frequent: Anxiety, depression, irritability, sleep disorder. Infrequent: Abnormal dreams, agitation, bruxism, confusional state, depressed mood, disorientation, early morning awakening, libido decreased, loss of libido, mood swings, nervousness, nightmare, panic attack, stress symptoms, tension.
Renal and Urinary Disorders
Infrequent: Dysuria, hematuria, hypertonic bladder, micturition disorder, nephrolithiasis, nocturia, pollakiuria, proteinuria, urinary retention.
Reproductive System and Breast Disorders
Frequent: Erectile dysfunction. Infrequent: Breast cyst, dysmenorrhea, menorrhagia, pelvic peritoneal adhesions, postmenopausal hemorrhage, premenstrual syndrome, prostatitis.
Respiratory, Thoracic and Mediastinal Disorders
Frequent: Asthma, pharyngolaryngeal pain. Infrequent: Dry throat, dyspnea, epistaxis, hemoptysis, hoarseness, interstitial lung disease, nasal mucosal disorder, nasal polyps, respiratory tract congestion, rhinorrhea, sinus congestion, sneezing, wheezing, yawning.
Skin and Subcutaneous Tissue Disorders
Frequent: Night sweats, rash. Infrequent: Acne, actinic keratosis, alopecia, cold sweat, dermatitis, dermatitis allergic, dermatitis contact, eczema, exanthem, face edema, photosensitivity reaction, pruritus, psoriasis, rash pruritic, skin lesion, urticaria.
Vascular Disorders
Frequent: Hot flush, hypertension, hypotension. Infrequent: Atherosclerosis, circulatory collapse, flushing, hematoma, thrombosis, varicose vein.

Postmarketing Reports
Psychiatric Disorders: Impulse control symptoms, pathological gambling, increased libido including hypersexuality.

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