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Requip

SIDE EFFECTS

Parkinson's Disease

During the premarketing development of REQUIP (ropinirole hcl) , patients received REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) (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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) participating in the double-blind, placebo-controlled studies and were numerically more common in the group treated with REQUIP (ropinirole hcl) . In these studies, either REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) and Numerically More Frequent Than the Placebo Group)

Adverse Experience REQUIP (ropinirole hcl)
(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 REQUIP (ropinirole hcl) , 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 REQUIP (ropinirole hcl) , 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 REQUIP (ropinirole hcl) (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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) who participated in the double-blind, placebo-controlled studies and were numerically more common in the group treated with REQUIP (ropinirole hcl) . In these studies, either REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) and Numerically More Frequent Than the Placebo Group)

Adverse Experience REQUIP (ropinirole hcl)
(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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) , 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 REQUIP (ropinirole hcl) (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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) participating in the 12-week double-blind, placebo-controlled studies and were numerically more common in the group treated with REQUIP (ropinirole hcl) .

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 REQUIP (ropinirole hcl) and Numerically More Frequent Than the Placebo Group)

Adverse Experience REQUIP (ropinirole hcl)
(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 REQUIP (ropinirole hcl) , 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

REQUIP (ropinirole hcl) has 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 REQUIP (ropinirole hcl) who experienced events of the type cited on at least 1 occasion while receiving REQUIP (ropinirole hcl) . 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 REQUIP (ropinirole hcl) , 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 REQUIP (ropinirole hcl) 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

REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) who experienced events of the type cited on at least one occasion while receiving REQUIP (ropinirole hcl) . 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 REQUIP (ropinirole hcl) , 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

The following adverse events (not listed above in clinical trials or other sections of the prescribing information) have been identified during postapproval use of ropinirole. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune Systems Disorders: Hypersensitivity reactions (including urticaria, angioedema, rash, and pruritus).

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

Drug Abuse And Dependence

Controlled Substance Class

REQUIP (ropinirole hcl) is not a controlled substance.

Physical and Psychological Dependence

Animal studies and human clinical trials with REQUIP (ropinirole hcl) did not reveal any potential for drug-seeking behavior or physical dependence.

Read the Requip (ropinirole hcl) Side Effects Center for a complete guide to possible side effects

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 REQUIP (ropinirole hcl) , adjustment of the dose of REQUIP (ropinirole hcl) may be required.

L-dopa

Coadministration 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 REQUIP (ropinirole hcl) 2 mg 3 times daily increased mean steady state C max of L-dopa by 20%, but its AUC was unaffected (n = 23 patients).

Digoxin

Coadministration of REQUIP (ropinirole hcl) (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

Coadministration 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 C max by 60% (n = 12 patients).

Estrogens

Population pharmacokinetic analysis revealed that estrogens (mainly ethinylestradiol: 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 REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) , then adjustment of the dose of REQUIP (ropinirole hcl) 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 REQUIP (ropinirole hcl) . 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.

Last reviewed on RxList: 11/30/2010
This monograph has been modified to include the generic and brand name in many instances.

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