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Pramipexole / Restless legs syndrome / Placebo / Medicine / Health / Dopamine agonists


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MIRAPEX safely and effectively. See full prescribing information for MIRAPEX. MIRAPEX® (pramipexole dihydrochloride
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Document Date: 2013-03-05 11:22:21


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City

Reference / /

Company

Placebo Group / Boehringer Ingelheim Pharmaceuticals Inc. / /

Event

FDA Phase / Product Issues / Product Recall / /

Facility

Laboratory Tests During / Laboratory Test Interactions *Sections / Laboratory Test Interactions There / /

IndustryTerm

food / treatment of Parkinson’s disease / treatment of the signs and symptoms / otitis media / treatment of  the signs and symptoms / administration site / /

MedicalCondition

epididymitis / photophobia / hepatic neoplasm / periodontitis / Restless Legs Syndrome MIRAPEX / grand mal convulsion / infestations Influenza / leg cramps / dysgraphia / facial palsy / dysarthria / duodenal ulcer / retinal detachment / Nervous System Dizziness / esophagitis / nail infection / Urinary incontinence / Hallucinations / macular degeneration / convulsion / cerebral hemorrhage / nasal polyps / Bursitis / bladder cancer / respiratory alkalosis / chorea / depressed level of consciousness / pulmonary fibrosis / balance disorder / blackouts / Injury / embolism / scotoma / pseudo lymphoma / pulmonary edema / tachycardia / ventricular fibrillation / muscular rigidity / neuroleptic malignant syndrome / diarrhea / hypoacusis / cardiac arrest / otitis media / sinus bradycardia / muscle rigidity / hypoglycemia / esophageal stenosis / supraventricular / atrial fibrillation / flu syndrome / upper respiratory tract infection / asthma / abdominal pain / paralysis / renal cyst / pulmonary infiltrates / hyperreflexia / gingivitis / tooth infection / amaurosis fugax / neoplasm / drug hypersensitivity Infections / urinary disorders / spinal osteoarthritis / chills / Carcinogenesis / hyperglycemia / folliculitis / mania / phlebitis / labyrinth disorders / Fever / hyporeflexia / lethargy / bronchiolitis / vomiting / Parkinson’s disease / myositis / pancreatitis / tooth disorder / osteoporosis / pyelonephritis / supraventricular tachycardia / infection / fungal infection / hypotonia / tonsillitis / ulcerative / duodenal ulcer / benign / basal cell carcinoma / renal failure / hyperkinesia / depression / paresthesia / appendicitis / fasciitis / glaucoma / carpal tunnel syndrome / loss of consciousness / nuchal rigidity / allergic reaction / gallbladder cancer / skin papilloma / Digestive System Nausea / headache / colorectal cancer / Skin disorders / seborrhea / seborrheic dermatitis / cardiac failure / abdominal neoplasm / Nervous System Dyskinesia / sciatica / dermatitis / urinary tract infection / bronchopneumonia / ventricular extrasystoles / nausea / pleurisy / Whole Accidental injury / herpes / alopecia / cardiomegaly / sinus arrhythmia / colon cancer / syncope / productive cough / endometrial cancer / lymphadenopathy / gastritis / vein thrombosis / renal disease / restlessness / sinusitis / vaginal candidiasis / neck pain / Infections / back pain / Influenza / nephrolithiasis / skin hyperpigmentation / pericarditis / sepsis / lacrimation disorders / hypotension / ataxia / intestinal obstruction / arrhythmia / extrasystoles / dyskinesia / extrapyramidal syndrome / squamous cell carcinoma / uterine leiomyoma Nervous system disorders / Urogenital System Impotence / petechiae / supraventricular extrasystoles / disease / gastroenteritis / dyspnea / dermal cyst / familial and genetic disorders / hematuria / brain edema / chronic obstructive pulmonary disease / blepharospasm / vertigo / migraine / delusional disorder / eye irritation / prostatic adenoma / osteoarthritis / oral candidiasis / pain / myocardial infarction / lung cancer / inguinal hernia / advanced Parkinson's disease / diabetes mellitus / thoracic and mediastinal disorders / postural hypotension / livedo reticularis / goiter / idiopathic Parkinson's disease / delirium / connective tissue disorders / tenosynovitis Neoplasms / pathological gambling / cough / thrombosis / diplopia / oral cavity cancer / hiatus hernia / anemia / cataract / furuncle / obsessive-compulsive disorder / respiratory distress / blepharitis / Akathisia / myopia / middle insomnia / bruxism / enteritis / viral infection / multiple myeloma / aphasia / hordeolum / dementia / lymphatic system disorders / hypocalcemia / myopathy / herpes zoster / arteriosclerosis / iron deficiency anemia / coma / skin cancer / psychotic disorder / cellulitis / hemorrhoids / osteomyelitis / pneumothorax / Ear disorders / Cardiovascular System Postural hypotension / Dyskinesia / breast pain / libido disorders / Parkinson's Disease / esophageal spasm / ataxia / dry mouth / gingival infection / leukocytosis / onychomycosis / uterine hemorrhage / vaginal discharge / melanoma / hyponatremia / gout / metrorrhagia / ovarian cyst / drowsiness / gastrointestinal hemorrhage / prostatitis / apnoea syndrome / lymphadenitis / disorder / bradycardia / poisoning / psoriasis / varicose vein / eyelid ptosis / prostate cancer / gastroesophageal reflux disease / vaginal infection / breast cancer / Parkinson's Disease MIRAPEX / shoulder pain / adenocarcinoma / nutrition disorders / polymyalgia / rheumatoid arthritis / keratitis / adenoma / Pneumonia / laryngospasm / lung neoplasm / cystitis / respiratory failure / arthralgia / personality disorder / nasopharyngitis / hemangioma / hepatic neoplasm / aphthous stomatitis / Dysphagia / lymphoma / malignant melanoma / narcolepsy / eczema / oliguria / fecal incontinence / ear pain / melanomas / sexual dysfunction / rosacea / proteinuria / renal artery stenosis / orthostatic hypotension / neuralgia / stupor / sunburn / cognitive disorder / sleep walking / dystonia / dizziness / extrapyramidal syndrome / irritable bowel syndrome / sleep disorders / Symptomatic orthostatic hypotension / pyoderma / hypokalemia / metastases / akinesia / anticholinergic syndrome / rash / breast disorders / atrial septal defect / tinnitus / hypercholesterolemia / fibrosis / eye hemorrhage / cholelithiasis Immune system disorders / choking / gastric cancer / osteonecrosis / orchitis / cholecystitis / Myoclonus / influenza-like illness / chest pain / aneurysm / bundle branch block / cheilitis / parasomnia / leukopenia / chronic lymphocytic leukemia / early Parkinson's disease / thoracic and mediastinal disorders Nasal congestion / bronchitis / tendonitis / subcutaneous tissue disorders / neurogenic bladder / eye infection / myalgia / abdominal pain / muscle spasms / sleep talking / rhinitis / glycosuria / urethritis / motion sickness / hemiplegia / hyperthyroidism / colitis / tremor / conjunctivitis / renal neoplasm / fatigue / angina pectoris / atrioventricular block / deafness / Musculoskeletal System Arthritis / SIADH / laryngitis / tachycardia / pulmonary embolism / oral neoplasm / hypokinesia / constipation / ageusia / pruritus / gastrointestinal neoplasm / reflux esophagitis / dissociation / paronychia / purpura / hallucination / insomnia / priapism / epistaxis / General disorders / thrombophlebitis / intervertebral discitis / Respiratory System Dyspnea / hypertension / accidental injury / acne / skin infection / gastric ulcer / Restless Legs Syndrome / neuroma / ovarian cancer / cerebral infarction / nodal arrhythmia / parosmia / psychomotor hyperactivity / initial insomnia / tooth abscess / amnesia / cerebral ischemia / sinus tachycardia / idiopathic Parkinson’s disease / shock / intervertebral disc disorder / otitis externa / ear infection / cardiovascular disease / disorientation / skin ulcer / skin irritation / ileus / hyperlipidemia / apnea / erythema / RLS / Hypesthesia / Rhabdomyolysis / Digestive System Constipation / dysphonia / dental caries / drug withdrawal syndrome / acute tonsillitis / photosensitivity allergic reaction / toothache / pleural effusion / menorrhagia / eye pain / tooth disease / breast neoplasm / thyroid neoplasm / hyperventilation / lobar pneumonia / pharyngitis / abscess / dehydration / /

MedicalTreatment

dialysis / hemodialysis / /

Organization

FDA / DOSAGE AND ADMINISTRATION / /

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Position

General / prescribing physician / /

Product

pseudo / cimetidine / Disease MIRAPEX / metoclopramide / General Dosing Considerations MIRAPEX / pramipexole dihydrochloride / Cl / Restless Legs Syndrome MIRAPEX / Archos 2 Vision Portable Audio Device / MIRAPEX / Maintenance Treatment MIRAPEX / Clinical Trials MIRAPEX / disease / MIRAPEX tablets / Renal Function / /

Technology

dialysis / Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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