| Document Date: 2009-06-29 18:30:54
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Company Type 2 Diabetes 5 / Type 2 Diabetes / GlaxoSmithKline / / Country United States / / Currency pence / / Event FDA Phase / / Facility Laboratory Abnormalities / / IndustryTerm food / / MedicalCondition anaphylactic reaction / Vascular Disease / severe chronic heart failure / allergic reaction / Thyrotoxicosis / chest pain / Left ventricular dysfunction / symptomatic heart failure / essential hypertension / ischemic heart disease / excessive hypotension / transient worsening heart failure / severe bradycardia / hyperthyroidism / Stevens-Johnson syndrome / syncope / low blood pressure / fatigue / angina pectoris / injury / Bradycardia / tachycardia / angina / hypersensitivity / diarrhea / patients’ underlying disease / hypoglycemia / chronic bronchitis / hypotension / acute myocardial infarction / severe heart failure / mild-to-moderate hypertension / Peripheral Vascular Disease / Hypertension / ventricular dysfunction / bronchospasm / Second- or third-degree AV block / Bronchial asthma / bronchospastic disease / Left Ventricular Dysfunction Following Myocardial Infarction / emphysema / spontaneous hypoglycemia / Carcinogenesis / hyperglycemia / chronic / Diabetes / Sick sinus syndrome / serious hypersensitivity / status asthmaticus / renal insufficiency / myocardial infarction / Diabetes Mellitus / heart failure / Pheochromocytoma / angioedema / thyroid storm / cardiogenic shock / postural hypotension / Nonallergic Bronchospasm / coronary artery disease / Prinzmetal’s Variant Angina / Dizziness / Non-allergic bronchospasm / insulin-induced hypoglycemia / mild-to-moderate heart failure / lightheadedness / mild-to-severe chronic heart failure / Heart Failure/Fluid Retention Worsening heart failure / / MedicalTreatment intravenous therapy / / Organization Alternative Administration / DOSAGE AND ADMINISTRATION / FDA / / / Position PHYSICIAN / Major / / Product reserpine / Cyclosporine / COREG / rifampin / COREG CR / digoxin / epinephrine / carvedilol / COREG CR® (carvedilol phosphate) Extended-release Capsules / / Technology alpha / AV / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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• History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. (4) ------------------