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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Lotrel safely and effectively. See full prescribing information for Lotrel. Lotrel (amlodipine besylate and benazepr
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Document Date: 2012-10-09 15:31:11


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City

Reference / /

Company

SUSPECTED ADVERSE REACTIONS / Novartis Pharmaceuticals Corporation / /

Country

United States / /

Event

Product Issues / /

IndustryTerm

castor oil / receptor binding site / chemical name / treatment of hypertension / /

MedicalCondition

polyuria / renal artery stenosis / head and neck angioedema / Symptomatic postural hypotension / mild hypertension / chest pain / laryngeal edema / Headache / mitral stenosis / arthritis / esophagitis / ventricular extrasystole / dermatitis / facial angioedema / dysfunction / Intestinal Angioedema / facial flushing / muscle spasms / excessive hypotension / nausea / dysgeusia / orthostatic symptoms / pruritis / thrombocytopenia / neuritis / rhinitis / alopecia / pemphigus / hyperhidrosis / Mitral Valve Stenosis / severe obstructive coronary artery disease / nocturia / erectile dysfunction / Stevens-Johnson syndrome / peripheral neuropathy / tremor / persistent nonproductive cough / syncope / gout / fatigue / injury / eosinophilic pneumonitis / compensatory tachycardia / gastritis / pulmonary edema / low-renin hypertension / Myocardial Infarction Worsening angina / associated renal insufficiency / tachycardia / diarrhea / Obstructive Hypertrophic Cardiomyopathy / Hepatitis / muscle cramps / gingival hyperplasia / constipation / hypoglycemia / pruritus / Back pain / cramps / micturition disorder / agranulocytosis / hepatic insufficiency / upper respiratory tract infection / gynecomastia / dissociation / hypotension / acute myocardial infarction / severe heart failure / arrhythmia / proteinuria / abdominal pain / hyperkalemia / Insomnia / congestive heart failure / hemolytic anemia / acute liver failure / angioedema / facial edema / hypertension / airway obstruction / vasculitis / moderate hypertension / Flushing / chronic dosing / arthralgia / leucocytopenia / allergic reaction / dysgeusia / shock / Carcinogenesis / hyperglycemia / symptomatic hypotension / mild-to-moderate hypertension results / neutropenia / oliguria / severe aortic stenosis / diabetes / azotemia / erythema multiform / vomiting / pain / renal insufficiency / myocardial infarction / diabetes mellitus / urticaria / Hepatic Failure / angioedema / pancreatitis / post-myocardial infarction / oligohydramnios / Dizziness / renal failure / cough / anuria / Hypokalemia / impotence / diplopia / rash / Pharyngitis / paresthesia / predominantly cholestatic hepatitis / cholestasis / acute renal failure / tinnitus / increased angina / /

MedicalTreatment

Surgery / apheresis / hemodialysis / low-sodium diets / dialysis / /

Organization

Amlodipine Following administration / DOSAGE AND ADMINISTRATION / FDA / /

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Position

General / Major / /

Product

Lotrel / amlodipine besylate and benazepril hydrochloride / Benazepril hydrochloride / simvastatin / Amlodipine besylate / Amlodipine / talc / epinephrine / acetic acid / spironolactone / Renal Function Monitor / Renal Function / /

Technology

ultrasound / geriatrics / Pharmacokinetics / Pharmacodynamics / dialysis / /

URL

www.fda.gov/medwatch / /

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