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| __NOTOC__
| | #REDIRECT [[Diltiazem#Adverse Reactions]] |
| {{Diltiazem}}
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| {{CMG}}; {{AE}} {{AK}}
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| ==ADVERSE REACTIONS==
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| The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with [[atrial fibrillation]]/[[flutter ]]or [[PSVT ]]under double-blind or open-label conditions. Worldwide experience in over 1300 patients was similar.
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| Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Hypotension was the most commonly reported adverse event during clinical trials. Asymptomatic [[hypotension ]]occurred in 4.3% of patients. Symptomatic hypotension occurred in 3.2% of patients. When treatment for [[hypotension ]]was required, it generally consisted of administration of [[saline ]]or placing the patient in the [[Trendelenburg position]]. Other events reported in at least 1% of the diltiazem-treated patients were injection site reactions (eg, [[itching]], [[burning]]) - 3.9%, vasodilation ([[flushing]]) -1.7%, and [[arrhythmia ]]([[junctional rhythm]] or isorhythmic dissociation) - 1.0% | |
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| In addition, the following events were reported infrequently (less than 1 %):
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| '''Cardiovascular:''' [[Angina]], [[arrhythmia]],[[ AV block ]]([[first-degree AV block| first-degree]]), AV block ([[second degree AV block|second-]] or [[third degree AV block|third-degree –]] see [[Diltiazem hydrochloride tablet warnings|WARNINGS, Cardiac Conduction]]), [[bradycardia]], [[bundle branch block]], [[congestive heart failure]], [[ECG]] abnormality, [[flushing]], [[hypotension]], [[palpitations]], [[syncope]], [[tachycardia]], [[ventricular extrasystoles]].
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| '''Nervous System:''' Abnormal dreams, [[amnesia]], [[depression]], [[gait ]]abnormality, [[hallucinations]], [[insomnia]], [[nervousness]], [[paresthesia]], personality change, [[somnolence]], [[tremor]].
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| '''Gastrointestinal:''' [[Anorexia]], [[constipation]], [[diarrhea]], [[dysgeusia]], [[dyspepsia]], mild elevations of [[alkaline phosphatase]], [[SGOT]], [[SGPT]], and [[LDH ]](see [[Diltiazem hydrochloride tablet warnings|WARNINGS, Acute Hepatic Injury]]), [[thirst]], [[vomiting]], weight increase.
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| '''Dermatological:''' [[Petechiae]], [[photosensitivity]], [[pruritus]], [[urticaria]].
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| '''Other:''' [[Amblyopia]], [[CPK ]]elevation, dry mouth, [[dyspnea]], [[epistaxis]], eye irritation, [[hyperglycemia]], [[hyperuricemia]], [[impotence]], [[muscle cramps]], nasal congestion, [[nocturia]], [[osteoarticular pain]], [[polyuria]], [[sexual difficulties]], [[tinnitus]].
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| The following postmarketing events have been reported infrequently in patients receiving CARDIZEM: acute generalized exanthematous [[pustulosis]], allergic reactions, [[alopecia]], [[angioedema ]](including facial or [[periorbital edema]]), [[asystole]], [[erythema multiforme]] (including [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]]), [[extrapyramidal symptoms]], [[gingival hyperplasia]], [[hemolytic anemia]], increased [[bleeding time]], [[leukopenia]], [[photosensitivity ]](including lichenoid keratosis and [[hyperpigmentation ]]at sun-exposed skin areas), [[purpura]], [[retinopathy]], [[myopathy]], and [[thrombocytopenia]]. There have been observed cases of a generalized rash, some characterized as [[leukocytoclastic vasculitis]]. In addition, events such as[[ myocardial infarction]] have been observed, which are not readily distinguishable from the natural history of the disease in these patients. A definitive cause and effect relationship between these events and CARDIZEM therapy cannot yet be established. [[Exfoliative dermatitis]] (proven by rechallenge) has also been reported.
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| <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = DILTIAZEM HYDROCHLORIDE INJECTION [AKORN, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=81c5cf23-a6f8-454a-9575-d01edf49ed34 | publisher = | date = | accessdate = 5 March 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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