Diltiazem hydrochloride injection adverse reactions: Difference between revisions
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==ADVERSE REACTIONS== | |||
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. | |||
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% | |||
In addition, the following events were reported infrequently (less than 1 %): | |||
'''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]]. | |||
'''Nervous System:''' Abnormal dreams, [[amnesia]], [[depression]], [[gait ]]abnormality, [[hallucinations]], [[insomnia]], [[nervousness]], [[paresthesia]], personality change, [[somnolence]], [[tremor]]. | |||
'''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. | |||
'''Dermatological:''' [[Petechiae]], [[photosensitivity]], [[pruritus]], [[urticaria]]. | |||
'''Other:''' [[Amblyopia]], [[CPK ]]elevation, dry mouth, [[dyspnea]], [[epistaxis]], eye irritation, [[hyperglycemia]], [[hyperuricemia]], [[impotence]], [[muscle cramps]], nasal congestion, [[nocturia]], [[osteoarticular pain]], [[polyuria]], [[sexual difficulties]], [[tinnitus]]. | |||
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. | |||
<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> | <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> | ||
Revision as of 21:20, 5 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
ADVERSE REACTIONS
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.
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%
In addition, the following events were reported infrequently (less than 1 %):
Cardiovascular: Angina, arrhythmia,AV block ( first-degree), AV block (second- or third-degree – see WARNINGS, Cardiac Conduction), bradycardia, bundle branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.
Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor.
Gastrointestinal: Anorexia, constipation, diarrhea, dysgeusia, dyspepsia, mild elevations of alkaline phosphatase, SGOT, SGPT, and LDH (see WARNINGS, Acute Hepatic Injury), thirst, vomiting, weight increase.
Dermatological: Petechiae, photosensitivity, pruritus, urticaria.
Other: Amblyopia, CPK elevation, dry mouth, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties, tinnitus.
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 asmyocardial 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. [1]
References
- ↑ "DILTIAZEM HYDROCHLORIDE INJECTION [AKORN, INC.]". Retrieved 5 March 2014.