Labetalol injection adverse reactions: Difference between revisions

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#REDIRECT [[Labetalol#Adverse Reactions]]
 
{{Labetalol}}
 
{{CMG}}; {{AE}} {{SS}}
 
==Adverse Reactions==
 
Labetalol injection is usually well tolerated. Most adverse effects have been mild and transient and in controlled trials involving 92 patients did not require labetalol withdrawal. Symptomatic postural [[hypotension]] (incidence 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol injection. Moderate [[hypotension]] occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
 
The following also were reported with labetalol injection with the incidence per 100 patients as noted:
 
'''Cardiovascular System''': [[Ventricular arrhythmia]] in 1.
 
'''Central and Peripheral Nervous Systems''': [[Dizziness]] in 9; [[tingling]] of the scalp/skin 7; [[hypoesthesia]] (numbness) and [[vertigo]], 1 each.
 
'''Gastrointestinal System''': [[Nausea]] in 13; [[vomiting]] 4; [[dyspepsia]] and taste distortion, 1 each.
 
'''Metabolic Disorders''': Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
 
'''Psychiatric Disorders''': [[Somnolence]]/[[yawning]] in 3.
 
'''Respiratory System''': [[Wheezing]] in 1.
 
'''Skin''': [[Pruritus]] in 1.
 
The incidence of adverse reactions depends upon the dose of labetalol. The largest experience is with oral labetalol. Certain of the side effects increased with increasing oral dose as shown in the table below which depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.
 
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In addition, a number of other less common adverse events have been reported:
 
'''Cardiovascular''': [[hypotension]], and rarely, [[syncope]], [[bradycardia]], [[heart block]].
 
'''Liver and Biliary System''': Hepatic necrosis, [[hepatitis]], [[cholestatic jaundice]], elevated liver function tests.
 
'''Hypersensitivity''': Rare reports of [[hypersensitivity]] (e.g., [[rash]], urticaria, [[pruritus]], [[angioedema]], [[dyspnea]]) and [[anaphylactoid]]reactions.
 
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol during investigational use and extensive foreign marketing experience.
 
===Clinical Laboratory Tests===
 
Among patients dosed with labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested, and more rarely, reversible increases in blood urea.
 
==References==
 
{{Reflist|2}}
 
[[Category:Beta blockers]]
 
[[Category:Cardiovascular Drugs]]
 
[[Category:Drugs]]
 
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Latest revision as of 23:57, 21 July 2014