"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Hypotension and postural hypotension have been the most frequently reported adverse reactions (See WARNINGS section). Nausea and vomiting occurred in about three percent of patients, primarily when bretylium (bretylium tosylate injection ) tosylate was administered rapidly by the intravenous route (See PRECAUTIONS section). Vertigo, dizziness, light-headedness and syncope, which sometimes accompanied postural hypotension, were reported in about 7 patients in 1000.
Bradycardia, increased frequency of premature ventricular contractions, transitory hypertension, initial increase in arrhythmias (See WARNINGS section), precipitation of anginal attacks, and sensation of substernal pressure have also been reported in a small number of patients, i.e., approximately 1-2 patients in 1000.
Renal dysfunction, diarrhea, abdominal pain, hiccups, erythematous macular rash, flushing, hyperthermia, confusion, paranoid psychosis, emotional lability, lethargy, generalized tenderness, anxiety, shortness of breath, diaphoresis, nasal stuffiness and mild conjunctivitis, have been reported in about 1 patient in 1000. Hyperthermia has also been reported (see WARNINGS). The relationship of bretylium (bretylium tosylate injection ) tosylate administration to these reactions has not been clearly established.
Read the Bretylium (bretylium tosylate injection) Side Effects Center for a complete guide to possible side effects
Digitalis toxicity may be aggravated by the initial release of norepinephrine caused by Bretylium (bretylium tosylate injection ) Tosylate Injection.
The pressor effects of catecholamines such as dopamine or norepinephrine are enhanced by Bretylium (bretylium tosylate injection ) Tosylate. When catecholamines are administered, dilute solutions should be used and blood pressure should be monitored closely. (See WARNINGS)
Although there is little published information on concomitant administration of lidocaine and Bretylium (bretylium tosylate injection ) Tosylate, these drugs are often administered concurrently without any evidence of interactions resulting in adverse effects or diminished efficacy.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Bretylium Information
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