"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Limited data are available in regard to enalapril overdosage in humans. In a suicide attempt, one patient took 150 mg felodipine together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient's blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae.
Human overdoses with any combination of enalapril and felodipine ER have not been reported.
Single oral doses of enalapril above 1000 mg/kg and ≥ 1775 mg/kg were associated with lethality in mice and rats, respectively. Oral doses of felodipine at 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality.
In interaction studies on the acute oral toxicity of the combination in mice, pretreatment with felodipine (50 mg/kg) for one hour led to an increase in mortality at doses of enalapril maleate that exceeded 1000 mg/kg. Significant lethality with felodipine was not increased by pretreatment of mice for one hour with 100 mg/kg of enalapril maleate.
Treatment: To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the Physicians' Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.
The most likely effect of overdose with LEXXEL (enalapril maleate-felodipine) is vasodilation, with consequent hypotension and tachycardia. Repletion of central fluid volume (Trendelenburg positioning, infusion of crystalloids) may be sufficient therapy, but pressor agents (norepinephrine or high-dose dopamine) may be required.
Enalaprilat may be removed from general circulation by hemodialysis at a rate of 62 mL/min and has been removed from neonatal circulation by peritoneal dialysis. (See WARNINGS, Anaphylactoid reactions during membrane exposure.) It has not been established whether felodipine can be removed from the circulation by hemodialysis.
LEXXEL (enalapril maleate-felodipine) is contraindicated in patients who are hypersensitive to any component of this product. Because of the enalapril component, LEXXEL (enalapril maleate-felodipine) is contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/29/2016
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