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SYMPTOMATIC HYPOTENSION: Symptomatic hypotension was seen rarely in uncomplicated hypertensive patients. In hypertensive patients receiving RENITEC, hypotension is more likely to occur if the patient has been volume - depleted, e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting (see INTERACTIONS and SIDE EFFECTS). In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatremia or functional renal impairment. In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of RENITEC and/or diuretic is adjusted. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with RENITEC. This effect is anticipated, and usually is not a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or RENITEC may be necessary.
AORTIC STENOSIS/HYPERTROPHIC CARDIOMYOPATHY: As with all vasodilators, ACE inhibitors should be given with caution to patients with obstruction in the outflow tract of the left ventricle.
HYPERSENSITIVITY/ANGIONEUROTIC EDEMA: Angioneurotic edema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including RENITEC. This may occur at any time during treatment. In such cases, RENITEC should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient.
Very rarely, fatalities have been reported due to angioedema associated with laryngeal edema or tongue edema. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures to ensure a patent airway, should be administered promptly.
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (also see CONTRAINDICATIONS).
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
Patients receiving concomitant ACE inhibitor and neprilysin inhibitor therapy may be at increased risk for angioedema (see CONTRAINDICATIONS and INTERACTIONS).
ANAPHYLACTOID REACTIONS DURING HYMENOPTERA DESENSITIZATION: Rarely, patients receiving ACE inhibitors during desensitization with hymenoptera venom have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each desensitization.
HEMODIALYSIS PATIENTS: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes (e.g., AN 69†) and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
COUGH: Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
SURGERY/ANESTHESIA: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril blocks angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
HYPERKALEMIA: See SERUM POTASSIUM under INTERACTIONS.
Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, potassium-containing salt substitutes, or other drugs that may increase serum potassium (e.g., trimethoprim-containing products).
The use of potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes, or other drugs that may increase serum potassium, particularly in patients with impaired renal function, may lead to a significant increase in serum potassium. Hyperkalemia can cause serious, sometimes fatal, arrhythmias.
If concomitant use of RENITEC and any of the previously-mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium.
HYPOGLYCEMIA: Diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor should be told to closely monitor for hypoglycemia, especially during the first month of combined use (see INTERACTIONS).
RENAL FUNCTION IMPAIRMENT: In some patients hypotension following the initiation of therapy with ACE inhibitors may lead to some further impairment in renal function. Acute renal failure, usually reversible, has been reported in this situation.
Patients with renal insufficiency may require reduced and/or less frequent doses of RENITEC (see DOSAGE & ADMINISTRATION). In some patients, with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, increases of blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen. This is especially likely in patients with renal insufficiency.
Some patients with no apparent pre-existing renal disease have developed usually minor and transient increases in blood urea and serum creatinine when RENITEC has been given concomitantly with a diuretic. Dosage reduction and/or discontinuation of the diuretic and/or RENITEC may be required.
Use in Pregnancy: The use of RENITEC during pregnancy is not recommended. When pregnancy is detected, RENITEC should be discontinued as soon as possible, unless it is considered life-saving for the mother.
In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor drug during the first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated.
ACE inhibitors can cause fetal and neonatal morbidity and mortality when administered to pregnant women during the second and third trimesters. Use of ACE inhibitors during this period has been associated with fetal and neonatal injury including hypotension, renal failure, hyperkalemia, and/or skull hypoplasia in the newborn. Maternal oligohydramnios, presumably representing decreased fetal renal function, has occurred and may result in limb contractures, craniofacial deformations and hypoplastic lung development. If RENITEC is used, the patient should be apprised of the potential hazard to the fetus.
These adverse effects to the embryo and fetus do not appear to have resulted from intrauterine ACE-inhibitor exposure limited to the first trimester.
In those rare cases where ACE inhibitor use during pregnancy is deemed essential, serial ultrasound examinations should be performed to assess the intraamniotic environment. If oligohydramnios is detected, RENITEC should be discontinued unless it is considered life-saving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants whose mothers have taken RENITEC should be closely observed for hypotension, oliguria and hyperkalemia. Enalapril, which crosses the placenta, has been removed from the neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion.
Use in Lactation: Enalapril and enalaprilat are secreted in human milk in trace amounts. Caution should be exercised if RENITEC is given to a nursing mother.
Use in Children: RENITEC is not indicated for use in children.
