|
PRECAUTIONS
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 DRUG
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.
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 AND 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.
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).
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 69t) 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 also DRUG INTERACTIONS, SERUM POTASSIUM.
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, or potassium-containing salt substitutes.
The use of potassium supplements,
potassium-sparing diuretics, or potassium-containing salt substitutes
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 above-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 DRUG INTERACTIONS).
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.
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 REN!TEC 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.
NURSING MOTHERS
Enalapril and enalaprilat are secreted in human milk in trace amounts.
Caution should be exercised if RENITEC is given to a nursing mother.
PEDIATRIC USE
RENITEC has not been studied in children
1
2
3
|
