Apo-Enalapril

Apo-Enalapril Warnings

enalapril

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Warnings
Angioedema: Angioedema has been reported in patients treated with enalapril. Angioedema associated with laryngeal edema and/or shock may be fatal. If angioedema occurs, APO-ENALAPRIL should be promptly discontinued and the patient should be observed until the swelling subsides. Where swelling is confined to the face, lips and mouth, the condition will usually resolve without further treatment, although antihistamines may be useful in relieving symptoms. There patients should be followed carefully until the swelling has resolved. However where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, subcutaneous adrenaline (0.5 mL 1:1000) should be administered promptly when indicated.
Hypotension: Symptomatic hypotension has occurred after administration of enalapril, usually after the first or second dose or when the dose was increased. It is more likely to occur in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. In patients with ever congestive heart failure, with or without associated renal insufficiency, excessive hypertension has been observed and may be associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death. Because of the potential fall in blood pressure in these patients, therapy should be started under very close medical supervision, usually in a hospital. Such patients should be followed closely for the first two weeks of treatment and whenever the dose of enalapril and/or diuretic is increased. 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. (See Adverse Reactions).
If hypotension occurs, the patient should be placed in supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses which usually can be given without difficulty once the blood pressure had increased after volume expansion.
Neutropenia/Agranulocytosis: Agranulocytosis and bone marrow depression have been caused by angiotensin converting enzyme inhibitors. Several cases of agranulocytosis and neutropenia have been reported in which a causal relationship to enalapril cannot be excluded. Current experience with the drug shows the incidence to be rare. Periodic monitoring of white blood cell counts should be considered especially in patients with collagen vascular disease and renal disease.
Caution! Use in Pregnancy: When used in pregnancy, during the second and third trimester. ACE inhibitors can cause injury and even death to the developing foetus. When pregnancy is detected, APO-ENALAPRIL should be discontinued as soon as possible.
ACE inhibitors can cause fetal and neonatal morbidity when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected APO-ENALAPRIL should be discontinued as soon as possible.
In rare cases (probably less than every thousand pregnancies) in which there is no alternative to ACE inhibitors therapy will be found, the mothers should be apprised of the potential hazards to their fetuses. Serial ultrasound examinations should be performed to assess fetal development and well-being and the volume of amniotic fluid.
If oligohydramnios is observed, APO-ENALAPRIL should be discontinued unless it is considered lifesaving for the mother. A non-stress test (NST), and/or a biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. If concerns regarding fetal well-being still persist, a contraction stress testing (CST) should be considered. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with history of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as a means of reversing hypotension and/or substituting for impaired renal function, however, limited experience with those procedures has not been associated with significant clinical benefit.
Enalapril has been removed from the neonatal circulation by peritoneal dialysis with some clinical benefit and may, theoretically, be removed by exchange transfusion, although there is no experience with the latter procedure.
Human Data: It is not known whether exposure limited to the first trimester of pregnancy can adversely affect fetal outcome. The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurely and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE-inhibitor exposure.
Animal Data: Maternal and fetal toxicity occurred in some rabbits given enalapril at doses of 1 mg/Kg/day or more. Saline supplementation prevented the maternal and fetal toxicity seen at doses of 3 and 10 mg/Kg/day, but not at 30 mg/Kg/day (50 times the maximum human dose). Enalapril was not teratogenic in rabbits. There was no fetotoxicity or teratogenicity in rats treated with up to 200 mg/Kg/day of enalapril (333 times the maximum human dose). Fetotoxicity expressed as a decrease in average fetal weight, occurred in rats given 1200 mg/Kg/day of enalapril, but did not occur when these animals were supplemented with saline. The drug crosses the placental barrier in rats and hamsters.
Since the use of APO-ENALAPRIL during pregnancy can cause injury and even death to the developing fetus, patients should be advised to report promptly to their physician of they become pregnant.
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