Description
Latin name
Enam
release form
tablets
Packaging
In 1 aluminum strip 10 tablets.
In a cardboard box 2 strips.
Indications
Essential hypertension of any severity.
Renovascular hypertension.
Heart failure of any severity.
In patients with clinical manifestations of HF, Enam ® is also indicated for:
increasing patient survival
slowing the progression of HF
reducing the frequency of hospitalizations for heart failure.
Prevention of the development of clinically severe heart failure.
In patients without clinical symptoms of heart failure with left ventricular dysfunction, Enam ® is indicated for: slowing the development of clinical manifestations of heart failure
reducing the frequency of hospitalizations for heart failure.
Prevention of coronary ischemia in patients with left ventricular dysfunction.
Enam ® is indicated for: reducing the incidence of myocardial infarction
reducing the frequency of hospitalizations for unstable angina pectoris.
Use during pregnancy and lactation
The use of Enam ® during pregnancy is not recommended.
When diagnosing pregnancy, Enam ® should be discontinued immediately,
unless taking the drug is considered vital for the mother.
Published results of a retrospective epidemiological study of infants whose mothers were taking ACE inhibitors during the first trimester of pregnancy noted an increased risk of developing serious congenital malformations,
compared to newborns whose mothers did not take ACE inhibitors during the first trimester of pregnancy.
The incidence of birth defects was low, and the results of this study have not been reconfirmed.
ACE inhibitors can cause illness or death in the fetus or newborn when used by pregnant women during the second and third trimesters of pregnancy.
The use of ACE inhibitors in these periods was accompanied by a negative effect on the fetus and newborn, which manifested itself in the form of arterial hypotension, renal failure, hyperkalemia and / or hypoplasia of the cranial bones in the newborn.
It was also reported that prematurity, intrauterine growth retardation and non-closure of the arterial (Botallov) duct,
, however, it is unclear whether these cases were associated with ACE inhibitors.
Perhaps the development of oligohydramnios occurs due to a decrease in fetal kidney function.
This complication can lead to contracture of the extremities, deformation of the bones of the skull, including its facial part, hypoplasia of the fetal lungs.
When prescribing Enam ® during pregnancy, the patient must be informed of the potential risk to the fetus.
These undesirable effects on the embryo and the fetus do not appear to be the result of the intrauterine action of ACE inhibitors during the first trimester of pregnancy.
In those rare cases where the use of an ACE inhibitor during pregnancy is considered necessary, periodic ultrasound examinations should be performed to evaluate the amniotic fluid index.
If oligohydramnion is detected during ultrasound examination, it is necessary to stop taking Enam ®,
unless taking the drug is considered vital for the mother.
However, both the patient and the doctor must know that oligohydramnios develops with irreversible damage to the fetus.
If ACE inhibitors are used during pregnancy and oligohydramnios develops, depending on the week of pregnancy, a stress test, a non-stress test, or determination of the biophysical profile of the fetus may be necessary to assess the functional state of the fetus.
Newborns whose mothers took Enam ® during pregnancy should be thoroughly examined for arterial hypotension, oliguria, and hyperkalemia.
With the development of oliguria, special attention should be directed to maintaining blood pressure and renal perfusion.
enalapril crosses the placental barrier. It can be partially removed from the blood circulation of the newborn using peritoneal dialysis. Theoretically, it can also be removed by exchange blood transfusion.
Enalapril and enalaprilat are excreted in mother ² ¢s breast milk in trace amounts.
If it is necessary to use the drug during breastfeeding, the patient should stop breastfeeding.
Composition
Each tablet 2.5 mg, 5 mg, 10 mg and 20 mg contains: Active ingredient:
enalapril maleate 2.5 mg, 5 mg, 10 mg or 20 mg, respectively.
Excipients: 2.5 mg and 5 mg tablets: anhydrous lactose,
maleic acid,
zinc stearate
tablets 10 mg and 20 mg:
lactose anhydrous,
zinc stearate.
Dosage and administration
Enam ® is taken orally, regardless of food intake.
Essential hypertension
The initial dose is 10-20 mg 1 time per day, depending on the severity of hypertension.
For mild hypertension, the recommended starting dose is 10 mg once daily.
With other degrees of hypertension, the initial dose is 20 mg once a day.
Maintenance dose – 1 tablet 20 mg once a day.
The dosage is selected individually for each patient, but the maximum dose should not exceed 40 mg
per day, which is taken once or divided into 2 doses, depending on the patient’s tolerance to the drug.
Renovascular hypertension
Since in patients of this group blood pressure and renal function may be especially sensitive to ACE inhibition, therapy is started with a low initial dose of 5 mg or less. Then the dose is selected in accordance with the needs and condition of the patient.
Typically, the effective dose of Enam ® is 20 mg once daily with daily use.
Caution should be exercised when using Enam ® in patients who have recently taken diuretics (see “Concomitant treatment of hypertension with diuretics” below).
Dosage with concomitant treatment of hypertension with diuretics
Symptomatic arterial hypotension may develop after the first administration of Enam ®.
Such an effect is most likely in patients who take diuretics.
The drug is recommended to be used with caution, as in these patients there may be a violation of the water-electrolyte balance. Reception of diuretics should be stopped 2-3 days before the start of therapy with Enam ®.
If this is not possible, then the initial dose of Enam ® should be reduced (to 5 mg or less) to determine the primary effect of the drug on blood pressure. Further, the dosage should be selected taking into account the needs and condition of the patient.
Dosage for renal failure
The interval between doses of Enam ® should be increased and / or the dose should be reduced.
Creatinine clearance, ml / min Initial dose, mg / day
<80> 30 ml / min 5-10 mg
