enalapril | enam tablets 2.5 mg 20 pcs.

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, EnamВ® 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, EnamВ® 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.

EnamВ® 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 EnamВ® during pregnancy is not recommended.

When diagnosing pregnancy, EnamВ® 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 EnamВ® 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 EnamВ®,

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 EnamВ® 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’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

10 ml / min 2.5 mg


* See "Precautions", "Special Instructions".

** Enalapril undergoes dialysis. Dose adjustment on days when dialysis is not performed should be carried out depending on the level of blood pressure.

Heart failure / asymptomatic left ventricular dysfunction

Initial dose of Enam®, in patients with clinically severe heart failure or asymptomatic left ventricular dysfunction,

is 2.5 mg. In this case, the use of the drug should be carried out under close medical supervision to determine the primary effect of the drug on blood pressure. Enam® can be used to treat heart failure with severe clinical manifestations, usually together with diuretics and, when necessary, with cardiac glycosides.

In the absence of symptomatic arterial hypotension (resulting from treatment with Enam®) or after its correction, the dose of the drug should be gradually increased to the usual maintenance dose of 20 mg, which is either taken once or divided into 2 doses, depending on the patient's tolerance to the drug.

Dose selection may be carried out within

2-4 weeks or shorter if there are residual signs and symptoms of heart failure.

Such a therapeutic regimen effectively reduces mortality rates in patients with clinically severe HF.

Both before and after the start of treatment with Enam®, regular monitoring of blood pressure and renal function should be carried out (see the “Special Instructions” section), since the development of arterial hypotension with the subsequent (more rare) occurrence of acute renal failure was reported .

In patients taking diuretics, if possible, the dose of diuretics should be reduced before treatment with Enam®.

The development of arterial hypotension after taking the first dose of Enam® does not mean that arterial hypotension will re-develop with prolonged treatment, and does not indicate the need to stop taking the drug.

In the treatment with Enam®, the serum potassium content should also be monitored (see section “Interaction with other drugs”).

Side effects

In general, Enam® is well tolerated.

In clinical trials, the total incidence of adverse events with enalapril did not exceed that with placebo.

In most cases, adverse events were mild, transient and did not require discontinuation of therapy.

When using enalapril, the following adverse events were observed (very often: 10%, often: 1% and <10%, infrequently: 0.1% and <1%, rarely 0.01% and <0.1% , very rarely: <0.01%, frequency is unknown: it is impossible to estimate the frequency based on available data): Disorders from the blood and lymphatic system

Infrequently: anemia (including aplastic and hemolytic).

Rarely: neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, suppression of bone marrow function, pancytopenia, lymphadenopathy, autoimmune diseases.

Endocrine disorders

Frequency unknown: syndrome of inadequate secretion of antidiuretic hormone.

Metabolism and nutritional disorders

Infrequently: hypoglycemia (see section "Special instructions").

Disorders of the nervous system and mental disorders

Often: headache, depression.

Infrequently: confusion, drowsiness, insomnia, increased nervousness, paresthesia, systemic dizziness.

Rarely: unusual dreams, sleep disturbances.

Visual disturbances

Very common: blurred vision.

Disorders of the heart and blood vessels

Very often: dizziness.

Often: marked decrease in blood pressure, fainting, chest pain, rhythm disturbance, angina pectoris, tachycardia.

Infrequent: orthostatic hypotension, palpitations, myocardial infarction or stroke *,

may be secondary to severe arterial hypotension

in patients at high risk (see section "Special instructions").

Rarely: Raynaud's syndrome.

* The incidence was comparable to that observed in clinical trials with a placebo or other comparison drug.

Disorders of the respiratory system, chest and mediastinal organs

Very often: cough.

Often: shortness of breath.

Infrequently: rhinorrhea, sore throat, hoarseness, bronchospasm / bronchial asthma.

Rarely: pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia.

Digestive Disorders

Very often: nausea.

Often: diarrhea, abdominal pain, taste disturbance.

Infrequently: intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, stomach irritation,

dry oral mucosa, gastric ulcer and duodenal ulcer.

Rarely: stomatitis / aphthous ulcers, glossitis.

Very rare: intestinal edema.

Disorders of the liver and biliary tract

Rarely: liver failure, hepatitis (hepatocellular or cholestatic), hepatitis (including necrosis),

cholestasis (including jaundice).

Disorders of the skin and subcutaneous tissues

Often: skin rash, hypersensitivity reactions / angioedema: angioedema of the face, limbs, lips,

tongue, vocal folds and / or larynx (see section “Special instructions”).

Infrequently: increased sweating, skin itching, urticaria, alopecia.

Rarely: erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.

The development of a symptom complex has been reported, which may include all or some of the following symptoms:

fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, a positive antinuclear antibody test,

increased erythrocyte sedimentation rate (ESR) and leukocytosis.

Skin rashes, photosensitization, and other skin reactions may also occur.

Disorders of the kidneys and urinary tract

Infrequently: impaired renal function, renal failure, proteinuria.

Rare: oliguria.

Genital and breast disorders

Infrequently: erectile disfunction.

Rarely: gynecomastia.

Common disorders

Very common: asthenia.

Often: fatigue.

Infrequently: muscle cramps, flushing of the face, tinnitus, discomfort, fever.

Laboratory and instrumental data

Often: hyperkalemia, increased serum creatinine concentration.

Infrequently: increased concentration of urea in the blood, hyponatremia.

Rarely: increased activity of hepatic transaminases, increased serum bilirubin concentration.

The following adverse events were identified during post-registration observation,

however, a causal relationship with enalapril was not established: urinary tract infection,

upper respiratory tract infection, bronchitis, cardiac arrest, Atrial fibrillation, herpes zoster, melena

, ataxia, pulmonary embolism and pulmonary infarction, hemolytic anemia, including cases of hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.

overdose

Symptoms:

hypotension.

Treatment:

should be put on the patient, legs raised.

In mild cases of overdose, the patient is prescribed saline.

In more serious cases, in the conditions of the hospital carry out activities aimed at stabilizing blood pressure,

in / in enter saline or plasma substitutes. Possible use of hemodialysis

Storage conditions

At a temperature not exceeding 25 РC.

Keep out of the reach of children!

The Expiration of

is 3 years.

Deystvuyuschee substances

enalapril

dosage form

dosage form

tablets