Enalapril-Astrapharm tablets are used for the following indications:
Treatment of arterial hypertension; Treatment of clinically significant heart failure; Prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).
Composition
The active substance is enalapril (one tablet contains 10 mg of enalapril maleate).
Excipients: lactose monohydrate; potato starch; povidone; magnesium stearate; dye "Azorubine" (carmoisine) (E 122).
Contraindication
Hypersensitivity to enalapril, to any of the excipients or to any other ACE inhibitor; history of angioedema associated with the use of ACE inhibitors; hereditary or idiopathic angioedema; pregnancy or planning to become pregnant; Enalapril-Astrapharm should not be used with drugs containing aliskiren, in patients with diabetes mellitus or with impaired renal function (GFR <60 ml / minute / 1.73 m 2); enalapril should not be used in combination with neprilysin inhibitors (for example, sacubitril); enalapril should not be used within 36 hours after switching from / to taking sacubitril / valsartan, a drug containing a neprilysin inhibitor.
Method of application
Food intake does not affect the absorption of Enalapril-Astrapharm tablets. Since the tablet is not divided, if the drug is prescribed in a dose of less than 5 mg, enalapril preparations with the possibility of such a dosage should be used.
The dosage should be selected individually according to each patient's condition and blood pressure response.
Arterial hypertension
The dose of the drug ranges from an initial 5 mg to a maximum of 20 mg, depending on the degree of arterial hypertension and the patient's condition. "Enalapril-Astrapharm" is taken once a day. For mild arterial hypertension, the recommended initial dose is 5-10 mg.
In patients with a very active RAAS (e.g. renovascular hypertension, salt and/or fluid imbalance, cardiac decompensation or severe hypertension), an excessive fall in blood pressure after the initial dose is possible. In such patients, a starting dose of 5 mg or lower is recommended, and the initiation of treatment should be under medical supervision.
Previous treatment with high doses of diuretics may lead to fluid depletion and a risk of hypotension at the beginning of enalapril therapy. For such patients, a starting dose of 5 mg or less is recommended. If possible, diuretic treatment should be discontinued 2-3 days before starting treatment with Enalapril-Astrapharm. Renal function and serum potassium should be monitored.
The usual maintenance dose is 20 mg once daily. The maximum maintenance dose is 40 mg daily.
Heart failure/asymptomatic left ventricular dysfunction
For the treatment of clinically pronounced heart failure, Enalapril-Astrapharm should be used together with diuretics and, if necessary, digitalis or β-blockers. The initial dose of the drug for patients with clinically pronounced heart failure or asymptomatic left ventricular dysfunction is 2.5 mg, while the use of the drug should be carried out under close medical supervision in order to establish the initial effect of the drug on blood pressure. In the absence of effect or after appropriate correction of symptomatic hypotension that occurred at the beginning of treatment of heart failure with Enalapril-Astrapharm, the dose should be gradually increased to the usual maintenance dose of 20 mg, which is prescribed once or divided into 2 doses, depending on what is better tolerated by the patient. Dose selection is recommended to be carried out within 2-4 weeks. Such a therapeutic regimen effectively reduces mortality rates in patients with clinically pronounced heart failure. The maximum dose is 40 mg per day in 2 divided doses.
Suggested dose titration of Enalapril-Astrapharm for patients with heart failure/asymptomatic left ventricular dysfunction:
week 1: days 1-3 - 2.5 mg/day in 1 dose; days 4-7 - 5 mg/day in 2 doses; week 2 - 10 mg/day in 1 or 2 doses; weeks 3 and 4 - 20 mg/day in 1 or 2 doses.
Both before and after starting treatment with Enalapril-Astrapharm, blood pressure and renal function should be carefully monitored, as hypotension and (less frequently) subsequent renal failure have been reported. Patients taking diuretics should have their dose reduced if possible before starting treatment with Enalapril-Astrapharm. The development of hypotension after the initial dose of Enalapril-Astrapharm does not mean that hypotension will persist with continued treatment and does not indicate the need to discontinue the drug. Serum potassium and renal function should also be monitored.
Experience with enalapril in children with hypertension is limited. For children who can swallow tablets, the dose should be individualized based on the patient's condition, blood pressure response to treatment, and body weight. The recommended initial dose is 2.5 mg for patients weighing 20 to 50 kg and 5 mg for patients weighing ≥ 50 kg. Enalapril-Astrapharm is taken once daily. The dosage should be adjusted as needed to a maximum of 20 mg per day for patients weighing 20 to 50 kg and 40 mg for patients weighing ≥ 50 kg.
Enalapril-Astrapharm is not recommended for newborns and children with a glomerular filtration rate <30 ml/minute/1.73 m2 due to lack of data.
Application features
Drivers
When driving or operating other machinery, the possible development of dizziness or increased fatigue should be taken into account.
Overdose
There are limited data on overdose with the drug. The main signs of overdose, according to the data, are pronounced arterial hypotension, which begins approximately 6 hours after taking the drug and coincides with the blockade of the renin-angiotensin system, and stupor. Symptoms associated with overdose with ACE inhibitors may include circulatory shock, electrolyte imbalance, renal failure, hyperventilation of the lungs, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough. Plasma levels of enalaprilat exceeding 100 and 200 times the maximum levels achieved with therapeutic doses have been reported after taking 300 mg and 440 mg of enalapril, respectively.
For the treatment of overdose, intravenous infusions of isotonic solution are recommended. If hypotension occurs, the patient should be placed in a horizontal position. The need for infusions of angiotensin II and / or intravenous administration of catecholamines may be considered. If the drug has been taken recently, measures to eliminate enalapril maleate (such as artificial vomiting, gastric lavage, administration of absorbents and sodium sulfate) are recommended. Enalaprilat can be removed from the systemic circulation by hemodialysis. Pacemaker therapy is indicated for bradycardia resistant to therapeutic agents. Vital signs, electrolyte concentrations and serum creatinine levels should be monitored continuously.
Side effects
When using the drug "Enalapril-Astrapharm", in most cases the side effects were minor, temporary in nature and did not require discontinuation of therapy.
From the blood system: anemia (including aplastic and hemolytic), neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, lymphadenopathy, autoimmune diseases.
On the part of the endocrine system: syndrome of inappropriate antidiuretic hormone secretion.
Metabolic disorders: hypoglycemia.
Nervous system and psyche: dizziness, depression, headache, confusion, drowsiness, insomnia, nervousness, paresthesias, vertigo, sleep disorders, abnormal dreams.
From the organs of vision: blurred vision.
Cardiovascular system: hypotension (including orthostatic hypotension), syncope, chest pain, arrhythmia, angina pectoris, tachycardia, orthostatic hypotension, palpitations, myocardial infarction or stroke, possibly due to excessive reduction in blood pressure in high-risk patients, Raynaud's phenomenon.
Respiratory system: cough, shortness of breath, rhinorrhea, sore throat and hoarseness, bronchospasm/asthma, pulmonary infiltrates, rhinitis, allergic alveolitis/eosinophilic pneumonia.
Gastrointestinal: nausea, diarrhea, abdominal pain, taste perversion, intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritation, dry mouth, peptic ulcers, stomatitis/aphthous ulcers, glossitis, intestinal angioedema.
Hepatobiliary system: hepatic failure; hepatocellular or cholestatic hepatitis; hepatitis, including necrosis; cholestasis (including jaundice).
Skin: rash, hypersensitivity/angioedema of the face, extremities, lips, tongue, glottis and/or larynx, increased sweating, itching, urticaria, alopecia, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.
A complex symptom complex has been reported, including some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis. Rash, photosensitivity, and other skin reactions may also occur as side effects.
From the urinary system: renal dysfunction, renal failure, proteinuria, oliguria.
From the reproductive system: impotence, gynecomastia.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
