Enalapril-Astrapharm
Release Forms:
The composition 1 tablets:
- active substance: enalapril;
- 1 tablet contains enalapril maleate 10 mg, 20 mg
- excipients: for tablets of 10 mg lactose monohydrate, potato starch; povidone, magnesium stearate dye “Azorubin” (carmoizine) (E 122) for tablets of 20 mg lactose monohydrate, potato starch; povidone, magnesium stearate.
Dosage form. Tablets.
Main physical and chemical properties: tablets of 10 mg tablets of pink color with infusions of more intense color, flat-cylindrical shape with beveled edges and notch;
20 mg tablets: White, flat, cylindrical tablets with beveled edges and a notch.
10 tablets in a blister; 2, 6, 9 or 10 blisters in a box.
Indication.
Angiotensin-converting enzyme inhibitors, monocomponent.
– Treatment of hypertension.
– Treatment of clinically severe heart failure.
– Prevention of clinically severe heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).
Contraindication.
Hypersensitivity to enalapril, to any of the excipients, or to any other ACE inhibitor.
History of angioneurotic edema associated with ACE inhibitors.
Hereditary or idiopathic angioneurotic edema.
Pregnancy or pregnancy planning (see section “Use during pregnancy or breastfeeding”).
Enalapril-Astrapharm should not be used with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min / 1.73 m2).
Enalapril should not be used in combination with neprilysin inhibitors (eg sacubitril). Enalapril should not be used for 36 hours after switching from/to sacubitril/valsartan, a neprilysin inhibitor-containing product (see sections “Special warnings and special precautions for use” and “Interaction with other medicinal products and other forms of interaction”).
Application method.
Eating does not affect the absorption of Enalapril-Astrapharm tablets. Because the tablet does not divide, enalapril with the possibility of such dosing is used if the drug is administered at a dose of less than 5 mg.
The dosage should be selected individually according to the condition of each patient (see section “Special instructions”) and the response of blood pressure in response.
Hypertension
The dose is from an initial 5 mg to a maximum of 20 mg, depending on the degree of hypertension and the patient’s condition (see below). Enalapril-Astrapharm is taken once a day. In mild hypertension, the recommended starting dose is 5-10 mg.
Patients with highly activated RAAS (eg, renovascular hypertension, salt and/or fluid imbalance, cardiac decompensation, or severe hypertension) may have an excessive reduction in blood pressure after the initial dose. An initial dose of 5 mg or less is recommended for such patients, and treatment should be initiated under medical supervision.
Pre-treatment with high doses of diuretics may result in fluid deficiency and a risk of hypotension at the start of enalapril therapy. An initial dose of 5 mg or less is recommended for such patients. If possible, treatment with diuretics should be stopped 2-3 days before treatment with Enalapril-Astrapharm. Renal function and serum potassium should be checked.
The usual maintenance dose is 20 mg once a day. The maximum maintenance dose is 40 mg per day.