Equacard
From the cardiovascular system: often - marked decrease in blood pressure, orthostatic hypotension; uncommon - acute myocardial infarction, tachycardia, palpitations; Raynaud's syndrome; rarely - bradycardia, tachycardia, worsening symptoms of chronic heart failure, impaired atrioventricular conduction, chest pain.
From the side of the central nervous system: often - dizziness, headache; uncommon - mood lability, paresthesia, sleep disturbances, stroke; rarely - confusion, asthenic syndrome, convulsive twitching of the muscles of the limbs and lips, drowsiness.
From the hematopoietic and lymphatic systems: rarely - decrease in hemoglobin, hematocrit; very rarely - leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, erythropenia, hemolytic anemia, lymphadenopathy, autoimmune diseases.
From the respiratory system: often - cough; infrequently - rhinitis; very rarely - sinusitis, bronchospasm, allergic alveolitis/eosinophilic pneumonia, shortness of breath.
Amlodipine
From the side of the central nervous system: often - headache (especially at the beginning of treatment), dizziness, increased fatigue, drowsiness; uncommon - general malaise, hypoesthesia, asthenia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, unusual dreams, nervousness, increased excitability, depression, anxiety, increased sweating; rarely - convulsions, apathy, agitation; very rarely - ataxia, amnesia.
From the digestive system: often - nausea, abdominal pain; uncommon - vomiting, change in bowel habits (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dry oral mucosa, thirst; rarely - gum hyperplasia, increased appetite; very rarely - pancreatitis, gastritis, jaundice (usually cholestatic), hyperbilirubinemia, increased activity of liver transaminases, hepatitis.
From the cardiovascular system: often - peripheral edema (ankles and feet), palpitations, "flushes" of blood to the skin of the face; uncommon - excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely - development or worsening of chronic heart failure; very rarely - fainting, shortness of breath, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema, migraine.
From the hematopoietic and lymphatic systems: very rarely - thrombocytopenic purpura, leukopenia, thrombocytopenia.
Allergic reactions: rarely - skin itching, rash (including erythematous, maculopapular rash); very rarely - urticaria, angioedema, erythema multiforme.
Ekvacard®
The frequency of the adverse reactions listed below was determined according to the following (World Health Organization classification): very often - at least 10%; often at least 1% but less than 10%; infrequently not less than 0.1%, but less than 1%; rarely not less than 0.01%, but less than 0.1%; very rarely less than 0.01%, including individual reports.
Lisinopril
From the cardiovascular system: often pronounced decrease in blood pressure. orthostatic hypotension; infrequently acute myocardial infarction, tachycardia, palpitations; Raynaud's syndrome; rarely, bradycardia, tachycardia, worsening symptoms of CHF, impaired atrioventricular conduction, chest pain.
From the central nervous system: often dizziness, headache, infrequently mood lability, paresthesia, sleep disturbances, stroke; rarely, confusion, asthenic syndrome, convulsive twitching of the muscles of the limbs and lips, drowsiness.
From the hematopoietic and lymphatic systems: rarely, a decrease in hemoglobin, hematocrit; very rarely leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, erythropenia, hemolytic anemia, lymphadenopathy, autoimmune diseases.
From the respiratory system: often cough, infrequently rhinitis, very rarely sinusitis, bronchospasm, allergic alveolitis/eosinophilic pneumonia, shortness of breath.
From the digestive system: often diarrhea, vomiting; infrequently dyspepsia, and imputation of taste, abdominal pain; rarely dryness of the oral mucosa: very rarely pancreatitis, jaundice (hepatocellular or cholestatic), hepatitis, liver failure, interstitial edema, anorexia.
From the skin: infrequently, skin itching, rash; rarely, angioedema of the face, limbs, lips, tongue, larynx, urticaria, alopecia, psoriasis; very rarely: increased sweating, vasculitis, pemphigus, photosensitivity, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, Stevens-Johnson syndrome.
From the urinary system: often impaired renal function; uncommon: uremia, acute renal failure; very rarely anuria, oliguria, proteinuria.
From the reproductive system: infrequently - impotence, rarely gynecomastia.
Metabolism: very rarely hypoglycemia.
From the laboratory parameters: infrequently, increased concentration of urea in the blood, hypercreatininemia, hyperkalemia, increased activity of “liver” transaminases, rarely hyperbilirubinemia, hyponatremia, increased erythrocyte sedimentation rate, false-positive test results for antinuclear antibodies.
From the musculoskeletal system: rarely - arthralgia/arthritis, myalgia.
Amlodipine
From the central nervous system: often headache (especially at the beginning of treatment), dizziness, fatigue, drowsiness: infrequently general malaise, hypoesthesia, asthenia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, unusual dreams, nervousness, increased excitability , depression, anxiety, increased sweating; rarely convulsions, apathy, agitation; very rarely ataxia, amnesia.
From the digestive system: often nausea, abdominal pain: infrequently vomiting, change in bowel habits (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dry oral mucosa, thirst; rarely, gum hyperplasia, increased appetite; very rarely pancreatitis, gastritis, jaundice (usually cholestatic), hyperbilirubinemia, increased activity of “liver” transaminases, hepatitis.
From the cardiovascular system: often peripheral edema (ankles and feet), palpitations, “flushes” of blood to the skin of the face; infrequently excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely - development or worsening of CHF; very rarely, fainting, shortness of breath, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema, migraine.
From the hematopoietic and lymphatic systems: very rarely thrombocytopenic purpura, leukopenia, thrombocytopenia.
From the urinary system: infrequently pollakiuria, painful urge to urinate, nocturia; very rarely dysuria, polyuria.
From the reproductive system and mammary glands: infrequently, gynecomastia, impotence.
From the respiratory system: infrequently shortness of breath, rhinitis; very rarely cough.
From the musculoskeletal system: infrequently muscle cramps, myalgia. arthralgia, back pain, arthrosis; rarely myasthenia.
From the skin: infrequently, alopecia; rarely dermatitis; very rarely alopecia, xeroderma, cold clammy note, skin pigmentation disorder.
Allergic reactions: rarely, skin itching, rash (including erythematous, maculopapular rash); very rarely - urticaria, angioedema, erythema multiforme.
From the senses: infrequently, ringing in the ears, blurred vision, diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, eye pain; very rarely parosmia.
Metabolism: very rarely hyperglycemia.
Other: uncommon - weight loss, weight gain, taste disturbance, nosebleeds, chills.
Instructions for use EKVATOR®
All warnings below related to the use of individual components also apply to the drug Equator®.
Lisinopril
Arterial hypotension
A marked decrease in blood pressure with the development of clinical symptoms can be observed in patients with a decrease in blood volume and/or sodium content due to diuretics, fluid loss, or for other reasons, for example, increased sweating, prolonged vomiting and/or diarrhea, or severe renin-dependent arterial hypertension. It is necessary that restoration of fluid and/or sodium loss be carried out before starting therapy with Equator®. It is necessary to monitor blood pressure after taking the initial dose. Such conditions apply to patients with coronary artery disease or cerebrovascular diseases, in whom a pronounced decrease in blood pressure can lead to myocardial infarction or stroke.
A transient hypotensive reaction is not a contraindication to subsequent use of lisinopril, which can usually be used immediately after an increase in blood pressure following an increase in blood volume.
Some patients with heart failure with normal or low blood pressure may experience an additional decrease in systemic blood pressure when taking lisinopril. This effect is expected and does not usually require discontinuation of treatment. If hypotension becomes symptomatic, dose reduction or discontinuation of lisinopril may be necessary.
Double blockade of the RAAS
Dual blockade of the RAAS is associated with an increased risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy. Dual blockade of the RAAS using ACE inhibitors, angiotensin II receptor antagonists or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.
In some cases, when the combined use of ACE inhibitors and angiotensin II receptor antagonists is absolutely indicated, careful supervision by a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary. This applies to the use of candesartan or valsartan as adjunctive therapy to ACE inhibitors in patients with chronic heart failure. Carrying out double blockade of the RAAS under the careful supervision of a specialist and mandatory monitoring of renal function, water-electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistence of symptoms of chronic heart failure, despite other adequate therapy .
Arterial hypotension in acute myocardial infarction
Treatment with lisinopril should not be initiated in patients with acute myocardial infarction who are at risk of further serious hemodynamic deterioration after treatment with vasodilators (patients with a systolic blood pressure of 100 mmHg or lower, and those with cardiogenic shock). During the first 3 days after myocardial infarction, the dose of lisinopril should be reduced if systolic blood pressure is 120 mm Hg. Art. or lower. Maintenance doses should be reduced to 5 mg or temporarily to 2.5 mg if systolic blood pressure is 100 mmHg. Art. or lower. If arterial hypotension persists (systolic blood pressure less than 90 mm Hg persists for more than 1 hour), lisinopril should be discontinued.
Aortic and mitral valve stenosis/hypertrophic cardiomyopathy
As with other ACE inhibitors, lisinopril should be administered with caution to patients with mitral valve stenosis and left ventricular outflow tract obstruction (aortic stenosis or hypertrophic cardiomyopathy).
Kidney failure
In renal failure (creatinine clearance <80 ml/min), the initial dose of lisinopril should be adjusted depending on the patient's creatinine clearance and then depending on the patient's response to treatment. During therapy, potassium levels and creatinine concentrations in the blood serum should be monitored.
In patients with heart failure, hypotension after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. Acute renal failure has been reported in such cases, but is usually reversible.
In some patients with bilateral renal artery stenosis or with arterial stenosis of a solitary kidney who received ACE inhibitors, increases in serum urea and creatinine concentrations were observed, usually reversible when treatment was discontinued. This is especially likely in patients with kidney failure. In the case of concomitant renovascular hypertension, there is an increased risk of developing severe arterial hypotension and renal failure. In such patients, treatment should be initiated under close medical supervision at low doses and the dose titrated carefully. Since treatment with diuretics may contribute to the development of the above conditions, their use should be discontinued and renal function monitored during the first weeks of lisinopril therapy.
In some patients with arterial hypertension without significant preexisting renovascular hypertension, an increase in serum urea and creatinine concentrations was observed, usually slight and transient, especially in cases where lisinopril was used concomitantly with a diuretic. This is especially likely in patients with pre-existing renal failure. A dose reduction and/or discontinuation of the diuretic and/or lisinopril may be required.
In acute myocardial infarction, treatment with lisinopril should not be started in patients with signs of renal failure, which was defined as a serum creatinine concentration exceeding 177 µmol/l and/or proteinuria exceeding 500 mg/24 hours. In case of renal dysfunction during treatment with lisinopril ( serum creatinine concentration exceeds 265 µmol/l or 2 times higher than the corresponding value before treatment), the advisability of discontinuing lisinopril should be considered.
Angioedema
Angioedema of the face, extremities, lips, tongue, vocal folds and/or larynx has been reported in patients taking ACE inhibitors, including lisinopril. In these cases, taking Equator® should be stopped immediately and careful medical observation should be carried out until the symptoms disappear completely.
Swelling of the face, lips and limbs usually goes away on its own, however, antihistamines should be used to reduce the severity of symptoms. Angioedema, accompanied by swelling of the larynx or swelling of the tongue, can be fatal. If swelling of the tongue, pharynx or larynx is detected, which may be the cause of airway obstruction, emergency measures must be immediately initiated. Appropriate measures include:
- use of a 0.1% solution of epinephrine (adrenaline) subcutaneously at a dose of 0.3-0.5 mg or 0.1 mg IV slowly, followed by the use of corticosteroids (IV) and antihistamines and simultaneous monitoring of vital functions.
Angioedema of the intestine has rarely been observed in patients taking ACE inhibitors. Patients complained of abdominal pain (with or without nausea and vomiting); in some cases, no previous facial angioedema was observed and C-1 esterase activity was within normal limits. Angioedema of the intestine was diagnosed according to computed tomography of the gastrointestinal tract or ultrasound, or during surgery; symptoms disappeared after discontinuation of the ACE inhibitor. When conducting a differential diagnosis of abdominal pain in patients taking ACE inhibitors, the development of angioedema of the intestine should be taken into account.
In patients with a history of angioedema not associated with ACE inhibitor use, use of ACE inhibitors may be associated with a higher risk of developing angioedema.
Anaphylactic reactions in patients on hemodialysis
Cases of anaphylactic shock have been reported in patients undergoing hemodialysis using polyacrylonitrile membranes (eg, AN69®) and concomitantly receiving ACE inhibitors, and this combination should be avoided. Patients are recommended to use either a different type of dialysis membrane or an antihypertensive drug of a different pharmacotherapeutic group.
Anaphylactic reactions in patients during LDL apheresis procedures
Rarely, life-threatening anaphylactic reactions have developed in patients receiving ACE inhibitors during LDL apheresis with dextran sulfate. Such reactions can be prevented by stopping the ACE inhibitor before each apheresis procedure.
Desensitization by Hymenoptera venom
Sometimes patients taking ACE inhibitors developed anaphylactic reactions when desensitized by hymenoptera venom (for example, wasps or bees). Such life-threatening situations can be avoided by discontinuing the ACE inhibitor before the desensitization procedure.
Effects on the liver
In rare cases, the use of ACE inhibitors was accompanied by a syndrome that began with cholestatic jaundice or hepatitis and developed into fulminant liver necrosis and, in some cases, led to death. The mechanism of this syndrome is unclear. Patients receiving Equator® who experience jaundice or elevated liver enzymes should discontinue the drug and closely monitor their condition.
Neutropenia/agranulocytosis
Rare cases of neutropenia, agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and in the absence of other aggravating factors, neutropenia is rare. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of the ACE inhibitor. Equator® should be used with extreme caution in patients with systemic connective tissue diseases, during immunosuppressive therapy, during treatment with allopurinol or procainamide, or a combination of these aggravating factors, especially in the presence of pre-existing renal impairment. Some of these patients developed serious infections, which in some cases did not respond to antibiotic treatment. In such patients, during treatment with Equator®, it is necessary to periodically monitor the number of leukocytes (blood test with leukocyte count). Patients should be warned about the need to inform the doctor about the appearance of the first signs of an infectious disease.
Race
Representatives of the Black race who used ACE inhibitors were more likely to experience angioedema compared to patients of other races.
Like other ACE inhibitors, lisinopril is less effective as an antihypertensive agent in black patients compared to patients of other races. This effect may be associated with a pronounced predominance of low-renin status in black patients with arterial hypertension.
Cough
Cough was frequently observed during the use of ACE inhibitors. As a rule, the cough is non-productive, persistent and stops after discontinuation of the drug. In the differential diagnosis of cough, cough associated with the use of ACE inhibitors must be taken into account.
Surgery/general anesthesia
During surgery or general anesthesia with the use of drugs that cause arterial hypotension, lisinopril can block the formation of angiotensin II associated with the compensatory release of renin.
If arterial hypotension develops as a result of the above mechanism, correction can be made by increasing the volume of blood volume.
Hyperkalemia
An increase in serum potassium levels was observed in some patients receiving ACE inhibitors. Patients at risk for the development of hyperkalemia are patients with renal failure, type 2 diabetes mellitus, acute heart failure, dehydration, metabolic acidosis, or concomitant use of potassium-sparing diuretics, potassium-containing dietary supplements, potassium-containing salt substitutes, or any other drugs that increase potassium levels in the blood. serum (for example, heparin). If simultaneous use with the above drugs is necessary, it is recommended to monitor the potassium content in the blood serum.
Patients with diabetes mellitus
In patients with diabetes mellitus taking oral hypoglycemic drugs or receiving insulin, blood glucose concentrations should be monitored during the first month of treatment with an ACE inhibitor.
Amlodipine
The safety and effectiveness of amlodipine in hypertensive crisis has not been established.
Patients with heart failure
Calcium channel blockers, incl. amlodipine should be used with caution in patients with congestive heart failure as it may increase the risk of cardiovascular complications and mortality.
Use in patients with liver failure
In patients with hepatic impairment, a prolongation of amlodipine T1/2 and an increase in the AUC value are observed, but appropriate dosing recommendations have not been developed. Therefore, amlodipine should be started at the lowest dose in the dosing range; Treatment should be initiated and dose increased with caution. In patients with severe hepatic impairment, slow dosage titration and close medical monitoring may be required.
Elderly patients
Elderly patients with impaired renal function should undergo dose adjustment using lisinopril and amlodipine separately.
During treatment, body weight control and dental supervision are necessary (to prevent pain, bleeding and gum hyperplasia).
Impact on the ability to drive vehicles and operate machinery
Lisinopril
When operating vehicles or machinery, the possibility of dizziness or fatigue should be taken into account.
Amlodipine
Amlodipine may have a slight or moderate effect on the ability to drive vehicles and machines. Due to the possible development of dizziness, headache, fatigue and nausea, the speed of psychomotor reactions may be impaired. Caution is recommended, especially at the beginning of treatment.
