As with other ACE inhibitors, one should keep in mind the likelihood of developing symptomatic arterial hypotension (even a few hours after taking the first dose of the drug), especially in patients with severe heart failure with or without kidney function, and in patients with disturbances of water-electrolyte balance, conditioned by previous therapy with diuretics, diet with restriction of table salt, diarrhea, vomiting, on hemodialysis and in severe renin-dependent arterial hypertension ii.
In patients with IHD, cerebrovascular disease, a significant reduction in blood pressure can lead to the development of acute myocardial infarction and / or stroke.
In patients at risk for developing symptomatic arterial hypotension, treatment should be started under close medical supervision, preferably in a hospital setting, starting at lower doses and then following a careful dose titration.
In some patients with heart failure with normal or low blood pressure, the use of Zokardis® 30 can cause an additional reduction in blood pressure. This effect is predictable and usually does not serve as a reason for cancellation of treatment. If excessive arterial hypotension in the patient persists, a dose reduction or withdrawal of the Zokardis® 30 drug may be required.
In patients with acute myocardial infarction with the risk of severe hemodynamic disorders due to the use of vasodilating agents (patients with systolic blood pressure <100 mm Hg, cardiogenic shock) therapy with Zokardis® 30 should not be started, ego can lead to the development of severe arterial hypotension.In the case of persistent arterial hypotension (systolic BP <90 mm Hg for more than one hour), the use of Zokardis® 30 should be discontinued. In the development of severe heart failure after acute myocardial infarction, Zokardis® 30 should be used only in patients with stable hemodynamic parameters.
There is an increased risk of severe hypotension and renal insufficiency with the use of ACE inhibitors in patients with renovascular hypertension and / or bilateral renal artery stenosis or stenosis of the renal artery to a solitary kidney. In patients in this group, the use of Zokardis® 30 is contraindicated.
In patients with unilateral stenosis of the renal artery, renal failure may be accompanied by only small changes in the concentration of creatinine in the blood plasma. Therapy with Zokardis® 30 in patients in this group should start with small doses in a hospital setting under close medical supervision. The subsequent increase in the dose should be done with caution, under the control of the concentration of creatinine in the blood plasma.
In patients with renal insufficiency, Zokardis® 30 should be used with caution, therapy should be started with smaller doses and regular monitoring of kidney function. Renal failure was reported in the appointment of ACE inhibitors, mainly in patients with severe heart failure or kidney disease, including renal artery stenosis. In some patients without signs of kidney pathology, there was an increase in the concentration of urea and creatinine in the blood plasma, especially with the simultaneous use of diuretics. You may need to reduce the dose of an ACE inhibitor and / or stop using a diuretic. During the first few weeks of therapy, regular monitoring of kidney function is recommended. Proteinuria can occur, in particular, in patients with impaired renal function or taking relatively high doses of ACE inhibitors. Patients with a history of renal disease need to determine the protein content in the urine (the use of test strips to study the first morning dose of urine) before and periodically after treatment.Anaphylactoid reactions such as face swelling, blood flushes to the face, arterial hypotension and shortness of breath during the first minutes of hemodialysis were observed with the use of ACE inhibitors in dialysis using polyacrylonitrile membranes of high throughput (eg AN69®). Therefore, for such patients it is recommended either the use of dialysis membranes of a different type, or the use of antihypertensive drugs of another group.
There is evidence that patients receiving ACE inhibitors with LDL-apheresis (low-density lipoprotein plasmapheresis) with dextran sulfate have a high incidence of anaphylactoid reactions similar to those found in patients undergoing hemodialysis using membranes with high capacity. If LDL-apheresis is performed, ACE inhibitors should be temporarily replaced with antihypertensive drugs from another group.
There have been reports of the development of life-threatening anaphylactic reactions in patients receiving ACE inhibitors concomitantly with the procedure for desensitization (for example, the Hepatoptera (Heminoptera)) or after insect bites.Such reactions can be avoided if the use of ACE inhibitors is temporarily stopped before desensitization begins. However, they can develop again when the drug is given again. ACE inhibitors should be used with caution in patients who undergo such desensitization and in patients receiving immunotherapy with bee venom.
It is reported the appearance of cough in the treatment with ACE inhibitors. Usually, cough is unproductive and stops after the drug is discontinued. Cough due to treatment with ACE inhibitors should be taken into account in the differential diagnosis of cough.
Rarely with the treatment with ACE inhibitors, there is a syndrome that starts with cholestatic jaundice, which progresses up to fulminant necrosis and, in some cases, leads to a legal outcome. The mechanism of development of this syndrome is unclear. Patients who have jaundice and / or a marked increase in hepatic enzyme activity when ACE inhibitor treatment is treated should immediately discontinue the use of ACE inhibitors and provide medical supervision.
In some patients taking ACE inhibitors, including, the drug Zokardis® 30, there is an increase in potassium in the blood plasma.The risk group for hyperkalemia includes patients suffering from renal insufficiency and / or diabetes mellitus taking potassium-sparing diuretics or potassium-containing substitutes for edible salt, other drugs that increase the potassium content in the blood plasma (eg, heparin). If the use of the above medicines against the background of treatment with Zokardis® 30 is necessary, regular monitoring of the potassium content in the blood plasma is recommended.
In extensive surgical procedures with general anesthesia, ACE inhibitors can induce arterial hypotension until the development of shock, since the formation of angiotensin II can be blocked by the compensatory release of renin. If the use of Zokardis® 30 is deemed necessary, then the BCC should be carefully monitored when carrying out the above measures. Before surgical interventions (including dental procedures), the surgeon / anesthesiologist should be alerted to the patient's use of Zokardis® 30. Neutropenia, agranulocytosis, thrombocytopenia, anemia may develop with ACE inhibitor therapy.With the normal function of the nights and the absence of other complications, neutropenia occurs rarely. This condition can develop in patients with impaired renal function, especially if the patient has systemic connective tissue diseases (eg, systemic lupus erythematosus, scleroderma), during immunosuppressive therapy, in cases of concomitant use of allopurinol or procainamide, as well as a combination of all of the above factors. Some of these patients developed severe infections, in some cases resistant to intensive antibiotic therapy. If Zokardis ® 30 is still used in such patients, regular monitoring of the number of leukocytes in the blood (in the first 3 months of treatment - every 2 weeks, and further - regular monitoring) is recommended, and during treatment all patients should be instructed about the need to inform the doctor about any signs of development of a possible infection (eg, sore throat, fever), in which the study of the leukocyte formula is shown. If neutropenia or a suspected neutropenia is detected (neutrophil count less than 1000 / mm3) the preparation Zokardis® 30 and other concomitant medications should be discontinued. These changes are reversible. After the withdrawal of the ACE inhibitor, the amount of neutrophils reaches the initial level.
In patients with diabetes mellitus receiving hypoglycemic agents for ingestion and / or insulin, the concentration of glucose in the blood plasma must be carefully monitored during the first month of treatment with Zokardis® 30.
Reports of angioedema (angioedema) of the face, limbs, lips, tongue, vocal folds and / or larynx have been reported in patients who received ACE inhibitors at different periods of treatment. In such cases, treatment with Zokardis® 30 should be discontinued immediately, an antihypertensive drug from another group should be prescribed, and appropriate medical supervision of the patient should be established until the symptoms disappear completely. The patient should be placed in a hospital for medical observation for a period of at least 12-24 hours, and not discharged from the hospital until the symptoms have completely disappeared. Even in those cases where only the difficulty of swallowing is disturbed without difficulty in breathing,patients should be under medical supervision for a long time, since therapy with antihistamines and corticosteroids may not be sufficient. Angioedema of the larynx or tongue can be fatal. Swelling of the tongue, vocal cords, or larynx can lead to airway obstruction; appropriate therapy should be performed in the shortest possible time and include immediate subcutaneous administration of a 0.1% solution of epinephrine (0.3-0.5 ml) or a slow intravenous injection of a 1 mg / ml adrenaline solution diluted according to the instructions for use, ECG and blood pressure monitoring, as well as measures to ensure airway patency. Patients with an angioedema edema of another etiology in the history of taking ACE inhibitors are at increased risk for the development of this pathology.
In patients of the Negroid race, the frequency of angioedema development with ACE inhibitors is higher than in representatives of other races.
Similar to other ACE inhibitors, the Zokardis® 30 preparation may be less effective in reducing blood pressure in members of the Negroid race than in individuals of other races,due to the low level of renin in patients with hypertension in this population. This difference can be eliminated by the addition of diuretics.
The drug contains lactose, so its use in patients with hereditary intolerance to galactose, a deficiency of lactase and a syndrome of malabsorption of glucose and galactose is contraindicated.
During the period of application of the drug Zokardis * 30 it is not recommended to drink alcoholic beverages. alcohol increases the antihypertensive effect of the drug.