Preparation Lizinopril H STADA, as a rule, is prescribed to patients with arterial hypertension after titrating the dose of each component of the drug - lisinopril up to 20 mg and hydrochlorothiazide to 12.5 mg or with insufficient combination efficiency hydrochlorothiazide 12.5 mg + lisinopril 10 mg, or with insufficient effectiveness of monotherapy with lisinopril in a dose of 20 mg.
Symptomatic arterial hypotension rarely noted against the background of the combination hydrochlorothiazide + lisinopril in patients with hypertension without concomitant diseases. The risk of a marked decrease in blood pressure increases in patients with reduced circulating blood volume caused by previous therapy with diuretics, dialysis, diarrhea or vomiting, severe salt-free diet, and in patients with renovascular hypertension. Before starting treatment with Lysinopril H STADA in patients at risk of developing symptomatic arterial hypotension, it is necessary to correct the volume of circulating blood and water-electrolyte balance,then carefully monitor the effect of the initial dose of the drug on the patient.
In patients with chronic heart failure and simultaneous renal insufficiency or without it, symptomatic arterial hypotension may result from the use of "loop" diuretics in large doses, hyponatremia or renal dysfunction and is more often observed in severe CHF. Severe arterial hypotension after initiation of treatment with ACE inhibitors in patients with chronic heart failure may lead to impaired renal function; cases of acute renal failure are noted. The use of lisinopril H STADA in such patients should be started under strict medical supervision, preferably in a hospital setting. Such a tactic must be followed even when prescribing Lysinopril H STADA to patients with cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to a stroke (see the section "With caution").
In the case of a marked decrease in blood pressure, the patient should be placed in the "lying down" position on the back and, if necessary, replenished the volume of circulating blood (intravenous infusion of 0.9% sodium chloride solution).Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.
Care should be taken when doing physical exercises, in hot weather; in connection with dehydration, the risk of excessive lowering of blood pressure increases.
Aortic stenosis, hypertrophic obstructive cardiomyopathy. Like other drugs with vasodilating properties, the drug LISINOPRITE H STADA should be administered with caution to patients with aortic stenosis and hypertrophic obstructive cardiomyopathy.
Renal failure. Thiazide diuretics are ineffective with a significant decrease in the glomerular filtration rate and can cause an irreversible impairment of renal function. Therefore, the drug Lisinopril N STADA, which includes hydrochlorothiazide, is contraindicated for use in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min); in patients with creatinine clearance from 30 ml / min to 80 ml / min, it is prescribed only after preliminary titration of the doses of individual components (lisinopril and hydrochlorothiazide) to those in the combined preparation (see Fig.sections "Pharmacokinetics", "Contraindications", "With caution", "Method of application and dose ").
In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, on the background of treatment with ACE inhibitors there was an increase in the concentration of urea and serum creatinine, usually reversible after discontinuation of treatment. More often observed in patients with chronic renal failure. Such patients require careful monitoring and careful titration of the dose under the control of kidney function, especially in the first few weeks of therapy (see "With caution").
In some patients without a history of renal dysfunction, there was a slight and transient increase in serum urea and creatinine, while concomitant administration of lisinopril and a diuretic. With an increase in these indices against the background of Lizinopril H STADA, it should be discontinued. It is possible to resume therapy with a combination of individual preparations of lisinopril and hydrochlorothiazide in smaller doses or any of them in monotherapy.
Patients who underwent renal transplantation. There is no experience with lisinopril in patients who have undergone kidney transplantation, so use Lizinopril H STADA in such patients with caution (see "With caution").
Hypersensitivity / angioedema. Angioedema of the face, lips, tongue, epiglottis and / or larynx, upper and lower extremities was rarely seen in patients taking lisinopril and other ACE inhibitors. It can develop in any period of treatment. A higher incidence of angioedema due to the use of ACE inhibitors is noted in representatives of the Negroid race.
In case of angioedema edema, the drug lisinopril H STADA should be immediately discontinued, the patient should be monitored until the symptoms completely regress.
With angioedema and edema of the face and lips the condition usually normalizes without additional treatment may require the appointment of antihistamines.
Angioedema, edema of the tongue, epiglottis and / or larynx can be fatal, the probability of airway obstruction is high,especially in patients with a history of surgical intervention on the respiratory organs, therefore urgent therapy is necessary (subcutaneous injection of 0.3-0.5 ml epinephrine (adrenaline) solution 1: 1000) and / or emergency measures to ensure airway patency. In the case of angioedema, only the areas of the tongue (without respiratory disorders) patients may require long-term follow-up with antihistamines and glucocorticosteroids.
With angioneurotic edema of the intestine on the background of the use of ACE inhibitors, patients with abdominal pain with nausea and vomiting (or without them); in some cases there were no indications of angioedema in the anamnesis, and C-1 esterase levels were normal. The diagnosis was confirmed by computer tomography, ultrasound of the abdominal organs or at the time of surgery, as well as resolution of symptoms after the withdrawal of the ACE inhibitor. Angioedema of the intestine should be borne in mind in the differential diagnosis of abdominal pain in patients taking the drug Lisinopril N STADA.
Patients with a history of angioedema,even unrelated to the treatment with ACE inhibitors, are at increased risk for developing angioedema due to treatment with Lysinopril H STADA (see Contraindications section).
Anaphylactic reactions during hemodialysis or apheresis of LDL. Anaphylactic reactions were noted in patients who, with the use of ACE inhibitors, underwent hemodialysis using dialysis membranes with high permeability (AN69®) or a procedure for the apheresis of low density lipoproteins using dextran sulfate (see the section "Contraindications").
If these procedures are necessary in patients taking Lisinopril H STADA, another type of membrane for dialysis, another sorbent should be considered when performing low density lipoprotein apheresis or another type of antihypertensive drug.
Anaphylactic reactions during desensitization. The appointment of ACE inhibitors against the background of desensitizing therapy with Hepaticoptera venom (bees, wasps) can lead to the development of an anaphylactic reaction. For a period of the preparation of lysinopril H STADA should be abolished.
Liver failure. Thiazide diuretics should be used with caution in the treatment of patients with liver failure, since even minor changes in the water-electrolyte balance can contribute to the development of the hepatic coma. The use of ACE inhibitors was associated (rarely) with the development of a syndrome that began with cholestatic jaundice and hepatitis and progressed to fulminant necrosis and (sometimes) death.
Patients who develop jaundice or have an increased activity of "liver" transaminases against the background of Lysinopril H STADA treatment should immediately stop taking the drug and be under close medical supervision (see the sections "Contraindications", "With caution").
Cough. As with ACE inhibitors, with the use of the drug Lysinopril H STADA, there may be a dry, long cough that disappears after withdrawal preparation.
Surgery / general anesthesia. In patients taking the drug Lisinopril N STADA,in the conduct of extensive surgery or general anesthesia with the use of drugs that cause a reduction in blood pressure, lisinopril, blocking the formation of angiotensin II, can cause a marked decrease in blood pressure; in this situation, a correction of the volume of circulating blood may be required.
Before surgery (including dental surgery), it is necessary to alert the surgeon / anesthesiologist about the use of an ACE inhibitor.
Neutropenia / agranulocytosis. In connection with the potential risk of development of neutropenia / agranulocytosis associated with the use of ACE inhibitors, against the background of treatment with the drug Lysinopril H STADA, it is necessary to periodically monitor the picture of peripheral blood. With extreme caution, use the preparation Lizinopril H STADA in patients with systemic connective tissue diseases (scleroderma, systemic lupus erythematosus), with immunosuppressants, allopurinol, procainamide or a combination of these factors, especially with concomitant renal failure (see "Interaction" ).Patients should be informed of the need to tell the doctor about any signs of an infection. In patients with normal renal function and the absence of other complicating factors, neutropenia and agranulocytosis develop rarely and are reversible in the withdrawal of an ACE inhibitor.
Hyperkalemia. Thiazide diuretics increase the excretion of potassium, whereas ACE inhibitors promote potassium retention; respectively, their combination provides prevention of both hypokalemia induced by a diuretic and hyperkalemia caused by an ACE inhibitor.
Risk factors for hyperkalemia include chronic renal failure, diabetes mellitus, the use of potassium drugs, or drugs that cause hyperkalemia (eg, heparin), especially in patients with impaired renal function. Before the beginning of treatment, if necessary, the volume of circulating blood and salts should be corrected.
Metabolic and endocrine effects. Thiazide diuretics affect glucose tolerance, so patients with diabetes mellitus may need a dosage adjustment of hypoglycemic drugs, including insulin, during treatment.With the use of thiazide diuretics, latent diabetes mellitus may appear; it is possible to increase the concentration of cholesterol and triglycerides in blood plasma in some patients there was an increase in hyperuricemia and / or clinical manifestations of gout. When used in combination with lisinopril, these side effects of hydrochlorothiazide are significantly weakened. Thiazide diuretics, by reducing the excretion of calcium ions by the kidneys can cause hypercalcemia. Expressive hypercalcemia may be a manifestation of latent hyperparathyroidism. It is recommended to stop taking Lizinopril N STADA, which includes hydrochlorothiazide, prior to the assessment of parathyroid gland function.
During the treatment with Lysinopril H STADA it is necessary to regularly monitor the glycemic and lipid profile, as well as the content of potassium, the concentration of urea and creatinine in the blood plasma.
Anti-doping test. Hydrochlorothiazide, which is part of the drug Lisinopril N STADA, can lead to a positive result of the anti-doping test.
Alcohol during the period of treatment is not recommended to use (see section "Interaction").
Racial characteristics.how and other ACE inhibitors, lisinopril when used in monotherapy may be less effective in representatives of the Negroid race, which is characterized by a low level of renin activity. This difference is virtually eliminated by the simultaneous use of lisinopril and hydrochlorothiazide.