Lisinopril Stada tablets 5 mg 30 pcs ➤ instructions for use

Lisinopril: active ingredients

The name of the drug is identical to its active substance - lisinopril dihydrate. Separately, you can find the drug under other trade names. As a rule, its cost under other names is significantly higher.

The following can be used as auxiliary components by various manufacturers:

• corn starch or pregelatinized;
• calcium hydrogen phosphate;
• mannitol;
• magnesium stearate;
• colloidal silicon dioxide;
• microcrystalline cellulose;
• talc.

The drug is produced in the form of oblong white tablets. Its edges are rounded and there is a risk in the center. Each tablet contains 5 mg, 10 mg or 20 mg of active ingredient. The medicine is packaged in 10 tablets in a blister. The package contains 30 doses (3 blisters).

How does Lisinopril work?

The drug acts on the renin-angiotensin system of the heart, interfering with dilatation of the left ventricle. At the same time, there is a decrease in the load on the myocardium. The substance reduces pressure in the capillaries of the lungs, as well as in peripheral vessels. When treated with Lisinopril, the tolerance of the cardiac myocardium to increased stress increases. In addition, the activity of renil in plasma increases.

After taking a single dose, the first positive effect occurs after 50-60 minutes. The manifestation of the therapeutic effect intensifies within 7 hours and persists throughout the day. Therapy lasting for several weeks achieves the maximum possible hypotensive effect.

Eating does not interfere with the absorption of the active substance, but at the same time does not contribute to it. Therefore, taking the medicine does not depend on the time of eating. Absorption of Lisinopril reaches 25%. The drug molecules bind weakly to blood proteins. Half-life occurs after 12 hours. Substances are excreted unchanged by the kidneys. Lisinopril does not form metabolites.

Overdose of the drug Lisinopril-ratiopharm, symptoms and treatment

A sharp decrease in blood pressure with impaired perfusion of vital organs, shock, imbalance of blood electrolytes, acute renal failure, tachycardia, bradycardia, dizziness, anxiety and cough. It is necessary to stop using the drug. In case of intoxication, gastric lavage is recommended. In case of arterial hypotension, the patient should be placed on his back with his legs raised up. To correct blood pressure, intravenous administration of physiological solution and/or plasma substitutes is indicated. If necessary, angiotensin is administered intravenously. Lisinopril can be removed from the body using hemodialysis (during this, high-flow polyacrylonitrile metalsulfonate membranes, for example AN69, cannot be used). In case of life-threatening angioedema, the use of antihistamines is necessary. If the clinical situation is accompanied by swelling of the tongue, glottis, or larynx, it is necessary to urgently begin treatment with subcutaneous administration of 0.3–0.5 ml of adrenaline solution (1:1000); intubation or laryngotomy is indicated to ensure airway patency . If bradycardia persists after therapy, it is necessary to perform electrical stimulation. It is necessary to constantly monitor vital signs, serum electrolyte concentrations and creatinine.

What is lisinopril prescribed for?

The name of the drug suggests that it belongs to the so-called group of “by-catch”, the action of which is primarily aimed at lowering blood pressure in the fight against hypertension. However, a doctor may prescribe treatment with Lisinopril in other cases:

• for chronic heart failure;
• in acute myocardial infarction not accompanied by arterial hypotension;
• to combat nephropathy of diabetic etiology, both type 1 and type 2.
• with arterial hypertension.

Self-administration of the drug is unacceptable. The dose, frequency of doses and duration of treatment are determined only by the doctor.

Interactions of the drug Lisinopril-ratiopharm

Alcohol, diuretics and other antihypertensive drugs (α- and β-adrenergic receptor blockers, calcium antagonists, etc.) potentiate the hypotensive effect of lisinopril. When used simultaneously with potassium-sparing diuretics (spironolactone, amiloride, triamterene), hyperkalemia may develop, therefore, when using these drugs, it is necessary to monitor the concentration of potassium in the blood plasma. Hyperkalemia is also possible with the simultaneous use of cyclosporine, potassium supplements, and nutritional supplements containing potassium, which is of particular importance for diabetes mellitus and renal failure. NSAIDs (especially indomethacin), sodium chloride reduce the antihypertensive effect of lisinopril. When used with lithium preparations, there may be a delay in the excretion of lithium from the body and, accordingly, an increase in the risk of its toxic effect. It is necessary to constantly monitor the level of lithium in the blood. Bone marrow depressants combined with lisinopril increase the risk of neutropenia and/or agranulocytosis. Allopurinol, cytostatics, immunosuppressants, corticosteroids, procainamide, when used simultaneously with lisinopril, can cause the development of leukopenia. Estrogens and sympathomimetics reduce the antihypertensive effectiveness of lisinopril. Lisinopril-ratiopharm can be used simultaneously with glyceryl trinitrate, which is administered intravenously or transdermally. Prescribe with caution to patients with acute myocardial infarction for 6–12 hours after administration of streptokinase (risk of hypotension). Lisinopril-ratiopharm enhances the manifestations of alcohol intoxication. Narcotics, anesthetics, sleeping pills, tricyclic antidepressants enhance the hypotensive effect. When performing dialysis during therapy with lisinopril, there is a risk of developing anaphylactic reactions if high-flow polyacrylonitrile metalsulfonate membranes (for example AN69) are used. Hypoglycemic oral drugs (for example, sulfonyl urea derivatives - metformin, biguanides - glibenclamide) and insulin when used with ACE inhibitors can enhance the hypotensive effect, especially at the beginning of treatment. Taking antacids may reduce the hypotensive effect.

Contraindications to the use of Lisinopril

Contraindications to the use of Lisinopril are pregnancy and breastfeeding. If the expectant mother suffers from hypertension, her condition is monitored in a hospital setting. High blood pressure in such cases is corrected with safe doses of diuretics.

If replacing the drug during breastfeeding is not possible, you should definitely transfer the child to artificial feeding or feeding with donor milk.

Other contraindications are:

• excess potassium in the blood;
• renal dysfunction;
• gout;
• renal artery stenosis;
• elderly age;
• cerebrovascular insufficiency;
• hypotension;
• childhood;
• tissue obstruction that interferes with normal outflow;
• availability of a donor kidney.

Lisinopril

Arterial hypotension

Most often, a pronounced decrease in blood pressure occurs with a decrease in blood volume caused by diuretic therapy, a decrease in the content of sodium chloride in food, dialysis, diarrhea or vomiting. In patients with CHF and with or without concurrent renal failure, a pronounced decrease in blood pressure is possible. When using the drug Lisinopril, some patients with CHF, but with normal or reduced blood pressure, may experience a marked decrease in blood pressure, which is usually not a reason to discontinue treatment.

In such patients, treatment with Lisinopril should be started under the strict supervision of a physician (with caution in selecting the dose of the drug and diuretics).

Before starting treatment with the drug, if possible, the sodium content should be normalized and/or the blood volume should be replenished, and the effect of the initial dose of Lisinopril on the patient should be carefully monitored.

Under strict medical supervision, Lisinopril should be used in patients with coronary heart disease, cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke. Transient arterial hypotension is not a contraindication for further use of the drug. After blood pressure has been restored, it is possible to continue using the drug.

Renal dysfunction

In patients with impaired renal function (creatinine clearance less than 80 ml/min), the initial dose of lisinopril should be changed in accordance with the creatinine clearance (see section "Dosage and Administration"). Regular monitoring of potassium levels and creatinine concentrations in blood plasma is a mandatory treatment strategy for such patients. In patients with CHF, arterial hypotension can lead to deterioration of renal function. Cases of acute renal failure, usually reversible, have been reported in such patients. In case of acute myocardial infarction, drug therapy should not be started in patients with signs of renal impairment, i.e. with a plasma creatinine concentration of 177 µmol/l and/or proteinuria more than 500 mg/day. If renal function is impaired during the use of the drug (creatinine concentration exceeds 265 µmol/l or its value doubles before the start of therapy), it is necessary to consider discontinuing the drug.

Renal artery stenosis

In case of renal artery stenosis (especially with bilateral stenosis or in the presence of stenosis of the artery of a single kidney), as well as with peripheral circulatory failure due to a lack of sodium ions and/or fluid, the use of the drug Lisinopril can lead to impaired renal function, acute renal failure, which usually turns out to be irreversible even after discontinuation of the drug.

In acute myocardial infarction

The drug Lisinopril can be used simultaneously with standard therapy for acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers).

The drug Lisinopril can be used simultaneously with a solution of nitroglycerin for intravenous administration or with nitroglycerin for administration using therapeutic transdermal systems, as well as nitroglycerin for sublingual use. The use of Lisinopril is not recommended in patients who have suffered acute myocardial infarction if systolic blood pressure does not exceed 100 mmHg. rt. Art. In case of persistent arterial hypotension (SBP less than 90 mm Hg for more than 1 hour), the drug must be discontinued.

Surgery/general anesthesia

During extensive surgical interventions, as well as when using other drugs that cause a decrease in blood pressure, lisinopril, by blocking the formation of angiotensin II, can cause a pronounced, unpredictable decrease in blood pressure. Before surgery (including dentistry), the surgeon/anesthesiologist should be informed about the use of an ACE inhibitor.

In elderly patients, the use of standard doses leads to higher concentrations of lisinopril in the blood, so special care is required when determining the dose.

Mitral stenosis/aortic stenosis/hypertrophic obstructive cardiomyopathy

Lisinopril, like other ACE inhibitors, should be administered with caution to patients with left ventricular outflow tract obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as to patients with mitral stenosis.

Anaphylactoid reactions during desensitization

There are isolated reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy, for example, with hymenoptera venom. ACE inhibitors should be used with caution in patients susceptible to allergic reactions undergoing desensitization procedures. The use of ACE inhibitors should be avoided in patients receiving bee venom immunotherapy. However, this reaction can be avoided by temporarily discontinuing the ACE inhibitor before starting the desensitization procedure.

Hypersensitivity/angioedema

Angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx, which may occur during any period of treatment, has rarely been reported in patients taking an ACE inhibitor, including lisinopril. In this case, treatment with the drug should be stopped as soon as possible, and the patient should be monitored until symptoms completely regress. Angioedema with laryngeal edema can be fatal. Swelling of the tongue, epiglottis or larynx can cause airway obstruction, so appropriate therapy (0.3-0.5 ml of 1:1000 epinephrine (adrenaline) solution subcutaneously) and/or measures to ensure airway patency should be immediately carried out. In cases where the swelling is localized only on the face and lips, the condition most often goes away without treatment, but the use of antihistamines is possible.

The risk of developing angioedema is increased in patients who have a history of angioedema not associated with previous treatment with ACE inhibitors.

In rare cases, intestinal angioedema develops during therapy with ACE inhibitors. In this case, patients experience abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without previous angioedema of the face and with normal levels of Cl-esterase. The diagnosis is made using computed tomography of the abdominal cavity, ultrasound, or at the time of surgery. Symptoms disappear after stopping ACE inhibitors. In patients with abdominal pain taking ACE inhibitors, the possibility of developing angioedema of the intestine must be taken into account when making a differential diagnosis.

Concomitant use with mTOR inhibitors

(mammalian Target of Rapamycin - target of rapamycin in mammalian cells), for example, temsirolimus, sirolimus, everolimus, racecadotril (an enkephalinase inhibitor used to treat acute diarrhea), estramustine

In patients concomitantly receiving therapy with mTOR inhibitors, racecadotril, estramustine, the risk of developing angioedema (for example, swelling of the airways or tongue with or without impairment of respiratory function) may be increased (see section "Interaction with other drugs").

Anaphylactic reactions during low-density lipoprotein (LDL) apheresis

In rare cases, life-threatening anaphylactoid reactions may occur in patients receiving ACE inhibitors during LDL apheresis using dextran sulfan. To prevent an anaphylactoid reaction, ACE inhibitor therapy should be temporarily discontinued before each apheresis procedure.

Hemodialysis

Anaphylactoid reactions have also been observed in patients on hemodialysis using high-flow dialysis membranes (eg, AN69®) who are also taking ACE inhibitors. In such cases, the use of a different type of dialysis membrane or another antihypertensive agent should be considered.

Neutropenia/agranulocytosis/thrombocytopenia/anemia

During therapy with ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may develop. With normal renal function and the absence of other complications, neutropenia rarely occurs. ACE inhibitors are used only in emergency cases in the presence of systemic vasculitis, immunosuppressive therapy, taking allopurinol or procainamide, as well as when combining all of these factors, especially against the background of previous renal failure. There is a risk of developing severe infectious diseases that are resistant to intensive antibiotic therapy. When carrying out therapy with Lisinopril in patients with the above factors, it is necessary to regularly monitor the number of leukocytes.

Lithium preparations

The combined use of Lisinopril and lithium preparations is not recommended (see section “Interaction with other drugs”).

Dry cough

Cough has been reported when using ACE inhibitors. The cough is dry and prolonged, which disappears after stopping treatment with an ACE inhibitor. In the differential diagnosis of cough, cough caused by the use of an ACE inhibitor must also be taken into account.

Ethnic differences

It should be taken into account that patients of the Negroid race have a higher risk of developing angioedema. Like other ACE inhibitors, lisinopril is less effective in lowering blood pressure in black patients. This effect may be associated with a pronounced predominance of low-renin status in black patients with arterial hypertension.

Double blockade of the RAAS

Cases of hypotension, syncope, stroke, hyperkalemia and renal dysfunction (including acute renal failure) have been reported in susceptible patients, especially when used concomitantly with drugs that affect this system. Therefore, double blockade of the RAAS by combining an ACE inhibitor with an ARA II or aliskiren is not recommended. Combination with aliskiren and drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate or severe renal impairment (GFR <60 ml/min/1.73 m2 body surface area) (see sections "Contraindications" and "Interaction" with other drugs") and is not recommended in other patients.

Concomitant use of lisinopril and ARB II in patients with diabetic nephropathy is contraindicated and is not recommended in other patients.

Potassium-sparing diuretics, potassium supplements, potassium-containing table salt substitutes and food supplements

Concomitant use with ACE inhibitors is not recommended (see section “Interaction with other drugs”).

Patients with diabetes mellitus

When using the drug in patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, blood glucose concentrations should be regularly monitored during the first month of therapy.

Liver dysfunction

The use of ACE inhibitors can lead to the development of cholestatic jaundice with progression up to fulminant liver necrosis, so it is necessary to stop taking the drug if the activity of “liver” transaminases increases and symptoms of cholestasis appear.

Hyperkalemia

During therapy with ACE inhibitors, including lisinopril, hyperkalemia may develop. Risk factors for hyperkalemia include renal failure, old age, diabetes mellitus, certain concomitant conditions (for example, decreased blood volume, acute heart failure, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as potassium supplements or potassium-containing substitutes for table salt and the use of other drugs that increase the content of potassium in the blood plasma (for example, heparin). Hyperkalemia can cause serious heart rhythm problems, sometimes fatal. The simultaneous use of the above drugs should be carried out with caution.

Kidney transplant

There are no data on the use of lisinopril after kidney transplantation. Primary hyperaldosteronism

Patients with primary hyperaldosteronism are usually resistant to treatment with antihypertensive drugs that affect the RAAS. In this regard, Lisinopril is not recommended for use in such patients.

It is not recommended to drink alcohol (ethanol) during treatment with Lisinopril.

Lisinopril: instructions for use

The drug is taken once a day. It is important to observe the time interval between medication doses. Superimposing the effect of one dose on another threatens severe hypotension, up to loss of consciousness.

If the first tablet was taken at lunch, then the second tablet should not be taken in the morning hours of the next day. It is important to keep taking your medication at lunchtime.

A single dose is prescribed by the attending physician based on the following studies:

• blood pressure conditions;
• heart function;
• vascular health;
• risk factors.

If an increase in the single dose is not required, as a rule, a single dose of 2.5 mg of Lisinopril is sufficient to normalize the patient's condition. Dose adjustments can be made no earlier than after 4 weeks of continuous use of the drug, since it is after this time that the maximum possible therapeutic effect is achieved.

If increasing the dose does not give the required result, a similar drug from a different pharmacological group is prescribed, the action of which in a different way will help normalize blood pressure.

If treatment of an insulin-dependent patient is required, Lisinopril is taken under the strict supervision of a specialist in a hospital setting.