Composition
1 tablet contains:
Active ingredient: Â
lisinopril dihydrate (lisinopril) – 10.92 mg (10.00 mg)
Pharmacological action
Inhibits ACE, prevents the transition of angiotensin I to angiotensin II, increases the concentration of endogenous vasodilating PG. Reduces the formation of arginine-vasopressin and endothelin?1, having vasoconstrictor properties. Lowers OPSS, systemic blood pressure, afterload on the myocardium, pressure in the pulmonary capillaries.
Increases cardiac output and myocardial exercise tolerance in patients with heart failure. Increases (secondary) plasma renin activity. The effect manifests itself in 1 hour, increases within 6-7 hours, and lasts up to 24 hours. The hypotensive effect reaches optimal values with repeated use for several weeks. Inhibits the tissue renin-angiotensin system of the heart, prevents the development of myocardial hypertrophy and left ventricular dilatation, or promotes their reverse development (cardioprotective effect).
Reduces the number of cases of sudden death, reduces the likelihood of recurrent myocardial infarction, coronary blood flow disorders and the occurrence of myocardial ischemia. According to a study of the ATLAS in patients with chronic heart failure, the use of lisinopril in high doses (35 mg), in comparison with its use in low doses (5 mg) reduced the combined end point: overall mortality + all causes of hospitalization at 12%, the number of hospitalization by 13%, the number of hospitalizations by reason of decompensation of heart failure by 24%.
The results of the CALM study (candesartan-lisinopril combination therapy) showed a greater severity of nephroprotective and antihypertensive effects in the group of patients receiving combined treatment after 24 weeks.
Indications
Arterial hypertension (mono – and combination therapy), including renovascular; chronic heart failure (as part of combination therapy for the treatment of patients taking digitalis preparations and/or diuretics); acute myocardial infarction (in the first 24 hours with stable hemodynamic parameters to maintain these indicators, as well as for the prevention of left heart chamber dysfunction and heart failure); diabetic nephropathy (to reduce albuminuria in insulin-dependent patients with normal blood pressure and non-insulin-dependent patients with arterial hypertension).
Contraindications
Hypersensitivity to lisinopril or other ACE inhibitors; a history of angioedema, including from the use of ACE inhibitors, hereditary angioedema or idiopathic edema; pregnancy, breast-feeding, age up to 18 years (safety and efficacy of use have not been determined).
Side effects
From the nervous system and sensory organs: headache, dizziness, increased fatigue, impaired consciousness, irritability, nervousness, transient cerebrovascular accident, fainting, ataxia, memory loss, drowsiness, insomnia, peripheral neuropathy, paresthesia, tremor, convulsions, visual disorders (diplopia, photophobia, decreased visual acuity), tinnitus. Cardiovascular and blood disorders (hematopoiesis, hemostasis): palpitations, chest pain, marked decrease in blood pressure, arrhythmia (atrial and ventricular tachycardia, atrial fibrillation, bradycardia, etc. ), cardiac arrest, myocardial infarction, orthostatic reactions, vasculitis, bone marrow depression, leukopenia, thrombocytopenia, anemia. Respiratory system disorders: dry cough, malignant lung tumors, hemoptysis, infiltration, embolism and infarction of the lung, bronchospasm, asthma, pleural effusion, pain during breathing, bronchitis, laryngitis, sinusitis, pharyngitis, rhinitis, nosebleeds, runny nose, paroxysmal postural dyspnoea. Gastrointestinal disorders: dry mouth, dyspepsia, heartburn, nausea, vomiting, diarrhea/constipation, flatulence, gastrointestinal spasms, abdominal pain, hepatotoxicity (hepatitis, cholestatic jaundice, fulminant liver necrosis with a possible fatal outcome), gastritis, pancreatitis. From the genitourinary system: impaired renal function, acute renal failure, pyelonephritis, dysuria, oliguria, anuria, uremia, edema, decreased libido, impotence. Musculoskeletal disorders: arthritis, arthralgia, myalgia, neck and back pain. Skin disorders: rash, urticaria, alopecia, photosensitization, pemphigus, skin damage and infections, toxic epidermal necrolysis, Stevens-Johnson syndrome. Other: weight loss (increase), fever, sweating, allergic reactions, including angioedema, development of infections, including herpes Zoster, diabetes mellitus, dehydration, gout, increased titer of antinuclear antibodies, creatinine, urea concentrations, hyperkalemia, hyponatremia, hyperuricemia.
Interaction
The hypotensive effect is enhanced by diuretics, weakened by Indometacin. When combined with nitrates, propranolol and digoxin, no clinically significant adverse pharmacokinetic interactions were observed. Increases the toxicity of lithium. Potassium-sparing diuretics, potassium supplements, and potassium-containing medications increase the risk of hyperkalemia.
How to take, course of use and dosage
Inside,1 time a day. The dose is determined individually, depending on the indications, the state of renal function and concomitant therapy. Usually, the initial dose is 2.5-5 mg, the average maintenance dose is 5-20 mg, and the maximum daily dose is 80 mg.
Overdose
Symptoms: acute arterial hypotension. Treatment: introduction of saline solution and other symptomatic therapy. It is removed during hemodialysis.
Special instructions
Most often, a pronounced decrease in blood pressure occurs with a decrease in BCC caused by diuretic therapy, a decrease in the content of table salt in food, dialysis, diarrhea or vomiting. Under the supervision of a doctor, it is recommended to use Lisinopril-Teva in patients with CHD, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke. The use of Lisinopril-Teva may lead to impaired renal function, acute renal failure, which is usually irreversible even after discontinuation of the drug.
Transient arterial hypotension is not a contraindication for further use of the drug.
In the case of renal artery stenosis (especially in bilateral stenosis or in the presence of stenosis of the artery of a single kidney), as well as in peripheral circulatory insufficiency caused by hyponatremia and hypovolemia, the use of Lisinopril-Teva may lead to impaired renal function, acute renal failure, which usually turns out to be irreversible after discontinuation of the drug.
Lisinopril-Teva can be used simultaneously with standard therapy for acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers).
The drug Lisinopril-Teva can be used simultaneously with intravenous use of nitroglycerin or with the use of therapeutic transdermal nitroglycerin systems.
It is not recommended to use Lisinopril-Teva in patients who have had an acute myocardial infarction, if the systolic blood pressure does not exceed 100 mm Hg. During surgical interventions, as well as when using other drugs that cause a decrease in blood pressure, lisinopril, blocking the formation of angiotensin II, can cause a pronounced unpredictable decrease in blood pressure. Before surgery (including dental surgery), the surgeon/anesthesiologist should be informed about the use of an ACE inhibitor.
In elderly patients, the use of standard doses leads to a higher concentration of the drug in the blood, so special care is required when determining the dose, despite the fact that there are no differences in the antihypertensive effect of Lisinopril-Teva in elderly and young patients.
Since the potential risk of agranulocytosis cannot be excluded, periodic monitoring of peripheral blood is required.
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 the symptoms completely regress. Angioedema with laryngeal edema can be fatal.
Edema of the tongue, epiglottis, or larynx can cause airway obstruction, so appropriate therapy (0.3-0.5 ml of 1: 1000 epinephrine (epinephrine) solution subcutaneously) and/or measures to ensure airway patency should be performed immediately. In cases where edema is localized only on the face and lips, the condition most often passes without treatment, but antihistamines can be used. ACE inhibitors are more likely to cause angioedema in black patients than in other races.
The risk of developing angioedema is increased in patients who have a history of angioedema that is not associated with previous treatment with ACE inhibitors. Patients taking ACE inhibitors during the hymenopteran venom desensitization procedure are extremely rare and may develop life-threatening anaphylactoid reactions. This can be avoided by temporarily discontinuing treatment with an ACE inhibitor before each hymenoptera desensitization procedure.Anaphylactoid reactions are also observed in patients undergoing hemodialysis using high-flow dialysis membranes (AN69®), who are simultaneously taking ACE inhibitors. In such cases, the possibility of using a different type of dialysis membrane or other antihypertensive agent should be considered. In patients receiving oral hypoglycemic drugs and insulin, blood glucose should be monitored regularly during the first month of ACE inhibitor therapy.
Very rarely, when using ACE inhibitors, a syndrome was observed that began with cholestatic jaundice and progressed to fulminant liver necrosis, sometimes with a fatal outcome. The mechanism of development of this syndrome is unknown. If jaundice occurs against the background of the use of Lisinopril-Teva or a pronounced increase in the activity of” hepatic ” transaminases, the drug is canceled and the patient’s condition is monitored.
Coughing has been reported with ACE inhibitors. The cough is dry and prolonged, which disappears after discontinuation of treatment with an ACE inhibitor. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of an ACE inhibitor.
Influence on the ability to drive vehicles and mechanisms
Caution should be exercised when taking Lisinopril-Teva due to the fact that hypotension, dizziness and drowsiness may develop, which may affect the ability to drive vehicles and work with potentially dangerous mechanisms.
Form of production
Tablets
Active ingredient
Lisinopril
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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