Expiration date: 02/2025
Release form and composition:
Pill light blue color, ploskotsylindriceskie, with facet, with engraving C43 on one side.
1 tablet contains:
lisinopril dihydrate 10.89 mg,
EMCO corresponds to the content of lisinopril 10 mg
hydrochlorothiazide 12.5 mg
Auxiliary substances: mannitol, aluminum lacquer dye indigotine (E132), pregelatinization starch, corn starch, calcium hydrogen phosphate dihydrate, starch partly Pregelatinised, magnesium stearate.
10 PCs. - blisters (1) - packs of cardboard.
10 PCs. - blisters (3) - cardboard packs.
Pill light green color, ploskotsylindriceskie, with facet, with engraving C44 on the same side.
1 tablet contains:
lisinopril dihydrate 21.77 mg,
EMCO corresponds to the content of lisinopril 20 mg
hydrochlorothiazide 12.5 mg
Auxiliary substances: mannitol, aluminum lacquer dye indigotine (E132), dye iron oxide yellow (E172), Pregelatinised starch, corn starch, calcium hydrogen phosphate dihydrate, starch partly Pregelatinised, magnesium stearate.
10 PCs. - blisters (1) - packs of cardboard.
10 PCs. - blisters (3) - cardboard packs.
Pharmacological action:
Antihypertensive drug. It has antihypertensive and diuretic effect.
Lisinopril
ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. Reducing the content of angiotensin II leads to a direct reduction in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces OPSS, blood PRESSURE, preload, pressure in the pulmonary capillaries, causes an increase in minute blood volume and increased tolerance to stress in patients with chronic heart failure. Dilates arteries to a greater extent than veins. Some effects are explained by the effect on tissue renin-angiotensin systems. With long-term use decreases the severity of myocardial hypertrophy and arterial walls resistive type. Improves blood flow to ischemic myocardium.
ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients who have suffered myocardial infarction without clinical manifestations of heart failure. The antihypertensive effect starts in approximately 6 hours and persists for 24 h. the Duration of effect depends on dose. Onset of action through 1 h. the Maximum effect is determined through 6-7 h In hypertension, the effect is noted in the first days after the start of treatment, stable effect develops in 1-2 months.
With the abrupt withdrawal of the drug, there is no marked increase in blood PRESSURE.
In addition to reducing blood PRESSURE lisinopril reduces albuminuria. In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.
Lisinopril does not affect the concentration of glucose in the blood of patients with diabetes and does not lead to an increase in cases of hypoglycemia.
Hydrochlorothiazide
Thiazide diuretic, the diuretic effect of which is associated with a violation of the reabsorption of ions of sodium, chlorine, potassium, magnesium, water in the distal nephron delays the excretion of calcium ions, uric acid. Has antihypertensive properties hypotensive effect develops due to the expansion of arterioles. Practically does not affect the normal level of blood PRESSURE.
Dioreticeski effect develops through 1-2 h, reaches a maximum after 4 h and lasts 6-12 h. Antihypertensive activity occurs within 3-4 day, but to achieve optimal therapeutic effect may be required 3-4 of the week.
Lisinopril and hydrochlorothiazide, if used simultaneously, have an additive antihypertensive effect.
Pharmacokinetics:
Lisinopril after receiving lisinopril inside the maximum concentration in serum is achieved after 7 no. Weakly bound to plasma proteins. The average degree of absorption of lisinopril is about 25%, with significant interindividual variability (6-60%). The food does not affect the absorption of lisinopril. Lisinopril is not metabolized and excreted unchanged solely by the kidneys. After repeated administration, the effective half-life of lisinopril is 12 no. Impaired renal function slows down the excretion of lisinopril, but this slowdown becomes clinically significant only when the glomerular filtration rate decreases below 30 ml/min.elderly patients have an average of 2 times higher level of the maximum concentration of the drug in the blood and AUC(the area under the curve aquconcentration in plasma - time raqu), compared with younger patients. Lisinopril is excreted from the body by hemodialysis.
To a small extent it penetrates the blood-brain barrier.
Hydrochlorothiszide not metabolized, but undergoes rapid excretion through the kidneys. The half-life of the drug ranges from 5, 6 to 14, 8 a.m. at least 61% of the interior of the drug is excreted unchanged within 24 h. Hydrochlorothiazide crosses the placental barrier, but does not penetrate the blood-brain barrier.
Indications:
- arterial hypertension (in patients, which shows the combined therapy).
Dosage regimen:
Assign inside of 1 tab. 1 time / day. If within 2-4 weeks is not achieved due therapeutic effect, the dose may be increased to 2 tab. 1 time / day.
In patients with CC 30-80 ml / min drug can be used only after the selection of the dose of the individual components of the drug. The recommended initial dose of lisinopril in uncomplicated renal failure is 5-10 mg.
Symptomatic hypotension may occur after taking the initial dose. Such cases are more common in patients who have had fluid and electrolyte loss due to previous diuretic treatment. Therefore, you should stop taking diuretics for 2-3 days before treatment.
Side effect:
The most common side effects: dizziness, headache.
From the cardiovascular system: a marked decrease in blood PRESSURE, chest pain rarely-orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, violation of AV conduction, myocardial infarction.
From the digestive system: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste change, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.
On the part of the skin: urticaria, sweating, photosensitization, itching, hair loss.
From the Central nervous system: lability of mood, impaired concentration, paresthesia, fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips rarely - asthenic syndrome, confusion.
Respiratory system: dyspnea, dry cough, bronchospasm, apnea.
From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, hematocrit, erythrocytopenia).
Allergic reactions: angioedema of the face, limbs, lips, tongue, epiglottis and/or larynx, skin rashes, itching, fever, vasculitis, positive reactions to antinuclear antibodies, increased ESR, eosinophilia.
From the genitourinary system: uremia, oliguria / anuria, renal dysfunction, acute renal failure, decreased potency.
Laboratory findings: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia, hyperglycemia, increased plasma levels of urea and creatinine, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, reduced glucose tolerance, increased liver transaminase activity, especially in the history of kidney disease, sugar diabetes and renovascular hypertension.
Other: arthralgia, arthritis, myalgia, fever, violation of fetal development, exacerbation of gout.
Contraindications:
- angioneurotic edema (including angioedema in history, associated with the use of ACE inhibitors)
- anuria
- expressed kidney failure (KK less 30 ml/min)
- hemodialysis using high-flow membranes
- hypercalcemia
- hyponatremia
- porphyria
- precoma
- hepatic coma
- severe forms of diabetes
- age up to 18 years (efficacy and safety not established)
- hypersensitivity to lisinopril, other ACE inhibitors or hydrochlorothiazide and auxiliary substances.
Caution: aortic stenosis/hypertrophic cardiomyopathy, bilateral renal artery stenosis, stenosis of artery only kidneys with progressive azotemia, condition after kidney transplantation, renal failure (QC more 30 ml/min), primary aldosteronism, arterial hypotension, bone marrow hypoplasia, hyponatremia (increased risk of hypotension in patients on malosolenoj or salt-free diet), hypovolemic state (i.e. diarrhea, vomiting), connective tissue diseases (including systemic lupus erythematosus, scleroderma), diabetes mellitus, gout, oppression of bone marrow hematopoiesis, hyperuricemia, hyperkalemia, IHD, cerebrovascular diseases (including cerebrovascular insufficiency), severe chronic heart failure, liver failure, old age.
Pregnancy and lactation:
The use of lisinopril in pregnancy is contraindicated. Upon determination of the pregnancy the drug you need to stop as early as possible. Taking ACE inhibitors in the II and III trimesters of pregnancy has an adverse effect on the fetus (there may be a marked decrease in blood PRESSURE, renal failure, hyperkalemia, hypoplasia of the bones of the skull, intrauterine death). Data on the negative effects of the drug on the fetus in the case of use during the first trimester no. For newborns and infants who have undergone intrauterine exposure to ACE inhibitors, it is recommended to monitor for the timely detection of a marked decrease in blood PRESSURE, oliguria, hyperkalemia.
During treatment with the drug it is necessary to cancel breastfeeding.
Special instruction:
Most often, a marked decrease in blood PRESSURE occurs with a decrease in the volume of fluid caused by diuretic therapy, a decrease in the amount of salt in food, dialysis, diarrhea or vomiting.
In patients with chronic heart failure with simultaneous renal failure or without it, may be a marked decrease in blood PRESSURE. It is more common in patients with severe chronic heart failure, as a result of the use of large doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment should begin under the strict supervision of a doctor. Such rules should be followed when appointing patients with coronary artery disease, cerebrovascular insufficiency, in which a sharp decrease in blood PRESSURE can lead to myocardial infarction or stroke.
Transient arterial hypotension is not a contraindication for further administration of the drug.
Before treatment, if possible, it is necessary to normalize the concentration of sodium and / or fill the lost volume of fluid, carefully monitor the effect of the initial dose of the drug on the patient.
In patients with chronic heart failure, a marked decrease in blood PRESSURE after initiation of treatment with ACE inhibitors can lead to further deterioration of renal function. Cases of acute renal failure were noted.
Patients with bilateral renal artery stenosis or renal artery stenosis, receiving ACE inhibitors, there was an increase in urea and serum creatinine, usually reversible after discontinuation of treatment. More common in patients with renal insufficiency.
Angioedema of the face, limbs, lips, tongue, epiglottis and/or larynx was rare in patients treated with ACE inhibitors, including lisinopril, which may occur at any time of treatment. In this case, treatment with lisinopril should be stopped as soon as possible and the patient should be monitored until complete regression of symptoms. In cases where there was only swelling of the face and lips, the condition often passes without treatment, however, it is possible to prescribe antihistamines. Angioedema with laryngeal edema can be fatal. When the tongue, epiglottis or larynx are covered, airway obstruction may occur, so appropriate therapy (0.3-0.5 ml of epinephrine (epinephrine) 1:1000 p/K) and/or measures to ensure airway patency should be carried out immediately.
Patients who have a history of angioedema, not associated with previous treatment with ACE inhibitors, may be at increased risk of its development during treatment with ACE inhibitor.
With the use of ACE inhibitors was noted to cough. Cough dry, long, which disappears after discontinuation of treatment with ACE inhibitor. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of ACE inhibitor.
Anaphylactic reaction was also noted in patients subjected to hemodialysis using dialysis membranes with high permeability (AN69®), which simultaneously take ACE inhibitors. In such cases, it is necessary to consider the possibility of using another type of membrane for dialysis or other antihypertensive agent.
When using drugs that reduce blood pressure, patients with extensive surgery or during General anesthesia, lisinopril may block the formation of angiotensin II.
The marked decrease in blood PRESSURE, which is considered a consequence of this mechanism, can be eliminated by increasing the BCC.
Before surgery (including dentistry) it is necessary to warn the anesthesiologist about the use of ACE inhibitors.
In some cases, hyperkalemia was noted. Risk factors for hyperkalemia include kidney failure, diabetes, potassium supplementation, or drugs that cause an increase in the concentration of potassium in the blood (eg, heparin), especially in patients with impaired renal function.
In patients who are at risk of symptomatic hypotension (who are on a low-salt or salt-free diet) with or without hyponatremia, as well as in patients who received high doses of diuretics, the above conditions must be compensated before treatment (loss of fluid and salts).
Thiazide diuretics can affect glucose tolerance, so it is necessary to adjust the dose of hypoglycemic agents for oral administration. Thiazide diuretics can reduce the release of calcium by the kidneys and cause hypercalcemia. Severe hypercalcemia may be a symptom of latent hyperparathyroidism. It is recommended to stop treatment with thiazide diuretics before the test to assess the function of the parathyroid glands.
During treatment with the drug requires regular monitoring of blood plasma potassium, glucose, urea, lipids.
During treatment, it is not recommended to drink alcoholic beverages, because alcohol increases the hypotensive effect of the drug.
Caution should be exercised when exercising, hot weather (risk of dehydration and excessive reduction of blood PRESSURE due to lower BCC).
Impact on the ability to drive and operate machinery
During treatment, you should refrain from driving and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions, as possible dizziness, especially at the beginning of treatment.
Overdose:
Symptoms: marked decrease in blood PRESSURE, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.
Treatment: symptomatic therapy, intravenous fluid, blood PRESSURE control therapy, aimed at correcting dehydration and violations of water-salt balance. Control of urea, creatinine and serum electrolytes, as well as diuresis.
Drug interaction:
With simultaneous use with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, increases the risk of hyperkalemia, especially in patients with impaired renal function. Therefore, they can be jointly prescribed only on the basis of an individual doctor's decision with regular monitoring of serum potassium levels and kidney function.
While the use of vasodilators, barbiturates, phenothiazine, tricyclic antidepressants, ethanol has increased hypotensive action.
With simultaneous use with NSAIDs (indomethacin and others), estrogens, there is a decrease in the antihypertensive effect of lisinopril.
While the use of lithium drugs slows the excretion of lithium from the body (increased cardiotoxic and neurotoxic effects of lithium).
While the use of antacids and colestyramine decreases absorption in the gastrointestinal tract.
The drug increases the neurotoxicity of salicylates, weakens the action of hypoglycemic drugs for oral administration, norepinephrine, epinephrine and anti-podagric drugs, enhances the effects (including side) cardiac glycosides, the action of peripheral muscle relaxants, reduces the excretion of quinidine.
Reduces the effect of oral contraceptives.
Ethanol increases the hypotensive effect of the drug.
While taking methyldopa increases the risk of hemolysis.
Terms and conditions of storage:
The drug should be stored out of reach of children at temperature not exceeding 30°C. shelf Life - 2 years.
