Iruzid, pills 10mg+12.5mg, 30pcs

Composition

1 tablet contains:

Active ingredients:

lisinopril,

hydrochlorothiazide; Auxiliary substances:

calcium phosphate dibasic,

mannitol,

corn starch, pregelatinized corn starch,

magnesium stearate,

yellow iron oxide,

purified water.

Pharmacological action

Iruzid – diuretic, antihypertensive.

Pharmacodynamics

Antihypertensive combined agent. It has antihypertensive and diuretic effects.

Lisinopril

ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of PG. Reduces OPSS, blood pressure, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and an increase in exercise tolerance in patients with chronic heart failure. Dilates the arteries to a greater extent than the veins.

Some of the effects are attributed to effects on the tissue renin-angiotensin system. With prolonged use, the severity of hypertrophy of the myocardium and arterial walls of the resistive type decreases. Improves blood supply to the 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 a myocardial infarction without clinical manifestations of heart failure.

The antihypertensive effect begins after approximately 6 hours and persists for 24 hours. The duration of the effect also depends on the dose. The action starts in 1 hour, and the maximum effect is determined in 6-7 hours. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months.

When the drug is abruptly discontinued, there is no pronounced increase in blood pressure.

In addition to lowering blood pressure, lisinopril reduces albuminuria. In patients with hyperglycemia, it helps to normalize the function of damaged glomerular endothelium.

Lisinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus 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 sodium, chlorine, potassium, magnesium, and water ions in the distal nephron; delays the excretion of calcium and uric acid ions. It has antihypertensive properties; hypotensive effect develops due to the expansion of arterioles. It has virtually no effect on normal blood pressure. The diuretic effect occurs in 1-2 hours, reaches a maximum in 4 hours and lasts 6-12 hours.

The antihypertensive effect occurs after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

Lisinopril and hydrochlorothiazide, if used simultaneously, have an additive antihypertensive effect.

Indications

Arterial hypertension (in patients who are indicated for combination therapy).

Use during pregnancy and lactation

The use of lisinopril during pregnancy is contraindicated. If pregnancy is established, Iruzide should be discontinued as soon as possible.

Taking inhibitors in the second and third trimester of pregnancy has an adverse effect on the fetus (there may be a pronounced decrease in blood pressure, renal failure, hyperkalemia, cranial hypoplasia, intrauterine death).

There are no data on the negative effects of the drug on the fetus when used during the first trimester. Newborns and children who have been exposed to intrauterine ACE inhibitors are recommended to be monitored for timely detection of a pronounced decrease in blood pressure, oliguria, and hyperkalemia.

Breastfeeding should be discontinued during treatment with Iruzide.

Contraindications

• hypersensitivity to drug, other ACE inhibitors and derivatives of sulfonamides;
• anuria;
• severe renal insufficiency (Cl creatinine < 30 ml/min);
• angioedema (including in the anamnesis in the application of ACE inhibitors);
• hemodialysis using a high-flow membranes;
• hypercalcemia;
• hyponatremia;
• porphyria;
• precoma;
• hepatic coma;
• severe forms of diabetes;
• age to 18 years (efficacy and safety not established).

With caution:  aortic stenosis/hypertrophic cardiomyopathy; bilateral renal artery stenosis; stenosis of the artery of a single kidney with progressive azotemia; condition after kidney transplantation; renal failure (creatinine clearance >30 ml/min); primary hyperaldosteronism; arterial hypotension; bone marrow hypoplasia; hyponatremia (increased risk of hypotension in patients on a low-salt or salt-free diet); hypovolemic conditions (including diarrhea, vomiting); connective tissue diseases (systemic lupus erythematosus, scleroderma); diabetes mellitus; gout, hyperuricemia; suppression of bone marrow hematopoiesis; hyperkalemia; IHD; cerebrovascular diseases (including cerebral circulatory failure); severe chronic heart failure; liver failure; elderly age.

Side effects

From the CCC side:  marked decrease Blood pressure, chest pain; rarely-orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, impaired electrical conductivity, myocardial infarction.

From the digestive tract:  nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste changes, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.

From the side of the skin:  urticaria, increased sweating, photosensitivity, pruritus, hair loss.

Nervous system disorders:  mood lability, impaired concentration, paresthesia, increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips; rarely-asthenic syndrome, confusion.

Respiratory system disorders:  dyspnoea, bronchospasm, apnea.

From the hematopoietic system:  leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decreased hemoglobin, hematocrit, erythrocytopenia).

Allergic reactions:  angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx, skin rashes, pruritus, fever, vasculitis, positive reactions to antinuclear antibodies, increased blood pressure ESR, eosinophilia.

From the genitourinary system:  uremia, oliguria/anuria, impaired renal function, acute renal failure, decreased potency.

Laboratory parameters:  hyperkalemia and/or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia, hyperglycemia, increased urea and creatinine levels in blood plasma; hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance, increased activity of hepatic transaminases, especially in the presence of a history of kidney disease, diabetes mellitus, etc. renovascular hypertension.

Other services:  dry cough, arthralgia, arthritis, myalgia, fever, fetal development disorder, gout exacerbation.

Interaction

When used concomitantly with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, the risk of hyperkalemia increases, especially in patients with impaired renal function. Therefore, they can be co-administered only on the basis of an individual decision of the attending physician, with regular monitoring of serum potassium levels and kidney function.

When used concomitantly with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants — ethanol-increased hypotensive effect.

When used concomitantly with NSAIDs (Indometacin, etc. ), estrogens — a decrease in the antihypertensive effect of lisinopril.

When used concomitantly with lithium preparations, the elimination of lithium from the body slows down (increased cardiotoxic and neurotoxic effects of lithium).

When used concomitantly with antacids and colestyramine-reduced absorption in the gastrointestinal tract.

The drug increases the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic drugs, norepinephrine, epinephrine and anti-gouty drugs, increases the effects (including side effects) of cardiac glycosides, the effect of peripheral muscle relaxants, reduces the excretion of quinidine.

Reduces the effect of oral contraceptives. Ethanol enhances the antihypertensive effect of the drug. When taking methyldopa at the same time, the risk of developing hemolysis increases.

How to take it, course of administration and dosage

With essential arterial hypertension, the drug is prescribed orally for 1 tablet 1 time a day.

If necessary, the dose can be increased to 2 tablets once a day.

Dosage for renal failure

In patients with creatinine clearance from 30 to 80 ml / min, the drug can be used only after selecting the dose of individual components of the drug. The recommended initial dose of lisinopril for uncomplicated renal failure is 5-10 mg.

Previous diuretic therapy

Symptomatic hypotension may occur after the initial dose of Iruzide. Such cases are more common in patients with fluid and electrolyte loss due to previous diuretic treatment.Therefore, you should stop taking diuretics 2-3 days before starting treatment with Iruzide

Overdose

Symptoms: marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.

Treatment: symptomatic therapy, intravenous fluid use, blood pressure control, therapy aimed at correcting dehydration and disorders of the water-salt balance. Control of urea, creatinine and electrolytes in the blood serum, as well as diuresis.

Special instructions

Symptomatic hypotension

Most often a marked decrease in blood pressure. BP occurs when fluid volume decreases due to diuretic therapy, reduced salt intake, dialysis, diarrhea, or vomiting (see “Interactions” and “Side Effects”). In patients with chronic heart failure with simultaneous renal failure or without it, a pronounced decrease in blood pressure is possible. Hypotension is more often detected in patients with severe heart failure as a result of high-dose diuretics, hyponatremia, or impaired renal function. In such patients, treatment should be started under the strict supervision of a doctor. Such rules should be followed when prescribing to patients with CHD or cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

A transient hypotensive reaction is not a contraindication for taking the next dose of the drug.

Before starting treatment, if possible, the sodium concentration should be normalized and / or the lost volume of fluid should be replenished, and the effect of the initial dose of the drug on the patient should be carefully monitored.

Impaired renal function

In patients with chronic heart failure, a pronounced decrease in Blood pressure after starting treatment with ACE inhibitors can lead to further deterioration of renal function. Cases of acute renal failure have been reported. In patients with bilateral renal artery stenosis or single kidney artery stenosis treated with ACE inhibitors, an increase in serum urea and creatinine was observed, usually reversible after discontinuation of treatment. These changes were more common in patients with renal insufficiency.

Increased sensitivity/Angioedema

Angioedema of the face, extremities, lips, tongue, epiglottis, and / or larynx may occur during any period of treatment, and has rarely been reported in patients treated with ACE inhibitors, including lisinopril. In this case, treatment with lisinopril should be discontinued as soon as possible and the patient should be monitored until symptoms fully regress. In cases where edema occurs only on the face and lips, it most often passes without treatment, but antihistamines can be prescribed.

Angioedema with laryngeal edema can be fatal. When the tongue, epiglottis, or larynx is affected, airway obstruction may occur, so appropriate therapy (0.3–0.5 ml of epinephrine (epinephrine)solution) should be given immediately 1: 1000 p / s) and / or take measures to ensure the patency of the respiratory tract.

Patients who have a history of angioedema that is not associated with previous treatment with ACE inhibitors may have an increased risk of developing angioedema during treatment with an ACE inhibitor.

Cough

When using an ACE inhibitor, a dry, prolonged cough was observed, 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.

Patients undergoing hemodialysis

Anaphylactic reaction was also observed in patients undergoing hemodialysis using dialysis membranes with high permeability, who simultaneously take ACE inhibitors. In such cases, the possibility of using a different type of dialysis membrane or another antihypertensive drug should be considered.

Surgery/General anesthesia

When using blood pressure-lowering drugs in patients undergoing extensive surgery or during general anesthesia, lisinopril may block the formation of angiotensin II. Marked decrease BP, which is considered a consequence of this mechanism, can be eliminated by increasing the BCC.

Before surgery (including dental surgery), the surgeon/anesthesiologist should be warned about the use of ACE inhibitors.

Serum Potassium

In some cases, hyperkalemia was observed.

Risk factors for developing hyperkalemia include renal failure, diabetes mellitus, taking potassium supplements or drugs that cause an increase in the concentration of potassium in the blood (for example, heparin), especially in patients with impaired renal function.

In patients who are at risk of symptomatic hypotension (those on a low-salt or salt-free diet) with or without hyponatremia, as well as in patients who have received high doses of diuretics, fluid and salt loss should be compensated before starting treatment.

Metabolic and endocrine effects

Thiazide diuretics can affect glucose tolerance, so it is necessary to adjust the dose of antidiabetic drugs.

Thiazide diuretics may reduce urinary calcium excretion and cause hypercalcemia. Severe hypercalcemia may be a symptom of latent hyperparathyroidism. It is recommended to discontinue treatment with thiazide diuretics before performing a parathyroid function test.

During treatment with the drug, regular monitoring of blood plasma potassium, glucose, urea and lipids is necessary.

During the treatment period, it is not recommended to consume alcoholic beverages, because alcohol increases the hypotensive effect of the drug.

Caution should be exercised when exercising, in hot weather (risk of dehydration and excessive weight loss). Blood pressure due to a decrease in BCC).

Influence on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. During the treatment period, you should refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, since dizziness is possible, especially at the beginning of the course of treatment.

Form of production

Iruzid tablets.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Lisinopril, Hydrochlorothiazide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets