Iruzid, 20 mg+12, 5 mg tablets, 30 pcs.

Iruzid is a diuretic, antihypertensive.

Pharmacodynamics

Hypotensive combined agent. It has antihypertensive and diuretic action.

Lisinopril

A ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. Reduction of angiotensin II leads to a direct reduction of aldosterone release. Reduces bradykinin degradation and increases GH synthesis. Reduces RPS, BP, preload, pulmonary capillary pressure, causes an increase in the minute blood volume and increases exercise tolerance 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. Long-term use reduces the severity of myocardial hypertrophy and resistive arterial walls. It improves the blood supply to the ischemic myocardium.

The ACE inhibitors prolong life expectancy in patients with chronic heart failure and slow the progression of left ventricular dysfunction in patients who have had myocardial infarction without clinical manifestations of heart failure.

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

When the drug is abruptly withdrawn, no pronounced increase in BP is observed.

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

Lisinopril does not affect blood glucose concentrations in patients with diabetes mellitus and does not lead to increased incidence of hypoglycemia.

Hydrochlorothiazide

Thiazide diuretic whose diuretic effect is associated with disruption of reabsorption of sodium, chloride, potassium, magnesium and water ions in the distal nephron; it delays excretion of calcium and uric acid ions. It has antihypertensive properties; hypotensive effect is developed due to dilation of the arterioles.

It has practically no effect on normal BP. Diuretic effect occurs after 1-2 hours, reaches a maximum after 4 hours and lasts for 6-12 hours.

The antihypertensive effect occurs within 3-4 days, but it may take 3-4 weeks to achieve 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).

Composition

1 tablet contains:

Active substances:

lisinopril,

hydrochlorothiazide;

Associates:

calcium phosphate bicarbonate,

mannitol,

corn starch,

Pregelatinized corn starch,

magnesium stearate,

iron oxide yellow,

purified water.

How to take, the dosage

In cases of essential arterial hypertension, the drug is prescribed orally 1 tablet once a day.

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

Dose in renal failure

In patients with creatinine Cl 30 and up to 80 ml/min, the drug can be used only after adjustment of the dose of individual components of the drug. The recommended starting dose of lisinopril in uncomplicated renal failure is 5-10 mg.

Pre-treatment with diuretics

Symptomatic hypotension may occur after the initial dose of Irusid®. This is more common in patients with fluid and electrolyte loss due to prior diuretic treatment. Therefore it is necessary to discontinue diuretics 2-3 days prior to start of treatment with Iruside®.

Interaction

In concomitant use with potassium-saving diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium – the risk of hyperkalemia increases, especially in patients with impaired renal function. This is why they can be combined only on the basis of an individual decision of the attending physician with regular monitoring of serum potassium levels and renal function.

In concomitant use with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol – increased hypotensive effect.

In concomitant use with NSAIDs (indomethacin, etc.), estrogens – reduction of the antihypertensive effect of lisinopril.

In concomitant use with lithium preparations, the elimination of lithium from the body is delayed (increase of the cardiotoxic and neurotoxic effects of lithium).

In concomitant use with antacids and colestiramine – reduced absorption in the gastrointestinal tract.

The drug increases neurotoxicity of salicylates, attenuates the effects of oral hypoglycemic agents, norepinephrine, epinephrine and antipodagric agents, increases the effects (including side effects) of cardiac glycosides, effects of peripheral myorelaxants, reduces excretion of quinidine.

Decreases the effect of oral contraceptives. Ethanol increases the hypotensive effect of the drug. Concomitant administration of methyldopa increases the risk of hemolysis.

Special Instructions

Symptomatic hypotension

A pronounced BP decrease most often occurs with a decrease in fluid volume caused by diuretic therapy, reduction of salt in food, dialysis, diarrhea or vomiting (see “Interactions” and “Adverse effects”). In patients with chronic heart failure with concomitant renal failure or without it, marked BP decrease is possible. Hypotension is more often revealed in patients with severe heart failure as a consequence of using high doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment should be started under strict medical supervision. Similar rules should be followed when prescribing to patients with CHD or cerebrovascular insufficiency, in whom a sharp decrease in BP may lead to myocardial infarction or stroke.

Transient hypotensive reaction is not a contraindication for the next dose of the drug.

Before starting treatment, if possible, normalize sodium concentration and/or replenish lost fluid volume, and carefully monitor the effect of the initial dose of the drug on the patient.

Renal dysfunction

In patients with chronic heart failure, a marked decrease in BP after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. Cases of acute renal failure have been reported. In patients with bilateral renal artery stenosis or artery stenosis of the only kidney receiving ACE inhibitors, there have been increased serum urea and creatinine, usually reversible after discontinuation of treatment. These changes occurred more frequently in patients with renal insufficiency.

Hypersensitivity/Angeoneurotic edema

Angeoneurotic edema of the face, extremities, lips, tongue, epiglottis and/or larynx may occur during any period of treatment, rarely observed in patients treated with ACE inhibitors, including lisinopril. In such a case, lisinopril treatment should be discontinued as soon as possible and the patient should be monitored until the symptoms have completely resolved. If the swelling is limited to the face and lips, it usually resolves without treatment, but antihistamines may be prescribed.

The angioedema with laryngeal edema can be fatal. When the tongue, epiglottis or larynx are involved, airway obstruction may occur, so appropriate therapy (0.3-0.5 ml of epinephrine (adrenaline) solution 1:1000 p/k) and/or measures to ensure airway patency should be taken immediately.

In patients who already have a history of angioedema not associated with previous treatment with ACE inhibitors, there may be an increased risk of its development during treatment with an ACE inhibitor.

Cough

Dry, prolonged cough has been noted with ACE inhibitor use and disappears after discontinuation of ACE inhibitor treatment. In the differential diagnosis of cough, cough caused by ACE inhibitor use must also be considered.

Patients on hemodialysis

Anaphylactic reactions have also been noted in patients undergoing hemodialysis using high permeability dialysis membranes who simultaneously take ACE inhibitors. In such cases, another type of dialysis membrane or another antihypertensive drug should be considered.

Surgery/General anesthesia

Lisinopril may block angiotensin II formation when using BP lowering drugs in patients undergoing major surgery or during general anesthesia. A marked decrease in BP, which is considered to be a consequence of this mechanism, can be corrected by increasing the blood pressure.

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

Serum potassium

In some cases, hyperkalemia has been noted.

Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, taking potassium preparations or drugs that cause an increase in blood potassium concentration (e.g., heparin), especially in patients with impaired renal function.

In patients who are at risk of symptomatic hypotension (those on a low-salt or no-salt diet) with or without hyponatremia, as well as in patients who have received high doses of diuretics, fluid and salt loss must be compensated before starting treatment.

Metabolic and endocrine effects

Tiazide diuretics may affect glucose tolerance, so doses of antidiabetic drugs should be adjusted.

Tiazide diuretics may decrease urinary calcium excretion and cause hypercalcemia. Severe hypercalcemia may be a symptom of hidden hyperparathyroidism. It is recommended to stop treatment with thiazide diuretics until parathyroid function test is performed.

Periodic treatment with the drug requires regular monitoring of plasma potassium, glucose, urea and lipids.

Any alcoholic beverages are not recommended during treatment, because alcohol increases the hypotensive effect of the drug.

Cautions should be taken when exercising and in hot weather (risk of dehydration and excessive lowering of BP due to decreased BV).

Impact on the ability to drive a car or perform work requiring increased speed of physical and mental reactions. During the treatment period it is necessary to refrain from driving motor transport and engaging in potentially dangerous activities requiring increased concentration and rapid psychomotor reactions, since dizziness is possible, especially at the beginning of treatment.

Contraindications

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

Side effects

Systemic diseases: marked BP decrease, chest pain; rarely – orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, AV conduction disorders, myocardial infarction.

Gastrointestinal disorders: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, change in taste, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.

Skin disorders: urticaria, increased sweating, photosensitization, skin itching, hair loss.

Nervous system disorders: mood lability, concentration disorders, paresthesia, fatigue, somnolence, convulsive twitching of the limbs and lips; rarely – asthenic syndrome and mental confusion.

Respiratory system: dyspnea, bronchospasm, apnea.

Hematopoietic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, hematocrit, erythrocytopenia).

Allergic reactions: angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx, skin rash, itching, fever, vasculitis, positive reactions to antinuclear antibodies, increased CRP, eosinophilia.

Urogenital system disorders: uremia, oliguria/anuria, renal dysfunction, acute renal failure, decreased potency.

Laboratory findings: Hyperkalemia and/or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia, hyperglycemia, increased plasma urea and creatinine levels; hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance, increased activity of liver transaminases, especially in the presence of a history of renal disease, diabetes and renovascular hypertension.

Others: dry cough, arthralgia, arthritis, myalgia, fever, impaired fetal development, exacerbation of gout.

Overdose

Symptoms: expressed BP decrease, dry mouth, drowsiness, urinary retention, constipation, restlessness, increased irritability.

treatment: symptomatic therapy, IV fluid administration, BP control, therapy aimed at correction of dehydration and water-salt balance disorders. Monitoring of urea, creatinine and electrolytes in serum, as well as diuresis.

Pregnancy use

The use of lisinopril during pregnancy is contraindicated.

Iruzid should be discontinued as soon as possible if pregnancy is established. Taking inhibitors in the II and III trimester of pregnancy has adverse effects on the fetus (pronounced decrease of BP, renal failure, hyperkalemia, skull hypoplasia, intrauterine death are possible).

There are no data about negative effect of the drug on the fetus in case of its use during the first trimester. Newborns and infants who have had intrauterine exposure to ACE inhibitors are recommended to be monitored for timely detection of marked BP decrease, oliguria, hyperkalemia.

Breastfeeding should be stopped during treatment with Iruside.