Iruzid tablets 20 + 12.5mg, # 30

Arterial hypertension (in patients for whom combination therapy is indicated).

Inside.
1 tablet of IruzidЃ 10 mg + 12.5 mg or 20 mg + 12.5 mg once a day. Sometimes, if necessary, the dose can be increased to IruzidЃ 20 mg + 25 mg once a day.

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

Prior diuretic therapy:
Symptomatic hypotension may occur after the initial dose of the drug. Such cases are more common in patients who have had fluid and electrolyte loss due to prior diuretic treatment. Therefore, it is necessary to stop taking diuretics 2-3 days before starting treatment with the drug (see special instructions).

Tablets 20 + 12.5 mg: one tablet contains:

Active substances: lisinopril dihydrate (in terms of anhydrous lisinopril) 20 mg and hydrochlorothiazide 12.5 mg.
Excipients: mannitol, calcium phosphate dihydrate, corn starch, pregelatinized starch, iron dye yellow oxide, magnesium stearate.

Hypersensitivity to the drug, other ACE inhibitors and sulfonamide derivatives, anuria, severe renal failure (creatinine clearance less than 30 ml / min.), Angioedema (including a history of the use of ACE inhibitors), hemodialysis using high-flow membranes, hypercalcemia , hyponatremia, porphyria, precoma, hepatic coma, severe forms of diabetes mellitus, age up to 18 years (efficacy and safety have not been established).

Trade name of the drug: IruzidЃ

International non-proprietary name:

lisinopril + hydrochlorothiazide

Dosage form:

pills

Composition:

Tablets 10 + 12.5 mg: one tablet contains:

Active substances: lisinopril dihydrate (in terms of anhydrous lisinopril) 10 mg and hydrochlorothiazide 12.5 mg.
Excipients: mannitol, calcium phosphate dihydrate, corn starch, pregelatinized starch, indigo carmine, magnesium stearate.

Tablets 20 + 12.5 mg: one tablet contains:

Active substances: lisinopril dihydrate (in terms of anhydrous lisinopril) 20 mg and hydrochlorothiazide 12.5 mg.
Excipients: mannitol, calcium phosphate dihydrate, corn starch, pregelatinized starch, iron dye yellow oxide, magnesium stearate.

Tablets 20 + 25 mg: one tablet contains:

Active ingredients: lisinopril dihydrate (in terms of anhydrous lisinopril) 20 mg and hydrochlorothiazide 25 mg.
Excipients: mannitol, calcium phosphate dihydrate, corn starch, pregelatinized starch, iron dye red oxide, magnesium stearate.

Description:
tablets 10 + 12.5 mg: blue, biconvex, hexagonal tablets.
tablets 20 + 12.5 mg: yellow, biconvex, hexagonal tablets.
tablets 20 + 25 mg: light pink, biconvex, round tablets.

Pharmacotherapeutic group:

combined antihypertensive agent (ACE inhibitor + diuretic).

ATX CODE —09¬ј03

Pharmacological properties
Pharmacodynamics
Combined antihypertensive agent. It has antihypertensive and diuretic effects.

Lisinopril
ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in the content of angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces the total peripheral vascular resistance, blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in the minute blood volume and an increase in stress tolerance in patients with chronic heart failure. Expands arteries more than veins. Some of the effects are attributed to the effect on tissue renin-angiotensin systems. With prolonged use, the severity of hypertrophy of the myocardium and the walls of the resistive arteries decreases. Improves blood supply to the ischemic myocardium.ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow down the progression of left ventricular dysfunction in patients who have had myocardial infarction without clinical manifestations of heart failure. The antihypertensive effect begins in about 6 hours and lasts for 24 hours. The duration of the effect also depends on the size of the dose. The onset of action is after 1 hour. The maximum effect is determined after 6-7 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, a stable effect develops after 1-2 months.The antihypertensive effect begins in about 6 hours and lasts for 24 hours. The duration of the effect also depends on the size of the dose. The onset of action is after 1 hour. The maximum effect is determined after 6-7 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, a stable effect develops after 1-2 months.The antihypertensive effect begins in about 6 hours and lasts for 24 hours. The duration of the effect also depends on the size of the dose. The onset of action is after 1 hour. The maximum effect is determined after 6-7 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, a stable effect develops after 1-2 months.

With a sharp withdrawal of the drug, 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 the damaged glomerular endothelium.

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

Hydrochlorothiazide
Thiazide diuretic, the diuretic effect of which is associated with impaired reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron; delays the excretion of calcium ions, uric acid. Has antihypertensive properties; the hypotensive effect develops due to the expansion of arterioles. 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 for use
Arterial hypertension (in patients for whom combination therapy is indicated).

Contraindications
Hypersensitivity to the drug, other ACE inhibitors and sulfonamide derivatives, anuria, severe renal failure (creatinine clearance less than 30 ml / min.), Angioedema (including a history of the use of ACE inhibitors), hemodialysis using high-flow membranes, hypercalcemia, hyponatremia, porphyria, precoma, hepatic coma, severe forms of diabetes mellitus, age up to 18 years (efficacy and safety have not been established).

Pregnancy and lactation
The use of lisinopril during pregnancy is contraindicated. When pregnancy is established, the drug should be discontinued as early as possible. Taking inhibitors in the II and III trimester of pregnancy has an adverse effect on the fetus (a marked decrease in blood pressure, renal failure, hyperkalemia, cranial hypoplasia, intrauterine death are possible). There is no data on the negative effects of the drug on the fetus when used during the first trimester. For newborns and infants who have been exposed to intrauterine exposure to ACE inhibitors, it is recommended to be monitored for the timely detection of a pronounced decrease in blood pressure, oliguria, hyperkalemia.

For the period of drug treatment, breastfeeding should be canceled.

Carefully
Aortic stenosis / hypertrophic cardiomyopathy, bilateral renal artery stenosis, stenosis of a solitary kidney artery with progressive azotemia, condition after renal transplantation, renal failure (creatinine clearance more than 30 ml / min.), Primary hyperaldosteronism, arterial hypotension, bone marrow hypoplasia ( the risk of arterial 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, suppression of bone marrow hematopoiesis, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular diseases (including cerebral circulation insufficiency), severe chronic heart failure,liver failure, advanced age.

Dosing and Administration
Inside.
1 tablet of IruzidЃ 10 mg + 12.5 mg or 20 mg + 12.5 mg once a day. Sometimes, if necessary, the dose can be increased to IruzidЃ 20 mg + 25 mg once a day.

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

Prior diuretic therapy:
Symptomatic hypotension may occur after the initial dose of the drug. Such cases are more common in patients who have had fluid and electrolyte loss due to prior diuretic treatment. Therefore, it is necessary to stop taking diuretics 2-3 days before starting treatment with the drug (see special instructions).

Side effects
The most common side effects are dizziness, headache.

Other side effects:
On the part of the cardiovascular system: a marked decrease in blood pressure, chest pain, rarely - orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, atrioventricular conduction disturbance, myocardial infarction.

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

On the part of the skin: urticaria, increased sweating, photosensitivity, pruritus, hair loss.

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

From the respiratory system: dyspnea, bronchospasm, apnea.

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

Allergic reactions: angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx (see special instructions), skin rashes, itching, fever, vasculitis, positive reactions to antinuclear antibodies, increased ESR, eosinophilia.

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

Laboratory indicators: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia, hyperglycemia, increased levels of urea and creatinine in the blood plasma, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased tolerance to glucose, especially in patients with glucose tolerance a history of kidney disease, diabetes mellitus and renovascular hypertension.

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

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

Treatment: symptomatic therapy, intravenous fluid administration, blood pressure control, therapy aimed at correcting dehydration and disturbances in water-salt balance. Control of urea, creatinine and serum electrolytes, as well as urine output.

Interaction with other drugs
When used simultaneously 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 the individual decision of the attending physician with regular monitoring of serum potassium levels and renal function.

With simultaneous use with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol - an increase in the hypotensive effect.

With simultaneous use with non-steroidal anti-inflammatory drugs (indomethacin, etc.), estrogens - a decrease in the antihypertensive effect of lisinopril. With simultaneous use with lithium preparations - slowing down the elimination of lithium from the body (increasing the cardiotoxic and neurotoxic effects of lithium).

With simultaneous use with antacids and cholestyramine - a decrease in absorption in the gastrointestinal tract.

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

Reduces the effect of oral contraceptives. Ethanol enhances the hypotensive effect of the drug. With the simultaneous administration of methyldopa, the risk of hemolysis increases.

Special instructions
Symptomatic hypotension
Most often, a pronounced decrease in blood pressure occurs with a decrease in fluid volume caused by diuretic therapy, a decrease in the amount of salt in food, dialysis, diarrhea or vomiting (see interactions with other drugs and side effects). In patients with chronic heart failure with or without concurrent renal failure, a marked decrease in blood pressure is possible. It is more common in patients with severe heart failure as a result of high doses of diuretics, hyponatremia, or impaired renal function. In such patients, treatment should be started under the strict supervision of a physician. Similar rules must be followed when prescribing patients with ischemic heart disease, cerebrovascular insufficiency,in whom a sharp drop 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, the effect of the initial dose of the drug on the patient should be carefully monitored.

Renal dysfunction
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 stenosis of the renal arteries or stenosis of an artery of a single kidney, who received ACE inhibitors, there was an increase in urea and creatinine in serum, usually reversible after discontinuation of treatment. More common in patients with renal failure.

Hypersensitivity / Angioedema
Angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx has been rare in patients treated with an ACE inhibitor, including lisinopril, which may occur at any time during treatment. In this case, treatment with lisinopril should be stopped as soon as possible and the patient should be monitored until the symptoms completely regress. In cases where swelling occurs only on the face and lips, the condition most often goes away without treatment, however, antihistamines may be prescribed.

Angioedema with laryngeal edema can be fatal. When the tongue, epiglottis or larynx are covered, airway obstruction may occur, therefore appropriate therapy (0.3-0.5 ml of epinephrine (adrenaline) solution 1: 1000 subcutaneously) and / or measures to ensure airway patency should be carried out immediately.

Patients who already have a history of angioedema not associated with previous treatment with ACE inhibitors may be at increased risk of developing it during treatment with an ACE inhibitor.

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

Patients on hemodialysis
Anaphylactic reaction was also observed in patients undergoing hemodialysis using dialysis membranes with high permeability, who simultaneously take ACE inhibitors. In such cases, consideration should be given to using a different type of dialysis membrane or other antihypertensive drug.

Surgery / General anesthesia
Lisinopril can block the formation of angiotensin II when using drugs that lower blood pressure in patients with major surgery or during general anesthesia.

A pronounced decrease in blood pressure, which is considered a consequence of this mechanism, can be eliminated by increasing the volume of circulating blood.

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

Serum Potassium Hyperkalemia has been
reported in some cases.

Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, taking potassium supplements or drugs that increase 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 (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 (loss of fluid and salts) before starting treatment.

Metabolic and endocrine effects
Thiazide diuretics can affect glucose tolerance, therefore, it is necessary to adjust the dose of antidiabetic drugs.

Thiazide diuretics can reduce urinary calcium excretion and cause hypercalcemia. Severe hypercalcemia may be a symptom of latent hyperparathyroidism. It is recommended that treatment with thiazide diuretics be discontinued before the test to assess the function of the parathyroid glands.

During the period of drug treatment, regular monitoring of potassium, glucose, urea, fats and lipids in blood plasma is required.

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

Care should be taken when exercising, in hot weather (risk of dehydration and an excessive decrease in blood pressure due to a decrease in circulating blood volume).

Influence on the ability to drive vehicles and work with equipment
During the period of treatment, one should refrain from driving vehicles and engaging in potentially hazardous 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 release of
tablets 10 + 12.5 mg, 20 + 12.5 mg, 20 + 25 mg
30 tablets each in PVC / PVDC-Al blister.
One blister is placed together with instructions for use in a cardboard box.

Storage conditions
List B.
At a temperature not higher than 25 ? C.
Keep out of the reach of children!

Shelf life is
3 years.
Do not use after the expiration date printed on the package.

Terms of dispensing from pharmacies
Prescription.