Iruzid

General characteristics. Structure:

Tablets of 10+12,5 mg: one tablet contains:
Active agents: dihydrate lisinopril (in terms of lisinopril anhydrous) 10 mg and a hydrochlorothiazide of 12,5 mg.

Excipients: Mannitolum, phosphate calcium dihydrate, starch corn, starch prezhelatinizirovanny, indigo carmine, magnesium stearate.

Tablets of 20+12,5 mg: one tablet contains:
Active agents: dihydrate lisinopril (in terms of lisinopril anhydrous) 20 mg and a hydrochlorothiazide of 12,5 mg.

Excipients: Mannitolum, phosphate calcium dihydrate, starch corn, starch prezhelatinizirovanny, dye ferrous oxide yellow, magnesium stearate.

Tablets of 20+25 mg: one tablet contains:
Active agents: dihydrate lisinopril (in terms of lisinopril anhydrous) 20 mg and a hydrochlorothiazide of 25 mg.

Excipients: Mannitolum, phosphate calcium dihydrate, starch corn, starch prezhelatinizirovanny, dye ferrous oxide red, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. The hypotensive combined means. Possesses anti-hypertensive and diuretic action.

Lisinopril
APF inhibitor, reduces formation of II angiotensin of angiotensin I. Decrease in content of angiotensin II leads to direct reduction of allocation of Aldosteronum. Reduces degradation of bradikinin and increases synthesis of prostaglandins. Reduces the general peripheric vascular resistance, the arterial pressure (AP), preloading, pressure in pulmonary capillaries, causes increase in minute volume of blood and increase in tolerance to loadings in patients with chronic heart failure. Expands arteries more than veins. Some effects are explained by influence on fabric a system renin-angiotenzinovye. At prolonged use expressiveness of a hypertrophy of a myocardium and walls of arteries of resistive type decreases. Improves blood supply of an ischemic myocardium. APF inhibitors extend life expectancy at patients with chronic heart failure, slow down progressing of dysfunction of a left ventricle at the patients who had a myocardial infarction without clinical displays of heart failure. The anti-hypertensive effect begins approximately in 6 hours and remains within 24 hours. Effect duration also depends on dose size. The beginning of action - in 1 hour. The maximum effect is defined in 6-7 hours. At arterial hypertension the effect is noted in the first days after an initiation of treatment, stable action develops in 1-2 months.
At sharp drug withdrawal the expressed increase in arterial pressure is not observed.
In addition to a lowering of arterial pressure lisinopril reduces an albuminuria. At patients with a hyperglycemia contributes to normalization of function of the damaged glomerular endothelium.
Lisinopril does not influence concentration of glucose in blood at patients with a diabetes mellitus and does not lead to increase of cases of a hypoglycemia.

Hydrochlorothiazide
Thiazide diuretic which diuretic effect is connected with disturbance of a reabsorption of ions of sodium, chlorine, potassium, magnesium, water in distal department of nephron; removal of calcium ions, uric acid detains. Has anti-hypertensive properties; hypotensive action develops due to expansion of arterioles. Practically does not exert impact on normal arterial pressure. The diuretic effect occurs in 1-2 hours, reaches a maximum in 4 hours and 6-12 hours proceed. Anti-hypertensive action comes in 3-4 days, but for achievement of optimum therapeutic effect 3-4 weeks can be required.
Lisinopril and hydrochlorothiazide if are applied at the same time, render the additive anti-hypertensive effect.

Indications to use:

Arterial hypertension (at patients to whom the combination therapy is shown).

Route of administration and doses:

Inside.
On 1 tablet Ирузида® 10 of mg of +12,5 mg or 20 mg +12,5 mg of 1 times a day. Sometimes, if necessary, it is possible to increase a dose to Ирузида® 20 mg +25 mg of 1 times a day.

Dose at a renal failure:
At patients with clearance of creatinine from 30 and less than 80 ml/min., drug can be used only after selection of a dose of separate components of drug. The recommended initial dose of lisinopril at not complicated renal failure makes 5-10 mg.

The previous therapy by diuretics:
Symptomatic hypotension can arise after reception of an initial dose of drug. Such cases meet more often at patients who had a loss of liquid and electrolytes owing to the previous treatment by diuretics. Therefore it is necessary to stop reception of diuretics in 2-3 days prior to treatment by drug (see special instructions).

Features of use:

Symptomatic hypotension
Most often the expressed lowering of arterial pressure arises at the decrease in volume of liquid caused by therapy by diuretics, reduction of amount of salt in food, dialysis, diarrhea or vomiting (see interaction with other medicines and side effect). At patients with chronic heart failure with a simultaneous renal failure or without it, perhaps expressed lowering of arterial pressure. It comes to light at patients with heavy degree of heart failure, as a result of use of high doses of diuretics, a hyponatremia or an impaired renal function more often. At such patients treatment should be begun under strict control of the doctor. The similar rules should follow at appointment as the patient with coronary heart disease, cerebrovascular insufficiency at which the sharp lowering of arterial pressure can lead to a myocardial infarction or a stroke.

Tranzitorny hypotensive reaction is not a contraindication for reception of the following dose of drug.

Prior to treatment whenever possible it is necessary to normalize concentration of sodium and/or to fill the lost liquid volume, to carefully control action of an initial dose of drug on the patient.

Renal failure
At patients with chronic heart failure, the expressed lowering of arterial pressure after an initiation of treatment with APF inhibitors can lead to further deterioration in renal function. Cases of an acute renal failure are noted.

Patients with a bilateral stenosis of renal arteries or a stenosis have arteries of the only kidney, the receiving APF inhibitors, increase in urea and creatinine in blood serum, usually reversible after the treatment termination was noted. Met at patients with a renal failure more often.

Raised чувствителъностъ / the Quincke's disease
The Quincke's disease of the person, extremities, lips, language, epiglottis and/or throat was noted seldom at the patients treated by APF inhibitor including lisinopril which can arise during any period of treatment. In that case treatment by lisinopril needs to be stopped as soon as possible and for the patient to establish observation before full regression of symptoms. The state most often undergoes in cases when hypostasis arose only on a face and lips, without treatment, however, perhaps purpose of antihistaminic drugs.

The Quincke's disease with hypostasis of a throat can be fatal. When are captured language, the epiglottis or a throat can occur obstruction of respiratory tracts therefore it is necessary to carry out immediately the corresponding therapy (0,3-0,5 ml of solution of Epinephrinum (adrenaline) 1:1000 subcutaneously) and/or measures for ensuring passability of respiratory tracts.

At patients who in the anamnesis already had a Quincke's disease which is not connected with the previous treatment by APF inhibitors the risk of its development can be increased during treatment by APF inhibitor.

Cough
At use of APF inhibitor cough was noted. Cough dry, long which disappears after the treatment termination by APF inhibitor. At the differential diagnosis of cough, it is necessary to consider also the cough caused by APF inhibitor use.

The patients who are on a hemodialysis
Anaphylactic reaction is noted also at the patients subjected to a hemodialysis with use of dialysis membranes with high-permeability which at the same time accept APF inhibitors. In such cases it is necessary to consider the possibility of use of other type of a membrane for dialysis or other anti-hypertensive drug.

Surgery / General anesthesia
At use of drugs, the reducing ABP, for patients at extensive surgical intervention or during the general anesthesia lisinopril can block formation of angiotensin II.

The expressed decrease in the ABP which is considered the investigation of this mechanism can be eliminated with increase in volume of the circulating blood.

Before surgical intervention (including stomatology) it is necessary to warn the surgeon/anaesthesiologist about use of APF inhibitors.

Potassium in serum
The hyperpotassemia was in certain cases noted.

Risk factors for development of a hyperpotassemia include a renal failure, a diabetes mellitus, administration of drugs of potassium or the drugs causing increase in potassium concentration in blood (for example, heparin), especially at patients with an impaired renal function.

At patients who have a risk of symptomatic hypotension (being on a low-salt or electrolyte-deficient diet) with or without hyponatremia, and also at patients who received high doses of diuretics the above-named states before an initiation of treatment need to be compensated (loss of liquid and salts).

Metabolic and endocrine effects
Thiazide diuretics can influence tolerance to glucose therefore it is necessary to adjust doses of antidiabetic medicines.

Thiazide diuretics can reduce release of calcium with urine and cause a hypercalcemia. The expressed hypercalcemia can be a symptom of the hidden hyperparathyreosis. It is recommended to stop treatment by thiazide diuretics before test according to function of epithelial bodies.

During treatment by drug regular control in a blood plasma of potassium, glucose, urea, fats and lipids is necessary.

During treatment it is not recommended to take alcoholic beverages as alcohol strengthens hypotensive effect of drug.

It is necessary to be careful when performing physical exercises, hot weather (risk of development of dehydration and excessive lowering of arterial pressure because of decrease in volume of the circulating blood).

Influence on ability of control of vehicles and to work with the equipment
During treatment it is necessary to refrain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions as dizziness, especially at the beginning of a course of treatment is possible.

Side effects:

Most often side effects meet: dizziness, headache.

Other by-effects:
From cardiovascular system: the expressed lowering of arterial pressure, a stethalgia, is rare - orthostatic hypotension, tachycardia, bradycardia, emergence of symptoms of heart failure, disturbance of atrioventricular conductivity, a myocardial infarction.

From a digestive tract: nausea, vomiting, abdominal pains, dryness in a mouth, diarrhea, dyspepsia, anorexia, taste change, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.

From integuments: small tortoiseshell, increase in sweating, photosensitization, skin itch, hair loss.

From a nervous system: lability of mood, disturbance of concentration of attention, paresthesia, increased fatigue, drowsiness, convulsive twitchings of muscles of extremities and lips, it is rare - an asthenic syndrome, confusion of consciousness.

From respiratory system: диспноэ, bronchospasm, apnoea.

From system of a hemopoiesis: leukopenia, thrombocytopenia, neurosinging, agranulocytosis, anemia (decrease in a hemoglobin content, hematocrit, erythrocytopenia).

Allergic reactions: a Quincke's disease of the person, extremities, lips, language, an epiglottis and/or a throat (see special instructions), skin rashes, an itch, fever, a vasculitis, positive reactions to antinuclear antibodies, increase in SOE, an eosinophilia.

From urinogenital system: uraemia, oliguria/anury, renal failure, acute renal failure, decrease in a potentiality.

Laboratory indicators: a hyperpotassemia and/or a hypopotassemia, a hyponatremia, a hypomagnesiemia, a hypochloraemia, a hypercalcemia, a hyperuricemia, a hyperglycemia, increase in level of urea and creatinine in a blood plasma, a hyperbilirubinemia, a hypercholesterolemia, a gipertriglitseridemiya, decrease in tolerance to glucose, increase in activity of "hepatic" transaminases, especially in the presence in the anamnesis of diseases of kidneys, a diabetes mellitus and renovascular hypertensia.

Others: dry cough, arthralgia, arthritis, mialgiya, fever, disturbance of fetation, exacerbation of gout.

Interaction with other medicines:

At simultaneous use with kaliysberegayushchy diuretics (Spironolactonum, Triamterenum, amiloride), potassium drugs, the salt substitutes containing potassium - the risk of development of a hyperpotassemia, especially at patients with an impaired renal function increases. Therefore it is possible to appoint them jointly only on the basis of the individual decision of the attending physician at regular control of level of potassium in serum and function of kidneys.

At simultaneous use with vazodilatator, barbiturates, fenotiazina, tricyclic antidepressants, ethanol - strengthening of hypotensive action.

At simultaneous use with non-steroidal anti-inflammatory drugs (indometacin, etc.), estrogen - decrease in anti-hypertensive effect of lisinopril. At simultaneous use with lithium drugs - delay of removal of lithium from an organism (strengthening of cardiotoxic and neurotoxic effect of lithium).

At simultaneous use with antacids and Colestyraminum - decrease in absorption in digestive tract.

Drug strengthens a neurotoxicity of salicylates, weakens effect of peroral hypoglycemic drugs, Norepinephrinum, Epinephrinum and antigouty drugs, strengthens effects (including collateral) cardiac glycosides, action of peripheral muscle relaxants, reduces quinidine removal.

Reduces effect of oral contraceptives. Ethanol strengthens hypotensive effect of drug. At a concomitant use Methyldopums the risk of development of hemolysis increases.

Contraindications:

Hypersensitivity to drug, other APF inhibitors and derivatives of streptocides, an anury, the expressed renal failure (clearance of creatinine less than 30 ml/min.), a Quincke's disease (including in the anamnesis from use of APF inhibitors), a hemodialysis with use of high-flowing membranes, a hypercalcemia, a hyponatremia, a porphyria, a prekoma, a hepatic coma, severe forms of a diabetes mellitus, age up to 18 years (efficiency and safety are not established).

Pregnancy and period of a lactation
Use of lisinopril during pregnancy is contraindicated. At pregnancy establishment administration of drug needs to be stopped as soon as possible. Reception of inhibitors in II and the III trimester of pregnancy makes an adverse effect on a fruit (the expressed lowering of arterial pressure, a renal failure, a hyperpotassemia, a skull hypoplasia, pre-natal death are possible). There are no data on negative impacts of drug on a fruit in case of use during the I trimester. It is recommended to observe newborns and babies who underwent pre-natal influence of APF inhibitors for early detection of the expressed lowering of arterial pressure, an oliguria, a hyperpotassemia.

For treatment by drug it is necessary to cancel breastfeeding.

With care
Aortal stenosis / a hypertrophic cardiomyopathy, a bilateral stenosis of renal arteries, a stenosis of an artery of the only kidney with the progressing azotemia, a state after transplantation of kidneys, a renal failure (clearance of creatinine more than 30 ml/min.), primary hyper aldosteronism, arterial hypotension, a marrow hypoplasia, a hyponatremia (the increased risk of development of arterial hypotension in the patients who are on a low-salt or electrolyte-deficient diet), hypovolemic states (including diarrhea, vomiting), diseases of connecting fabric (a system lupus erythematosus, a scleroderma), a diabetes mellitus, gout, oppression of a marrowy hemopoiesis, a hyperuricemia, a hyperpotassemia, coronary heart disease, cerebrovascular diseases (including insufficiency of cerebral circulation), heavy chronic heart failure, a liver failure, advanced age.

Overdose:

Symptoms: The expressed lowering of arterial pressure, dryness in a mouth, drowsiness, an urination delay, locks, concern, an acrimony.

Treatment: symptomatic therapy, intravenous administration of liquid, monitoring arterial pressure, the therapy directed to correction of dehydration and disturbances of water-salt balance. Control of urea, creatinine and electrolytes in blood serum, and also a diuresis.

Storage conditions:

List B.
At a temperature not above 25 °C.
To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets of 10+12,5 mg, 20+12,5 mg, 20+25 mg
On 30 tablets in PVC / ПВДХ-Ал the blister.
One blister is placed together with the application instruction in a cardboard pack.