Lysoretic tablets 10mg + 12.5mg, No. 28

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

Take orally, once a day.

Arteral hypertension
1 tablet Lizoretic 10 mg) 12.5 mg 1 time per day. If necessary, the dose can be increased to Lizoretic 20 mg + 12.5 mg per day.

Doses for renal failure
In patients with creatinine clearance of more than 30 and less than 80 ml / min., The drug can be used only after titrating the dose of 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 Lysoretic. (see Special instructions).

Active ingredients: lisinopril 10 mg and hydrochlorothiazide 12.5 mg

Excipients: calcium hydrogen phosphate, mannitol. corn starch, pre-glazed starch, iron dye red oxide, iron dye yellow oxide, magnesium stearate, purified water.

• 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,

• precom,

• hepatic coma,

• diabetes mellitus (severe forms),

• pregnancy,

• lactation period,

• age up to 18 years (efficacy and safety have not been established).

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, hypoplasia of bone marrow the development of arterial hypotension in patients on a low-salt or salt-free diet), conditions accompanied by a decrease in circulating blood volume (including diarrhea, vomiting), connective tissue diseases (systemic lupus erythematosus, scleroderma), diabetes mellitus, gout, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular insufficiency, severe chronic heart failure, liver failure, old age.

Trade name of the drug: Lisoretic

Dosage form:

pills.

Composition:

Each 10 mg + 12.5 mg tablet contains:

Active ingredients: lisinopril 10 mg and hydrochlorothiazide 12.5 mg

Excipients: calcium hydrogen phosphate, mannitol. corn starch, pre-glazed starch, iron dye red oxide, iron dye yellow oxide, magnesium stearate, purified water.

Each 20 mg + 12.5 mg tablet contains:

Active ingredients: lisinopril 20 mg and hydrochlorothiazide 12.5 mg

Excipients: calcium hydrogen phosphate, mannitol, corn starch, pregelatinized starch, magnesium stearate, purified water.

Description

Dosage 10 mg + 12.5 mg: beige-pink, round, biconvex, with a dividing line on one side.

Dosage 20 mg + 12.5 mg: from white to almost white, round, biconvex.

Pharmacotherapeutic group:

Combined antihypertensive agent (ACE inhibitor + diuretic).

ATX code: —09¬ј03

pharmachologic effect

Pharmacodynamics
Lysoretic is a combination of an angiotensin-converting enzyme inhibitor (lisinopril) and a diuretic (hydrochlorothiazide). 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 aldosierone. Reduces the degradation of bradykinin and increases prostaglandin synthesis. Reduces the total peripheral vascular resistance, blood pressure (BP), preload, pulmonary capillary pressure, causes an increase in the minute blood volume and an increase in exercise tolerance in patients with heart failure. Expands arteries more than veins. Some of the effects are attributed to the effect on tissue retin-angiotensin systems. With prolonged use, the hypertrophy of the myocardium and the walls of the resistive arteries decreases. Improves blood supply to the ischemic myocardium. ACE inhibitors lengthen life expectancy in patients with chronic heart failure,slow down the progression of left ventricular dysfunction in patients with myocardial infarction without clinical manifestations of heart failure. The onset of action after 1 hour, the maximum effect is determined after 6-7 hours, duration - 24 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.
Hydrochlorothiazide. Thiazide diuretic, the diuretic effect of which is associated with impaired reabsorption of sodium, chlorine, potassium, magnesium, water ions 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,

• precom,

• hepatic coma,

• diabetes mellitus (severe forms),

• pregnancy,

• lactation period,

• age up to 18 years (efficacy and safety have not been established).

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, hypoplasia of bone marrow the development of arterial hypotension in patients on a low-salt or salt-free diet), conditions accompanied by a decrease in circulating blood volume (including diarrhea, vomiting), connective tissue diseases (systemic lupus erythematosus, scleroderma), diabetes mellitus, gout, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular insufficiency, severe chronic heart failure, liver failure, old age.

Method of administration and dosage

Take orally, once a day.

Arteral hypertension
1 tablet Lizoretic 10 mg) 12.5 mg 1 time per day. If necessary, the dose can be increased to Lizoretic 20 mg + 12.5 mg per day.

Doses for renal failure
In patients with creatinine clearance of more than 30 and less than 80 ml / min., The drug can be used only after titrating the dose of 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 Lysoretic. (see Special instructions).

Side effect

In most patients, side effects were mild and transient. The most common were: dizziness, headache.
Side effects that were less common:
From the cardiovascular system: a pronounced 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.
From the nervous system:mood lability, impaired concentration, paresthenia, increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely - asthenic syndrome, confusion.
From the respiratory system - dyspnea, bronchospasm, apnea.
On the part of the skin - urticaria, sweating, hair loss, photosensitivity.
Allergic reactions: angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx (see 'Special instructions'), skin rashes, itching, fever, vasculitis, positive results for antinuclear antibodies, increased ESR, eosinophilia.
From the side of the hematopoietic organs:leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decreased hemoglobin, hematocrit, erythrocytopenia). From the genitourinary system - uremia, oliguria / anuria, impaired renal function, acute renal failure, decreased potency.
Laboratory indicators: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hyperuricemia, hyperglycemia, increased levels of urea and creatinine, rarely - increased activity of 'hepatic' transaminases, hyperbilibinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance.
Others: dry cough, arthralgia / arthritis, myalgia, impaired fetal kidney development, exacerbation of gout.

Overdose

Symptoms: a marked decrease in blood pressure.
Treatment: induce vomiting and / or gastric lavage, symptomatic therapy aimed at correcting dehydration and disturbances in the input-salt balance. With arterial hypotension, inject isotonic solution. Control of urea, creatinine and serum electrolytes, as well as urine output.

Interaction with other medicinal products

With simultaneous use: 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;
with vasodilators, barbiturates, phenothiazines, antidepressants, ethanol - increased hypotensive action;
with non-steroidal anti-inflammatory drugs (indomethacin, etc.), estrogens - a decrease in the antihypertensive effect of lisinopril;
with lithium preparations - slowing down the elimination of lithium from the body (increasing the cardiotoxic and neurotoxic effects of lithium);
with antacids and colestramine- decreased absorption in the gastrointestinal tract. It enhances the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic agents, norepinephrine, epinephrine and anti-gout agents, 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.

special instructions

Symptomatic hypotension
Most often, pronounced blood pressure occurs with a decrease in the volume of circulating blood caused by diuretic therapy, a decrease in the amount of salt in food, dialysis, diarrhea or vomiting (see 'Interaction with other drugs' and 'Side effects'), In patients with chronic heart failure with simultaneous renal failure or without it, possibly the development of symptomatic hypotension. 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 should be followed when prescribing to patients with ischemic heart disease, 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.
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 renal artery stenosis or stenosis of an artery of a single kidney, who received ACE inhibitors, there was an increase in serum urea and creatinine, 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 was rarely observed in patients treated with ACE inhibitors, including lisinopril, which can 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. Anti-neurotic edema 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 epinephrine (adrenaline) solution 1: 1000 subcutaneously) and / or measures to ensure airway patency should be carried out immediately.who have had a history of angioedema not associated with previous treatment with ACE inhibitors, the risk of its development may be increased during treatment with an ACE inhibitor (see 'Contraindications'),
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, it is necessary to take into account the cough caused by the use of an ACE inhibitor.
Patients on dialysis
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 agent.
Surgery / General Anesthesia
Lisinopril can block the formation of angiotensin II in patients undergoing major surgery or during general anesthesia with blood pressure lowering drugs.
A pronounced decrease in blood pressure, which is considered a consequence of this mechanism, can be eliminated by an increase in 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 (for example, heparin), especially in patients with impaired renal function. 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 treatment with Lizoretic, regular monitoring of potassium, glucose, urea, fats and creatinine in blood plasma is necessary.
During the period of treatment, it is not recommended to consume alcoholic beverages, since alcohol enhances the hypotensive effect of the drug.
Caution should be exercised during exercise, 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 mechanisms 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.

Release form

10 or 14 tablets in blisters.
1, 2, 3 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

List B. In a dry, dark place at temperatures below 25 ? C. Keep out of the reach of children.

Shelf life

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

Terms of dispensing from pharmacies:

on prescription.