Литэн® N

General characteristics. Structure:

Liten of N of 10 mg +12,5mg
Active agents: lisinopril dihydrate of 10,888 mg (respectively lizinoprila10 mg) and Hydrochlorthiazidum of 12,5 mg
Excipients: hydrophosphate calcium dihydrate, Mannitolum, starch corn, starch prezhelatizirovanny, magnesium stearate, talc, silicon of dioxide colloid anhydrous, ferrous oxide yellow C.I.77492,E172
Liten of N of 20 mg +12,5 mg
Active agents: lisinopril a dihydrate of 21,776 mg (according to lisinopril of 20 mg) and Hydrochlorthiazidum of 12,5 mg
Excipients: hydrophosphate calcium dihydrate, Mannitolum, starch corn, starch prezhelatizirovanny, magnesium stearate, talc, silicon of dioxide colloid anhydrous, ferrous oxide yellow C.I.77492,E172, iron oxide red C.I.77491,E172

Description. Tablets of 10 mg +12,5mg
From light yellow till yellow color, hexagonal tablets with a smooth surface, integral edges and risky in the middle.
Tablets of 20 mg +12,5mg
From light pink till pink color hexagonal tablets with a smooth surface and integral edges and risky in the middle.

Pharmacological properties:

Pharmacodynamics. Liten of N is a combination of inhibitor of an angiotensin-converting enzyme (lisinopril) and diuretic (Hydrochlorthiazidum). Possesses anti-hypertensive and diuretic action.
Lisinopril. APF inhibitor, reduces formation of II angiotensin of angiotensin I. Decrease leads the content of angiotensin II to direct reduction of allocation of Aldosteronum. Reduces degradation of bradikinin and increases prostaglandin synthesis. Reduces the general peripheric vascular resistance, the arterial pressure (AP), preloading, pressure pulmonary capillaries, causes increase in minute volume of blood and increase in tolerance to loadings in patients with heart failure. Expands arteries more than veins. Some effects are explained by influence on fabric a system renin-angiotenzinovye. At prolonged use the 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 beginning of action in 1 hour, the maximum effect is defined in 6 hours, duration – 24 hours. At arterial hypertension the effect is noted in the first days after an initiation of treatment, stable action develops in 1-2 months.
Hydrochlorthiazidum 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 Hydrochlorthiazidum 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:

To accept inside, once a day.
Arterial hypertension
On 1 tablet of Liten of N of 10 mg of 1 times a day. If necessary the N of 20 mg of 1 times can increase a dose to Liten in days.
Doses at a renal failure
Patients with clearance of creatinine have more than 30 ml/min. and less than 80 ml/min., drug can be used only after titration 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 Liteny N (see. Special instructions).

Features of use:

Symptomatic hypotension
Most often expressed to the ABP arises at decrease in volume of the circulating blood 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, development, symptomatic hypotension is possible. It comes to light at patients with severe forms 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 sharp decrease in the ABP can lead to a myocardial infarction or a stroke.
Tranzitorny hypotensive reaction is not a contraindication for reception of the following dose of drug.
Renal failure
At patients with chronic heart failure, the expressed decrease in the ABP 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.
The increased sensitivity / 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 inhibitors 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.
Антиневротическй hypostasis 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 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, can be raised risk of its development during treatment by APF inhibitor (see. "Contraindications").
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 dialysis
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 angipertenzivny means.
Surgery / General anesthesia
At use of means, 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 disturbance with function of kidneys.
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 releases 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 Liten regular control in a blood plasma of potassium, glucose, urea, fats and creatinine is necessary for N.
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 decrease in the ABP because of decrease in volume of the circulating blood).

Influence on ability of control of vehicles and mechanisms
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 of patients had easy by-effects and passing. The most frequent were: dizziness, headache.
By-effects which met less often:
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 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, a bronchospasm, an apnoea.
From integuments – a small tortoiseshell, perspiration, a hair loss, a photosensitization.
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 takes on antinuclear antibodies, increase in SOE, an eosinophilia.
From bodies of a hemopoiesis: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in a hemoglobin content, hematocrit, erythrocytopenia).
From urinogenital system – uraemia, an oliguria/anury, a renal failure, an acute renal failure, decrease in a potentiality.
Laboratory indicators: a hyperpotassemia and/or a hypopotassemia, a hyponatremia, a hypomagnesiemia, a hypochloraemia, a hyperuricemia, a hyperglycemia, increase in level of urea and creatinine, it is rare – increase in activity of "hepatic" transaminases, a giperbilibinemiya, a hypercholesterolemia, a gipertriglitseridemiya, decrease in tolerance to glucose.
Others: dry cough, arthralgia/arthritis, mialgiya, disturbance of development of kidneys of a fruit, 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;
with vazodilatator, barbiturates, fenotiazina, tricyclic antidepressants, ethanol – strengthening of hypotensive action;
with non-steroidal anti-inflammatory drugs (indometacin, etc.), estrogen – decrease in anti-hypertensive effect of lisinopril;
with lithium drugs – delay of removal of lithium from an organism (strengthening of cardiotoxic and neurotoxic effect of lithium);
with antacids and kolestraminy - decrease in a vsavyvaniye in digestive tract.
Strengthens a neurotoxicity of salicylates, weakens action of peroral hypoglycemic means, Norepinephrinum, Epinephrinum and antigouty means, strengthens effects (including collateral) cardiac glycosides, action of peripheral muscle relaxants, reduces quinidine removal.
Reduces effect of oral contraceptives.

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, a diabetes mellitus (severe forms), pregnancy, the lactation period, age up to 18 years (efficiency and safety are not established).

With care: an 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 less 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), the states which are followed by decrease in volume of the circulating blood (including diarrhea, vomiting), diseases of connecting fabric (a system lupus erythematosus, a scleroderma), a diabetes mellitus, gout, a hyperuricemia, a hyperpotassemia, coronary heart disease, cerebrovascular insufficiency, heavy chronic heart failure, a liver failure, advanced age.

Overdose:

Symptoms: the expressed decrease in the ABP.
Treatment: to cause vomiting and/or to wash out a stomach, the symptomatic therapy directed to correction of dehydration and disturbances of water-salt balance. At arterial hypotension to enter isotonic solution. Control of urea, creatinine and electrolytes in blood serum, and also a diuresis.

Storage conditions:

To store in the dry place at a temperature not above 30 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets on 10 mg + 12,5mg and 20 mg + 12,5 mg
On 10 tablets in the blister from PVC / aluminum foil. On 2 or 3 blisters together with the application instruction in a cardboard pack.