Parallel

General characteristics. Structure:

Active ingredient: 5 mg of an amlodipin (in the form of an amlodipin of a besilat), 10 mg of lisinopril (in the form of dihydrate lisinopril).

Vvspomogatelny substances: sodium krakhmalglikolit (type A), magnesium stearate (Е - 470), cellulose microcrystallic (Е-460).

The hypotensive combined means. Has the hypotensive and anti-anginal effect caused by properties of the components which are a part of drug.

Pharmacological properties:

Pharmacodynamics. Lisinopril reduces the general peripheric resistance of vessels, arterial pressure, preloading and an afterload, pressure in pulmonary capillaries, does not influence heart rate, at the same time increase in minute volume of blood and strengthening of a blood-groove in kidneys is possible. Expands arteries more than veins. Improves blood supply of an ischemic myocardium. At prolonged use reduces a hypertrophy of a myocardium and walls of arteries of resistant type. Slows down progressing of dysfunction of a left ventricle after the myocardial infarction which is not complicated by heart failure.

Does not influence concentration of glucose in blood at patients with a diabetes mellitus. Hypotensive action develops in 1 h after reception, the maximum effect - in 6 h, action duration - 24 h. At the termination of treatment there is no syndrome of "cancellation" (sharp increase in arterial pressure).

Amlodipin renders hypotensive and anti-anginal effects. The mechanism of hypotensive action of an amlodipin is caused by the direct weakening impact on unstriated muscles of vessels. Anti-anginal action is caused by expansion of coronary and peripheral arteries and arterioles: at stenocardia reduces expressiveness of ischemia of a myocardium; expanding peripheral arterioles, reduces the general peripheric resistance of vessels, reduces an afterload by heart, reduces the need of a myocardium for oxygen. Time of approach of effect - 2-4 h; duration - 24 h.

Indications to use:

Essential hypertensia.

Route of administration and doses:

Drug is appointed in that case when one of drug components do not manage to reach the desirable level of arterial pressure at monotherapy.

Dose for adults (at monotherapy) - 1 tablet a day irrespective of meal. Depending on individual sensitivity the dose can be raised to 2 tablets a day.

It is recommended to patients who accepted diuretics earlier for two - three days prior to therapy to cancel diuretic. If it is impossible, the initial dose makes V * tablets in days. In this case after reception of the first dose of drug it is necessary to control a condition of the patient as there can be symptomatic hypotension. At a renal failure the initial dose should be lowered (lisinopril is removed by kidneys) and to define individually, depending on reaction to drug and at rather frequent monitoring procedure of functional indicators of kidneys and level of potassium and sodium in blood serum.

At a liver failure drug is taken with caution (removal of an am-lodipin can be late). There is no precisely specified dosage.

For patients of pozhshy age (> 65 years) titration of a dose individually also depends on reaction to drug. An optimum maintenance dose - 1 tablet a day (10 mg of lisinopril / 5 mg of an amlodipin).

Features of use:

Considerable symptomatic hypotension at patients with a hyponatremia and/or a hypovolemia can be observed. Prior to the beginning of a course of therapy it is necessary to correct a hyponatremia or a hypovolemia and at use of the first doses of drug it is necessary to monitor its influence on arterial pressure.

At cerebrovascular diseases and coronary heart disease it is necessary to consider that considerable decrease in the ABP can lead to a brain stroke or a myocardial infarction. In case of a mitral stenosis of an aorta or a subaortic hypertrophic stenosis of PARALEL it is necessary to apply with care.

At a renal artery stenosis (especially if it is bilateral or there is only one kidney and narrowing of the mouth of a renal artery is noted), in the presence of a hyponatremia and/or, and also in case of insufficiency of blood supply, lisinopril can lead hypovolemia to depression of function of kidneys, an acute renal failure which after interruption of therapy is reversible.

At a liver failure allocation of an amlodipin from an organism can be late. There is no precisely specified dose, but such patients should take drug with caution.

At reception of APF inhibitors, in particular lisinopril, there can be a Quincke's disease with a face edema, extremities, lips, an epiglottis and a throat. In that case it is necessary to cancel immediately drug, the patient has to be under control of the doctor before total disappearance of signs. If hypostasis develops on a face, lips and extremities, it, as a rule, spontaneously passes, but decrease in intensity of its signs is well influenced by use of antihistaminic drugs. The Quincke's disease with hypostasis of a throat can lead to a lethal outcome. The paraglossa, an epiglottis and a throat can lead to obstruction of respiratory tracts therefore immediate acceptance of such therapeutic actions is necessary: to enter subcutaneously 0,1% adrenaline solution in a dose of 0,3 - 0,5 ml (0,3 - 0,5 mg) or 0,1 ml (0,1 mg) slowly intravenously then it is necessary to enter a glucocorticoid and antihistaminic drug under control of the vital functions of the patient.

Anaphylactic reactions when carrying out a hemodialysis with use of a membrane about polyacryle - a nitrile (AN 69) are possible, during an aferez of lipoproteins of low density and at desensitization to hymenopterous insects (poison of a bee, wasp).

At damage of a liver the elimination half-life of an amlodipin increases therefore drug should be used with care. To patients at whom jaundice develops or increase in liver enzymes is noted, it is necessary to stop administration of drug and to ask for medical care.

Drug should be used with care to patients with the kolagenny vascular diseases receiving immunodepressive therapy, treatment by Allopyrinolum or procaineamide or the complicating factors having a combination this, especially if there are already renal failures. Because unambiguously it is impossible to exclude a possibility of an agranulocytosis, it is periodically necessary to control a blood pattern.

At extensive surgical interventions or at use of anesthetic, causing hypotension, lisinopril slows down compensatory release of angiotensin II. Arterial hypotension which is noted in this case can be eliminated by introduction of normal saline solution of sodium of chloride.

At use of a standard dose for elderly people higher level of active ingredients in a blood plasma therefore this patients need to establish a dose with care though in efficiency of a considerable difference it was not observed at young and elderly patients was noted.

Use during pregnancy or feeding by a breast. Drug is contraindicated at pregnancy, as well as other APF inhibitors. In P-Sh pregnancy trimesters (9-12 week) defeat or death of a fruit is possible. It is connected with arterial hypotonia, a renal failure and a hyperpotassemia that influences function of kidneys of a fruit. Decrease in amount of amniotic waters can lead to defeat of a fruit with deformation of a skull and person, and also with disturbance of development of extremities, an underdevelopment of lungs and death of a fruit.

During feeding by a breast drug is not used as lisinopril is emitted in breast milk. The possibility of allocation of an amlodipin in breast milk is unknown. Children. Due to the lack of data of use of drug it is contraindicated to children.

Ability to influence speed of response at control of motor transport or other mechanisms. Drug can influence ability to drive the car or to work with mechanisms with the increased risk of traumatism (especially at the beginning of reception) therefore it is individually necessary to define at what dose it is impossible to drive the car or to work in the conditions of the increased traumatism.

Side effects:

Side reactions usually passing are also a little expressed therefore interruption of a course of treatment is not demanded. Side reactions classify by systems of bodies and for emergence frequency as: very often (> 10%), are widespread (> 1% - <10%), infrequently (> 0,1% - <1%), it is rare (> 0,01% - <0,1%), is very rare (<0,01%).

From circulatory and lymphatic systems: very seldom - oppression of marrow, an agranulocytosis, a leukopenia, a neutropenia, thrombocytopenia, anemia (including hemolitic), a lymphadenopathy.

From TsNS: often - a headache, dizziness, drowsiness; sometimes - вертиго, a parasthesia, a hypesthesia, disturbance of flavoring feelings, a syncope, a tremor; very seldom - confusion of consciousness, a depression, a faint, peripheral neuropathy.

From mentality: seldom - lability of mood, a sleep disorder, sleeplessness, a faint; seldom - mental disorders, irritability.

From cardiovascular system and blood: often - tachycardia, orthostatic hypotension, face reddening; seldom - a myocardial infarction, tachycardia, heartbeat, a stroke, Reynaud's phenomenon, arterial hypotension; very seldom - arrhythmia (including ventricular tachycardia and atrial fibrillation), a vasculitis.

From a respiratory organs: often - cough, sometimes - rhinitis, short wind; very seldom - a bronchospasm, an allergic alveolitis / eosinophilic pneumonia, sinusitis.

From a digestive tract and a metabolism: often - nausea, vomiting, an abdominal pain, diarrhea; seldom - a gastric disturbance, dyspepsia, dysfunction of intestines, dryness in a mouth; very seldom - pancreatitis, an intestinal Quincke's disease, gastritis, a hyperplasia of gums, hyper - and a hypoglycemia.

From the alimentary system: very seldom - a liver failure, hepatitis, jaundice (including cholestatic), a cholestasia.

From skin and immune system: seldom - hypersensitivity, rash, an itch, a Quincke's disease (persons, extremities, lips, language or a throat), an alopecia, hemorrhagic rash, skin discoloration, perspiration; seldom - psoriasis, urticaria; very seldom - a toksichsky epidermal necrolysis, Stephens-Johnson's syndrome, a multiformny erythema, a pemphigus, a skin lymphocytoma, autoimmune frustration. Syndromes can include one or several symptoms: a feverish state, a vasculitis, a mialgiya, arthralgia / arthritis, positive ANC (antibodies to nucleic acids), increase SOE, an eosinophilia or a leukocytosis, rash, photosensitivity or other manifestations.

From a musculoskeletal system: seldom - an arthralgia, a mialgiya, spasms, a dorsodynia.

From kidneys and urinary system: often - a renal failure; sometimes - a dysuria, a nocturia, increase in frequency of an urination; seldom - an acute renal failure, uraemia; very seldom - an oliguria / anury.

General disturbances: often - peripheral hypostases, fatigue; seldom - an adynamy, a stethalgia, a sensation of discomfort, deterioration in health, a leukopenia.

Others: seldom - a vision disorder, a sonitus, impotence, a gynecomastia.

Laboratory indicators: seldom - increase in level of urea, creatinine and liver enzymes, a hyperpotassemia, change of body weight, is rare - decrease in level of hemoglobin and a hematocrit, increase in level of bilirubin in blood serum, a hyponatremia.

Interaction with other medicines:

The interactions connected with lisinopril:

· substances which increase potassium level: kaliysberegayushchy diuretics, additives of potassium or substitutes which can increase potassium level. Heparin in combination with APF inhibitors can lead to a hyperpotassemia, especially at patients with a renal failure;

· diuretics: the sharp lowering of arterial pressure can be noted; other anti-hypertensive means: the additive action;

· non-steroidal anti-inflammatory drugs: decrease antigipertenzivno-go actions is possible;

· lithium salt: extent of release of lithium therefore lithium level in a blood plasma needs to be controlled regularly can decrease;

· drugs, anesthetics in combination with lisinopril strengthen hypotensive action.

 Lisinopril slows down release of potassium at a simultaneous priimeneniye with diuretics. Lisinopril strengthens manifestations of a drunkenness.

The interactions connected with amlodipiny:

· CYP3A4 inhibitors: researches with participation of patients of advanced age showed that diltiazem inhibits metabolism of an amlodipin, it is probable through CYP3A4 (concentration in a blood plasma increases by 50% and the effect of an amlodipin increases) that it is also possible at use of other CYP3A4 inhibitors. Care at combined use is required with amlodipiny;

· inductors CYP3A4: combined use with anticonvulsant drugs (for example, carbamazepine, phenobarbital, Phenytoinum, фосфенитоин, Primidonum), the rifampicin, medicines supporting St. John's Wort / Hypericum perforatum can lead to reduction of concentration of an amlodipin in a blood plasma; амлодипин significantly does not influence pharmacokinetics of cyclosporine, an atorvastatin.

Sildenafil did not influence pharmacokinetics of an amlodipin, but at the combined use of an amlodipin and sildenafil each of drugs independently from each other found hypotensive effect. Use of an amlodipin as monotherapy is safe  together with thiazide diuretics, beta-blockers, APF inhibitors, nitrates, sublingual drugs of nitroglycerine, digoxin, warfarin, atorvastatiny, sildenafily, antiacid means (aluminum, magnesium hydroxide, диметикон), Cimetidinum, NPVP, antibiotics and peroral hypoglycemic means.

Contraindications:

Hypersensitivity to drug components. Heavy arterial hypotension, a Quincke's disease in the anamnesis (caused by any APF inhibitor, idiopathic or hereditary); the expressed stenosis of an aorta or the mitral valve, a hypertrophic cardiomyopathy, cardiogenic shock, heart failure after the postponed myocardial infarction (during the first 28 days), unstable stenocardia (for an exception of stenocardia of Printsmetal).

Overdose:

Symptoms: the expressed expansion of peripheral vessels which is followed by an excessive lowering of arterial pressure, cardiovascular shock, an imbalance of electrolytes, a renal failure, a hyperventilation, tachycardia, bradycardia, dizziness, concern and cough.

Symptomatic treatment: it is necessary to provide to the patient horizontal position, to exercise control of cardiac performance, arterial pressure, indicators of exchange of electrolytes and exchange of water, and also to carry out correction of these indicators in case of need. At heavy arterial hypotension it is necessary to give to the patient horizontal position, having raised it the lower extremities and to appoint intravenous administration of solutions for infusions. At inefficiency of this therapy it is necessary to appoint vasoconstrictors (vazopressor) of peripheral action if their use is not contraindicated. For interruption of blocking of calcium channels it is possible to enter calcium a gluconate.

As absorption of an amlodipin is long, the gastric lavage can be effective.

Lisinopril can be removed from an organism by a hemodialysis, but амлодипин through big ability to connect to protein is not exposed to a hemodialysis.

Storage conditions:

In the place protected from moisture and light at a temperature not above 25 °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:

On 10 tablets in a blister strip packaging. One or two blister strip packagings together with the application instruction in a pack from a cardboard.