Export - a drug, which relates simultaneously to the group of calcium channels and antagonists of angiotensin receptors ІІ due to the combination in its composition of two substances: and.

Their combination makes it faster and more efficient to achieve a hypotensive effect in patients with elevated arterial pressure. It is used in patients with circulatory disorders in vessels and arteries, to eliminate spasms of vessels, as well as for preventing memory disorders and concentration.

Export affects the vessels, expanding them, reducing pressure and increasing blood flow in the brain. In therapy is used by patients undergoing heart attack or stroke, to prevent possible repetitions of the disease, thereby allowing to prevent hospitalization and avoid fatal outcome.

Dosage Form and Prices

The medicine is produced in the form of tablets, which differ in the dosage of the active substance:

The price of the drug depends on the selected dosage and ranges from 1028 to 2089 rubles. for packaging.

International unpatient name Medicines (MNN) - Amlodipine / Valsartan.

Composition and mechanism of action

Amlodipine and Valsartan are active ingredients of the drug, their number will differ depending on the dosage selected. There can be 6.94 or 13.87 mg of amlodipine and 80 or 160 mg of valsartan. In addition, it includes: magnesium stearate, crosspovidon, silicon dioxide, talc, titanium dioxide, iron oxide red or yellow, water and hypimosellos.

The drug is assumed orally, after entering the body reaches its maximum value after 6-12 hours. Binds to proteins, metabolized in the liver and excreted from the body kidneys.

With constant reception of the drug can be achieved better effectSince the medicine has accumulative properties, and maximum efficiency acquires a week after the start of reception.

Properties

The drug is used to reduce blood pressure, the effect can be fixed already two hours after receiving the tablet. To improve well-being, it will be necessary on average five hours, while the effect will be maintained during the day. The manufacturer ensures that the patient will not notice any pressure drops or pulse.

Assessment of the results of treatment

Also, if necessary, it is possible to abruptly cancel the drug without consequences, this means that there is no cancellation syndrome. It is also clinically proven that when taking patients with heart failure, the number of hospitalization or sudden heart stop is significantly lower.

What does the exefor differ from co-export and exefor n?

The exefor differs from the co-export and the exof to the components constituting it. In the last two, the substance of the hydrochlorothiazide is additionally used, which has a diuretic effect and is used for an additional hypotensive effect, since it derives an extra liquid from the body.

Indications and contraindications

The main indication to the use of exforts is arterial hypertension in cases where a separate reception of amplodipine and valsartan does not produce effect. Also testimony can be:

Most often, the medicine is used precisely from pressure that consistently rises to high indicators.

Export has also have a number of contraindications that should not be ignored to avoid negative impact on the body. These include:

• individual intolerance to any component in the preparation;
• liver and renal failure;
• other violations of the functioning of the liver;
• myocardial infarction in acute form;
• angina;
• simultaneous reception with drugs from epilepsy and rifampicin;
• the whole period of pregnancy and feeding the baby breasts;
• children under 18.

Instructions for use

In each package, the manufacturer has an instruction manual for the use of a medication that is required to be studied for the effectiveness of therapy. According to annotations, the exeph is accepted inward once a day, regardless of food. A tablet cannot be chewed or divided into parts, it is enough to simply drink it with water.

At the same time, the maximum permissible amount is 10 + 320 mg. More this dosage take the medicine is prohibited in order to avoid side effects.

Possible side effects

Due to the incorrect reception of the drug may occur sideflines. Among them are allocated:

In the case of receiving co-exphorus and exforts N, an increase in urination frequency is observed, since drugs have a diuretic effect.

In case of detection of at least one symptom from the above, it is necessary to immediately consult a doctor for adjustments at the dose of the drug, or its full cancellation, followed by the appointment of a new drug.

Interaction with alcohol and drugs

Possible sharing medication with other diuretics, beta-blockers, aPF inhibitors, antibiotics, warfarin. No changes for the health of the patient in the body does not occur, so the dose adjustment is not required.

It is not recommended to receive a tool together with preparations containing potassium, biological additives or substitutes of salt, as there may be a significant increase in blood potassium. Reception of medication with alcohol is prohibited, as it is fraught with a sharp decrease in pressure and manifestation of adverse reactions.

Analogs

In the event that the prescribed medicine is not available, you can pay attention to its analogues. It should also be noted that a lot has recently appeared. russian analogs, as well as substitutes for imported production. Analogues are:

1. Amlosartan.
2. Bi-sorkord.
3. Vazar A.
4. Valodip.
5. Diffors.
6. Combsart.

Reviews doctors and patients

Larisa, 48 years old: "I was prescribed this medicine when I was on vacation abroad. Suddenly grabbed the pressure and had to contact local specialists. They are considered to be almost the most efficient and widely used. I have been using for two years already, I'm not going to cancel the reception. Previously, the pressure constantly reached 200, and now stably hold on to 130. Helps! "

Anna, 31 years old: "The medicine prescribed my mom for a long time ago, the year has already passed. She my hypertensive and all my life suffered from high pressure. He was constantly sick, nauseous, there were cases of vomiting. Saw a huge number of tablets and did not help anything. But then she was appointed exorph, and all this time the pressure holds 130/80. I am very happy that I can not worry about her, and she is pleased that there are no more problems with pressure. "

Arthur Nododov, therapist: "I want to responsibly declare that the drug is beautiful. He is really one of those samples that are created not to pump out money, but in order to help people. I appoint constantly and very rejoice when patients thank you for the fact that the remedy has gained a second breath. I definitely recommend. "

Maria good, therapist: "I had a case in practice when a woman at the age appealed to me every day with complaints about headaches. And everyone knew that she had pressure, but she did not want any medicine. As long as she does not catch crisis. Here she remembered my appointments and decided to buy an exef. Now the pressure has normalized, the complaints were held. "

Export - an effective hypotensive drug, which has proven its effectiveness on the example of many patients who felt improved well-being after its admission. It is not recommended to independently assign a medicine without examining a doctor, as there are a number of side effects and contraindications that need to be tracking to not harm general status Health.

Hypertensive disease is a progressive disease, and over time of one hypotensive drug becomes not enough.

The optimal solution is a drug that combines the properties of two groups of antihypertensive agents.

Export - quality original preparation Swiss-made combining antagonist calcium channels and Sartan.

Components supplemented in its composition complement and strengthen each other's action, effectively fighting with increased pressure.

Amlodipine is used as a blocker of calcium channels in the preparation of exphor. It prevents the flow of calcium into the cells of the muscular layer of vessels, thereby expanding them and lowering the pressure.

Additional useful feature Amlodipine is a positive effect on renal blood flow.

The benefits of the means include the lack of influence on the pulse frequency and the function of the sinus node, therefore the drug is effective for patients with angina and atherosclerosis of coronary vessels.

Valsartan - Blocator At II receptor, which has a selective action on the first type receptors, effectively reduces arterial pressure Without demolitioning the number of heartbreaks.

Due to the absence of influence on ACE, there is no side effects in the form of cough. The effect of applying the drug is long, does not decrease sharply after cancellation.

It has been proven to improve the forecast against the background of the fee of Valsartan in patients with HSN and after myocardial infarction.

Indications for use

The preparation of exphor is shown for patients with hypertensive disease or hypertension of various genesis, for which monotherapy has become ineffective.

Method

Tablets are accepted inside, 1 tablet, regardless of meals. Selection of dosages is made by a doctor, minimal - 5 mg ampodipine and 80 mg of valsartan.

If necessary, the dose increases, bringing to 10 mg and 320 mg, respectively.

Release form, composition

Available in tablets with film shell containing combination of amlodipine and valsartan in dosages 5 / 80mg, 5/160, 10/160, 5/320 and 10/320.

Tablets are placed in blisters of 7, 10 or 14 pieces, which in various combinations are placed in a cardboard pack.

Active substances Are amlodipine Blessing (6.94 or 13.87 mg in a tablet), an equivalent dose of amlodipine in 5 or 10 mg. Valsartan is added in dosages 80, 160 or 320 mg.

Additionally The tablet contains crosspovidon, magnesium stearate, talc, dyes.

Suction components of the tablet occurs in thin intestineThe maximum concentration in the blood of amlodipine occurs after 6-10 hours at bioavailability of 70%, and Valsartan - after 2 hours with bioavailability of no more than 25%. Amlodipine after suction binds to plasma proteins and enters the liver, excreted by the kidneys.

Valsartan is connected mainly with albumin, most of it remains unchanged and is not metabolized. 83% of the substance is excreted through the intestines, the rest is with urine.

Interaction with other drugs

When using a medicinal product, the exeph in conjunction with potassium preparations or potassium-saving diuretics, as well as with heparin, it is necessary to carefully monitor the concentration of ion in the blood in order to avoid hypercalemia.

Side effects

Allergic reactions with proper use of exforts are observed very rarely, manifested in the form of rashes or itching.

The most common unwanted reactions from the following systems Organs:

The cardiovascular system	Increase the number of heart abbreviations, excessive pressure drop, fainting.
Respiratory system	Symptoms of rhinitis, inflammation of the mucous membrane, very rarely - cough.
Digestive system	Dry mouth, nausea, increasing the frequency of defecation.
Nervous system	Reducing the concentration of attention, dizziness, impairment, violation of the vestibular apparatus, anxiety.
Musculina	Evenkers in the field of joints, pain in the muscles and back, convulsions.
Genothawic	Increasing the frequency and volume of urination, erectile dysfunction.

Side effects

Amlodipine in turn can additionally call side effects In the form of exacerbation of gastritis, shortness of breath, increasing potassium content in the blood, decrease in leukocyte levels and platelets.

Rarely occur total weakness, sweating increases, the mood becomes unstable. In patients with heart disease, rhythm disorders and attacks of angina, but there is no reliable connection between these events with the reception of amlodipine.

TO side effects Valsartan refers to the appearance of the infections of the upper respiratory tract, inflammation of the incomplete sinuses and the nasal cavity. Reducing blood neutrophils was observed in 2% of patients, the level of urea increased in 16%. In many patients, an increase in creatinine and potassium blood is observed in the background of Valsartan's therapy.

Overdose

In the event of an overdose by the drug, the experiment must be rinsed the stomach and take activated coal.

With a significant drop in blood pressure, patient should be put and lifted the foot end, controlling the performance of the heart.

Contraindications

Acceptance of exforts is contraindicated with increased sensitivity to components and during pregnancy. Use of the following states is not recommended:

• pathology of liver and biliary tract;
• impaired renal function (creatinine clearance less than 10 ml per minute);
• valve flaps in the form of stenosis, obstruction of the output path of the left ventricle, hypertrophic cardiomyopathy;
• elevated level Potassium blood, hyponatremia, deficiency of the BCC.

Application during pregnancy

Export is contraindicated in pregnant women, as the incoming blocker angiotensin receptors causes miscarriage, gross disorders of the development of the fetus or serious renal pathology.

Due to the lack of reliable data on the safety of exforts in nursing mothers there are no recommendations for its use.

Terms and Storage Terms

Use for two years, stored at room temperature.

Price

average cost in Russia:

• dosage 10 mg / 160 mg - 14 tablets 1020 rubles, 28 tablets 1800 rubles;
• 5 mg / 160 mg - 14 tablets 950 rubles, 28 tablets 1750 rubles;
• 5 mg / 80 mg - 14 tablets 880 rubles, 28 tablets 1630 rubles.

average cost in Ukraine:

• dosage 10 mg / 160 mg - 14 Tablets 365 hryvnia, 28 tablets 590 hryvnia;
• 5 mg / 160 mg - 350 hryvnia - 14 tablets, 28 tablets 580 hryvnia;
• 5 mg / 80 mg - 340 hryvnia - 14 tablets, 28 tablets 520 hryvnia.

Analogs

The direct analogue of the drug exhodst is heightened. The tablets use the same concentrations of amlodipine and valsartan.

Smears is a drug of Russian production, its price for 28 tablets varies from 230 to 340 rubles depending on the dosage.

There are many similar combined drugs having a combination of hypotensive substances as part of a combination:

1. Amlodipine and the AT II receptor blocker are also combined, in this drug - losartan. Russia's production, cost of about 600 rubles.
2. Equator: The combination of amlodipine and the ACE inhibitor of Lisinopolis, in addition to hypotensive action, has vasodilatory and anti-infanal properties. Hungarian drug, price from 500 to 700 rubles for 30 tablets.
3. Enorum: a combination of enalapril and nitrendipine, calcium channel blockers, Spanish production, cost - 410 rubles.
4. Gizar: Lozartan and Tiazid Diuretik Hydrochlorostiazide. Due to the diuretic effect, patients with left-detecting deficiency are prescribed. Manufacturer - Netherlands, price averages 420 rubles for 14 tablets.

Catad_pgroup Combined hypotensive

Export - instructions for use

EXFORGE ®.

Registration number: LCP-002605/07

Tradename drug: Export

International UnPatented Name (MNN): amlodipine / valsartan

Dosage form : Tablets covered with film shell

Structure: 1 tablet covered with film shell contains:
Active substances: amlodipine cheafect 6.94 mg or 13.87 mg (which corresponds to 5 mg or 10 mg of amlodipine, respectively) and Valsartan 80 mg or 160 mg;
Excipients: Cellulose Microcrystalline, Crosspovidon, Magnesium Stearate, Silicon Colloidal Dioxide, Hydromellos (Hydroxypropylmethylcellulose), Titanium Dioxide (E171), Iron Oxide Yellow (E172), Polyethylene Glycol 4000 (macrogol 4000), Talc
Tablets covered with film shell, 10/160 mg also contain iron oxide red (E172)

Description: Tablets coated with film shell, 5/80 mg: Dark yellow, round with beveled edges, coated with film shell, with an "NVR" on one side and "NV" to another.
Tablets coated with film shell, 5/160 mg: dark yellow, oval with beveled edges, coated with film shell, with an "NVR" on one side and "ECE" to another.
Tablets coated with film shell, 10/160 mg: light yellow, oval with beveled edges, coated with film shell, with the "NVR" on one side and "UIC" to another.

Pharmacotherapeutic group: Hypotensive combined means (block "slow" calcium channels + angiotensin II receptor antagonist).
ATX code C09DB01.

Pharmacological properties
Pharmacodynamics
The exefor is a combination of two antihypertensive components with a complementary arterial pressure control mechanism (AD): amlodipine, Dihydropyridid \u200b\u200bderivative, refers to the class of "slow" calcium channels (BMKK) and Valsartan to the class of angiotensin receptor antagonists. The combination of these components has a mutually complementary anti-hypotensive effect, which leads to a more pronounced decrease in blood pressure compared to those against the background of monotherapy by each drug.
Amlodipine
Amlodipine, which is part of the export, inhibits the transmembrane flow of calcium ions to cardiomyocytes and smooth muscle vessels. The mechanism of antihypertensive action of amlodipine is associated with a direct relaxing effect on smooth muscles Vessels causing a decrease in peripheral vascular resistance and decreased blood pressure.
After receiving B. therapeutic doses Patients S. arterial hypertension Amlodipine causes the extension of the vessels, leading to a decrease in blood pressure (in the position of the patient lying and standing). Reducing the blood pressure is not accompanied by a significant change in the frequency of heart abbreviations (CSS) and the level of catecholamines at long use.
The concentration of the drug in the blood plasma correlates with the clinical effect of both young and elderly patients.
In the arterial hypertension in patients with normal kidney function, amlodipine in therapeutic doses leads to a decrease in the resistance of the renal vessels, an increase in the speed of glomerular filtration and the effective renal plasma blood flow without changing the filtration fraction and the proteinuria level.
Also as with the use of other BMKK, the reception of amlodipine in patients with the normal function of the left ventricle (LV) caused a change in hemodynamic indicators of the heart function at rest and exercise: There was a slight increase in the heart index, without significant influence on maximum speed Pressure increases in LV (DP / DT) and finite-diastolic pressure and volume of LV. Hemodynamic studies in intact animals and people showed that the decrease in blood pressure under the influence of amlodipine in the range of therapeutic doses is not accompanied by a negative inotropic effect Even with simultaneous use with beta-adrenoblockers.
Amlodipine does not change the function of the synoatrial node or atrioventricular conductivity in intact animals and people. When amloodipine is used in combination with beta-blockers in patients with arterial hypertension or angina, the decrease in blood pressure is not accompanied by undesirable changes in the parameters of the ECG parameters.
Proved clinical efficacy of amlodipine in patients with chronic stable angina, vasospadic angina and angiographically confirmed by the defeat of the coronary arteries.
Valsartan.
Valsartan is an active and specific antagonist of angiotensin II receptors, intended for intake. It acts selectively for AT 1 subtype receptors, which are responsible for the well-known effects of angiotensin II. Increasing the plasma concentration of free angiotensin II due to the blockade of AT 1 -receptors under the influence of Valsartan can stimulate unclocated AT 2 -receptors, which counteract the effects of AT 1 stimulation effects. Valsartan does not have any pronounced agonistic activity against AT 1 -receptors, the affinity of Valsartan to AT 1 subtype receptors of approximately 20,000 times higher than to the subtype receptors 2.
Valsartan does not inhibit angiotensin-converting an ACE enzyme, also known as kininosis II, which turns angiotensin I in angiotensin II and causes the destruction of bradykinin.
Since the use of angiotensin II antagonists does not occur inhibition of ACE and the accumulation of bradykinin or substance P, the development of dry cough is unlikely.
In comparative clinical studies Valsartan with an ACF inhibitor The dry cough rate was significantly lower (p<0,05) у больных, получавших валсартан (у 2,6% пациентов, получавших валсартан, и у 7,9% - получавших ингибитор АПФ). В клиническом исследовании, включавшем больных, у которых ранее при лечении ингибитором АПФ развивался сухой кашель, при лечении валсартаном это осложнение было отмечено в 19,5% случаев, при лечении тиазидным диуретиком - в 19,0% случаев. В то же время, в группе больных, получавших лечение ингибитором АПФ, кашель наблюдался в 68,5% случаев (р<0,05). Валсартан не вступает во взаимодействие и не блокирует рецепторы других гормонов или ионные каналы, имеющие важное значение для регуляции функций of cardio-vascular system.
In the treatment of valsartan patients with arterial hypertension, a decrease in blood pressure is noted, not accompanied by a change in heart rate.
The antihypertensive effect manifests itself within 2 hours in most patients after one-time reception of the drug. The maximum decrease in blood pressure is developing in 4-6 hours. After taking the drug, the duration of the hypotensive effect is preserved more than 24 hours. With reuse, the maximum decrease in blood pressure, regardless of the adopted dose, is usually achieved within 2-4 weeks and is supported on the level achieved during long-term therapy. A sharp discontinuation of the reception of Valsartan is not accompanied by a sharp increase in blood pressure or other undesirable clinical consequences. The use of valsartan in patients with chronic heart failure (NYHA classes II-IV) leads to a significant decrease in the number of hospitalizations. This effect is maximally pronounced in patients who do not receive ACE inhibitors or beta-adrenoblays. When receiving a valsartan in patients with left-deuded deficiency (stable clinical flow) or with a violation of the function of LV after the myocardial infarction, there is a reduction in cardiovascular mortality.
Amlodipine / Valsartan
In patients with arterial hypertension, which received the exeph 1 time / day, the antihypertensive effect was maintained within 24 hours.
Export in doses of 5/80 mg and 5/160 mg in patients with source systolic arterial pressure (garden) 153-157 mm Hg. Art. and diastolic arterial pressure (DDA)\u003e 95 mm Hg. Art. and less than 110 mm Hg. Art. Reduces blood pressure by 20-28 / 14-19 mm Hg. Art. (Compared with 7-13 / 7-9 mm Hg. Art. when receiving placebo).
Export in a dose of 10/160 mg and 5/160 mg normalizes blood pressure (reduction of DDA in the sitting position less than 90 mm Hg. Art. At the end of the study) in 75% and 62% of patients with inadequate control of blood pressure on the background of Wovssartan monotherapy in a dose of 160 mg / day.
Export at a dose of 10/160 mg normalizes blood pressure in 78% of patients with inadequate control control on the background of amlodipine monotherapy at a dose of 10 mg.
In patients with arterial hypertension, with a combination of valsartan in a dose of 160 mg with amlodipine in doses of 10 mg and 5 mg, an additional decrease in the garden and Dad on 6.0 / 4.8 mm RT is achieved. Art. and 3.9 / 2.9 mm Hg. Art. Accordingly, compared with patients who continued to obtain only Valsartan at a dose of 160 mg or only amlodipine at a dose of 5 and 10 mg.
When titrating the dose of exof from 5/160 mg to 10/160 mg in patients with arterial hypertension with DD\u003e 110 mm RT, Art. and less than 120 mm Hg. Art. There is a decrease in blood pressure in the sitting position at 36/29 mm Hg. Art., comparable with a decrease in blood pressure when titrating a dose combination of an ACF inhibitor and a thiazide diuretic.
In two long-term studies with a long observation period, the Effect of Exports remained for 1 year. A sudden stopping of the reception of the exforts is not accompanied by a sharp increase in blood pressure.
In patients with adequate control of blood pressure, but developed pronounced edema against the background of amlodipine monotherapy, with the use of combination therapy, comparable control of blood pressure was achieved with a smaller probability of edema development.
Therapeutic efficacy of exforts does not depend on age, gender and race patient.

Pharmacokinetics
Pharmacokinetics of valsartan and amlodipine are characterized by linearity.
Amlodipine
Suction
After receiving inside Amlodipine in therapeutic doses, the maximum concentration of amlodipine in the blood plasma is reached after 6-12 hours. The magnitude of the absolute bioavailability is an average of 64% - 80%. Meal does not affect the bioavailability of amlodipine.
Distribution
The distribution volume is approximately 21 l / kg. In vitro amlodipine studies, it was shown that in patients with arterial hypertension of approximately 97.5% of the circulating preparation associated with blood plasma proteins.
Metabolism
Amlodipine intensively (approximately 90%) is metabolized in the liver with the formation of active metabolites.
Election
The removal of amlodipine from the plasma is two-phase character with half-life (TV) approximately 30 to 50 hours. Equilibrium blood plasma concentrations are achieved after a long application for 7-8 days. 10% of unchanged amlodipine and 60% amlodipine in the form of metabolites are excreted by the kidneys.
Valsartan.
Suction
After taking inside the valsartan, the maximum concentration in the blood plasma is reached after 2-3 hours. The average absolute bioavailability is 23%.
Pharmacokinetic Valsartan curve has a downward multi-exponential character (T½α<1 ч и Т½ß около 9 ч). При приеме валсартана с пищей отмечается снижение биодоступности (по значению площадь под кривой, AUC) на 40% и максимальной концентрации (С mах) в плазме крови почти на 50%, хотя приблизительно через 8 часов после приема препарата концентрации валсартана в плазме крови в группе пациентов, принимавших его с пищей, и в группе, принимавшей натощак, выравниваются. Уменьшение AUC, однако, не сопровождается клинически значимым снижением терапевтического эффекта, поэтому валсартан можно назначать вне зависимости от времени приема пищи.
Distribution
The volume of the distribution (VD) of Valsartan during the equilibrium state after intravenous administration was about 17 liters, which indicates the absence of an extensive distribution of valsartan in the tissues. Valsartan is largely associated with serum proteins (94-97%), mainly with albumin.
Metabolism
Valsartan is not expressed in pronounced metabolism (about 20% of the adopted dose is determined in the form of metabolites). Hydroxyl metabolite is determined in plasma of blood at low concentrations (less than 10% of Valsartan AUC). This metabolite is pharmacologically active.
Election
Valsartan is carried out mainly unchanged through the intestines (about 83% dose) and with kidneys (about 13% dose). After intravenous administration, the plasma clearance of Valsartan is about 2 l / h and its kidney clearance is 0.62 l / h (about 30% of the total clearance). T½ Valsartan is 6 hours.
Amlodipine / Valsartan
After taking inside the drug, the maximum concentrations of valsartan and amlodipine are achieved after 3 and 6-8 hours, respectively. The speed and degree of absorption of the exphor is equivalent to bioavailability of valsartan and amlodipine when receiving each of them in the form of separate tablets.
Pharmacokinetics in special clinical cases
Children
The pharmacokinetic features of the use of exforts in children under 18 are not installed.
Elderly patients
The time of achievement with MAK amlodipine in the blood plasma in young and elderly patients is equally. In elderly patients, amlodipine clearance is slightly reduced, which leads to an increase in AUC and T½.
In senior patients, the systematic exposure to Valsartan was somewhat more pronounced than in patients of young age, however, it was not clinically significant. Since the tolerability of the components of the drug in the elderly and more young patients are equally good, it is recommended to apply conventional dosing modes.
Patients with impaired kidney function
In patients with impaired kidney function, pharmacokinetic parameters of amlodipine do not significantly change. No correlation was identified between the kidney function (creatinine clearance) and the systemic effects of valsartan (AUC) in patients with different degrees of renal function.
The initial dose changes in patients with initial and moderate disorders of the kidney function (Creatinine clearance (CC) 30-50 ml / min) are not required.
Patients with impaired liver function
Hepatic insufficiency patients have reduced amlodipine clearance, which leads to an increase in AUC approximately 40-60%. On average, patients with chronic liver diseases of weak and moderate degree bioavailability (AUC) of valsartan doubles compared to healthy volunteers (appropriate age, gender and body weight).

Indications for use
Arterial hypertension (patients who are shown combined therapy).

Contraindications

• Increased sensitivity to amlodipine, valsartan and other components of the drug;
• Pregnancy.

The safety of the use of exforts in patients with one-sided or double-stenosis stenosis of renal arteries or stenosis of the artery of the only kidney, in patients after recently transferred kidney transplantation, as well as children and adolescents under 18 years old have not been established.

CAREFULLY
Violations of the liver function
Walssartan is mainly unchanged with bile, while amlodipine is intensively metabolized in the liver. Care should be taken when appointing exfourge to patients with liver diseases (especially during obstructive diseases of the biliary tract).
Disorders of the kidney function
Patients with initial and moderate disorders of the kidney function (QC 30-50 ml / min) of the dose correction is not required. Care should be taken when prescribing a drug with severe impaired kidney function, since the safety data for the use of the drug in such cases (CC is less than 10 ml / min) are not received.
As well as with the use of other vasodilators, it should be especially safe when prescribing the drug in patients with mitral or aortic stenosis, and hypertrophic obstructive cardiomyopathy.
It should be caution to prescribe exeph in patients with hyperkalemia, a deficiency in sodium organism and / or a decrease in circulating blood (BCC).

Application during pregnancy and during lactation
Given the mechanism of action of angiotensin II receptor antagonists, it is impossible to exclude the risk for the fetus. It is known that the appointment of ACE inhibitors affecting the renin angiotensin-aldosterone system (RAAS) pregnant in the II and III trimesters leads to damage or death of a developing fetus. According to a retrospective analysis of the use of ACE inhibitors during I trimester, pregnancy was accompanied by the development of the pathology of the fetus and a newborn. In case of unintentional intake of Valsartan, pregnant women describe the development of spontaneous abortion, low-body and disorders of the function of the kidneys in newborns. Export, as well as any other drug that has a direct impact on Raas should not be prescribed during pregnancy and women who want to become pregnant. Patients of childbearing need to be informed about the possible risk for the fetus associated with the use of drugs affecting Raas. If pregnancy has been detected during the treatment period, the drug should be canceled as soon as possible. It is not known whether Valsartan penetrates and / or amlodipine into breast milk. Since the experimental studies have noted the allocation of valsartan with breast milk, it is not recommended to use exeph during breastfeeding period.

Method of application and dose
The drug should be taken inside by drinking with a small amount of water, 1 time per day, regardless of the time of meals. Recommended daily dose - 1 Export Tablet containing amlodipine / valsartan at a dose of 5/80 mg or 5/160 mg or 10/160 mg.
When prescribing patients elderly, patients with initial or moderate impaired renal function (QC\u003e 30 ml / min), with impaired liver function or liver disease, with cholestasis phenomena Dosing mode changes are not required.

SIDE EFFECT
The safety of the use of exphorus is estimated more than 2600 patients.
The following criteria for estimating the frequency of occurrence of unwanted phenomena were used: the concept of "very often" is used if undesirable phenomena are marked more than 10% of patients; The concept of "often" - in 1% -10%, the concept of "sometimes" - in 0.1-1%, the concept of "rare" in 0.001-0.1%, the concept of "in some cases" is less than that of 0.001% of patients. Within each group allocated in the frequency of occurrence, adverse reactions Distributed in order to reduce their importance.
Infection and invasion
Often: Naphorgitis, flu.
Allergic and immunological reactions
Seldom: increased sensitivity.
From the senses
Rarely: violations, noise in the ears; Sometimes: dizziness associated with impaired function of the vestibular apparatus.
Mental violations
Rarely: anxiety.
From the CNS and peripheral nervous system
Often: headache; Sometimes: dizziness, drowsiness, orthostatic dizziness, paresthesia.
From the cardiovascular system
Sometimes: tachycardia, heartbeat, ortostatic hypotension; rarely: syncopal state, pronounced decreased blood pressure
From the respiratory system
Sometimes: cough, pain in the throat and larynx.
From side digestive system
Sometimes: diarrhea, nausea, abdominal pain, constipation, dry mouth.
Dermatological reactions
Sometimes: skin rash, erythema; Rarely: hyperhydrosis, examine, itching.
From the bone-muscular system
Sometimes: the edema of the joints, pain in the back, arthralgia; seldom: muscle spasms, feeling of gravity in the whole body.
From side gOOD SYSTEM
Rarely: Pollakiuria, polyuria, erectile dysfunction.
Others
Often: Pastoznost, swelling of the face, peripheral edema, increased fatigue, blood tides to face, asthenia, feeling of heat.
In comparative and placebo-controlled clinical studies, the frequency of peripheral edema was statistically lower in patients who received a combination of amlodipine with valsartan (5.8%) than in patients receiving amlodipine monotherapy (9%).
Laboratory indicators: Increased nitrogen of blood urea (more than 3.1 mmol / l) was observed slightly more often in groups receiving amlodipine / valsartan (5.5%) and Valsartan in the form of monotherapy (5.5%), compared with the placebo group (4.5%).
Unwanted phenomena, which were previously reported when using each of the components, may occur when applying the exforts, even if they were not observed in clinical studies.
Amlodipine
In those clinical studies where Amlodipine was used as a monotherapy, other undesirable phenomena were also noted (regardless of their causal connection with the studied drug): most often - nausea; Less often - Alopecia, change in the frequency of defecation, dyspecia, shortness of breath, rhinitis, gastritis, hyperplasia Gumsion gum, gynecomastia, hyperglycemia, erectile dysfunction, increase in urging, leukopenia, general malaise, mood lability, dryness, Malgy, peripheral neuropathy, pancreatitis, hepatitis , increased sweating, thrombocytopenia, vasculitis, angioedema edema, multiform erythema.
In a long-term placebo-controlled study (PRAISE-2) in patients with heart failure of the III and IV degree (on NYHA) of non-ahemic etiology, when using amlodipine, an increase in the frequency of pulmonary edema is noted, in the absence of significant differences in the frequency of development of the deterioration of heart failure in comparison with placebo.
In rare cases, at the beginning of therapy, the "slow" calcium channels (BMKK) or with an increase in the dose of BMKK, especially in patients suffering from severe form ischemic Disease Hearts (IBS), there was an increase in frequency, duration and severity of angina or development acute infarction Myocardium. Also, on the background of the treatment of BMKK, arrhythmia development was observed (including stomatricular Tachycardia and atrial fibrillation). It is not possible to distinguish the occurrence of data from the natural flow of the underlying disease.
Valsartan.
In clinical studies, with the use of Valsartan as monotherapy, the following undesirable phenomena were noted (regardless of their causal connection with the drug studied): viral infections, infections of the upper respiratory tract, sinusitis, rhinitis, neutropenia, insomnia. Neutropenia was revealed in 1.9% of patients who received Valsartan, and 1.6% of patients receiving an ACF inhibitor.
In controlled clinical studies, in 3.9% and in 16.6% of patients with heart failure, who received Valsartan, there was an increase in the level of creatinine and nitrogen of blood urea by more than 50%, respectively. For comparison, in patients receiving placebo, the increase in creatinine and urea nitrogen was observed in 0.9% and 6.3% of cases.
The doubling of the serum creatinine was revealed in 4.2% of patients after the myocardial infarction received by Valsartan and in 3.4% of the captive receiving. In controlled clinical studies, 10% of heart failure patients have noted an increase in serum potassium level by more than 20% for comparison, in patients receiving placebo, the increase in potassium concentration was observed in 5.1%. Cases.

Interaction with other medicines
Amlodipine
With amlodipin monotherapy, there is no clinically significant interaction with thiazide diuretics, beta-adrenoblockers, ACE inhibitors, nitrates long action, nitroglycerin for sublingual use, digoxin, warfarin, atorvastatin, sildenafil, Maaloks (aluminum hydroxide gel, magnesium hydroxide, symmetics), cimetidine, nonsteroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs.
Valsartan.
It has been established that under the monotherapy of Valsartan there is no clinically significant interaction with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glyibenklamide.
With simultaneous use with biologically active additivescontaining potassium, potassium-saving diuretics, potassium-containing salt substitutes, or with other drugs that can cause an increase in blood potassium concentration (for example, with heparin), caution should be taken and carry out frequent control of potassium concentration in the blood.

OVERDOSE
Data on cases of overdose of the drug is currently absent. With overdose of Valsartan, it is possible to expect the development of a pronounced decrease in blood pressure and dizziness. Overdose amlodipine can lead to excessive peripheral vasodilation and possible reflex tachycardia. It also reported on the occurrence of pronounced and long systemic arterial hypotension until the development of the shock with a fatal outcome.
Treatment: In case of accidental overdose, vomiting should be caused (if the drug has been accepted recently) or wash the stomach. Application activated coal Healthy volunteers at once or 2 hours after receiving Amlodipine significantly reduced its absorption. With a clinically pronounced arterial hypotension caused by exforge, it is necessary to put a patient with raised legs, take active measures to maintain the activities of the cardiovascular system, including frequent control of the function of the heart and respiratory system, BCC and the amount of urine allocated. In the absence of contraindications in order to restore the vascular tone and hell possible, use (with caution) of the vasoconstrictor. Intravenous administration Gluconate calcium can be effective to eliminate the calcium channel blockade.
The removal of valsartan and amlodipine during hemodialysis is unlikely.

SPECIAL INSTRUCTIONS
If necessary, the abolition of ß-adrenoblockers before starting therapy to exforge, the dose of ß-adrenoblockers should be reduced gradually. Since amlodipine is not a ß-adrenoblocator, the use of the drug Exphief does not prevent the development of the "cancellation" syndrome, which occurs with a sharp discontinuation of treatment with P-adrenoblockers.
Deficiency in sodium organism and / or reduction of the BCC
In placebo-controlled studies in patients with uncomplicated arterial hypertension, a pronounced arterial hypotension was observed in 0.4% of cases. In patients with an activated renin-angiotensin-aldosterone system (for example, with a BCC and / or sodium deficiency in patients receiving high doses of diuretics), when taking blockers angiotensin receptors, the symptomatic arterial hypotension is possible. Before starting treatment, the exforce should be corrected to correct the sodium content in the body and / or OCC or begin therapy under careful medical supervision. In the event of the development of the patient's arterial hypotension, it should be laid with raised legs, if necessary, to carry out the physiological infusion of the physiological solution. After stabilization of blood pressure, the exforge can be continued.
Hypercalemia
With the simultaneous use of a drug with biologically active additives containing potassium, potassium-saving diuretics, potassium-containing salt substitutes, or with other drugs that can cause a blood potassium concentration (for example, with heparin), caution should be taken and carry out regular control of potassium concentration in blood. .

Impact on the ability to control vehicles and work with mechanisms
There are no data on the effect of the drug on the ability to manage vehicles and work with mechanisms. Due to the possible occurrence of dizziness or increased fatigue, caution should be taken when driving vehicles or working with mechanisms.

Form release
Tablets coated with film shell, 5 mg / 80 mg, 5 mg / 160 mg or 10 mg / 160 mg: 7, 10 or 14 pcs, in blister; 1.2, 4, 8, 14 or 40 blisters of 7 tablets; 3, 9 or 28 blisters of 10 tablets; 1. 2, 4, 7, or 20 blisters of 14 tablets along with the instructions for use in a cardboard pack.

STORAGE CONDITIONS
In a dry place at a temperature not higher than 30 ° C.
Keep out of the reach of children.

SHELF LIFE
2 years.
The drug should not be used after the expiration date.

Conditions of vacation from pharmacies
On prescription.

MANUFACTURER
NOVARTIS PHARMA AG, produced Novartis Pharma Stein AG, Switzerland / Novartis Pharma AG, Switzerland, Manufactured by Novartis Pharma Stein AG, Switzerland
Address
Lichtstraße 35, CH-4002 Basel, Switzerland / Lichtstrasse 35, CH-4002 Basel, Switzerland
Additional information About preparation
115035, Moscow, Sadovnicheskaya ul., 82/2

• Instructions for use Export
• Composition of the drug Exphief
• Indications of the drug Exphief
• Conditions for storage of the drug Export
• The shelf life of the drug Exeffer

ATX code: Cardiovascular system (C)\u003e Preparations affecting the renin angiotensin system (C09)\u003e Angiotensin II antagonists in combination with other drugs (C09D)\u003e angiotensin II antagonists in combination with calcium channel blockers (C09DB)\u003e Valsartan in combination with amlodipine (C09DB01)

Release form, composition and packaging

tab., Pok. film Obol., 5 mg + 80 mg: 14 or 28 pcs.
Reg. №: RK-LS-5-№ 014820 dated January 26, 2015 - existing

Dark yellow, rounded shape, with beveled edges, with the inscription "NVR" on one side and "NV" - to another.

Excipients:

Film shell composition:

tab., Pok. film Obol., 5 mg + 160 mg: 14 or 28 pcs.
Reg. №: RK-LS-5-№ 014821 dated January 26, 2015 -

Tablets covered with film shell Dark yellow, oval shape, with beveled edges, with the inscription "NVR" on one side and "ECE" - to another.

Excipients: Silicon Dioxide Colloid Anhydrous, Crosspovidon, Magnesium Stearate, Cellulose Microcrystalline.

Film shell composition: Hypromellos, polyethylene glycol, talc, titanium dioxide (E171), iron oxide yellow (E172).

14 pcs. - Packaging cell contour (1) - cardboard boxes.
14 pcs. - Packaging cell contour (2) - cardboard boxes.

tab., Pok. film Obol., 10 mg + 160 mg: 14 or 28 pcs.
Reg. №: RK-LS-5-№ 014822 dated January 26, 2015 -

Tablets covered with film shell Light yellow color, oval shape, with beveled edges, with the inscription "NVR" on one side and "UIC" - to another.

Excipients: Silicon Dioxide Colloid Anhydrous, Crosspovidon, Magnesium Stearate, Cellulose Microcrystalline.

Film shell composition: HalpRellos, polyethylene glycol, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

14 pcs. - Packaging cell contour (1) - cardboard boxes.
14 pcs. - Packaging cell contour (2) - cardboard boxes.

Description medicinal preparation Export Based on officially approved instructions for the use of the drug and made in 2011. Renewal date: 12/03/2010

pharmachologic effect

Combined antihypertensive preparation containing active substances With the complementary mechanism of control of blood pressure. Amlodipine belongs to the class of calcium antagonists, Valsartan - to the class of angiotensin II receptor antagonists. The combination of these components has an additive antihypertensive effect, reducing blood pressure to a greater degree than each component separately.

When receiving an exfigure in single dose The antihypertensive effect is maintained within 24 hours. With prolonged use, the EFFECT effect is saved for 1 year. The sudden abolition of exofage is not accompanied by a rapid increase in hell. In patients who have adequately controlled by amlodipine, but in which an extremely pronounced angioedema edema was observed, with a combined therapy, the same control was reached with less expressed edema. Age, gender and race do not affect the effectiveness of the exof.

Pharmacokinetics

Pharmacokinetics of valsartan and amlodipine are characterized by linearity. Since the pharmacokinetic interaction between valsartan and amlodipine is absent, the pharmacokinetics for each drug is separately given.

Amlodipine

Suction

After the intake of amlodipine in the therapeutic doses of C Max amlodipine in the blood plasma is reached after 6-12 hours. The magnitude of the absolute bioavailability is an average of 64-80%. Meal does not affect the bioavailability of amlodipine.

Distribution

V D is approximately 21 l / kg. 97.5% of the circulating drug binds to plasma proteins.

Metabolism

Amlodipine intensively (approximately 90%) is metabolized in the liver with the formation of active metabolites.

Election

The removal of amlodipine from the plasma is two-phase character with terminal T 1/2 from 30 to 50 hours. C SS in blood plasma is achieved after a long use for 7-8 days. 10% of unchanged amlodipine and 60% amlodipine in the form of metabolites are excreted in urine.

Valsartan.

Suction

After receiving inside the valsartan C Max in the blood plasma is reached after 2-3 hours. The average absolute bioavailability is 23%. Pharmacokinetic curve of Valsartan has a downward multi-exponential character (T 1 / 2α<1 ч и T 1/2β около 9 ч). При приеме валсартана с пищей отмечается снижение биодоступности (по значению AUC) на 40% и C max в плазме крови почти на 50%, хотя приблизительно через 8 ч после приема препарата концентрации валсартана в плазме крови в группе пациентов, принимавших его с пищей, и в группе, принимавшей натощак, выравниваются. Уменьшение AUC, однако, не сопровождается клинически значимым снижением терапевтического эффекта, поэтому валсартан можно назначать вне зависимости от времени приема пищи.

Distribution

V D Valsartan in an equilibrium state after a / in administration was about 17 liters, which indicates the absence of an extensive distribution of valsartan in tissues. Valsartan is largely associated with serum proteins (94-97%), mainly with albumin.

Metabolism

Valsartan is not expressed in pronounced metabolism (about 20% of the adopted dose is determined in the form of metabolites). Hydroxyl metabolite is determined in plasma of blood at low concentrations (less than 10% of Valsartan AUC). This metabolite is pharmacologically active.

Election

Valsartan is excreted mainly unchanged with the feces (about 83% dose) and with urine (about 13% dose). After a / in administration, the plasma clearance of Valsartan is about 2 l / h and its kidney clearance is 0.62 l / h (about 30% of the total clearance). T 1/2 Valsartan is 6 hours.

Export

After taking inside the preparation, the exephine C Max Valsartan and Amlodipine is achieved after 3 h and 6-8 hours, respectively. The speed and degree of absorption of the exphor is equivalent to bioavailability of valsartan and amlodipine when receiving each of them in the form of separate tablets.

Dosing mode

Patients in whose blood pressure is not amenable to adequate control when using only one amlodipine (or other calcium channels of calcium channels - derivative dihydropyridine) or only one valsartan (or another angiotensin II receptor blocker) can be translated into the therapy by the preparation of exeph.

Recommended dose - 1 tab. / Sut (5 mg of amlodipine and 80 mg of valsartan, or 5 mg of amlodipine and 160 mg of valsartan, or 10 mg of amlodipine and 160 mg of valsartan). With clinical compliance, a direct transition from monotherapy to a combination with a fixed dose can be considered.

For convenience, patients receiving valsartan and amlodipine in separate tablets can be translated into export containing these components in the same doses.

Export can be taken with food or independently of meals with a small amount of water.

Side effects

Side effects are given according to their frequency using the following criteria:

• very often (≥1 / 10);
• often (\u003e 1/100, ≤1 / 10), infrequent (\u003e 1/1000, ≤1 / 100), rarely (\u003e 1/10,000, ≤ 1/1000), very rarely (<1/10 000), включая отдельные сообщения.

From the digestive system: Very often - vomiting;

infrequently - abdominal pain, constipation, violation of stool, diarrhea, dyspepsia, gastritis, pancreatitis, hepatitis, nausea, dry mouth, gum hyperplasia.

From the CNS and the peripheral nervous system: often - headache;

infrequently - dizziness, drowsiness, mood change, peripheral neuropathy;

rarely - fuzziness, paresthesia, excitement, noise in ears, fainting, asthenia, increased fatigue.

From the respiratory system: often - naphorgitis, flu-like symptoms;

infrequently - shortness of breath, cough, sore throat and larynx, rhinitis, sinusitis.

From the side of the cardiovascular system: infrequently - tachycardia, orthostatic hypotension, vasculitis;

rarely - the swelling of the face, the lower extremities, the swelling of the lungs, the feeling of tides.

Allergic reactions: infrequent - angioedema edema;

rarely - urticaria.

On the side of the musculoskeletal system: infrequently - pain in the back, arthralgia, edema of the joints;

rarely muscle cramps, feeling of gravity in the legs.

Dermatological reactions: infrequently erythema;

rarely hyperships.

From the endocrine system: infrequently - gynecomastia, hyperglycemia;

rarely - a violation of an erectile function.

From the hematopopitation system: Infrequent leukopenia, thrombocytopenia.

From the urinary system: infrequently - improving the level of creatinine;

rarely - stripped urination, polyuria;

very rarely - significant changes in laboratory test indicators, namely increasing urea nitrogen in the blood.

Application in pregnancy and breastfeeding

Export should not be appointed to women who are planning pregnancy. The doctor should warn a woman about potential risk when appointing an exfigure during pregnancy. If pregnancy is installed in the process of therapy, the reception of the drug must be discontinued immediately.

Application with violations of liver function

Care should be taken when appointing exfourge to patients with liver diseases (especially during obstructive diseases of the biliary tract). Walssartan is mainly unchanged with bile, while amlodipine is intensively metabolized in the liver.

Application with violations of the kidney function

Patients with initial and moderate disorders of the kidney function of the dose of exphortage is not required. Care should be taken when prescribing the drug patients with severe abnormalities of the kidney function (QC<10 мл/мин), так как данные по безопасности применения препарата в таких случаях не получены.

special instructions

In patients with uncomplicated arterial hypertension, excessive hypotension was observed. In patients with activated RAAS (with a BCC and / or sodium deficiency in patients receiving diuretics in high doses), which receive blockers angiotensin receptors, the symptomatic arterial hypotension is possible. It is recommended that this state is recommended before the appointment of exforts or careful medical observation at the beginning of therapy. If an arterial hypotension is observed when receiving an exof, then the patient should be placed in a horizontal position, if necessary, assign a physiological infusion to infusion. Treatment should be continued until the hell stabilization.

With simultaneous use with biologically active additives containing potassium, potassium-saving diuretics, potassium-containing salt substitutions, or with other drugs that can cause an increase in blood potassium concentration (for example, with heparin), caution and frequent determination of potassium concentration in blood is required.

Special caution should be observed in the appointment of exforces to patients with diseases of the liver and obstructive diseases of the biliary tract.

Patients with impaired kidney function from mild to moderate degree of dose correction is not required.

Special caution is shown for patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Impact on the ability to driving vehicles and control mechanisms

Overdose

Symptoms:a pronounced arterial hypotension with dizziness, as well as increasing peripheral vasodulation and reflex tachycardia. A significant and potentially prolonged systemic hypotension has been reported, up to shock and fatal outcome.

Treatment: If the drug takes place recently, you should cause vomiting or washing the stomach. The absorption of exforts is significantly reduced when using activated carbon immediately or for 2 hours after reception. The clinically significant arterial hypotension caused by an overdose of exforts requires active support for the state of the cardiovascular system, including constant control of the heart and respiratory function, the rise of limbs and attention to the ICC and the scope of urination. To restore the vascular tone and blood pressure can be a useful vasoconstrictor, while taking into account the absence of contraindications for its use. To remove the blockade of calcium channels, it may be advisable to / in the administration of calcium gluconate.

Medicinal interaction

Safe is the combination of the preparation of exeph with thiazide diuretics, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, siltenafil, antacids, cimetidine, NSAIDs, antibiotics and oral hypoglycemic drugs.

There is no clinically significant interaction with the following substances:

• cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine, Glyibenklamide.

With simultaneous use with biologically active additives containing potassium, potassium-saving diuretics, potassium-containing salt substitutions or with other drugs that can cause a blood potassium concentration (for example, with heparin), care and frequent determination of potassium concentration in the blood is required.

Export- Combined drug angiotensin II inhibitors.
Export contains two antihypertensive components with additional arterial pressure control mechanisms in patients with essential hypertension: Amlodipine refers to the calcium antagonists class, and Valsartan is to the class of angiotensin II antagonists. The combination of these ingredients has an addive antihypertensive effect, reducing blood pressure to a greater extent than each of the components separately.
Amlodipine inhibits the transmembrane penetration of calcium ions into the smooth muscles of the heart and blood vessels. The mechanism of antihypertensive action of amlodipine is due to the direct relaxing effect on the smooth muscles of vessels, which leads to a decrease in peripheral vascular resistance and leads to a decrease in blood pressure. Experimental data confirm that amlodipine is associated with dihydropyridine and nonhydropyridine communications places. The contracting processes of the heart muscle and the smooth muscles of the vessels depend on the passage of extracellular calcium into these cells through specific ion channels.
After the administration of therapeutic doses of patients with arterial hypertension, amlodipine causes vasodilation, which leads to a decrease in blood pressure in the provisions lying and standing. Such a decrease in blood pressure is not accompanied by a significant change in the velocity of cardiac abbreviations or levels of catecholamines in plasma with long-term use.
The effect correlates with plasma concentrations in young and elderly patients.
In patients with arterial hypertension and normal kidney function, the therapeutic doses of amlodipine leads to a decrease in the renal vascular resistance and the level of glomerular filtration, as well as the effective renal plasma flux without changes in the fraction, filtered, or proteinuria.
As in the case of other calcium channel blockers, measurement of hemodynamics of the heart function at rest and under load (or when walking) in patients with a normal ventricular function treated by amlodipin, as a whole showed a slight increase in the heart index without significantly influenced on DP / DT or on Finium diastolic pressure or volume of left ventricle. In hemodynamic studies, Amlodipin did not show a negative inotropic effect when used in therapeutic doses in intact animals and people, even with joint introduction with beta-blockers to people.
Amlodipine does not change the function of the sinus-atrial node or atrocadic conductivity in healthy animals or humans. In clinical studies in which amlodipine was used in combination with beta-blockers in patients with arterial hypertension or angina, changes in the electrocardiogram indicators were not marked.
Positive clinical effects of amlodipine were observed in patients with chronic stable angina, vasospast angina and ischemic disease, angiographically was confirmed.
Walssartan is an active, powerful and specific angiotensin II receptor antagonist, intended for intake. It acts selectively for subtype receptors AT 1, which are rarely responsible for the effects of angiotensin II. Increased levels of angiotensin II due to the blockade of AT 1-receptor with valsartan can stimulate free AO 2 receptors, which balances the effect of AO 1 receptors. Valsartan does not have any partial activity of agonist relative to AO 1 receptors and has much greater (approximately 20,000) relationship with AO 1 receptors than with AO 2 receptors.
Valsartan does not inhibit the ACE, also known as Kininina II, which turns angiotensin I in angiotensin II and destroys Bradikinin. Based on the lack of influence on ACE and the potentiation of bradykinine's activity or substance P, the use of angiotensin II receptor antagonists, as a rule, is not accompanied by a cough. In clinical studies, where Valsartan was compared with the ACE inhibitor, the dry cough radiation rate was significantly smaller (p<0,05) у пациентов, валсартан, чем у пациентов, принимавших ингибитор АПФ (2,6% по сравнению с 7,9 % в соответствии). У пациентов, ранее получавших лечение ингибитором АПФ, развивался сухой кашель, при лечении валсартаном это осложнение было отмечено в 19,5% случаев, а при лечении тиазидным диуретиком - в 19% случаев, тогда как в группе больных, получавших лечение ингибитором АПФ, кашель наблюдался в 68,5% случаев (Р <0,05). Валсартан не вступает во взаимодействие и не блокирует рецепторы других гормонов или ионные каналы, которые, как известно, играют важную роль в регуляции функций сердечно-сосудистой системы.
The prescription of the drug to patients with arterial hypertension leads to a decrease in blood pressure, without affecting the frequency of the pulse.
In most patients, after appointing an inward dose of the drug, the beginning of antihypertensive activity is noted within 2:00, and the maximum decrease in the blood pressure is reached within 4 - 6:00.
The antihypertensive effect is saved more than 24 hours after receiving a single dose. With regular use of the drug, the maximum therapeutic effect is usually achieved within 2-4 weeks and is supported on the level achieved during long-term therapy. The sudden cancellation of Valsartan does not entail the restoration of arterial hypertension or other side clinical phenomena.
It has been established that Valsartan significantly reduces the level of hospitalization of patients with chronic heart failure (NYHA class II-IY). A more significant effect was reached in patients who did not receive ACE inhibitors or beta blockers. It has also been established that Valsartan reduced cardiovascular mortality in clinically stable patients with leaf and left ventricle pathology or left-detecting dysfunction after myocardial infarction.

Pharmacokinetics

.
Valsartan and Amlodipine show the linearity of pharmacokinetics.
Suction. After receiving the therapeutic doses of amlodipine, the maximum concentration (MAX) in the blood plasma is achieved within 6-12 hours. Bioavailability is calculated from 64% to 80%. Meal does not affect the bioavailability of amlodipine.
Distribution. The distribution volume is approximately 21 l / kg. In vitro studies in Vitro, patients with essential hypertension patients, approximately 97.5% of the circulating preparation binds to plasma proteins.
Metabolism. Amlodipine intensively (about 90%) is metabolized in the liver to inactive metabolites.
Output. The withdrawal of amlodipine from the plasma is two-phase, with a half-life period of about 30-50 hours. The equilibrium levels in the blood plasma is achieved after constant introduction within 7-8 days. 10% of the initial amlodipine and 60% of amlodipine metabolites are derived from the urine.
Valsartan.
Suction. After receiving inside with Max Valsartan in the blood plasma is reached within 2-4 hours. The average bioavailability of the drug is 23%. Food reduces the exposition, as AUC shows (plasma concentration - time), Valsartan is about 40%, and with max - by 50%, although after 8:00 after applied, the concentration of valsartan in the plasma is the same for the group that took the drug on an empty stomach, and groups Patients who took the drug after eating. The decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect, so Valsartan can be taken regardless of meals.
Distribution. The equilibrium volume of valsartan distribution after intravenous administration is about 17 liters, which indicates that Valsartan is distributed in the tissues - non-contense.

Valsartan firmly binds to plasma proteins (94-97%), mainly from albumin.
Metabolism. Valsartan is largely transformed, since only 20% of the dose goes into metabolites. The plasma at low concentrations (less than 10% of Valsartan AUC) is identified by hydroxymetabolitis, which is pharmacologically inactive.
Output. For Valsartan, the bagatexponential kinetics of removal (half-life T 1/2 A<1:00 и Т 1/2 b примерно 9:00). Валсартан выводится главным образом в неизмененном виде с калом (примерно 83% дозы) и мочой (около 13% дозы). После введения клиренс валсартана в плазме составляет примерно 2 л / ч, а его ренальный клиренс - около 0,62 л / ч (примерно 30% общего клиренса). Период полувыведения валсартана - 6:00.
Valsartan / Amlodipine.
After oral administration of exforts with Max Valsartan and Amlodipine in the blood plasma is achieved through 3 and 6-8 hours, respectively. The speed and degree of suction of the exfource is equivalent to the bioavailability of valsartan and amlodipine when appointing in separate tablets.

Indications for use

A drug Exportit is used for essential hypertension in adult patients whose blood pressure is not regulated using amlodipine or hollow monotherapy.

Mode of application

Patients whose blood pressure is inadequately regulated by amlodipine or valsartan monoprepary, can be translated into combined therapy by the drug Export. Recommended dose - 1 tablet per day. Export tablets can be taken regardless of meals. It is recommended to take export by drinking it with a small amount of water.
Patients receiving Valsartan and Amlodipine separately can be translated into export, which contains the same doses of components.
Before the transition to a combination of fixed doses, an individual selection of a dose with components (i.e. amplodipine and valsartan) is recommended. In the event of a clinical need, you can consider the possibility of direct replacement of monotherapy to a combination of fixed doses.
Maximum daily dose - 1 Export Tablet 5 mg / 80 mg or 1 Extability tablet 5 mg / 160 mg, or 1 tablet of exphorus 10 mg / 160 mg (maximum allowable doses of the components of the drug - 10 mg for amlodipine content, 320 mg according to the content of valsartan) .
Dosage for individual groups of patients
Violation of kidney function
There are no accessible clinical data on the use of patients with severe renal impairment.
Patients with impaired kidney function is a mild or moderate severity of the dose correction is not required. In patients with violations of the kidney function, highly recommended to control the level of potassium and creatinine in the blood.
The simultaneous use of exfigure with alianisar is contraindicated to patients with impaired kidney function (SCF<60 мг / мин / 1,73 м 2).
Diabetes.
The simultaneous use of exforts with alicarer is contraindicated with diabetes patients.
Violation of the liver function.
Preparation Exeffers is contraindicated to patients with severe liver function disorders.
With caution, it is necessary to apply exeph patients with impaired liver function or obstructive diseases of the biliary tract. For patients with impaired liver function of light or moderate degree without cholestasis, the maximum recommended dose is 80 mg of valsartan.
Recommendations for the dosing of amlodipine in patients with a slight or moderate disruption of the liver function are not developed. When translating such patients with arterial hypertension (see the section "Indications") and a violation of the liver function to amlodipine or exeph, it is necessary to prescribe the smallest of the recommended doses of amlodipine in monotherapy or as part of combination therapy.
Elderly patients (over 65 years old)
For elderly patients, ordinary dose schemes are recommended.
Care should be taken with an increase in the dose of the drug to the elderly patients.
When translating such patients with arterial hypertension (see the section "Indications") and a violation of the liver function to amlodipine or exeph, it is necessary to prescribe the smallest of the recommended doses of amlodipine in monotherapy or as part of combination therapy.
Pediatric populations.
The safety and efficacy of the use of exforts to children (under the age of 18) was not investigated. No data.
Children. The study of the treatment of these drugs (under the age of 18) was not conducted. Therefore, before receiving more complete information, the exeph is not recommended to apply for the treatment of children.

Side effects

Safety Exphorusit was estimated during 5 controlled clinical studies. The adverse reactions that were observed most often or were significant or heavy: nico-pharyngitis, flu, hypersensitivity, headache, fainting, orthostatic hypotension, swelling, swelling of soft tissues, swelling of the face, peripheral swelling, increased fatigue, redness of the face, asthenia and riding.
In assessing the frequency of the occurrence of adverse reactions, the following criteria are used: very often (≥1 / 10); Often (≥1 / 100,<1/10); нечасто (≥1 / 1000, <1/100); редко (≥1 / 10000, <1/1000); очень редко (<1/10 000) неизвестно (частоту нельзя оценить по имеющимся данным).
Infections and invasion: Naphorgitis, flu.
From the blood and lymphatic system: reducing the level of hemoglobin and hematocrit, leukopenia, neutropenia, thrombocytopenia, sometimes with Purple,.
From the immune system: hypersensitivity.
Nutrition of nutrition and metabolism: anorexia, hypercalcemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypokalemia, hyponatremia.
From the psyche: depression, anxiety, insomnia / sleep disorders, mood swings, confusion.
From the nervous system: violation of coordination, dizziness, postural dizziness, disgusting, extrapyramidal symptoms, headache, hypertension, paresthesia, peripheral neuropathy, neuropathy, drowsiness, fainting, tremor, hyptestesia.
From the side of the bodies of vision: impairment of vision, weakening of vision.
From the side of hearing and labyrinths: noise in the ears, dizziness.
From the heart: heartbeat, fainting, tachycardia, arrhythmias (including bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction.
From the vessels: hyperemia, hypotension, orthostatic hypotension, vasculitis.
From the respiratory system: cough, shortness of breath, pharyngolanganeal pain, rhinitis.
GTS Disturbance: Abdominal discomfort and pain in the upper stomach areas.
Changing the rhythm of defecation: constipation, diarrhea, dry mouth, dyspepsia, gastritis, gumper hyperplasia, nausea, pancreatitis.
From the digestive system: atypical samples of liver functions, including an increase in the level of bilirubin in the blood, hepatitis, intrahephene cholestasis, jaundice.
From the side of the skin and subcutaneous fabrics: alopecia, angioedema edema, bullous dermatitis, erythema, multiform erythema, rash, hyperhydrosis, reaction photosensitivity, itching, purple, rash, skin discoloration, urticaria and other forms of rash, exfoliative dermatitis, Stevens-Johnson syndrome, Sweep quinque.
From the side of the musculoskeletal system: arthralga, pain in the back, swelling of the joint, muscle cramps, pain in the muscles, swelling of the ankle joint, the feeling of gravity.
From the side of the kidneys and the urinary system: increasing the level of creatinine in the blood, urination disorder, niccountura, polyaciuria, polyuria, renal failure and impaired kidney function.
Violation of the reproductive system: impotence, erectile dysfunction, gynecomastia.
General disorders: asthenia, discomfort, malaise, increased fatigue, swelling of the face, hyperemia, tides, chest pain, not related to heart, swelling, peripheral swelling, pain, swelling of soft tissues.
Peripheral edema, a known side effect of amlodipine in patients receiving a combination of amplodipine / Valsartan, generally noted with a lower frequency than ample an amlodipine application separately. In the course of double-blind controlled clinical studies, the average frequency of peripheral edema is evenly distributed throughout the dose interval, accounted for 5.1% for a combination of amlodipine / valsartan.
Additional information on the components of the drug.
Unwanted reactions, previously noted when applying one of the components of the drug (amlodipine or valsartan), may occur when applying the drug exhodst, \u200b\u200beven if they were not marked during clinical studies or postmarketing period.

Contraindications

Contraindications for the use of the drug Exportare:
- increased sensitivity to active substance, dihydropyridine derivatives or any of the aids of the drug.
- severe liver function, biliary cirrhosis of the liver or cholestasis.
- simultaneous use of angiotensin receptor antagonists (ARA), including Valsartan, or ACE inhibitors (APF) with alianized patients with diabetes or with impaired kidney function (SCF<60 мг / мин / 1,73 м 2).
- contraindicated pregnant and women planning pregnancy (see section "Application during pregnancy or breastfeeding").
- severe hypotension.
- Shock (including cardiogenic shock).
- obstruction of the output path of the left ventricle (for example, hypertrophic obstructive cardiomyopathy and stenosis of the aorta of severe).
- Hemodynamically unstable heart failure after acute myocardial infarction.

Pregnancy

Exportcontraindicated to apply pregnant women or women planning pregnancy. If during treatment with this means a pregnancy is confirmed, its use must be immediately discontinued and replaced with another drug authorized for use in pregnant women.
The data of epidemiological studies of the risk of teratogenicity after the exposition of ACE inhibitors during the first trimester of pregnancy was convincing; However, a small risk increase cannot be excluded. Although the data of controlled epidemiological studies of angiotensin II receptor antagonists (ARII) are absent, such a risk may occur when the preparations of this class can occur.
The exposition of Arai in the second and third trimester is known to have a toxic effect on human fruit (reducing the function of the kidneys, oligohydramnion, delay in the ossification of the bones of the skull) and the newborn (renal failure, arterial hypotension, hypercalemia).
If Arai was used since the second trimester of pregnancy, an ultrasound study of the kidney and bones of the fetus skull is recommended.
Babies whose mothers took AIAI should be under thorough observation in case of arterial hypotension.
Breastfall period
Since information on the use of the drug Export during breastfeeding period is absent, the drug is not recommended to be used during breastfeeding period. It is desirable to apply alternative preparations with the studied safety profile, especially in case of breastfeeding newborns or premature babies.

Interaction with other medicines

Interacial interaction
Research of inter-road interactions of the drug Exportwith other drugs were not conducted.

Other hypotensive drugs
Frequently used hypotensive preparations (for example, alpha blockers, diuretics) and other drugs that may cause hypotensive undesirable phenomena (for example, tricyclic antidepressants, alpha-blockers used to treat benign prostate gland hyperplasia), can enhance the combination hypotensive effect.
Interactions associated with amlodipine

Medicines, while using the simultaneous use of which should be attentive
Cyp3a4 inhibitors
The simultaneous use of amlodipine with more or less powerful CYP3A4 inhibitors (protease inhibitors, azole antiharya, macrolides, such as erythromycin or clarithromycin, verapamil or diltiazem) can lead to increased systemic influence of amlodipine. Clinical manifestations of such pharmacokinetic changes can be strengthened in elderly patients. Clinical monitoring and dose correction may be required.
Cyp3a4 inductors (anticonvulsant drugs (for example carbamazepine, phenobarbital, phenytoin, phosphenitoine, prison), rifampicin, hyperthydrated (Hypericum Perforatum)
There are no studies on the effects of CYP3A4 inductors to amlodipine. The simultaneous use of CYP3A4 inductors (for example rifampicin, Hypericum Perforatum) can lead to a decrease in amlodipine concentration in blood plasma. It is recommended to use amlodipine with CYP3A4 inductors with caution.
Simvastatin. Multiple use of doses of 10 mg of amlodipine with 80 mg of simvastatin leads to an increase in the exposure of simvastatin by 77% compared with the use of one simvastatin. It is recommended to reduce the dose of simvastatin to 20 mg for patients receiving amlodipine.
Dentrenolen (infusion). In animals, lethal cases of ventricular fibrillations and cardiovascular collapse were observed due to hyperkalemia after the use of verapamil and Dantrolena in. Due to the risk of hypercalemia, it is recommended to avoid sharing by calcium channels, such as amlodipine, patients prone to the development of malignant hyperthermia and in the treatment of malignant hyperthermia.
Medicines, while using the simultaneous use of which should be attentive
During clinical studies, Amlodipin did not affect the pharmacokinetics of atorvastatin, dioxin, warfarin or cyclosporine.
Interactions associated with waltzart
Simultaneous use is not recommended
Lithium. With the simultaneous use of lithium with APE inhibitors or angiotensin II receptor antagonists, including Valsartan, a reversible increase in serum concentrations of lithium and its toxicity was noted. The simultaneous use of valsartan and lithium is not recommended. If the use of such a combination is necessary, the level of lithium in serum should be carefully monitored. The risk of increasing lithium toxicity may be further enhanced with the joint use with the exforge and diuretics.
Potassium supplements, potassium diuretics, salt substitutes containing potassium or other drugs that can raise potassium level
If drugs affecting potassium channels are prescribed in combination with valsartan, regular control of potassium content in plasma should be provided.
Medicines, while using the simultaneous use of which should be attentive
Non-steroidal anti-inflammatory preparations (NSAIDs), including selective COG-2 inhibitors, acetylsalicylic acid (\u003e 3 g / day) and non-selective NSAIDs
With the simultaneous use of angiotensin II and NSAVP antagonists, it is possible to weaken hypotensive action. Also, the simultaneous use of angiotensin II antagonists and the NSAID can increase the risk of deterioration of the kidney function and serum levels. Therefore, at the beginning of treatment, it is recommended to monitor the condition of the kidney function, as well as ensure the proper level of fluid in the patient's body.
Accumulator inhibitors (rifampicin, cyclosporine) or eflyux carriers (ritonavir)
The results of studies in vitro with a human liver cloth showed that Valsartan is a substrate of the hepatic carrier of the accumulation of OATP1B1 and the hepatic eflux carrier MRP2. The simultaneous use of accumulation carrier inhibitors (rifampicin, cyclosporine) or an eflyux carrier (ritonavir) can increase the system exposure of valsartan.
Double Blockade of Raas with Ara, ACE inhibitors or Alisian
The results of clinical studies have shown that the double blockade of the RAAS with the combined use of ACE inhibitors, ARA or alianized leads to an increase in the incidence of such unwanted phenomena, as hypotension, hypercalemia and reducing the kidney function (including acute renal failure), compared with the treatment of one drug, affecting Ras. Therefore, the simultaneous use of ARA - including Valsartan - or ACE inhibitors with alianisylane is contraindicated with patients with diabetes or impaired kidney function (SCF<60 мг / мин / 1,73 м 2).
Others.
In monotherapy, Valsartan did not establish clinically significant drug interactions with such drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glyibenklamide.

Overdose

Still missing overdose experience Exphorus. The main symptom of overdose of Valsartan is likely to be a pronounced arterial hypotension with dizziness. Overdose of amlodipine can lead to increasing peripheral vasodilation and, probably, to reflex tachycardia. A significant and potentially prolonged systemic hypotenside has been reported, up to shock and death.
If the drug is adopted recently, you should cause vomiting or rinse the stomach. Amlodipine absorption is significantly reduced when the activated carbon is applied immediately or within two hours after receiving amlodipine.
The clinically significant arterial hypotension caused by an overdose of exforts requires active support for the state of the cardiovascular system, including frequent control of cardiac and respiratory functions, lifting limbs, attention to the volume of circulating liquid and urination. To restore the vascular tone and blood pressure, a vasoconstrictor drug can be applied in the absence of contraindications for its use. With a declaring decline in blood pressure, which is a consequence of the calcium channel blockade, it may be advisable to administer calcium gluconate.
The withdrawal of valsartan and amlodipine with hemodialysis is unlikely.

Storage conditions

Store at a temperature not higher than 30 ° C, in the original packaging, in a protected from moisture, inaccessible to children.

Form release

Export - Tablets coated with film shell 5 mg / 80 mg; 5 mg / 160 mg; 10 mg / 160 mg.
Packaging: 14 or 28 tablets in the package.

Structure

1 Tablet Exportcontains amlodipine Blessing 6.94 mg in terms of amlodipine base of 5 mg and 80 mg of valsartan or amlodipine Blessing 6.94 mg in terms of amlodipine base 5 mg and 160 mg of valsartan, or amlodipine Blessing 13.87 mg in terms of amlodipine base 10 mg and 160 mg of valsartan.
Auxiliary substances: microcrystalline cellulose, crosspovidon, magnesium stearate, silicon colloidal dioxide, polyethylene glycol (macrogol) 4000, talc, hyprontellos, titanium dioxide (E 171), iron oxide yellow (E172), iron oxide (E172).

Additionally

The safety and efficacy of amlodipine in the treatment of hypertensive crisis is not established.
Patients with a deficiency in sodium organism and / or circulating blood volume.
In patients with uncomplicated arterial hypertension (0.4%), excessive hypotension was observed in the treatment of exforts within placebo-controlled studies. In patients with an activated renin-angiotensin system (with a reduced sodium and / or volume content and in the case of obtaining high doses of diuretics), which adopt angiotensin receptor blockers, symptomatic hypotension may occur. Recommended correction of this state before applying exforts or careful medical observation at the beginning of therapy.
In the occurrence of arterial hypotension, when applying the patient's exphorting should be put on the back and, if necessary, carry out infusion of the saline. After stabilization of blood pressure, you can continue treatment.
Hypercalemia.
It is safe to carry out simultaneous treatment with potassium additives, potassium-saving diuretics, saline substitutes containing potassium, or other drugs that can increase potassium levels (heparin, etc.), as well as to provide regular control of potassium content.
Stenosis of the renal artery.
Export should be used with caution in hypertension in patients with unilateral or bilateral stenosis of renal artery or stenosis of the only kidney since the levels of urea and creatinine in serum can increase.
Kidney transplantation.
The experience of safe use of exforces to patients with recently transferred kidney transplantation is absent.
Violation of the liver function.
Valsartan is output mainly unchanged with bile. The half-life of amlodipine is extended and the AUC indicator (plasma concentration - time) is higher in patients with damage to the liver function. Recommendations for dosages are not installed. Special caution is necessary when applying the exforts to patients with impaired liver function of light or moderate degree or obstructive diseases of the gallbladder.
The maximum recommended dose for patients with light or moderate impaired liver function without cholestasis is 80 mg of valsartan.
Violation of the kidney function.
Patients with impaired kidney function of light or moderate degree (SCF\u003e 30 ml / min / 1.73 m 2) Dose correction is not required. With moderate disorders of the kidney function, it is recommended to control the level of potassium and creatinine in the blood.
The simultaneous use of angiotensin receptor antagonists, including Valsartan, or ACE inhibitors with alicarer is contraindicated to patients with impaired kidney function (SCF<60 мг / мин / 1,73 м 2).
Primary hyperaldosteroneism.
Patients with primary hyperaldosteroneism should not be taken by angiotensin II Valsartan antagonist, since their renin angiotensin system is broken due to the main disease.
Angioedema swelling.
Swelling Quincke, including larynx edema and voice gap, which can lead to the obstruction of the respiratory tract, and / or edema of the face, lips, pharynx and / or language, were observed in patients who received Valsartan. Some of these patients had a history of quinque swelling at the reception of other drugs, including ACE inhibitors (ACE). The use of exforts should be immediately terminated when quinque occurs, re-use is not recommended.
Heart failure / after suffering myocardial infarction
Due to the oppression of renin-angiotensin-sensitive patients, disturbances of the kidney function are possible. In patients with severe heart failure, in which kidney functions may depend on the activity of renin-angiotensin-, the use of ACE inhibitors (APE) and angiotensin receptor antagonists caused the development of oliguria and / or progressive azotemia, as well as (in rare cases) acute renal failure and / Or death. Similar results were noted when using Valsartan. Patients with heart failure or after suffering myocardial infarction should evaluate the kidney function.
In a long-term placebo-controlled study (PRAISE-2) amlodipine in patients with heart failure of non-high-quality origin of class III and IV according to the NYHA classification (New York Cardiology Association) when applying amlodipine, the frequency of edema of the pulmonary edema was higher compared to such when the placebo is applied However, there was no significant difference in the appearance or worsening of heart failure. Patients with congestive heart failure calcium channel blockers, including amlodipine, should be used with caution, as they can increase the risk of cardiovascular events and deaths.
Aortic Stenosis and Mitral Valve
As in the treatment of other vasodilators, patients whose stenosis of a mitral valve or pronounced aortic stenosis is low, should be especially careful.
Double Blockade Renin-angiotensin- (Raas)
There is evidence that the sharing of ACE inhibitors, ARA or Aliskairen increases the risk of arterial hypotension, hypercalemia and reducing the kidney function (including acute renal failure). Therefore, it is not recommended to carry out a double blockade of Raas by combined the use of ACE inhibitors, ARA or aliano.
If the double blockade is absolutely necessary, it should be carried out solely under the supervision of a specialist with the implementation of frequent thorough monitoring of the kidney function, the concentration of electrolytes and blood pressure. It should not be jointly used inhibitors of ACE and ARA patients with diabetic nephropathy.
The use of the drug Exphief has not been studied in patients with other diseases, except for arterial hypertension.
The ability to influence the reaction rate when managing motor vehicles or other mechanisms.
In patients using exephs may occur dizziness or feeling of weakness after taking the drug, so they must take into account this when managing motor vehicles and working with potentially hazardous mechanisms.
Amlodipine can weakly or moderately affect the ability to control vehicles or work with mechanisms. If patients with amlodipine are tested, headache, fatigue, or nausea, their reaction may violate.

Main settings

Name:	Export
ATH code:	C09DB01 -