Universal reference book for medicines
Product name: ECWAMER ® (EKVAMER)

Active substance: amlodipine, lisinopril, rosuvastatin

Type: Antihypertensive and hypolipidemic drug

Manufacturer: GEDEON RICHTER (Hungary)
Composition, form of production and packaging

Capsules hard gelatinous, size 1, light pink;
contents of capsules - 1 round, biconvex tablet of white color (contains lisinopril and amlodipine) and 1 round, biconvex tablet coated with a yellow film coating (contains rosuvastatin).
1 caps.

amlodipine besylate 6.94 mg,

which corresponds to the content of amlodipine 5 mg

lisinopril dihydrate 10.88 mg,

which corresponds to the content of lisinopril 10 mg

rosuvastatin calcium 10.4 mg,

which corresponds to the content of rosuvastatin 10 mg

Auxiliary substances: microcrystalline cellulose, type 12 - 60.41 mg, microcrystalline cellulose, type 101 - 45.27 mg, lactose monohydrate - 48.1 mg, sodium carboxymethyl starch - 9.5 mg, magnesium hydroxide - 7.5 mg, magnesium stearate - 2 mg, Opadrai II yellow - 2 mg (polyvinyl alcohol 40%, titanium dioxide 23.5%, macrogol-3350 20.2%, talc 14.8%, iron oxide pigment yellow 1.5%), hard gelatin capsule 76 mg (dye blue patented 0.00022%, dye azorubin 0.03684%, dye sunlight sunset yellow 0.0204%, titanium dioxide 3.7037%, gelatin to 100%).

5 pieces.
- blisters (6) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
Capsules hard gelatinous, size 1, pink;
the contents of the capsules - 1 round, biconvex white tablet (contains lisinopril and amlodipine) and 2 round, biconvex tablets, coated with a yellow film coating (contain rosuvastatin).
1 caps.

amlodipine besylate 6.94 mg,

which corresponds to the content of amlodipine 5 mg

lisinopril dihydrate 10.88 mg,

which corresponds to the content of lisinopril 10 mg

rosuvastatin calcium 20.8 mg,

which corresponds to the content of rosuvastatin 20 mg

Auxiliary substances: cellulose microcrystalline, type 12 - 86.41 mg, microcrystalline cellulose, type 101 - 45.27 mg, lactose monohydrate 96.2 mg, sodium carboxymethyl starch 17.5 mg, magnesium hydroxide 15 mg, magnesium stearate 3 mg, Opadrai II yellow 4 mg (polyvinyl alcohol 40%, titanium dioxide 23.5%, macrogol-3350 20.2%, talc 14.8%, iron dye oxide yellow 1.5%), hard gelatin capsule 76 mg (dye azorubin 0.16%, titanium dioxide 1.8519%, gelatin up to 100 %).

5 pieces.
- blisters (6) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
Capsules hard gelatinous, size 1, purple;
contents of capsules - 2 round, biconvex tablets of white color (contain lisinopril and amlodipine) and 1 round, biconvex tablet, covered with a film coating of yellow color (contains rosuvastatin).
1 caps.

amlodipine besylate 13.88 mg,

which corresponds to the content of amlodipine 10 mg

lisinopril dihydrate 21.76 mg,

which corresponds to the content of lisinopril 20 mg

rosuvastatin calcium 10.4 mg,

which corresponds to the content of rosuvastatin 10 mg

Auxiliary substances: cellulose microcrystalline, type 12 - 94.82 mg, cellulose microcrystalline, type 101 - 90.54 mg, lactose monohydrate - 48.1 mg, sodium carboxymethyl starch - 11 mg, magnesium hydroxide - 7.5 mg, magnesium stearate - 3 mg, Opadrai II yellow - 2 mg (polyvinyl alcohol 40%, titanium dioxide 23.5%, macrogol-3350 20.2%, talc 14.8%, iron dye oxide yellow 1.5%), hard gelatin capsule 76 mg (dye azorubin 0.0882%, indigo carmine 0.0284%, titanium dioxide 2.2056% , gelatin up to 100%).

5 pieces.
- blisters (6) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
Capsules hard gelatinous, size No. 0, dark purple;
the contents of the capsules are 2 round, biconvex white tablets (containing lisinopril and amlodipine) and 2 round, biconvex tablets coated with a yellow film coating (containing rosuvastatin).
1 caps.

amlodipine besylate 13.88 mg,

which corresponds to the content of amlodipine 10 mg

lisinopril dihydrate 21.76 mg,

which corresponds to the content of lisinopril 20 mg

rosuvastatin calcium 20.8 mg,

which corresponds to the content of rosuvastatin 20 mg

Auxiliary substances: cellulose microcrystalline, type 12 - 120.82 mg, cellulose microcrystalline, type 101 - 90.54 mg, lactose monohydrate - 96.2 mg, sodium carboxymethyl starch - 19 mg, magnesium hydroxide - 15 mg, magnesium stearate - 4 mg, Opadrai II yellow - 4 mg (polyvinyl alcohol 40%, titanium dioxide 23.5%, macrogol 3350 20.2%, talc 14.8%, ferric oxide yellow 1.5%), hard gelatin capsule 97 mg (dye blue patented 0.02933%, dye azorubin 0.3067%, dye sunlight sunset yellow 0.02355%, titanium dioxide 3.7037%, gelatin up to 100%).

5 pieces.
- blisters (6) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Combined antihypertensive and hypolipidemic drug.
The composition of the drug Equamer ® includes three active substances - amlodipine, lisinopril and rosuvastatin. The mechanism of action of the drug Equamer ® is based on the pharmacological properties of the active substances.
Amlodipine

The dihydropyridine derivative, a slow calcium channel blocker (BCCI), has an antihypertensive effect.
It blocks slow calcium channels, reduces the transmembrane transition of calcium ions into the cell (mostly in the smooth muscle cells of the vessels, rather than in cardiomyocytes).
Antianginal action is due to the expansion of coronary and peripheral arteries and arterioles:

- with stenocardia reduces the severity of myocardial ischemia;
expanding peripheral arterioles, reduces OPSS, reduces afterload on the heart, reduces the need for myocardium in oxygen;
- Expanding coronary arteries and arterioles in unchanged and ischemic zones of the myocardium, increases the flow of oxygen into the myocardium (especially with vasospastic angina);
prevents spasm of the coronary arteries (including caused by smoking).
In patients with stable angina, a single daily dose increases exercise tolerance, slows the development of angina attacks and ischemic depression of the ST segment, reduces the incidence of angina attacks and the consumption of nitroglycerin and other nitrates.

Has a long-term dose-dependent antihypertensive effect.
Antihypertensive action is due to direct vasodilating effect on smooth muscle vessels. With arterial hypertension, a single dose provides a clinically significant reduction in blood pressure over a 24-hour period (in the patient's lying and standing position).
Orthostatic hypotension with amlodipine is rare.
Amlodipine does not cause a decrease in exercise tolerance, a fraction of the release of the left ventricle. Reduces the degree of myocardial hypertrophy of the left ventricle. Does not affect the contractility and conductance of the myocardium, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases GFR, has a weak natriuretic effect. When diabetic nephropathy does not increase the severity of microalbuminuria. Does not have any adverse effect on the metabolism and concentration of plasma lipids, can be used in the treatment of patients with bronchial asthma, diabetes and gout. A significant reduction in blood pressure is observed after 6-10 h, the duration of the effect is 24 h.
In patients with diseases of the cardiovascular system (including coronary atherosclerosis with one vessel and before stenosis of 3 or more arteries, carotid atherosclerosis), myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or in patients with angina, the use of amlodipine prevents an increase in thickness intima-media complex of carotid arteries, reduces mortality from myocardial infarction, stroke, PTCA, coronary artery bypass graft;
leads to a decrease in the number of hospitalizations for unstable angina and the progression of chronic heart failure (CHF); reduces the frequency of interventions aimed at restoring coronary blood flow.
Does not increase the risk of death or development of complications and deaths in patients with CHF (III-IV functional class according to the NYHA classification) against the background of therapy with digoxin, diuretics and ACE inhibitors.
In patients with CHF (III-IV functional class according to the NYHA classification) of non-ischemic etiology with the use of amlodipine, there is a possibility of pulmonary edema.
Lisinopril

The ACE inhibitor reduces the formation of angiotensin II from angiotensin I. Reducing the concentration of angiotensin II leads to a direct reduction in the release of aldosterone.
Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces OPSS, AD, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increased tolerance of the myocardium to physical exertion in patients with CHF. Expands arteries more than veins. Some effects are explained by the effect on the tissue renin-angiotensin system. With prolonged use, myocardial hypertrophy and the walls of arteries of resistive type decrease.
Improves the blood supply of the ischemic myocardium.

ACE inhibitors prolong life expectancy in patients with CHF, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure.

The onset of action is 1 hour after ingestion.
The maximum hypotensive effect is determined after 6-7 hours and persists for 24 hours. With arterial hypertension, the effect is noted in the first days after the start of treatment, stable effect develops in 1-2 months. With a sharp reversal of lisinopril, there was no pronounced increase in blood pressure. In addition to reducing blood pressure, lisinopril reduces albuminuria. In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium. Lizinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not increase the incidence of hypoglycemia.
Rosuvastatin

A selective, competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A into mevalonate, a precursor to cholesterol.
The main target of rosuvastatin is the liver, where the synthesis of cholesterol (Xs) and catabolism of LDL.
Rosuvastatin increases the number of LDL receptors on the surface of hepatocytes, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of VLDL synthesis, thereby reducing the total number of LDL and VLDL.

Rosuvastatin reduces the elevated concentration of LDL cholesterol (Xc-LDL), total cholesterol (Xs) and triglycerides (TG), and increases the concentration of high-density lipoprotein cholesterol (Xc-HDL), and also reduces the concentration of apolipoprotein B (ApoV), Xc-non-HDL, Xc -LVPP, TG-VLDL and increases the concentration of apolipoprotein A-I (ApoA-I) (see Tables 1 and 2), reduces the ratio of Xc-LDL / Xc-HDL cholesterol, total Xc / Xc-HDL, Xc-non-HDL / HDL and the ratio of ApoB / ApoA-I.

The therapeutic effect appears within the first week after the initiation of therapy with rosuvastatin and after 2 weeks of treatment it reaches 90% of the maximum possible.
The maximum therapeutic effect is usually achieved by week 4 and is maintained with regular use.
Table 1. Dose-dependent effect in patients with primary hypercholesterolemia (type IIa and IIb according to Fredrickson classification) (mean adjusted percentage change compared to baseline)

Dose Number of patients Xs-LDL Total Xc HS-HDL

Placebo 13 -7 -5 3

10 mg 17 -52 -36 14

20 mg 17 -55 -40 8

40 mg 18 -63 -46 10

Dose Number of patients TG X-ray ILV Apo B Apo A-I

Placebo 13 -3 -7 -3 0

10 mg 17 -10 -48 -42 4

20 mg 17 -23 -51 -46 5

40 mg 18 -28 -60 -54 0

Table 2. Dose-dependent effect in patients with hypertriglyceridemia (type IIb and IV according to Fredrickson classification) (mean percentage change compared to the baseline value)

Dose Number of patients TG Xc-LDL Total Xc

Placebo 26 1 5 1

10 mg 23 -37 -45 -40

20 mg 27 -37 -31 -34

40 mg 25 -43 -43 -40

Dose Number of patients with Hs-HDL cholesterol-HDL cholesterol- VLDL TG- VLDLP

Placebo 26 -3 2 2 6

10 mg 23 8 -49 -48 -39

20 mg 27 22 -43 -49 -40

40 mg 25 17 -51 -56 -48

Clinical efficacy

Rosuvastatin is effective in adult patients with hypercholesterolemia with or without hypertriglyceridemia, regardless of race, sex or age, incl.
in patients with diabetes mellitus and familial hypercholesterolemia.
In 80% of patients with hypercholesterolemia type IIa and IIb according to Fredrickson classification (average initial concentration of LDL-C is about 4.8 mmol / L) against the background of rosuvastatin 10 mg, the concentration of LDL-C is less than 3 mmol / l.
In patients with homozygous familial hypercholesterolemia who took rosuvastatin at a dose of 20 mg and 40 mg, the average decrease in the concentration of LDL-C was 22%.
In patients with hypertriglyceridemia with an initial TG concentration of 273 mg / dl to 817 mg / dL, who received rosuvastatin at doses from 5 mg to 40 mg once per day for 6 weeks, the concentration of TG in plasma was significantly reduced (see Table 2 ).

The additive effect is noted in combination with fenofibrate for the concentration of triglycerides and with nicotinic acid in relation to the concentration of HDL-C.

PHARMACOKINETICS

Amlodipine

Suction

After ingestion, amlodipine is slowly and almost completely absorbed from the digestive tract.
With MAX in the blood plasma is achieved in 6-12 hours after administration. The average absolute bioavailability is 64-80%. Simultaneous food intake does not affect the absorption of amlodipine.
Distribution

The average V d is 21 l / kg body weight, indicating that most of the amlodipine is in the tissues, and the smaller is in the blood.
Most of the amlodipine, which is in the blood (97.5%), binds to blood plasma proteins. C ss in blood plasma are achieved after 7-8 days of continuous admission of amlodipine. Amlodipine penetrates the GEB and the placental barrier.
Metabolism

Amlodipine undergoes a slow but active metabolism in the liver in the absence of a significant "first pass" effect through the liver.
Metabolites do not have significant pharmacological activity.
Excretion

After a single dose of amlodipine, T 1/2 varies from 35 to 50 hours, with repeated use is approximately 45 hours. About 60% of the dose taken internally is excreted by the kidneys mainly in the form of metabolites, 10% - unchanged, and 20-25% - through intestines with bile.
The total clearance of amlodipine is 0.116 ml / s / kg (7 ml / min / kg, 0.42 l / h / kg). Amlodipine is not removed during hemodialysis.
Pharmacokinetics in specific patient groups

Elongation of T 1/2 in patients with hepatic insufficiency suggests that with prolonged use, amlodipine cumulation in the body will be higher (increases to 60 h).

Renal failure does not significantly affect the pharmacokinetics of amlodipine.

In elderly patients, the withdrawal of amlodipine is slowed (T 1/2 to 65 h) compared to young patients, but this difference is not clinically significant.

Lisinopril

Suction

After oral administration, about 25% of lisinopril is absorbed from the digestive tract.
Simultaneous food intake does not affect the absorption of lisinopril. Absorption is on average 30%, bioavailability is 29%.
Distribution

After ingestion C max lisinopril in blood plasma is reached after 6-8 hours. It weakly binds to blood plasma proteins.
Lizinopril weakly penetrates through the BBB and the placental barrier.
Metabolism

Lizinopril is not biotransformed in the body.

Excretion

Lizinopril is excreted by the kidneys unchanged.
T 1/2 is 12 hours.
Pharmacokinetics in specific patient groups

In patients with CHF, absorption and clearance of lisinopril are reduced, bioavailability is 16%.

In patients with renal insufficiency (CC less than 30 ml / min), the concentration of lisinopril is several times higher than the plasma concentration in healthy volunteers, with an increase in the time to reach C max in plasma and an increase in T 1/2 .

In elderly patients, the concentration of lisinopril in blood plasma and AUC is 2 times greater than in young patients.
In elderly patients, the concentration of lisinopril in the blood plasma is increased, on average, by 60%.
In patients with liver cirrhosis, the bioavailability of lisinopril is reduced by 30%, and the clearance by 50% compared to patients with normal liver function.

Rosuvastatin

Suction

With MAX, rosuvastatin in the blood plasma is reached approximately 5 hours after ingestion.
Absolute bioavailability is approximately 20%.
Distribution

V d of rosuvastatin is approximately 134 liters.
Approximately 90% of rosuvastatin binds to blood plasma proteins, mainly albumin.
The systemic exposure of rosuvastatin increases in proportion to the dose.
Pharmacokinetic parameters do not change with daily use.
Metabolism

The metabolism of rosuvastatin occurs predominantly in the liver, which is the main site for the synthesis of cholesterol and the metabolism of LDL-C.
It is subject to limited metabolism (about 10%). Rosuvastatin is a non-core substrate for metabolism by isoenzymes of the cytochrome P450 system. The main isoenzyme involved in the metabolism of rosuvastatin is the isoenzyme CYP2C9. Isozymes CYP2C19, CYP3A4 and CYP2D6 are less involved in metabolism.
The main revealed metabolites of rosuvastatin are N-desmethyl and lactone metabolites.
N-desmethyl is about 50% less active than rosuvastatin, lactone metabolites are not pharmacologically active. More than 90% of the pharmacological activity of inhibiting the circulating HMG-CoA reductase is provided by rosuvastatin, the rest - by its metabolites.
Excretion

About 90% of the dose is excreted unchanged through the intestine (including absorbed and unabsorbed rosuvastatin).
The rest is excreted by the kidneys. Plasma T 1/2is approximately 19 hours. T 1/2 does not change with increasing dose of the drug. The average geometric plasma clearance is approximately 50 l / h (coefficient of variation of 21.7%). As in the case of other HMG-CoA reductase inhibitors, a membrane cholesterol transporter involved in the hepatic elimination of rosuvastatin plays an important role in the hepatic elimination of rosuvastatin.
Pharmacokinetics in specific patient groups

Sex and age do not have a clinically significant effect on the pharmacokinetics of rosuvastatin.

Pharmacokinetic studies showed approximately a twofold increase in the median AUC and C max of rosuvastatin in patients of the Mongoloid race (Japanese, Chinese, Filipinos, Vietnamese and Koreans) compared with patients of the Caucasoid race;
in patients of Indian nationality studies showed an increase in median AUC and the C max 1.3-fold. Pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among Caucasian and Negroid races.
In patients with mild to moderate renal impairment the value of the plasma concentration of rosuvastatin or the N-desmethyl does not change significantly. Patients with severe renal impairment (creatinine clearance less than 30 mL / min) rosuvastatin plasma concentration 3 times higher, and the concentration of N-desmethyl 9 times higher than in healthy volunteers. Plasma concentration of rosuvastatin in patients on hemodialysis were approximately 50% higher than in healthy volunteers.
Revealed no increase in T 1/2rosuvastatin in patients with a score of 7 or less on the scale of Child-Pugh. Two patients with points 8 and 9 on the Child-Pugh marked increase in T 1/2 of at least 2 times. Experience of rosuvastatin in patients with a score above 9 to Child-Pugh offline.
Genetic polymorphism of
HMG-CoA reductase inhibitors, including rosuvastatin, 10 communicate with transport proteins OATP1B1 (organic anion transport polypeptide involved in the capture of statins hepatocytes) and BCRP (efflux transporter).
Carriers genotypes SLCO1B1 (OATR1V1) c.521CC and ABCG2 (BCRP) c.421AA marked increase exposure (AUC) rosuvastatin in 1.6 and 2.4 times respectively as compared with native genotypes SLC01B1 c.521TT and ABCG2 c.421CC.
INDICATIONS

Ekvamer ® is indicated as a substitution therapy in adult patients, the state of which is adequately controlled using amlodipine, lisinopril and rosuvastatin, at the same doses as in the preparation Ekvamer ® , for the treatment of hypertension and related dyslipidaemia:
- primary hypercholesterolemia (type IIa Fredrickson classification except heterozygous familial hypercholesterolaemia) or mixed hypercholesterolaemia (type IIb Fredrickson classification) when diet and other non-pharmacological methods (naprime , Exercise, weight loss) are insufficient;
- homozygous familial hypercholesterolemia, when diet and other lipid-lowering therapy (eg, LDL apheresis) is not sufficiently effective;
- hypertriglyceridemia (Fredrickson type IV according to the classification).
DOSING MODE

The drug is taken orally, regardless of mealtime.
Typically, a combined drug fixed dose is not suitable for initial therapy.
Ekvamer ® is used as replacement therapy in adult patients who are already receiving amlodipine, lisinopril and rosuvastatin alone in the same doses as in the present formulation, and are titrated optimal maintenance doses are:
titrated optimal maintenance dose of drug Ekvamer ®
amlodipine - 5 mg lisinopril - 10 mg, and rosuvastatin - 10 mg dose capsule 5 mg 10 mg + 10 mg +
amlodipine - 5 mg lisinopril - 10 mg, and rosuvastatin - 20 mg dose capsule 5 mg + 10 mg + 20 mg
Amlodipine - 10 mg lisinopril - 20 mg, and rosuvastatin - 10 mg capsule 10 mg + 20 mg + 10 mg
of amlodipine - 10 mg lisinopril - 20 mg, and rosuvastatin - 20 mg capsule 10 mg + 20 mg + 20 mg
Recommended dose preparation of 1 capsule. / day. The maximum daily dose - 1 capsule.
If the correction is necessary dose, dose titration should be carried out using separate amlodipine and lisinopril rosuvastatin.
In patients with renal failure during therapy with Ekvamer ®should monitor renal function, potassium and sodium content in the blood plasma. In case of deterioration of renal function preparation should be discontinued. Such patients recommended selection of individual doses of the individual active components. Use of the drug in patients with severe renal insufficiency is contraindicated.
The drug is contraindicated in patients with liver disease in its active phase , and for patients with severe hepatic impairment (more than 9 points on the Child-Pugh) .
Safety and efficacy in children and adolescents has not been established.
In elderly patientsthe drug should be used with caution. In clinical studies, no evidence of change in the profile of the effectiveness or safety of amlodipine, lisinopril, or rosuvastatin, depending on age.
In the study of the pharmacokinetic parameters of rosuvastatin in patients belonging to different races, was an increase in systemic rosuvastatin plasma concentrations among patients of the Mongoloid race. Keep in mind this fact when administering the drug Ekvamer ® this group of patients. When assigning Rosuvastatin 10 mg and 20 mg recommended starting dose of rosuvastatin is the Mongoloid race for patients should be 5 mg.
Carriers genotypes SLCO1B1 (OATR1V1) c.521CC and ABCG2 (BCRP) c.421AA marked increase exposure (AUC) of rosuvastatin as compared with native genotypes SLC01B1 c.521TT and ABCG2 c.421CC. For carrier patients genotype and c.521CC c.421AA recommended maximum dose of rosuvastatin is 20 mg / day.
Rosuvastatin is associated with various transport proteins (in particular, c OATP1B1 and BCRP). When the joint application of rosuvastatin with drugs (such as cyclosporin, some inhibitors of HIV protease (including a combination of ritonavir with atazanavir, lopinavir and / or tipranavir), increase the concentration of rosuvastatin in plasma due to the interaction with trasportnaya proteins, may increase the risk of myopathy (including rhabdomyolysis ). In such cases, you should evaluate the possibility of alternative therapies destination or temporary cessation of rosuvastatin is used. If the use of the above drugs n essay, should weigh the benefits and risks of concomitant therapy with rosuvastatin and consider lowering the dose.
SIDE EFFECT

Undesirable side reactions are presented by system-organ class according to the classification MedDRA and a frequency of occurrence: very often - 1/10 assignments (10%?); often - 1/100 appointments (1% and <10%?); infrequently - 1/1000 prescriptions (0.1% and <1%?); rarely - 1/10 000 assignments (0.01% and <0.1%?); very rarely - less than 1/10 000 appointments (<0.01%); frequency is unknown - the data is insufficient to estimate the incidence.
Within each group, adverse reactions are distributed in order of their importance.
At a separate treatment with amlodipine, lisinopril and rosuvastatin reported the following undesirable side reactions.
Amlodipine

From hemopoiesis system: very rarely - thrombocytopenic purpura, leukopenia, and thrombocytopenia.
Allergic reactions: infrequently - pruritus, rash (including erythematous and makulo-papular rash, urticaria); very rarely - angioedema, erythema multiforme.
On the part of metabolism and nutrition: very rarely - hyperglycemia.
Psychiatric disorders: rarely - mood lability, abnormal dreams, anxiety, depression, anxiety; very rarely - apathy, agitation, amnesia.
From the nervous system:often - headache, dizziness, fatigue, drowsiness; rarely - fatigue, malaise, hypoesthesia, paresthesia, peripheral neuropathy, tremor, muscle stiffness, insomnia, taste perversion;
rarely convulsions; very rarely - headache, increased sweating, ataxia, parosmiya.
On the part of the organ of vision: rarely - diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, eye pain, blurred vision.
On the part of the organ of hearing: rarely - ringing in the ears.
Cardio-vascular system: often - tachycardia, peripheral edema (ankles and feet), "tides"; infrequently - marked reduction of blood pressure; very rarely - the development or exacerbation of congestive heart failure, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), heart attack, chest pain, syncope, vasculitis, orthostatic hypotension.
The respiratory system:rarely - dyspnea, rhinitis, epistaxis; very rarely - cough.
From the digestive system: often - nausea, abdominal pain;
infrequently - vomiting, constipation, diarrhea, flatulence, dyspepsia, anorexia, dryness of the oral mucosa, thirst; rarely - gingival hyperplasia, increased appetite; very rarely - pancreatitis, gastritis, jaundice (usually cholestatic), hyperbilirubinemia, elevated liver enzymes, hepatitis.
From the urinary system: rarely - frequent urination, painful urination, nocturia; very rarely - dysuria, polyuria.
On the part of genitals and mammary glands: rarely - erectile dysfunction, gynecomastia.
Skin and subcutaneous tissue disorders : rarely - dermatitis; very rare - alopecia, dermatoxerasia, "cold" sweat violation of skin pigmentation.
On the part of the musculoskeletal system:Infrequent - arthralgia, muscle cramps, myalgia, back pain, arthritis; rarely - myasthenia gravis.
Other: rarely - pain unspecified site, increase / decrease in body weight.
Lisinopril
From hemopoiesis system: seldom - a decrease in hemoglobin and hematocrit; very rarely - depression of bone marrow function, lymphadenopathy, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, and anemia; the frequency is unknown - erythropenia.
Allergic reactions:seldom - skin rash, itching; rarely - urticaria, angioneurotic edema of the face, extremities, lips, tongue, epiglottis and / or throat; very rarely - angioneurotic edema, bowel, autoimmune disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme exudative.
From endocrine system: the frequency is unknown - the syndrome of inappropriate secretion of antidiuretic hormone.
On the part of metabolism and nutrition: very rarely - hypoglycemia.
Mental disorders: often - sleep disturbance; infrequently - lability of mood; rarely - confusion; the frequency is unknown - confusion, depression.
From the nervous system:often - dizziness, headache; rarely - paresthesia, drowsiness; rare - asthenic syndrome; the frequency is unknown - syncope, convulsive twitching of the face and limbs.
Cardio-vascular system: often - an excessive decrease in blood pressure; infrequently - chest pain, myocardial infarction (because of significant decrease in blood pressure in at-risk patients), stroke (due to pronounced reduction of blood pressure in at-risk patients), Raynaud's syndrome; rarely - tachycardia, bradycardia, exacerbation of chronic heart failure, AV-conduction, heart palpitations, orthostatic hypotension; the frequency is unknown - vasculitis.
The respiratory system:often - dry cough, sinusitis, allergic alveolitis / eosinophilic pneumonia; rarely - rhinitis; very rarely - bronchospasm; the frequency is unknown - shortness of breath.
From the digestive system: often - hepatic impairment; infrequently - dyspepsia, taste perversion, abdominal pain; rarely - dryness of the oral mucosa; very rarely - pancreatitis, hepatocellular and cholestatic jaundice, hepatitis; the frequency is unknown - anorexia.
From the urinary system: often - renal dysfunction; rarely - acute renal failure, uremia; very rarely - oliguria, anuria; the frequency is unknown - proteinuria.
On the part of genitals and mammary gland: infrequently - decreased potency; rare - a gynecomastia.
Skin and subcutaneous tissue disorders: rare - alopecia, psoriasis, photosensitivity; very rarely - increased sweating, pemphigus, skin pseudolymphoma.
From the musculoskeletal system: frequency not known - myalgia, arthralgia / arthritis.
From the laboratory and instrumental studies: rarely - hyperkalemia, hyponatremia, increasing concentrations of urea and creatinine in blood serum; rarely - increased activity of liver enzymes, hyperbilirubinemia; very rarely - increased erythrocyte sedimentation rate, increased titers of antinuclear antibodies; the frequency is unknown - eosinophilia, leukocytosis.
Other:frequency is unknown - fever (there are reports on the development volchanochnopodobnogo syndrome which may include fever, myalgia, arthralgia / arthritis, increased titer of antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia, leukocytosis, may also develop a rash, photosensitivity reactions or other cutaneous manifestations).
With simultaneous use of ACE inhibitors and drugs for gold on / in the (sodium aurothiomalate) describes a symptom, including facial flushing, nausea, vomiting and reduced blood pressure.
Rosuvastatin
Side effects seen with rosuvastatin, usually expressed slightly and tested independently. As with other inhibitors of HMG-CoA reductase, the incidence of side effects is mainly dose dependent.
From hemopoiesis system: the frequency is unknown - thrombocytopenia.
Allergic reactions: rarely - itching, rash, urticaria; rarely - hypersensitivity reactions, including angioneurotic edema; frequency is unknown - Stevens-Johnson syndrome.
Endocrine system: often - type 2 diabetes (frequency will depend on the presence or absence of risk factors (concentration fasting glucose 5.6 mmol / l, BMI> 30 kg / m? 2 , an increased concentration of triglycerides, hypertension disease)); the frequency is unknown - thyroid dysfunction.
Mental disorders: frequency not known - depression.
From the nervous system: often - headache, dizziness;
very rarely - polyneuropathy, memory loss or reduction; the frequency is unknown - peripheral neuropathy, sleep disturbances (including insomnia and nightmares).
The respiratory system: the frequency is unknown - cough, shortness of breath.
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