Cardosal: instructions for use, analogues, price and reviews from doctors

Compound

One tablet of Cardosal 40 contains 40 mg of medoxomil olmesartan.
One tablet of Cardosal 20 contains 20 mg of medoxomil olmesartan.

One tablet of Cardosal 10 contains 10 mg of medoxomil olmesartan.

Additional substances: hyprolose, microcrystalline cellulose, lactose monohydrate, magnesium stearate.

Shell composition: hypromellose, talc, titanium dioxide.

Cardosal® 40

Olmesartan medoxomil, the active substance of the drug Cardosal 40, is a powerful specific antagonist of angiotensin II receptors (type AT1).

Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of arterial hypertension by acting on AT1 receptors. It is assumed that olmesartan medoxomil blocks all AT1 receptor-mediated actions of angiotensin II, regardless of the source and route of angiotensin II synthesis. The specific antagonism of olmesartan medoxomil towards angiotensin II receptors (AT1 type) leads to an increase in the activity of renin, angiotensin I and II in the blood plasma, and also helps to reduce the plasma concentration of aldosterone.

In arterial hypertension, olmesartan medoxomil causes a dose-dependent, prolonged decrease in blood pressure (BP). There is no data on the development of arterial hypotension after taking the first dose of the drug, tachyphylaxis during long-term treatment or withdrawal syndrome (a sharp increase in blood pressure after discontinuation of the drug).

Taking olmesartan medoxomil once a day provides an effective and uniform reduction in blood pressure over 24 hours, and the effect after a single dose is similar to the effect of taking the drug 2 times a day at the same daily dose.

The antihypertensive effect of olmesartan medoxomil usually develops within 2 weeks, and the maximum effect develops approximately 8 weeks after the start of therapy.

The effect of olmesartan medoxomil on mortality and complication rates has not been established.

The ROADMAP trial, a randomized trial of 4447 patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional cardiovascular risk factor, assessed the ability of olmesartan medoxomil to prolong the time to onset of microalbuminuria. During the study period (median follow-up of 3.2 years), patients received olmesartan medoxomil or placebo in addition to other antihypertensive agents other than angiotensin-converting enzyme (ACE) inhibitors or other angiotensin II receptor antagonists.

The study demonstrated a significant reduction in the risk of the primary endpoint (time to onset of microalbuminuria) in favor of olmesartan medoxomil. After adjusting for differences in BP using double-blind prespecified parameters, the risk reduction was 17% (relative risk (RR) 0.834; 95% confidence interval (CI): 0.681 to 1.021; p = 0.0789) for systolic BP (SBP) adjusted for area under the curve (AUC) and 18% (RR 0.823; 95% CI: 0.672 - 1.008; p = 0.0596) for diastolic blood pressure (DBP) adjusted for AUC in favor of olmesartan medoxomil. Microalbuminuria developed in 8.2% of patients in the olmesartan medoxomil group (178 of 2160 patients) and 9.8% in the placebo group (210 of 2139 patients).

Cardiovascular events (secondary endpoints) were reported in 96 patients (4.3%) receiving olmesartan medoxomil and in 94 patients (4.2%) receiving placebo. Cardiovascular mortality was higher in the olmesartan medoxomil group compared with the placebo group (15 (0.7%) and 3 (0.1%) patients, respectively). At the same time, in the olmesartan medocomil group and the placebo group, a similar incidence of non-fatal stroke was observed (in 14 (0.6%) and 8 (0.4%) patients, respectively), non-fatal myocardial infarction (in 17 (0.8%) and 26 (1.2%) patients, respectively) and mortality from non-cardiovascular causes (in 11 (0.5%) and 12 (0.5%) patients, respectively). Overall mortality was numerically higher in the olmesartan medoxomil group than in the placebo group (in 26 (1.2%) and 15 (0.7%) patients, respectively), which was mainly due to a higher number of fatal cardiovascular events.

The randomized ORIENT trial, conducted in Japan and China, examined the effects of olmesartan medoxomil on renal and cardiovascular outcomes in 577 patients with type 2 diabetes mellitus and advanced nephropathy. During the study (median follow-up of 3.1 years), patients received olmesartan medoxomil or placebo in addition to other antihypertensive drugs, including ACE inhibitors.

The composite cardiovascular endpoint included: death from cardiovascular causes in 10 (3.5%) patients in the olmesartan medoxomil group and in 3 (1.1%) patients in the placebo group); total mortality (19 (6.7%) cases in the olmesartan medoxomil group and 20 (7.0%) cases in the placebo group), non-fatal stroke (8 (2.8%) cases in the olmesartan medoxomil group and 11 (3.9 %) cases in the placebo group), non-fatal myocardial infarction (3 (1.1%) cases in the olmesartan medoxomil group and 7 (2.5%) cases in the placebo group).

Children and teenagers

The antihypertensive effect of olmesartan medoxomil in children and adolescents was analyzed in a randomized, double-blind, placebo-controlled study involving 302 patients aged 6 to 17 years. The study group consisted of black patients (112 people) and a racially mixed group (190 patients, 38 of whom were black). The etiology of arterial hypertension was predominantly primary (87% of the group consisting of patients of the Negroid race and 67% of the “mixed” group).

Patients weighing 20 to <35 kg were randomized to receive olmesartan medoxomil 2.5 mg (low dose) or 20 mg (high dose) once daily, and patients weighing ≥35 kg were randomized into groups receiving olmesartan medoxomil at doses of 5 mg (low dose) or 40 mg (high dose) once daily. At a dose adjusted according to body weight, olmesartan medoxomil significantly reduced both systolic and diastolic blood pressure. At both low and high doses of olmesartan, medoxomil significantly reduced systolic blood pressure by 6.6 and 11.9 mmHg, respectively. Art. (from the initial level). This effect was also observed during the 2-week randomized withdrawal phase, with both mean systolic and diastolic blood pressure showing statistically significant increases in the placebo group compared with the olmesartan medoxomil group. In children and adolescents, treatment was effective for both primary and secondary arterial hypertension. As in adult patients, blood pressure in black patients decreased to a lesser extent.

In the same study, 59 patients aged 1 to 5 years weighing ≥ 5 kg received 0.3 mg/kg olmesartan medoxomil once daily for three weeks in the open-label phase of the study and were then randomized in the double-blind phase of the study. into groups receiving either olmesartan medoxomil or placebo. At the end of the 2-week withdrawal phase, the mean systolic/diastolic blood pressure at the nadir was 3/3 mm Hg. Art. lower in the olmesartan medoxomil group; this difference in blood pressure was not statistically significant (95% CI: 2-7/1-7).

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

An angiotensin type 2 receptor blocker , which is a hormone and plays a major role in the development of arterial hypertension .

Olmesartan presumably inhibits the effects of angiotensin II type by blocking the corresponding receptors.

In arterial hypertension it causes a dose-dependent long-term decrease in pressure. There is no evidence of the occurrence of arterial hypotension, tachycardia (during long-term treatment) or withdrawal syndrome after taking the drug.

Taking olmesartan once a day provides a gentle and effective reduction in blood pressure throughout the day. The hypotensive effect develops after two weeks, and the greatest effect occurs approximately two months after the start of treatment.

Pharmacokinetics

The active substance is a prodrug. In the mucous membrane of the digestive tract, under the action of enzymes , it quickly turns into an active metabolite . Olmesartan medoxomil the blood in its original form . Bioavailability is approximately 25.6%. The highest concentration in the blood is achieved on average two hours after oral administration. Food intake does not affect bioavailability.

Binds to plasma proteins by 99.7%. The connection with blood cells is weak. 40% of the drug is excreted by the kidneys, another 60% - with bile. The half-life is 11-14 hours.

Cardosal® 20

Olmesartan medoxomil, the active ingredient of Cardosal® 20, is a potent specific antagonist of angiotensin II receptors (type AT1).

The antihypertensive effect of olmesartan medoxomil usually develops within 2 weeks, and the maximum effect develops approximately 8 weeks after the start of therapy.

The effect of olmesartan medoxomil on mortality and complication rates has not been established.

The ROADMAP trial, a randomized trial of 4447 patients with type 2 diabetes mellitus, normoalbuinuria, and at least one additional cardiovascular risk factor, assessed the ability of olmesartan medoxomil to prolong the time to onset of microalbuminuria.

During the study period (median follow-up of 3.2 years), patients received olmesartan medoxomil or placebo in addition to other antihypertensive agents other than angiotensin-converting enzyme (ACE) inhibitors or other angiotensin II receptor antagonists.

The study demonstrated a significant reduction in the risk of the primary endpoint (time to onset of microalbuminuria) in favor of olmesartan medoxomil. After adjustment for differences in BP using prespecified parameters for double-blind design, the risk reduction was 17% (relative risk (RR) 0.8 [34; 95% confidence interval (CI): 0.681 - 1.021; p = 0.0789 ) for systolic blood pressure (SBP) adjusted for area under the curve (AUC) and 18% (RR 0.823; 95% CI: 0.672 - 1.008; p = 0.0596) for diastolic blood pressure (DBP) adjusted for AUC in the benefits of olmesartan medoxomil. Microalbuminuria developed in 8.2% of patients in the olmesartan medoxomil group (178 of 2160 patients) and 9.8% in the placebo group (210 of 2139 patients).

The primary composite endpoint (time to first event: doubling of plasma creatinine concentration, development of end-stage chronic kidney disease, death from all causes) was recorded in 116 patients in the olmesartan medoxomil group (41.1%) and in 129 patients in the placebo group (45.4%) (RR 0.97; 95% CI: 0.75-1.24; p = 0.791). The secondary composite cardiovascular endpoint was recorded in 40 patients in the olmesartan medoxomil group (14.2%) and in 53 patients in the placebo group (18.7%). The composite cardiovascular endpoint included: death from cardiovascular causes in 10 (3.5%) patients in the olmesartan medoxomil group and in 3 (1.1%) patients in the placebo group; total mortality (19 (6.7%) cases in the olmesartan medoxomil group and 20 (7.0%) cases in the placebo group), non-fatal stroke (8 (2.8%) cases in the olmesartan medoxomil group and 11 (3.9 %) cases in the placebo group), non-fatal myocardial infarction (3 (1.1%) cases in the olmesartan medoxomil group and 7 (2.5%) cases in the placebo group).

Children and teenagers

Patients weighing 20 to <35 kg were randomized to receive olmesartan medoxomil 2.5 mg (low dose) or mg (high dose) once daily, and patients weighing ≥ 35 kg were randomized to receive olmesartan medoxomil 2.5 mg (low dose) or mg (high dose) once daily. groups receiving olmesartan medoxomil at doses of 5 mg (low dose) or 40 mg (high dose) once daily. At a dose adjusted according to body weight, olmesartan medoxomil significantly reduced both systolic and diastolic blood pressure. At both low and high doses of olmesartan, medoxomil significantly reduced systolic blood pressure by 6.6 and 11.9 mmHg, respectively. Art. (from the initial level). This effect was also observed during the 2-week randomized withdrawal phase, with both mean systolic and diastolic blood pressure showing statistically significant increases in the placebo group compared with the olmesartan medoxomil group. In children and adolescents, treatment was effective for both primary and secondary arterial hypertension. As in adult patients, blood pressure in black patients decreased to a lesser extent.

Contraindications

Renal failure , a condition after a kidney transplant.
Obstruction of the biliary tract.
Lactase deficiency , malabsorption or galactosemia.
Age less than 18 years.
Pregnancy and lactation .
Hypersensitivity to the components of the drug.

It is recommended to use the drug with caution in the following diseases and conditions:

obstructive hypertrophic cardiomyopathy;
heart valve stenosis
primary aldosteronism;
mild renal failure
hyperkalemia or hyponatremia;
chronic cardiac failure;
cardiac ischemia;
bilateral renal artery stenosis
cerebrovascular disorders;
decreased volume of circulating fluid due to diet , vomiting or diarrhea;
liver dysfunction;
elderly age;
combined use with diuretics.

Cardosal 40 tablets film 40 mg pack contact cell/pack of cards x28

CARDOSAL® Representative office: BERLIN-CHEMIE/MENARINI PHARMA GmbH ATX code: C09CA08 Marketing authorization holder: BERLIN-CHEMIE/MENARINI PHARMA, GmbH produced by DAIICHI SANKYO EUROPE, GmbH olmesartan medoxomil

Release form, composition and packaging

Cardosal® 10 White film-coated tablets, round, biconvex, imprinted “C13” on one side, with a subtle specific odor. 1 tab. olmesartan medoxomil 10 mg Excipients: microcrystalline cellulose, low-substituted hyprolose, lactose monohydrate, hyprolose 6-10 mPa×s, magnesium stearate. Film shell composition: hypromellose 5 mPa×s, talc, titanium dioxide (E171). 14 - blisters (1) - cardboard packs. 14 - blisters (2) - cardboard packs. 14 - blisters (4) - cardboard packs. 14 - blisters (7) - cardboard packs.

Cardosal® 20 White film-coated tablets, round, biconvex, stamped “C14” on one side, with a subtle specific odor. 1 tab. olmesartan medoxomil 20 mg Excipients: microcrystalline cellulose, low-substituted hyprolose, lactose monohydrate, hyprolose 6-10 mPa×s, magnesium stearate. Film shell composition: hypromellose 5 mPa×s, talc, titanium dioxide (E171). 14 - contour cell packaging (1) - cardboard packs. 14 - contour cell packaging (2) - cardboard packs. 14 - contour cell packaging (4) - cardboard packs. 14 - contour cell packaging (7) - cardboard packs.

Cardosal® 40 White, oval, biconvex, film-coated tablets, imprinted “C15” on one side, with a subtle specific odor. 1 tab. olmesartan medoxomil 40 mg Excipients: microcrystalline cellulose, low-substituted hyprolose, lactose monohydrate, hyprolose 6-10 mPa×s, magnesium stearate. Film shell composition: hypromellose 5 mPa×s, talc, titanium dioxide (E171). 14 - contour cell packaging (1) - cardboard packs. 14 - contour cell packaging (2) - cardboard packs. 14 - contour cell packaging (4) - cardboard packs. 14 - contour cell packaging (7) - cardboard packs.

Clinical and pharmacological group: Angiotensin II receptor antagonist

Registration No.: •tablets, film coated, 10 mg: 14, 28, 56 or 98 - LSR-010758/09, 12/29/09. Validity period of reg. beat is not limited. •tablets, film coated, 20 mg: 14, 28, 56 or 98 - LSR-000628/10, 02/03/10. Validity period of reg. beat is not limited. •tablets, film-coated, 40 mg: 14, 28, 56 or 98 - LSR-000629/10, 02/03/10. Validity period of reg. beat is not limited.

Pharmacological action Specific antagonist of angiotensin II receptors (type AT1) for oral administration. Angiotensin II is the primary vasoactive hormone of the RAAS and plays a significant role in the pathophysiology of arterial hypertension through AT1 receptors. It is assumed that olmesartan blocks all effects of angiotensin II mediated by AT1 receptors, regardless of the source and pathway of angiotensin II synthesis. In arterial hypertension, olmesartan causes a dose-dependent, long-term decrease in blood pressure. There is no data on the development of arterial hypotension after taking the first dose of the drug, on tachycardia during long-term treatment (for the drugs Cardosal® 20 and Cardosal® 40) and on the development of withdrawal syndrome (a sharp increase in blood pressure after discontinuation of the drug). Taking olmesartan medoxomil 1 time provides an effective and mild reduction in blood pressure within 24 hours, and the effect after a single dose is similar to the effect of taking drug 2 at the same daily dose. The hypotensive effect of olmesartan usually develops within 2 weeks, and the maximum effect develops approximately 8 weeks after the start of therapy.

Pharmacokinetics

Suction and distribution

Olmesartan medoxomil is a prodrug. It is rapidly converted to the pharmacologically active metabolite olmesartan by enzymes in the intestinal mucosa and in the portal blood during absorption from the gastrointestinal tract. Olmesartan medoxomil was not detected unchanged in blood plasma. The bioavailability of olmesartan averages 25.6%. Cmax of olmesartan in blood plasma is achieved on average 2 hours after oral administration of olmesartan medoxomil and increases approximately linearly with increasing single dose to 80 mg. Food intake does not have a significant effect on the bioavailability of olmesartan, therefore olmesartan medoxomil can be taken regardless of meals. There were no clinically significant differences in the pharmacokinetic parameters of olmesartan depending on gender. Olmesartan is bound to plasma proteins (99.7%), but the potential for a clinically significant shift in the magnitude of protein binding when olmesartan interacts with other highly binding and concomitantly used drugs is low (this is confirmed by the lack of clinically significant interaction between olmesartan and warfarin). The association of olmesartan with blood cells is insignificant.

Metabolism and excretion Total plasma clearance is usually 1.3 L/h (coefficient of variation - 19%) and is relatively low compared to hepatic blood flow (approximately 90 L/h). Renal excretion is approximately 40%, bile excretion is about 60%. Intrahepatic circulation of olmesartan is minimal. Since most of olmesartan is eliminated through the liver, its use in patients with biliary obstruction is contraindicated. T1/2 of olmesartan is 10-15 hours after repeated oral administration. A significant effect of therapy is achieved after taking the first few doses of the drug, and after 14 days of repeated use, no further accumulation is observed. Renal clearance is approximately 0.5-0.7 l/h and is independent of the dose of the drug.

Pharmacokinetics in special clinical situations

In patients with renal impairment, steady-state AUC was increased by approximately 62%, 82%, and 179% for mild, moderate, and severe renal impairment, respectively, compared with healthy volunteers. After a single oral dose, the AUC values for olmesartan were 6% and 65% higher in patients with mild and moderate hepatic impairment, respectively, compared to healthy volunteers. The unbound fraction of olmesartan 2 hours after dosing in healthy volunteers and in patients with mild and moderate hepatic impairment was 0.26%, 0.34% and 0.41%, respectively.

Indications for use of the drug CARDOSAL® are essential arterial hypertension.

Dosage regimen It is recommended to take Cardosal® orally every day at the same time, regardless of meals, 1 time/

The recommended starting dose for adults is 10 mg (1 tablet of the drug Cardosal® 10) 1 time/ In case of insufficient reduction in blood pressure when taking the drug at a dose of 10 mg/, the dose of the drug can be increased to 20 mg/ (the use of the drug Cardosal® 20 is possible) . If additional reduction in blood pressure is necessary, the dose of the drug can be increased to a maximum of 40 mg/day (the drug Cardosal® 40 can be used) or a diuretic (hydrochlorothiazide) can be additionally prescribed. The maximum daily dose is 40 mg.

Side effects Possible side effects are listed below in descending frequency of occurrence: very often (> 1/10), often (> 1/100 1/1000, 1/10,000, From the hematopoietic system: very rarely - thrombocytopenia. From the central nervous system: sometimes - dizziness, very rarely - headache. From the respiratory system: often - pharyngitis, rhinitis, very rarely - cough, bronchitis. From the digestive system: often - diarrhea, dyspepsia, gastroenteritis, very rarely - abdominal pain, nausea, vomiting, increased activity of liver enzymes. Allergic reactions: very rarely - skin itching, rash, angioedema, allergic dermatitis, urticaria. From the musculoskeletal system: often - back pain, bone pain, arthralgia, arthritis, very rarely - muscle cramps, myalgia. From the urinary system: often - hematuria, urinary tract infection, very rarely - acute renal failure, increased levels of creatinine and urea in the blood serum. From the cardiovascular system: sometimes - angina, tachycardia, rarely - severe decrease in blood pressure. Metabolism: often - increased CPK levels, hypertriglyceridemia, hyperuricemia, rarely - hyperkalemia. From the body as a whole: often - chest pain, flu-like symptoms, peripheral edema, very rarely - asthenia, fatigue, malaise, drowsiness.

Contraindications to the use of the drug CARDOSAL® - obstruction of the biliary tract, - renal failure (creatinine clearance less than 20 ml/min), condition after kidney transplantation (no experience of clinical use), - lactase deficiency, galactosemia or malabsorption syndrome, - pregnancy, - lactation period, - age under 18 years (efficacy and safety have not been established), - hypersensitivity to the active substance or to any of the excipients included in the drug.

The drug should be used with caution in the following conditions or diseases: - stenosis of the aortic or mitral valves, - hypertrophic obstructive cardiomyopathy, - primary hyperaldosteronism, - hyperkalemia, hyponatremia (risk of dehydration, arterial hypotension, renal failure), - renal failure (creatinine clearance more than 20 ml / min), - chronic heart failure, - bilateral renal artery stenosis or stenosis of the artery of a single kidney, - ischemic heart disease, - cerebrovascular diseases, - old age (over 65 years), - liver dysfunction, - conditions accompanied by a decrease in blood volume (including including diarrhea, vomiting), as well as when following a sodium-restricted diet, - simultaneous use with diuretics.

Use of the drug CARDOSAL® during pregnancy and lactation There is no experience with the use of olmesartan medoxomil in pregnant women. However, due to existing reports of severe teratogenic effects of drugs acting directly on the renin-angiotensin system, like any drug of this class, olmesartan is contraindicated during pregnancy. If pregnancy occurs during therapy with Cardosal®, the drug must be discontinued.

There is no data on whether olmesartan is excreted in breast milk, therefore, if it is necessary to use the drug Cardosal® during lactation, breastfeeding should be discontinued while taking the drug.

Use for impaired liver function With caution: impaired liver function.

Use for impaired renal function With caution in case of impaired renal function, with CC Special instructions Symptomatic arterial hypotension, especially after taking the first dose of the drug, may occur in patients with reduced blood volume and/or reduced sodium levels due to intensive diuretic therapy, limited dietary salt intake during dietary nutrition, as well as due to diarrhea or vomiting. Relevant factors should be eliminated before using Cardosal®.

In patients in whom vascular tone and renal function depend largely on the activity of the RAAS (for example, in patients with severe chronic heart failure or impaired renal function, including renal artery stenosis), treatment with other drugs acting on this system is associated with the possibility of developing acute arterial hypotension, azotemia, oliguria or, in rare cases, acute renal failure. The possibility of a similar effect cannot be excluded when using angiotensin II receptor antagonists.

There is an increased risk of severe hypotension and renal failure if a patient with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney is treated with drugs that affect the RAAS.

When using the drug Cardosal® in patients with impaired renal function, it is recommended to periodically monitor the level of potassium and creatinine in the blood serum. There is no experience with the use of Cardosal® in patients with recent kidney transplantation or in patients with late-stage renal impairment (for example, creatinine clearance less than 12 ml/min).

As with other angiotensin II receptor antagonists and ACE inhibitors, hyperkalemia may develop during treatment with Cardosal if the patient suffers from impaired renal function and/or chronic heart failure. In patients at this risk group, monitoring serum potassium levels is recommended.

As with other angiotensin II receptor antagonists, the combination of lithium and Cardosal® is not recommended.

As with other angiotensin II receptor antagonists, in black patients suffering from arterial hypertension, the effectiveness of therapy with Cardosal® is slightly lower than in patients of other races.

As with any antihypertensive drug, excessive reduction of blood pressure in patients with coronary artery disease or cerebrovascular insufficiency can lead to myocardial infarction or stroke.

Effect on the ability to drive vehicles and operate machines The effect of the drug Cardosal® on the ability to drive vehicles and operate machines has not been studied, therefore, during treatment with the drug Cardosal®, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed psychomotor reactions (dizziness and weakness are possible).

Overdose Symptoms: pronounced decrease in blood pressure. Treatment: with a pronounced decrease in blood pressure, it is recommended to place the patient on his back with his legs elevated. It is recommended to lavage the stomach and/or take activated charcoal, therapy aimed at correcting dehydration and disturbances in water-salt metabolism, and replenishing blood volume.

Drug interactions Concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that can increase serum potassium levels (for example, heparin) is not recommended, as this may lead to increased serum potassium levels

The antihypertensive effect of olmesartan therapy can be enhanced when used in combination with other antihypertensive drugs. NSAIDs, including acetylsalicylic acid in doses greater than 3 g/day, as well as COX-2 inhibitors and angiotensin II receptor antagonists may act synergistically, reducing glomerular filtration. With the simultaneous use of NSAIDs and angiotensin II receptor antagonists, there may be a risk of developing acute renal failure, therefore monitoring of renal function at the beginning of treatment, as well as regular intake of sufficient fluids, is recommended. However, simultaneous treatment may reduce the antihypertensive effect of angiotensin II receptor antagonists, leading to a partial loss of their therapeutic effectiveness.

When used simultaneously with antacids (magnesium and aluminum hydroxide), a moderate decrease in the bioavailability of olmesartan is possible.

There are reports of a reversible increase in serum lithium concentrations and toxicity during simultaneous use of lithium preparations with ACE inhibitors and angiotensin II receptor antagonists, therefore the use of olmesartan medoxomil in combination with lithium preparations is not recommended. If appropriate combination therapy is necessary, regular monitoring of serum lithium levels is recommended.

Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Conditions and periods of storage The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life: 3 years.

Side effects

Hematopoietic reactions: thrombocytopenia.
Reactions from nervous activity: dizziness , headache .
Reactions from breathing: cough, rhinitis, pharyngitis, bronchitis.
Digestive reactions: nausea, diarrhea, dyspepsia , abdominal pain, gastroenteritis , vomiting.
Skin reactions: itching , skin rash, allergic dermatitis, Quincke's edema, urticaria.
Reactions from the musculoskeletal system: pain in bones and joints, arthritis, back pain, cramps .
Reactions from the genitourinary tract: genitourinary tract infections, hematuria, acute renal failure.
Reactions from laboratory tests: increased levels of urea and creatinine in the blood, increased levels of liver enzymes.
Circulatory reactions: tachycardia, angina , decreased blood pressure.
Metabolic reactions: increased creatine phosphokinase levels, hyperuricemia, hypertriglyceridemia, hyperkalemia.
General reactions: flu-like symptoms, chest pain, asthenia , peripheral edema, malaise, fatigue, drowsiness .

Instructions for use of Cardosal (Method and dosage)

Instructions for use of Cardosal prescribe taking the drug orally every day at the same time, once a day.

The recommended initial dose is 10 mg once daily. If the blood pressure reduction is not sufficient when taking 10 mg per day, it can be increased to 20 mg per day. If additional pressure reduction is required, the dosage is increased to a maximum of 40 mg per day or a diuretic (for example, hydrochlorothiazide ).

The highest daily dose is 40 mg.

Cardosal® 10

Olmesartan medoxomil, the active ingredient of Cardosal® 10, is a potent specific antagonist of angiotensin II receptors (type AT1).

Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of arterial hypertension by acting on AT1 receptors. Olmesartan medoxomil is expected to block all AT1 receptor-mediated actions of angiotensin II, regardless of the source and route of angiotensin II synthesis. The specific antagonism of olmesartan medoxomil towards angiotensin II receptors (AT1 type) leads to an increase in the activity of renin, angiotensin I and II in the blood plasma, and also helps to reduce the plasma concentration of aldosterone.

The antihypertensive effect of olmesartan medoxomil usually develops within 2 weeks, and the maximum effect develops approximately 8 weeks after the start of therapy.

The effect of olmesartan medoxomil on mortality and complication rates has not been established. The ROADMAP trial, a randomized trial of 4447 patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional cardiovascular risk factor, assessed the ability of olmesartan medoxomil to prolong the time to onset of microalbuminuria. During the study period (median follow-up of 3.2 years), patients received olmesartan medoxomil or placebo in addition to other antihypertensive agents other than angiotensin-converting enzyme (ACE) inhibitors or other angiotensin II receptor antagonists.

The secondary composite cardiovascular endpoint was recorded in 40 patients in the olmesartan medoxomil group (14.2%) and in 53 patients in the placebo group (18.7%).

The composite cardiovascular endpoint included: death from cardiovascular causes in 10 (3.5%) patients in the olmesartan medoxomil group and in 3 (1.1%) patients in the placebo group; total mortality (19 (6.7%) cases in the olmesartan medoxomil group and 20 (7.0%) cases in the placebo group), non-fatal stroke (8 (2.8%) cases in the olmesartan medoxomil group and 11 (3.9 %) cases in the placebo group), non-fatal myocardial infarction (3 (1.1%) cases in the olmesartan medoxomil group and 7 (2.5%) cases in the placebo group).

Children and teenagers

In children and adolescents, treatment was effective for both primary and secondary arterial hypertension. As in adult patients, blood pressure in black patients decreased to a lesser extent.

Interaction

Concomitant use with potassium supplements, potassium-sparing diuretics or other drugs that can increase potassium in the blood is not recommended.

The antihypertensive effect of treatment with olmesartan is enhanced when used in combination with other antihypertensive drugs.

Nonsteroidal anti-inflammatory drugs, cyclooxygenase type 2 inhibitors, and angiotensin type 2 receptor blockers may interact synergistically to inhibit glomerular filtration. In this case, there is a possibility of acute renal failure . To avoid such phenomena, it is recommended to monitor kidney function at the beginning of therapy, as well as timely intake of a sufficient volume of fluid.

When used together with antacids , a moderate decrease in the bioavailability of olmesartan is possible.

The use of olmesartan together with lithium preparations is dangerous due to an increase in the concentration of the latter in the blood.

Interactions of the drug Cardosal

When used with other antihypertensive drugs, the effect of olmesartan medoxomil may be enhanced. When olmesartan medoxomil is used simultaneously with NSAIDs, its antihypertensive effect may be reduced and there may be a risk of acute renal failure. After therapy with antacids (magnesium-aluminum hydroxide), a decrease in the bioavailability of olmesartan medoxomil was noted. The combined use of warfarin and digoxin does not change the pharmacokinetics of olmesartan. It is not recommended to use olmesartan medoxomil with lithium preparations due to the increased toxicity of the latter. Due to the possibility of developing hyperkalemia, it is not recommended to use olmesartan medoxomil with potassium-sparing diuretics, drugs containing potassium, or with other drugs that can lead to an increase in serum potassium levels (for example, heparin). When using olmesartan medoxomil with pravastatin, no clinically significant interactions were observed. The interactions of olmesartan medoxomil with drugs that are metabolized by the cytochrome P450 enzyme have not been determined.

special instructions

When using the drug in people with impaired renal function, it is recommended to regularly monitor potassium and creatinine in the blood.

It should be remembered that an excessive decrease in pressure in patients with coronary artery disease or cerebrovascular changes can cause heart attack or stroke .

When driving a vehicle during treatment with this drug, you should be careful.

Cardosal's analogs

Level 4 ATC code matches:
Telmisartan

Irbesartan

Presartan

Nortivan

Candesartan

Kozaar

Aprovel

Teveten

Blocktran

Valsartan

Losartan

Atakand

Diovan

Valsacor

Mikardis

Vazar

Valz

Lorista

Lozap

Complete analogues of Cardosal: Olimestra, Olmesar.

Cardosal price, where to buy

In Russia, the price of Cardosal 10 No. 28 is 460-570 rubles, the price of Cardosal 20 No. 28 is 505-660 rubles, and Cardosal 40 with the same number is 670-715 rubles.

In Ukraine, prices for the drug in the same release forms are close to 248, 328 and 374 hryvnia, respectively.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine

ZdravCity

Cardosal tablets p.p.o.
40 mg 28 pcs. Daichi Sankyo Europe GmbH RUB 830 order
Cardosal tablets p.p.o. 10 mg 28 pcs. Daichi Sankyo Europe GmbH
RUR 582 order
Cardosal Plus tablets p.p.o. 12.5 mg+20 mg 28 pcs. Daichi Sankyo Europe GmbH
RUR 791 order
Cardosal tablets p.p.o. 20 mg 28 pcs. Daichi Sankyo Europe GmbH
RUR 758 order

Pharmacy Dialogue

Cardosal plus (tab. p.pl/vol. 12.5 mg + 20 mg No. 28) Daiichi Sankyo
RUR 772 order
Cardosal (tab.p/vol.40mg No. 28)Berlin-Chemie AG/Menarini
RUB 816 order
Cardosal (tab.p/vol.10mg No. 28)Berlin-Chemie AG/Menarini
RUR 576 order
Cardosal (tablet p/o 20 mg No. 28)Berlin-Chemie AG/Menarini
RUR 744 order

Pharmacy24

Cardosal plus 20/12.5 No. 28 tablets Daichie Sankio Europe GmbH/Berlin Chemie AG (Menarini Group), Nimechchina/Nimechchina
380 UAH.order
Cardosal 40 mg No. 28 tablets Berlin Chemi AG, /Daichi Sankio Europe GmbH/Labor.Menarini S.A., Nimechchina
427 UAH. order
Cardosal plus 20/25 No. 28 tablets Berlin Chemi AG, Nimechchina
380 UAH. order
Cardosal 20 mg No. 28 tablets Berlin Chemi AG, /Daichi Sankio Europe GmbH/Labor.Menarini S.A., Nimechchina
388 UAH order
Cardosal 10 mg N28 tablets Berlin Chemi AG, /Daichi Sankio Europe GmbH/Labor.Menarini S.A., Nimechchina
312 UAH. order