Cardosal - instructions for use, analogs, reviews and release forms (tablets 10 mg, 20 mg and 40 mg, plus 12.5 mg + 20 mg, 25 mg + 20 mg with a diuretic) drugs for the treatment of hypertension and pressure reduction in adults, children and during pregnancy. Composition

In this article, you can read the instructions for using the drug Cardosal. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Cardosal in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Cardosal in the presence of existing structural analogues. Use to treat hypertension and reduce blood pressure in adults, children, as well as during pregnancy and lactation.Composition of the preparation.

Cardosal - Angiotensin 2 receptor antagonist (type AT1). Angiotensin 2 is the primary vasoactive hormone of RAAS and plays a significant role in the pathophysiology of hypertension via AT1 receptors. It is assumed that olmesartan (active ingredient of the drug Cardosal) blocks all the effects of angiotensin 2 mediated by AT1 receptors regardless of the source and route of synthesis of angiotensin 2.

With arterial hypertension, olmesartan causes a dose-dependent prolonged decrease in blood pressure. There is no evidence of the development of arterial hypotension after taking the first dose of the drug, about tachycardia during long-term treatment (for Cardosal 20 and Cardosal 40) and about the development of withdrawal syndrome (a sharp increase in BP after drug withdrawal).

The use of olmesartan medoxomil once a day provides an effective and gentle decrease in blood pressure within 24 hours, and the effect after a single dose is similar to the effect of taking the drug 2 times a day in the same daily dose.

The hypotensive effect of olmesartan develops, as a rule, after 2 weeks, and the maximum effect develops approximately 8 weeks after the initiation of therapy.

Hydrochlorothiazide (in the preparation Cardosal Plus) - thiazide diuretic - disrupts the reabsorption of sodium, chlorine and water ions in the renal tubules. Increases the excretion of ions of potassium, magnesium, hydrocarbonates, delays the body of calcium ions. Diuretic effect occurs 2 hours after taking hydrochlorothiazide inwards, reaches a maximum after 4 hours and lasts up to 12 hours. It helps to decrease high blood pressure. When combined with the administration of olmesartan medoxomil and hydrochlorothiazide, there is a decrease in the loss of potassium ions caused by the action of the diuretic. The result of combined therapy with olmesartan medoxomil and hydrochlorothiazide is potentiation of the hypotensive effect, which depends on the dose of each component of the drug. Combination therapy is well tolerated by patients. With long-term treatment, the effectiveness of combination therapy (olmesartan medoxomil / hydrochlorothiazide) is maintained, the development of withdrawal syndrome is not observed.

Composition

Olmesartan medoxomil + auxiliary substances.

Hydrochlorothiazide + Olmesartan medoxomil + excipients (Cardosal Plus).

Pharmacokinetics

Olmesartan medoxomil

Olmesartan medoxomil is a prodrug. It quickly turns into pharmacologically active metabolite olmesartan under the action of enzymes in the intestinal mucosa and in portal blood during absorption from the digestive tract. Olmesartan medoxomil in unchanged form in the blood plasma was not detected. The bioavailability of olmesartan is 25.6% on average. Eating does not have a significant effect on the bioavailability of olmesartan, so olmesartan medoxomil can be taken regardless of food intake. Clinically significant differences in pharmacokinetic parameters of olmesartan, depending on sex, were not revealed.

Olmesartan binds to blood plasma proteins (99.7%), but the potential for a clinically significant shift in the amount of binding to proteins in the interaction of olmesartan with other highly-linked and concomitantly used drugs is low (the absence of a clinically significant interaction between olmesartan and warfarin). The association of olmesartan with blood cells is negligible.

Kidney excretion is approximately 40%, with bile - about 60%.The intrahepatic circulation of olmesartan is minimal. Since most of the olmesartan is excreted through the liver, its use in patients with bile duct obstruction is contraindicated.

A significant effect of therapy is achieved after the first few doses of the drug, and after 14 days of repeated use, further cumulation is not observed.

Hydrochlorothiazide

Hydrochlorothiazide binds to plasma proteins by 68%. Systemic bioavailability of hydrochlorothiazide with simultaneous use with olmesartanom medoxomil decreases by about 20%, but this small decrease in clinical terms is not significant. Simultaneous administration of hydrochlorothiazide, for its part, does not significantly affect the kinetics of olmesartan medoxomil. In controlled clinical trials, the pronounced antihypertensive effect of this combination was found, which exceeded the effect of each of the components separately, as well as the placebo effect.

Hydrochlorothiazide in the body is not metabolized and almost completely unchanged is excreted by the kidneys.After oral administration, about 60% of the dose of hydrochlorothiazide taken unchanged is withdrawn within 48 hours.

Indications

• essential arterial hypertension.

Cardosal Plus with a diuretic hydrochlorothiazide is used when olmesartan monotherapy with medoxomil is ineffective.

Forms of release

Tablets 10 mg, 20 mg and 40 mg.

Tablets 12.5 mg + 20 mg, 25 mg + 20 mg (Cardosal Plus).

Instructions for use and dosing regimen

Cardosal Tablets

It is recommended to take Cardosal preparation inside every day at the same time, regardless of food intake once a day.

The recommended initial dose for adults is 10 mg (1 tablet of Cardosal 10) once a day. In the case of insufficient reduction in blood pressure when taking the drug at a dose of 10 mg per day, the dose of the drug can be increased to 20 mg per day (possibly using Cardosal 20). If it is necessary to further reduce blood pressure, the dose of the drug can be increased to a maximum of 40 mg per day (Cardosal 40 may be used), or a diuretic (hydrochlorothiazide) may additionally be prescribed. The maximum daily dose is 40 mg.

Kardosal Plus tablets

Cardosal plus tablets are taken orally regardless of food intake.Prior to the appointment of the combined drug Cardosal plus, a preliminary dose selection of each of the active substances alone (i.e., olmesartan medoxomil and hydrochlorothiazide) is recommended.

The recommended dose is 1 tablet of Cardosal plus every day, containing 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide, in the absence of adequate control of BP against olmesartan monosomal medoxomil at a dose of 20 mg.

In the absence of adequate control of blood pressure when taking Cardosal plus, containing 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide, Cardosal plus, containing 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide, can be used daily for 1 tablet.

The maximum dose of Cardosal plus is 20 mg of olmesartan medoxomil and 25 mg hydrochlorothiazide once a day.

Side effect

• dizziness;
• headache;
• palpitation;
• marked decrease in blood pressure;
• orthostatic hypotension;
• skin rash;
• itching;
• angioedema;
• allergic dermatitis;
• hives;
• eczema;
• hyper- or hypokalemia, hypercalcemia, hypertriglyceridemia, hyperuricemia, increased lipid levels in the blood;
• a slight increase in the concentration of creatinine, uric acid and urea nitrogen in the blood serum;
• a slight decrease in the concentration of hemoglobin and hematocrit;
• leukopenia, neutropenia, agranulocytosis, thrombocytopenia;
• bronchitis;
• pharyngitis;
• rhinitis;
• cough;
• diarrhea;
• dyspepsia;
• gastroenteritis;
• abdominal pain;
• nausea;
• vomiting;
• hematuria;
• urinary tract infection;
• acute renal insufficiency;
• arthritis;
• backache;
• muscle cramps;
• myalgia;
• pain in the chest;
• influenza-like symptoms;
• peripheral edema;
• weakness;
• increased fatigue;
• sleep disturbance;
• malaise;
• anxiety;
• confusion of consciousness;
• apathy;
• depression;
• thrombosis;
• embolism;
• fever.

Contraindications

• hereditary lactose intolerance, lack of lactase in the body or glucose and lactose malabsorption syndrome;
• severe liver dysfunction (more than 9 on the Child-Pugh scale) (risk of developing a hepatic coma), bile duct obstruction and cholestasis;
• severe renal dysfunction (QC less than 30 ml / min.);
• refractory hypokalemia, hyponatremia, hypercalcemia and symptomatic hyperuricemia;
• pregnancy;
• lactation period;
• age to 18 years (efficacy and safety of the drug not studied);
• increased sensitivity to olmesartan medoxomil, hydrochlorothiazide or other derivatives of sulfonamides or to any of the excipients included in the preparation.

Carefully

• bronchial asthma;
• ischemic heart disease (IHD);
• chronic heart failure in the stage of decompensation;
• severe cerebrovascular disorders;
• stenosis of the aortic or mitral valve;
• hypertrophic obstructive cardiomyopathy;
• impaired hepatic and mild liver function (less than 9 on the Child-Pugh scale);
• impaired renal function (QC more than 30 ml / min, but less than 60 ml / min.);
• bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;
• a condition after recently transferred kidney transplantation (experience of application of a preparation is absent);
• primary aldosteronism;
• diabetes mellitus, gout;
• disturbance of water-electrolyte balance, dehydration;
• connective tissue diseases, including systemic lupus erythematosus;
• patients who follow a diet with salt restriction or who are on hemodialysis;
• when oppression of bone marrow hematopoiesis;
• conditions, accompanied by a decrease in the volume of circulating blood;
• (Bcc) incl. diarrhea, vomiting, or previous therapy with diuretics.

Application in pregnancy and lactation

The experience of using olmesartan medoxomil in pregnant women is absent. However, in view of the available reports of severe teratogenic effects of drugs acting on the RAAS, like any medicinal product of this class, Cardosal and Cardosal plus is contraindicated for use in pregnancy. In the case of planning or the onset of pregnancy during therapy with Cardosal plus, the drug should be discontinued as soon as possible. It is not known whether olmesartan medoxomil is excreted in breast milk, but thiazides are excreted in breast milk and can inhibit lactation, so if you need Cardosal Plus plus during lactation, breastfeeding for the period of taking it should be discontinued.

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety of the drug have not been studied).

Application in elderly patients

Elderly patients (over 65 years of age) with normal renal function (CC greater than 90 ml / min) do not need dose adjustment.

special instructions

Symptomatic arterial hypotension, especially after taking the first dose of the drug, can occur in patients with reduced BCC and / or reduced sodium concentration due to intensive therapy with diuretics, dietary restriction of dietary intake, and also due to diarrhea or vomiting. Corresponding factors should be eliminated before starting the use of Cardosal plus.

Thiazide diuretics, including hydrochlorothiazide, can cause a violation of bcc or water-electrolyte balance of blood serum (including hypokalemia, hyponatremia and hypochloraemic alkalosis). Symptoms-precursors are: dryness of the oral mucosa, thirst, weakness, drowsiness, anxiety, myalgia or cramps, muscle weakness, arterial hypotension, oliguria, tachycardia, nausea and vomiting (see Side effect).

The highest risk of developing hypokalemia exists in patients with cirrhosis of the liver, in patients with forced diuresis and in patients who simultaneously take glucocorticosteroids or ACTT (see Interactions with Other Drugs). Conversely, because of the antagonism of Cardosan plus olmesartan medoxomil in the angiotensin 2 receptor (AT1) receptor, there may be hyperkalemia - primarily in patients with impaired renal function and / or chronic heart failure, as well as patients with diabetes mellitus. Patients with risk factors are recommended regular monitoring of potassium concentration in the blood serum. Data on whether olmesartan medoxomil can reduce hyponatremia caused by diuretics or hinder its development is not. In hot weather, diluted hyponatremia may occur in patients prone to edema. Reduction of the chloride concentration in general is not very pronounced and usually does not require treatment.

Thiazides can reduce the excretion of calcium ions by the kidneys and also lead to a transient slight increase in serum calcium in the absence of a history of impaired metabolism.Hypercalcemia may indicate latent hyperparathyroidism. Before the study of the function of parathyroid glands, thiazides should be discontinued.

It is proved that thiazide diuretics increase the excretion of magnesium ions by the kidneys, which can lead to hypomagnesemia.

In patients who have vascular tone and kidney function depending to a large extent on the activity of RAAS (for example, in patients with severe chronic heart failure or renal dysfunction, including renal artery stenosis), treatment with other agents that affect RAAS 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 can not be ruled out with the use of angiotensin receptor antagonists P.

There is an increased risk of severe arterial hypotension and renal failure if a patient with bilateral stenosis of the renal arteries or stenosis of the artery of a single functioning kidney receives therapy with drugs that affect RAAS. When using Cardosal plus in patients with impaired renal function, it is recommendedconduct periodic monitoring of the concentration of potassium ions, creatinine and uric acid in the blood serum. The experience of using olmesartan medoxomil in patients with recent kidney transplantation or patents with the last stage of renal dysfunction is absent.

In patients with limited renal function, the use of thiazide diuretics may be accompanied by azotemia. With the obvious progression of renal failure, it is necessary to revise the therapy and decide on the question of the abolition of diuretics.

As with any antihypertensive drug, an excessive reduction in blood pressure in patients with ischemic heart disease or with cerebrovascular insufficiency can lead to myocardial infarction or stroke.

Thiazide diuretics can cause a violation of glucose tolerance, as well as an increase in the concentration of cholesterol, triglycerides and uric acid in the serum. In patients with diabetes mellitus, it may be necessary to adjust the dose of insulin or hypoglycemic agent for oral administration (see Interactions with other drugs). In the treatment of thiazide diuretics, latent diabetes mellitus can manifest.

There are reports that thiazide diuretics can contribute to the development of an attack of gout and cause an exacerbation of systemic lupus erythematosus. Hypersensitivity reactions to hydrochlorothiazide may be more likely in patients with a history of allergic history or bronchial asthma.

Impact on the ability to drive vehicles and manage mechanisms

The influence of Cardosal plus on the ability to drive vehicles and control mechanisms has not been specifically studied, therefore, during the treatment with Cardosal plus, caution should be exercised when driving vehicles and practicing potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Drug Interactions

Olmesartan medoxomil

It is not recommended to use together with potassium-sparing diuretics, potassium preparations, substitutes for salts containing potassium, or other drugs that can increase the concentration of potassium in the blood serum (for example, heparin) - it is possible to increase the potassium concentration in the blood serum.

Non-steroidal anti-inflammatory drugs (NSAIDs), including Acetylsalicylic acid at doses greater than 3 g per day, as well as cyclooxygenase-2 (COX-2) inhibitors, and angiotensin 2 receptor antagonists can act synergistically, reducing glomerular filtration. With the simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs) and angiotensin-2 receptor antagonists, there may be a risk of developing acute renal failure, so it is recommended that kidney function be monitored at the beginning of treatment and that a sufficient amount of fluid is taken regularly. However, simultaneous treatment can reduce the antihypertensive effect of angiotensin 2 receptor antagonists, leading to a partial loss of their therapeutic efficacy. When used simultaneously with antacids (magnesium and aluminum hydroxides), a moderate decrease in the bioavailability of olmesartan medoxomil is possible. There have been reports of a reversible increase in serum lithium concentration and toxicity during simultaneous use of lithium preparations with angiotensin converting enzyme (ACE) inhibitors and with angiotensin 2 receptor antagonists,therefore, the use of olmesartan medoxomil in combination with lithium preparations is not recommended. If it is necessary to use the appropriate combination therapy, regular monitoring of the concentration of lithium in the blood serum is recommended. In rare cases, ACE inhibitors can increase the hypoglycemic action of insulin and hypoglycemic agents for oral administration (eg, sulfonylureas) in patients with diabetes mellitus. In these cases, simultaneous use of ACE inhibitors may require a reduction in the dose of hypoglycemic agent for ingestion and insulin.

Hydrochlorothiazide

Glucocorticosteroids, adrenocorticotropic hormone (ACTH), amphotericin B (parenterally), carbenoxolone, penicillin G sodium salt, derivatives of salicylic acid: while taking them with hydrochlorothiazide, there may be an increase in electrolyte losses, especially the development of hypokalemia.

Simultaneous reception of ion-exchange drugs (colestyramine, colestipol) reduces the absorption of hydrochlorothiazide.

With the simultaneous use of hydrochlorothiazide with calcium salts, it is possible to increase the concentration of calcium in the blood serum, due to a decrease in its excretion.If it is necessary to prescribe calcium preparations, you should monitor its concentration in the blood serum and adjust its dose accordingly.

With the simultaneous use of hydrochlorothiazide with cardiac glycosides, arrhythmias can occur.

Medicines that can cause torsades des pointes (a special form of polymorphic ventricular tachycardia with a wave, screw or spindle configuration of the ventricular complexes in combination with an increase or decrease in the amplitude of QRS complex teeth that can lead to ventricular fibrillation or asystole) : Due to the risk of hypokalemia, caution is required when hydrochlorothiazide is used simultaneously with certain antiarrhythmics (quinidine, hydroquinidine, disopyramide, amiodarone, sotal lyophilidinum methylsulphate, Erythromycin for intravenous administration, halofanthin, amyloseptin, dicarboxylic acid, dicarboxylic acid, dicarboxylic acid, misinastine, nentamidine, sparfloxacin, terfenadine, vincamine for intravenous administration), which are known to cause piruet-type arrhythmia.

With the combined use of hydrochlorothiazide with nondepolarizing muscle relaxants (including tubocurarine chloride) - increased action of muscle relaxants.

Thiazides may increase the risk of side effects of amantadine. Treatment with thiazide diuretics can impair glucose tolerance. With the simultaneous use of M-holinoblokatorov (atropine) and thiazides, due to a decrease in the motility of the gastrointestinal tract, the bioavailability of thiazide diuretics may increase.

It may be necessary to reduce the dose of hypoglycemic agents for ingestion and insulin.

Antifungal agents (probenecid, sulfinpyrazone, allopurinol): it may be necessary to correct the dose of the hypo-uricemic agent (increasing the dose of probenecid or sulfinpyrazone), since hydrochlorothiazide can increase the concentration of uric acid in the blood serum. Simultaneous use with thiazide diuretics can increase the frequency of development of hypersensitivity reactions to allopurinol. The effect of sympathomimetics with simultaneous administration of thiazide diuretics may be weakened.

Thiazide diuretics can reduce the excretion of cytotoxic drugs by the kidneys and enhance their myelosuppressive effect.

When taking salicylates in high doses of hydrochlorothiazide may increase their toxic effect on the central nervous system.

There are reports of single cases of hemolytic anemia with concomitant administration of methyldopa with hydrochlorothiazide.

Simultaneous use of cyclosporine with hydrochlorothiazide may increase the risk of hyperuricemia and exacerbation of gout.

The simultaneous use of tetracyclines with thiazide diuretics increases the risk of an increase in urea concentration due to tetracyclines. This interaction does not apply to doxycycline.

Olmesartan medoxomil / hydrochlorothiazide in combination

The simultaneous use of lithium preparations with thiazide diuretics may increase the already high risk of lithium intoxication due to ACE inhibitors, therefore the combined use of Cardosal plus and lithium preparations is not recommended. If such a combination is still necessary, careful monitoring of the concentration of lithium in serum is also necessary.

With the simultaneous use of the drug Cardosal plus with Baclofen and amifostine, an increase in antihypertensive action is possible.

With the simultaneous use of other antihypertensive drugs, the hypotensive effect of Cardosal plus can increase. Ethanol (alcohol), barbiturates, narcotic analgesics or antidepressants when used with Cardosal plus can lead to aggravation of orthostatic hypotension.

Analogues of the drug Cardosal

Structural analogs for the active substance:

• Cardosal Plus;
• Olimestra;
• Olmesartan Medox.

Analogues on the curative effect (means for the treatment of hypertension):

• Adelphan Ezidrex;
• Amlodipine;
• Anaprilin;
• Arifon;
• Atenolol;
• Bisoprolol;
• Verapamil;
• Veroshpiron;
• Hypothiazide;
• Dibazol;
• Diltiazem;
• Diroton;
• Diver;
• Doxazosin;
• The Zocardis;
• Indapamide;
• Kapoten;
• Captopril;
• Carvedilol;
• Cloppelin tablets;
• Concor;
• Corvitol;
• Cordaflex;
• Corinfar;
• Lasix;
• Lysinopril;
• Lozap;
• Losartan;
• Lorist;
• Magnesium sulfate;
• Metoprolol;
• Mycardis;
• Moxonidine;
• Niperten;
• Nifedipine;
• Nifecard;
• Noliprel;
• Norvasc;
• Pape;
• Prazosin;
• Prestarium;
• Propranolol;
• Raunatin;
• Renitek;
• Spironolactone;
• Tritace;
• Felodipine;
• Physiotherapy;
• Fosicard;
• Furosemide;
• Hartil;
• Ebrantil;
• Egilok;
• Equator;
• Exforge;
• Enalapril;
• Enam;
• Enap;
• Enarenal.

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