Hyposart tablets 32 mg 28 pcs. (candesartan)

Release form

White tablets, round, flat, chamfered on both sides, with dividing mark on one side and engraved 32 on the other side.



packaging 14 pcs - blisters (2) - packs of cardboard.

Pharmacological action

Angiotensin II receptor antagonist. Angiotensin II is the main enzyme of RAAS, which takes part in the pathogenesis of arterial hypertension, heart failure and other cardiovascular diseases.

Candesartan is a selective antagonist of angiotensin II receptors, subtype 1 (AT1 receptors). It does not exhibit agonist properties (does not affect ACE and does not lead to the accumulation of bradykinin or substance P, does not bind to receptors of other hormones, does not affect the state of ion channels involved in the regulation of the cardiovascular system). As a result of the blocking of AT1 receptors of angiotensin II, a compensatory dose-dependent increase in the activity of renin, the concentration of angiotensin I, angiotensin II and a decrease in the concentration of aldosterone in blood plasma occurs.

Arterial hypertension

The intake of candesartan by mouth provides a dose-dependent, a smooth decrease in blood pressure due to a decrease in heart rate without a reflex increase in heart rate. There is no data on the development of severe arterial hypotension after taking the first dose or on the development of withdrawal syndrome after discontinuation of therapy.

The onset of antihypertensive action after taking the first dose of the drug usually develops within 2 hours, the duration of the effect is 24 hours. Against the background of continued therapy with candesartan in a fixed dose, the maximum decrease in blood pressure is usually achieved within 4 weeks and lasts throughout the treatment. The addition of a thiazide diuretic hydrochlorothiazide to candesartan enhances its antihypertensive effect.

The age and gender of the patient do not affect the effectiveness of the drug. Candesartan increases renal blood flow and does not alter or increase glomerular filtration rate, while renal vascular resistance and filtration fraction are reduced.

Candesartan has a less pronounced antihypertensive effect in patients of the Negroid race (a population with predominantly low plasma renin activity).

There is no evidence of the effect of candesartan on the progression of diabetic nephropathy. In patients with arterial hypertension and type 2 diabetes, candesartan does not adversely affect blood glucose concentration and lipid profile.

Heart failure

Candesartan therapy reduces mortality and hospitalization in patients with chronic heart failure (CHF), regardless of age, gender, and concomitant therapy, leading to a decrease in the functional class of CHF according to NYHA classification.

Candesartan is effective in patients taking simultaneously beta-blockers in combination with ACE inhibitors, while its effectiveness is independent of the dose of an ACE inhibitor. In patients with heart failure and decreased systolic function of the left ventricle (left ventricular ejection fraction (LVEF) less than 40%), candesartan reduces OPSS and jamming pressure in the pulmonary capillaries.

Indications

- arterial hypertension

- chronic heart failure and impaired systolic function of the left ventricle (LVEF 40%) as adjunctive therapy for ACE inhibitors or for intolerance to ACE inhibitors.

Contraindications

- hypersensitivity to candesartan or other components of the

preparation - lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome

- pregnancy

- breastfeeding period

- children and adolescents under 18 years of age (efficacy and safety have not been established)

- severe liver dysfunction and / or cholestasis

- simultaneous use with patients' aliskiren and aliskiren containing with diabetes mellitus or impaired renal function (GFR less than 60 ml / min).

Precautions: severe renal impairment (CC less than 30 ml / min), hemodialysis, bilateral renal artery stenosis or stenosis of a single kidney artery, hemodynamically significant stenosis of the aortic and / or mitral valve, hypertrophic obstructive cardiomyopathy (GOKMP), condition after kidney transplantation cerebrovascular disorders of ischemic origin and ischemic heart disease, hyperkalemia in patients with reduced BCC, general anesthesia and surgery (risk of developing arterial hypotension due to RAAS blockade), primary hyperaldosteronism.

Use during pregnancy and lactation

Hyposart is contraindicated in pregnancy, as it has a direct effect on RAAS and can cause fetal development disorders (especially in the second and third trimesters of pregnancy) or have a negative effect on a newborn, up to a fatal outcome, if the drug was used during pregnancy.

It is known that treatment with angiotensin II receptor antagonists (ARA II) can cause impaired fetal development (impaired renal function, oligohydramnios, delayed ossification of the bones of the skull) and the development of complications in the newborn (renal failure, hypotension, hyperkalemia). When establishing the fact of pregnancy, the Hyposart drug must be canceled as soon as possible.

When planning pregnancy, it is necessary to transfer the patient to adequate alternative therapy.

It is not known whether candesartan is excreted in breast milk, but it is known that it penetrates the milk of lactating rats.

During treatment with Hypososart, breast-feeding should be discontinued. Newborns whose mothers took Hyposart during pregnancy should be under close medical supervision because of the likelihood of developing hypotension.

Composition

1 tab. -

candesartan cilexetil 32 mg.

Excipients:

lactose monohydrate - 174 mg,

corn starch - 40 mg,

hyprolose (viscosity, water, 25 ° C (5%) 75-150 cps) - 4 mg,

hyprolose (viscosity, water, 25 ° C (5%) 1500-3000 cps) - 4 mg,

macrogol 6000 - 5.2 mg, magnesium

stearate - 0.8 mg.

Dosage and administration

The drug is taken orally, 1 time / day, regardless of the meal time.

Arterial hypertension

The recommended initial and maintenance dose of Hyposart is 8 mg 1 time / day. If necessary, the dose can be increased to 16 mg 1 time / day. The maximum antihypertensive effect is achieved within 4 weeks of therapy. The maximum daily dose is 32 mg 1 time / day.

If, against the background of the maximum daily dose, adequate control of blood pressure is not achieved, it is recommended to add a thiazide diuretic to the therapy (for example, hydrochlorothiazide). This can enhance the antihypertensive effect of the drug Hyposart.

In patients at risk of developing arterial hypotension (including patients with reduced BCC), therapy is recommended to be started with a dose of 4 mg.

In patients with mild and moderate renal impairment (CC 30-80 ml / min / 1.73 m2), including patients on hemodialysis, the initial dose of the drug is 4 mg. The dose should be titrated depending on the therapeutic effect. Clinical experience with the use of the drug in patients with severe renal impairment or end-stage renal failure (CC less than 15 ml / min) is limited.

The initial daily dose of the drug in patients with mild and moderate liver disease is 4 mg. Possible dose increase if necessary. There is no clinical experience with the use of the drug in patients with severe hepatic impairment and / or cholestasis.

Chronic heart failure

The recommended initial dose of Hyposart is 4 mg 1 time / day. An increase to the maximum daily dose of 32 mg 1 time / day or to the maximum tolerated dose is carried out by doubling the dose with an interval of at least 2 weeks.

Elderly patients and patients with impaired renal or hepatic function do not need to adjust the initial dose of the drug.

Safety and efficacy of Hyposart in children and adolescents under the age of 18 have not been established.

Concomitant therapy

Hyposart can be used simultaneously with other drugs for the treatment of heart failure, including ACE inhibitors, beta-blockers, diuretics, cardiac glycosides, or combinations of these drugs.

Side effects

Classification of the incidence of side effects: very often ( 1/10) often ( 1/100, <1/10) infrequently ( 1/1000, <1/100) rarely ( 1/10 000 , <1/1000) is very rare (<1/10 000), including single messages. Side effects of candesartan are mild and transient. The frequency of side effects does not depend on the dose of the drug and the age of the patient.

From the nervous system: often - dizziness, headache, weakness.

From the cardiovascular system: often - a pronounced decrease in blood pressure.

From the respiratory system: often - respiratory infections, pharyngitis, rhinitis, cough.

From the digestive system: very rarely - nausea, increased activity of hepatic transaminases, impaired liver function or hepatitis.

From the urinary system: often - impaired renal function, including renal failure in susceptible patients.

From the musculoskeletal system: very rarely - back pain, arthralgia, myalgia.

From the hemopoietic system: very rarely - leukopenia, neutropenia, thrombocytopenia and agranulocytosis.

Laboratory indicators: very rarely - hyperkalemia, hyponatremia, an increase in the concentration of creatinine in the blood, hyperuricemia, a slight decrease in hemoglobin.

Allergic reactions: very rarely - angioedema, skin rash, itching, urticaria.

Other: exacerbation of the course of gout, flushing of the face.

Drug Interaction

Use of candesartan concurrently with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or moderate and severe renal failure (GFR <60 ml / min / 1.73 m2).

Concomitant administration of candesartan with hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinylestradiol / levonorgestrel), glibenclamide, nifedipine and enalapril of clinically relevant pharmacokinetic interaction has been studied.

Candesartan is slightly metabolized in the liver (by CYP2C9 isoenzyme). No effect on CYP2C9 and CYP3A4 isoenzymes has been identified with respect to other cytochrome P450 isoenzymes currently unknown.

Hypotensives potentiate the antihypertensive effect of candesartan. Experience with the use of other drugs acting on RAAS shows that the concomitant use of the drug and potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium, potassium substitutes, or other agents capable of increasing the concentration of potassium in syrups for example, heparin), can lead to the development of hyperkalemia.

Transient elevations of serum lithium concentrations and the development of toxic effects have been reported with the simultaneous use of lithium and ACE inhibitors. A similar effect is possible with the simultaneous use of lithium and angiotensin II receptor antagonists, which requires periodic monitoring of serum lithium concentrations when combined with these drugs.

When APA II and NSAIDs are used concurrently, including selective COX-2 inhibitors and non-selective NSAIDs (eg, acetylsalicylic acid at a dose greater than 3 g / day), the antihypertensive effect of candesartan can be reduced.

Double RAAS blockade

As with ACE inhibitors, concomitant administration of ARA II and NSAIDs increases the risk of renal impairment, leading to the development of renal failure, leading to hyperkalemia in patients with impaired renal function. This combination should be used with caution, especially in elderly patients. All patients should receive sufficient fluid to monitor renal function at the beginning of therapy and thereafter.

Overdose

Symptoms: excessive blood pressure drop, dizziness, tachycardia. Some cases of overdose of the drug (up to 672 mg candesartan cilexetil), which resulted in recovery of patients without serious consequences, are described. Treatment: in case of a pronounced decrease in blood pressure, the patient should be placed in the supine position, his legs should be raised further - to carry out activities aimed at increasing BCC (introduction 0. 9% sodium chloride solution (in / in). Sympathomimetic drugs may be prescribed if necessary. It is recommended to carry out symptomatic therapy under the control of vital functions of the body. Hemodialysis is ineffective.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.

Expiration

2 years.

Deystvuyuschee substances

candesartan

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