Hydrohlorotyazyd , Candesartan | Atacand Plus tablets 16 / 12.5 mg, 28 pcs.

Release form

Tablets.

Packing

28 pcs.

Pharmacological action

atakand Plus - a combined antihypertensive drug. Candesartan selectively blocks AT II receptors (AT subtype,). Prevents the development of the effects of AT II - increased blood pressure due to vasoconstriction, stimulation of the synthesis and release of aldosterone, renin, vasopressin, catecholamines, sodium reabsorption, increased heart rate. Reduces OPSS, increases renal blood flow and glomerular filtration rate. Causes a compensatory increase in plasma renin activity, AT I and AT II concentrations.

Hydrochlorothiazide causes a mild diuretic effect, increasing the excretion of sodium, chlorine, potassium and water ions from the body, and reduces the volume of plasma. blood and extracellular fluid.

Reduces the content of sodium ions in the vascular wall, reducing its sensitivity to vasoconstrictive effects and thereby enhancing the hypotensive effect of candesartan. Atacand plus causes a prolonged hypotensive effect without an increase in heart rate.

Orthostatic arterial hypotension at the first dose is not observed, after the end of treatment, hypertension is not amplified. The antihypertensive effect develops gradually and lasts up to 24 hours. The maximum therapeutic effect is usually achieved 4 weeks after the start of treatment. In the process of absorption in the mucous membrane of the digestive tract, it undergoes hydrolysis with the formation of the active substance (candesartan).

Indications

Treatment of arterial hypertension in patients who are shown combination therapy.

Contraindications

hypersensitivity to the active or auxiliary components that make up the drug, a derivative of sulfonamides

impaired liver function and / or cholestasis

impaired renal function (creatinine Cl less than 30 ml / min / 1.73 m2)

anuria

refractory hypokalemia and hypercalcemia

gout

pregnancy

lactation age 18 years lacquer period security not installed).

Precautions: severe chronic heart failure, bilateral renal artery stenosis, single kidney artery stenosis, hemodynamically significant stenosis of the aortic and mitral valve, in patients with cerebrovascular disease and ischemic heart disease, hypertrophic obstructive cardiomyopathy, in patients with reduced BCC, cirrhosis suffering from lactose intolerance, with malabsorption of lactose and galactose, hyponatremia, primary hyperaldosteronism, surgical intervention, in patients after kidney transplantation, renal failure, diabetes mellitus.

Special instructions

Patients whose vascular tone and renal function mainly depend on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe chronic heart failure, kidney diseases, including renal artery stenosis), are especially sensitive to drugs acting on the renin-angiotensin-aldosterone system. The appointment of such drugs is accompanied in these patients by severe arterial hypotension, azotemia, oliguria, and less commonly, acute renal failure. The possibility of developing these effects is not excluded when using angiotensin II receptor antagonists. A sharp decrease in blood pressure in patients with ischemic cardiopathy, cerebrovascular diseases of ischemic origin using any antihypertensive drugs, can lead to the development of myocardial infarction or stroke.

Manifestation of hypersensitivity reactions to hydrochlorothiazide is most likely in patients with bronchial asthma, a history of allergic reactions that does not exclude the appearance of allergic symptoms in other patients.

When using thiazide-like diuretics, there have been cases of exacerbation or onset of symptoms of congestive seborrhea.

The drug contains lactose, therefore, it should not be taken by patients with rare hereditary diseases manifested in the absence of lactose tolerance, lactose deficiency or impaired glucose and lactose absorption.

Pediatric use

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

Effect on the ability to drive vehicles and control mechanisms

Effect on the ability to drive a car or work with machinery has not been studied, but the pharmacodynamic properties of the drug indicate that there is no such effect. Patients should be careful when driving or working with machinery, because during treatment, dizziness and increased fatigue may occur.

Composition

1 tab. contains candesartan cilexetil 16 mg,

hydrochlorothiazide 12.5 mg.

Dosage and administration

Inside, once a day, regardless of food intake. The recommended dose is 1 tablet. Once a day.

Titration of a dose of candesartan is recommended before transferring the patient to Atacand Plus therapy. If necessary, patients are transferred from Atacand monotherapy to Atacand Plus therapy.

The main hypotensive effect is achieved, as a rule, in the first 4 weeks after the start of treatment.

Side effects

Side effects identified in clinical trials were moderate and transient in nature and were comparable in frequency to the placebo group. The incidence of discontinuation of therapy due to side effects was similar when using candesartan / hydrochlorothiazide (3.3%) and placebo (2.7%).

In a pooled analysis of clinical trial results, the following side effects were noted due to the administration of candesartan / hydrochlorothiazide. The described side effects were observed with a frequency of at least 1% more than in the placebo group.

From the side of the central nervous system: dizziness, weakness

Candesartan

The following side effects during the post-marketing use of the drug were reported very rarely (

from the circulatory and lymphatic systems: leukopenia, neutropenia and agranulocytosis.

Metabolism, metabolic and metabolic disorders, and hyponatremia.

From the side of the central nervous system: dizziness, headache.

From the gastrointestinal tract: nausea.

From the liver and biliary tract: increased activity of liver enzymes, impaired liver function or hepatitis.

From the skin: angioedema, rash, urticaria, skin itching.

From the side of musculoskeletal and connective tissues: back pain, arthralgia, myalgia.

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

Hydrochlorothiazide

During monotherapy with hydrochlorothiazide, usually at a dose of 25 mg or more, the following side effects were noted: often (> 1/100), sometimes (> 1/1000 and

From the hemopoietic and lymphatic system: rarely - leukopenia, neutropenia / agranulocytosis, thrombocytopenia, aplastic anemia, bone marrow depression, anemia.

On the part of the immune system: rarely - anaphylactic reactions.

Metabolism disorder and metabolic diseases: often hyperglycemia, hyperuricemia, hyponatremia and hypokalemia.

From the side of the central nervous system: often - slight dizziness, headache rarely - sleep disturbance, depression, anxiety, paresthesia.

From the side of the organ of vision: rarely - transient blurred image.

From the CCC side: sometimes - orthostatic hypotension is rare - arrhythmia, necrotic vasculitis, skin vasculitis.

On the part of the respiratory system: rarely - shortness of breath (pneumonia and pulmonary edema).

From the digestive tract: sometimes - loss of appetite, diarrhea, constipation rarely - pancreatitis.

From the liver: rarely - intrahepatic cholestatic jaundice.

From the skin: sometimes - skin rash, urticaria, photosensitivity reactions rarely - necrosis of the epidermis, reactions similar to cutaneous erythematosis, recurrence of cutaneous erythematosis.

From the side of musculoskeletal and connective tissue: rarely - myalgia.

From the kidneys and the genitourinary system: often - glucosuria rarely - impaired renal function and interstitial nephritis.

General disorders: often - weakness rarely - feeling hot.

Laboratory indicators: often - hypercholesterolemia, hypertriglyceridemia rarely - increased creatinine.

An increase in plasma uric acid and ALT and blood glucose levels were noted as side effects when using candesartan cilexetil (approximate complaints frequency 1.1, 0.9 and 1%, respectively) slightly more often than when using placebo ( 0.4, 0 and 0, 2% respectively). In individual patients taking candesartan / hydrochlorothiazide, there was a slight decrease in hemoglobin concentration and an increase in plasma AST.

There has also been an increase in creatinine, urea, hyperkalemia and hyponatremia.

Drug Interactions

In pharmacokinetic studies, the combined use of Atacand Plus with hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinyl estradiol / levonorgestrel), glibenclamide, nifedipiline and echinamide has been studied. No clinically significant drug interactions have been identified.

Candesartan is not significantly metabolized in the liver (CYP2C9). Conducted studies on the interaction did not reveal the effect of the drug on CYP2C9 and CYP3A4, the effect on other isoenzymes of the cytochrome P450 system has not been studied.

The combined use of Atacand Plus with other antihypertensive drugs potentiates the hypotensive effect. The action of hydrochlorothiazide, leading to a loss of potassium, can be enhanced by other means leading to a loss of potassium and hypokalemia (for example, diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid derivatives).

Experience with other drugs acting on the renin-angiotensin-aldosterone system shows that concomitant therapy with potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, and other agents that increase serum potassium levels (for example, heparin) can lead to to the development of hyperkalemia.

Hypokalemia and hypomagnesemia induced by diuretic agents predispose to the possible cardiotoxic effect of digitalis glycoside and antiarrhythmic drugs. When taking Atacand® Plus in parallel with such drugs, control of the level of potassium in the blood is required.

With the combined use of lithium preparations with ACE inhibitors, a reversible increase in serum lithium concentration and the development of toxic reactions occur. Similar reactions can occur when using angiotensin II receptor antagonists, and therefore it is recommended to control the level of lithium in blood serum with the combined use of these drugs.

The diuretic, natriuretic and hypotensive effects of hydrochlorothiazide are weakened by NSAIDs.

Absorption of hydrochlorothiazide is weakened by the use of colestipol, colestyramine.

The action of non-depolarizing muscle relaxants (e.g. tubocurarine) can be enhanced by hydrochlorothiazide.

Thiazide-like diuretics can cause an increase in blood calcium levels due to a decrease in its excretion. If you need to use calcium-containing food additives or vitamin D, you should control the level of calcium in the blood plasma and, if necessary, adjust the dose.

Thiazide-like diuretics enhance the hyperglycemic effect of beta-blockers and diazoxide.

Anticholinergics (e.g., atropine, biperidine) may increase the bioavailability of thiazide-like diuretics due to decreased gastrointestinal motility.

Thiazide-like diuretics may increase the risk of adverse effects of amantadine.MFA, methotrexate) from the body and enhance their myelogen suppressing effect.

The risk of hypokalemia may increase with concomitant use of corticosteroids or ACTH.

With the use of Atacand® Plus, the incidence of orthostatic arterial hypotension may increase with the use of alcohol, barbiturates or general anesthetics.

In the treatment of thiazide-like diuretics, a decrease in glucose tolerance is possible, and therefore, a selection of a dose of hypoglycemic drugs (including insulin) may be required.

Hydrochlorothiazide may decrease the effect of vasoconstrictor amines (eg, epinephrine).

Hydrochlorothiazide may increase the risk of developing acute renal failure, especially in combination with large doses of iodinated excipient.

No significant interaction of hydrochlorothiazide with food was detected.

overdose

Symptoms: analysis of the pharmacological properties of the drug suggests that the main manifestation of overdose may be a clinically pronounced decrease in blood pressure and dizziness. Some cases of drug overdose (up to 672 mg candesartan), which resulted in the recovery of patients without serious consequences, were described.

The main manifestation of an overdose of hydrochlorothiazide is acute loss of fluid and electrolytes. Symptoms such as dizziness, decreased blood pressure, dry mouth, tachycardia, ventricular arrhythmia, loss of consciousness, and muscle cramps were also observed.

Treatment: in the development of a clinically pronounced decrease in blood pressure, it is necessary to carry out symptomatic treatment and to control the patient's condition. Lay the patient on his back and lift his legs. If necessary, the BCC should be increased, for example, by administration of an isotonic sodium chloride solution. Sympathomimetic agents may be prescribed if necessary. Withdrawal of candesartan and hydrochlorothiazide by hemodialysis is unlikely.

Storage Conditions

At a temperature not exceeding 30 РC.

Shelf life

3 years.

Deystvuyushtee substance

Gidrohlorotiazid, Candesartan

Terms of dispatch from

pharmacies Prescription

dosage form

tablets

AstraZeneca, Britain