Atacand Plus, pills 16/12.5mg, 28pcs

Composition

One tablet contains:

Active ingredients:

candesartan cilexetil 16 mg,

hydrochlorothiazide 12.5 mg.

Auxiliary substances:

carmellose calcium (carmellose calcium salt) 5.6 mg,

hyprolose 4.0 mg,

lactose monohydrate 68 mg,

magnesium stearate 1.3 mg,

corn starch 20 mg,

macrogol 2.6 mg,

iron oxide yellow dye CI 77492 0.21 mg,

iron oxide red dye CI 77491 0.050 mg

Pharmacological action

Atacand Plus is a combined antihypertensive drug. Candesartan selectively blocks AT II receptors (subtype AT, ). 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 moderate diuretic effect, increasing the excretion of sodium, chlorine, potassium and water ions from the body, and reduces plasma volume. blood and extracellular fluid.

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

Orthostatic hypotension is not observed at the first dose, and hypertension does not increase after the end of treatment. The hypotensive effect develops gradually and lasts up to 24 hours.

The maximum therapeutic effect is usually achieved 4 weeks after the start of treatment. During absorption in the mucous membrane of the digestive tract, it undergoes hydrolysis to form the Active ingredient (candesartan).

Indications

Arterial hypertension.

Use during pregnancy and lactation

• the drug Atakand Plus is contraindicated during pregnancy;
• during lactation (breastfeeding);
• in children and adolescents under 18 years of age (efficacy and safety have not been established).

Contraindications

Hypersensitivity, pregnancy, lactation, primary hyperaldosteronism (resistance to therapy).

With caution. Renal insufficiency, bilateral renal artery stenosis, renal artery stenosis of a single kidney, hyperkalemia, aortic and mitral valve stenosis, HOCMP, BCC reduction, childhood age.

Side effects

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

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

From the central nervous system:  dizziness, weakness

Candesartan

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

From the circulatory and lymphatic system:  leukopenia, neutropenia, and agranulocytosis.

Metabolic disorders and diseases caused by metabolic disorders: hyperkalemia, hyponatremia.

From the central nervous system:  dizziness, headache.

From the gastrointestinal tract:  nausea.

Liver and biliary tract disorders:  increased activity of liver enzymes, impaired liver function, or hepatitis.

From the side of the skin:  angioedema, rash, urticaria, pruritus of the skin.

Musculoskeletal and connective tissue disorders:  back pain, arthralgia, myalgia.

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

Hydrochlorothiazide

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

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

From the immune system:  rarely — anaphylactic reactions.

Metabolic disorders and diseases caused by metabolic disorders:  often — hyperglycemia, hyperuricemia, hyponatremia and hypokalemia.

From the central nervous system:  often — light dizziness, headache; rarely-sleep disorders, depression, anxiety, paresthesia.

From the side of the visual organ:  rarely — temporary blurriness of the image.

From the CCC side:  sometimes-orthostatic hypotension; rarely-arrhythmia; necrotic vasculitis, cutaneous vasculitis.

Respiratory system disorders:  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 side of the skin:  sometimes-skin rash, urticaria, photosensitization reactions; rarely-necrosis of the epidermis, reactions similar to cutaneous erythematosis, relapse of cutaneous erythematosis.

Musculoskeletal and connective tissue disorders:  rarely-myalgia.

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

General violations:  often — weakness; rarely-a feeling of heat.

Laboratory parameters:  often — hypercholesterolemia, hypertriglyceridemia; rarely-increased creatinine levels.

Increases in plasma uric acid and ALT and blood glucose levels were reported as side effects occurring slightly more frequently with candesartan cilexetil (estimated complaint rates of 1.1,0.9, and 1%, respectively) than with placebo (0.4,0, and 0.2%, respectively). In some patients taking candesartan / hydrochlorothiazide, a slight decrease in hemoglobin concentration and an increase in AST in blood plasma were observed.

Increased creatinine, urea, hyperkalemia, and hyponatremia were also observed.

Interaction

Pharmacokinetic studies have examined the concomitant use of Atacand Plus with hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinyl estradiol/levonorgestrel), glibenclamide, nifedipine, and enalapril. No clinically significant drug interactions were identified.

Candesartan is only slightly metabolized in the liver (CYP2C9). Interaction studies have not revealed the effect of the drug on CYP2C9 and CYP3A4, and the effect on other cytochrome P450 isoenzymes has not been studied.

The combined use of Atacand Plus with other antihypertensive agents potentiates the hypotensive effect. The effect of hydrochlorothiazide, which leads to potassium loss, can be enhanced by other agents that lead to potassium loss and hypokalemia (for example, diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid derivatives).

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

Diuretic-induced hypokalemia and hypomagnesemia predispose to possible cardiotoxic effects of digitalis glycoside and antiarrhythmic agents. When taking Atacand® Plus in parallel with such drugs, monitoring of blood potassium levels is required.

When lithium preparations are co-administered with ACE inhibitors, there is a reversible increase in the concentration of lithium in the blood serum and the development of toxic reactions. Similar reactions can also occur when using angiotensin II receptor antagonists, and therefore it is recommended to monitor the level of lithium in the 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 effect of non-depolarizing muscle relaxants (for example, tubocurarin) can be enhanced by hydrochlorothiazide.

Thiazide-like diuretics can cause an increase in blood calcium levels due to a decrease in its excretion. If it is necessary to use calcium-containing dietary supplements or vitamin D, the level of calcium in the blood plasma should be monitored and the dose adjusted if necessary.

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

Anticholinergic agents (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.

Thiazide-like diuretics can slow the elimination of cytostatic agents (such as cyclophosphamide, methotrexate) from the body and increase their myelosuppressive effect.

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

The use of Atacand Plus may increase the incidence of orthostatic hypotension when taking alcohol, barbiturates, or general anesthetics.

When treated with thiazide-like diuretics, glucose tolerance may decrease, and therefore it may be necessary to adjust the dose of hypoglycemic drugs (including insulin).

Hydrochlorothiazide may reduce the effect of vasoconstrictor amines (e. g., epinephrine).

Hydrochlorothiazide may increase the risk of acute renal failure, especially when combined with high doses of iodized filler.

No significant interaction of hydrochlorothiazide with food was detected.

How to take, course of use and dosage

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

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

The main antihypertensive effect is usually achieved in the first 4 weeks after the start of treatment.

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. Individual cases of overdose of the drug (up to 672 mg of candesartan) were described, which resulted in recovery of patients without serious consequences.

The main manifestation of hydrochlorothiazide overdose is acute loss of fluid and electrolytes. Other symptoms reported included dizziness, decreased blood pressure, dry mouth, tachycardia, ventricular arrhythmia, loss of consciousness, and muscle cramps.

Treatment: with the development of a clinically pronounced decrease in blood pressure, it is necessary to conduct symptomatic treatment and monitor the patient’s condition. Place the patient on his back and lift his legs. If necessary, the BCC should be increased, for example, by intravenous use of an isotonic sodium chloride solution. If necessary, sympathomimetic agents may be prescribed. Elimination of candesartan and hydrochlorothiazide by hemodialysis is unlikely.

Special instructions

Patients whose vascular tone and renal function are predominantly dependent on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe chronic heart failure, kidney diseases, including renal artery stenosis) are particularly sensitive to drugs acting on the renin-angiotensin-aldosterone system. The use of such drugs is accompanied in these patients by severe hypotension, azotemia, oliguria and, less often, 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, when using any antihypertensive agents, can lead to the development of myocardial infarction or stroke.

Hypersensitivity reactions to hydrochlorothiazide are most likely to occur in patients with bronchial asthma and a history of allergic reactions, which does not exclude the appearance of allergic symptoms in other patients.

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

The drug contains lactose, so it should not be taken in patients with rare hereditary diseases that manifest in the absence of lactose tolerance, lactose deficiency or glucose and lactose malabsorption.

Use in pediatrics

The safety and efficacy of Atacand Plus in children and adolescents under 18 years of age have not been established.

Influence on the ability to drive motor vehicles and manage mechanisms

The 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 vehicles or working with machinery, as dizziness and increased fatigue may occur during treatment.

Form of production

Atacand Plus-tablets.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Hydrochlorothiazide, Candesartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart Failure, Hypertension