Atacand 16mg 28 tablets — Made in Sweden — Free Delivery
(Atacand )
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Description Atacand 16mg 28 tablets — Made in Sweden — Free Delivery
Indications
Essential hypertension. heart failure and impaired systolic function of the left ventricle (left ventricular ejection fraction ≤40%) as an additional therapy to treatment with ACE inhibitors or in case of their intolerance.
Application
Arterial hypertension
The recommended starting and usual maintenance dose is 8 mg once daily. The dose can be increased to 16 mg 1 time per day. If sufficient control of blood pressure is not achieved after 4 weeks of treatment with a dose of 16 mg 1 time per day, then it can be increased to a maximum of 32 mg 1 time per day. If blood pressure control is not achieved using the preparation at this dose, the feasibility of alternative methods of treatment should be considered.
Therapy must be adjusted according to blood pressure. The maximum antihypertensive effect is achieved within 4 weeks from the start of treatment.
The elderly
The initial dose does not require adjustment.
Patients with reduced BCC
For patients at risk of developing arterial hypotension, for example, for patients with a possible decrease in BCC, an initial dose of 4 mg should be considered.
kidney failure
In patients with renal insufficiency, including those on hemodialysis, the initial dose is 4 mg. The dose must be adjusted according to blood pressure. Experience in patients with severe renal insufficiency or end-stage renal disease (creatinine clearance 15 ml/min) is limited.
Liver failure
Patients with mild to moderate hepatic insufficiency are recommended an initial dose of 2 mg 1 time per day. The dose can be adjusted according to blood pressure. There is no experience of use in patients with severe hepatic impairment.
Concomitant Therapy
It has been established that the additional use of hydrochlorothiazide in combination with Atacand causes an additive antihypertensive effect.
Negroid Patients
The antihypertensive effect of candesartan is less pronounced than in Caucasian patients. Uptitration of Atacanda and concomitant therapy for BP control are more frequently needed in blacks than in Caucasians.
Heart failure
The recommended starting dose of Atacand is 4 mg once daily. Uptitration to the target dose of 32 mg once daily or maximum tolerated dose is done by doubling the dose after a period of at least 2 weeks.
Side effects
In the treatment of hypertension
In controlled clinical trials, side effects were mild, transient, and comparable to placebo. The overall incidence of side effects did not indicate dose or age dependence. The rate of discontinuation due to adverse reactions was similar between candesartan cilexetil (3.1%) and placebo (3.2%).
The following common (1/100) adverse reactions (incidence of side effects that were at least 1% higher than the incidence of such effects with placebo) were reported:
from the nervous system: dizziness, headache;
infections and infestations: respiratory tract infections.
Results of laboratory studies
No clinically significant effect of Atacand on laboratory parameters was noted. When using other inhibitors of the renin-angiotensin-aldosterone system, a slight decrease in hemoglobin was detected. The level of creatinine, urea or potassium increased and the level of sodium decreased. An increase in ALT, which was regarded as an adverse event, was not much more often reported with Atacand than with placebo (1.3 vs. 0.5%). For patients receiving Atacand, constant monitoring of laboratory parameters is not necessary. However, patients with renal insufficiency are advised to periodically monitor serum potassium and creatinine levels.
In heart failure: The side effect profile of Atacand in patients with heart failure is consistent with the pharmacological properties of this preparation and the health status of patients. Common adverse reactions (≥1/100, 1/10) identified during clinical trials included:
- From the side of the cardiovascular system: arterial hypotension.
- Metabolic and nutritional disorders: hyperkalemia.
- From the urinary system: renal failure.
Indicators of laboratory tests: increased levels of creatinine, urea and potassium. Periodic monitoring of serum creatinine and potassium levels is recommended.
Post-marketing study: The following side effects have been reported very rarely (1/10,000):
- from the blood system: leukopenia, neutropenia and agranulocytosis;
- metabolic and nutritional disorders: hyperkalemia, hyponatremia;
- from the nervous system: dizziness, headache;
- from the gastrointestinal tract: nausea;
- from the hepatobiliary system: increased levels of liver enzymes, abnormal liver function or hepatitis;
- on the part of the skin and subcutaneous tissue: angioedema, rash, urticaria, itching;
- from the musculoskeletal system, connective tissue: back pain, arthralgia, myalgia;
- from the urinary system: impaired renal function, including renal failure in predisposed patients.
special instructions
kidney failure
As with other preparations that inhibit the renin-angiotensin-aldosterone system, changes in renal function can be expected in predisposed patients taking Atacand.
When using Atacand in patients with hypertension and renal insufficiency, periodic monitoring of serum potassium and creatinine levels is recommended. Experience in patients with severe renal insufficiency or end-stage renal disease (creatinine clearance 15 ml/min) is limited. In these patients, Atacand should be titrated in combination with BP monitoring.
Evaluation of the condition of patients with heart failure should include periodic evaluation of renal function, especially in the elderly over 75 years of age and in patients with renal insufficiency. During dose titration of Atacanda, monitoring of serum creatinine and potassium levels is recommended. Clinical studies in patients with heart failure did not include individuals with a serum creatinine level of 265 mmol/L (3 mg/dL).
Concomitant ACE inhibitor therapy for heart failure
The risk of side effects, especially in renal failure and hyperkalemia, may be increased when candesartan is used in combination with an ACE inhibitor. These patients require regular and careful monitoring.
Hemodialysis
During dialysis, blood pressure may be especially sensitive to blockade of the AT1 receptor due to a decrease in plasma volume and activation of the renin-angiotensin-aldosterone system. For patients on hemodialysis, it is necessary to carefully titrate Atacand and carefully monitor blood pressure.
Renal artery stenosis
Other preparations that affect the renin-angiotensin-aldosterone system, such as ACE inhibitors, may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery leading to one kidney. A similar effect can be expected with the use of angiotensin II receptor antagonists.
kidney transplant
There is no experience with the use of Atacand in patients who have recently undergone kidney transplantation.
Arterial hypertension
During the use of Atacand in patients with heart failure, hypotension may occur. As described for other preparations that affect the renin-angiotensin-aldosterone system, hypotension can also occur in patients with hypertension and reduced BCC, for example, those taking high doses of diuretics. At the beginning of therapy, caution should be exercised and an attempt should be made to correct hypovolemia.
Anesthesia and surgery
In patients treated with angiotensin II receptor antagonists, hypotension may develop during anesthesia and surgery due to blockade of the renin-angiotensin-aldosterone system. In very rare cases, hypotension may be severe enough to require intravenous fluids and/or vasopressors.
Stenosis of the aorta and mitral valve (obstructive hypertrophic cardiomyopathy)
As with other vasodilators, special care must be taken when treating patients with hemodynamically significant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism usually do not respond to antihypertensive preparations that act by inhibiting the renin-angiotensin-aldosterone system. Therefore, the use of Atacand is not recommended.
Hyperkalemia
Experience with other medicinal products that affect the renin-angiotensin-aldosterone system suggests that concomitant use of Atacand with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (eg, heparin) may lead to an increase in serum potassium levels in hypertensive patients.
Hyperkalemia may occur in patients with heart failure taking Atacand. During treatment with Atacand in patients with heart failure, it is recommended to periodically monitor the level of potassium in the blood serum, especially if this preparationis taken simultaneously with ACE inhibitors and potassium-sparing diuretics, for example, with spironolactone.
General information
In patients whose vascular tone and renal function depend primarily on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe congestive heart failure or with kidney disease, including renal artery stenosis), treatment with other preparations that affect this system has been associated with acute hypotension, azotemia, oliguria, or in rare cases with acute renal failure. The possibility of similar effects cannot be excluded with the use of angiotensin II receptor antagonists. As with any antihypertensive preparation, excessive blood pressure lowering in patients with ischemic cardiopathy or ischemic cerebrovascular disease may lead to myocardial infarction or stroke.
Atacand should not be taken in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
During pregnancy and breastfeeding
There are limited data on the use of Atacand during pregnancy, which are not enough to draw conclusions about the potential risk to the fetus when using the preparation in the first trimester. Renal perfusion of the fetus, which is formed in the II trimester, depends on the development of the renin-angiotensin-aldosterone system. The risk to the fetus is increased if Atacand is taken during the second or third trimester of pregnancy. The use during this period of preparations that act directly on the renin-angiotensin-aldosterone system can harm the fetus and newborn (hypotension, renal dysfunction, oliguria and / or anuria, oligohydramnios, skull hypoplasia, intrauterine growth retardation) and lead to death. Cases of pulmonary hypoplasia, facial anomalies, and limb contractures have been described.
In an animal study using candesartan cilexetil, kidney damage was found in the fetus in late pregnancy and neonates. This mechanism is considered to be pharmacologically mediated due to its influence on the renin-angiotensin-aldosterone system.
In view of the above information, Atakand is not recommended for use during pregnancy. If pregnancy is determined during treatment, the use of Atacand should be discontinued.
It has not been established whether candesartan passes into breast milk, but due to potential adverse effects on breastfed infants, Atacand should not be used during breastfeeding.
The effect of the preparation on the ability to drive vehicles and work with mechanisms is unlikely. While driving and working with mechanisms, dizziness and fatigue that may occur during the treatment period should be taken into account.
Interactions
No clinically significant interaction was found. compounds that have been studied in clinical pharmacokinetic studies have included hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e., ethinylestradiol/levonorgestrel), glibenclamide, nifedipine, and enalapril.
Candesartan is slightly eliminated by hepatic metabolism (CYP 2C9). The data of the conducted interaction studies indicate the absence of an effect on CYP 2C9 and CYP 3A4, however, the effect on other cytochrome P450 isoenzymes is unknown.
The antihypertensive effect of candesartan may be enhanced by other medicinal products known to lower blood pressure, whether prescribed as an antihypertensive agent or for other indications.
Experience with other medicinal products that affect the renin-angiotensin-aldosterone system suggests that concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (eg, heparin) may lead to an increase in the level of potassium in the blood serum.
There are reports of a rebound increase in serum lithium levels and toxicity during concomitant use of lithium with ACE inhibitors. A similar effect may occur with angiotensin II receptor antagonists. Therefore, with simultaneous use, careful monitoring of the level of lithium in the blood serum is recommended.
With the combined use of angiotensin II receptor antagonists with NSAIDs (for example, selective COX-2 inhibitors, acetylsalicylic acid (3 g / day) and non-selective NSAIDs), a decrease in the antihypertensive effect may occur.
As with ACE inhibitors, concomitant use of angiotensin II receptor antagonists and NSAIDs may increase the risk of worsening renal function, including possible acute renal failure and elevated serum potassium levels, especially in patients with impaired renal function. This combination is used with caution, especially in the elderly. Patients should be adequately hydrated and the need to monitor renal function at the start of concomitant therapy and periodically throughout treatment should be considered.
Eating does not affect the bioavailability of candesartan.
Overdose
Symptoms: hypotension and dizziness. in the information on an individual case of overdose (up to 672 mg of candesartan cilexetil), the patient recovered without consequences.
Treatment: symptomatic, control of vital functions. The patient should be placed supine with the lower limbs raised. If this is not enough, it is necessary to increase the volume of blood plasma by infusion, for example, isotonic saline solution. Candesartan is not excreted by hemodialysis.
Storage conditions
At temperatures up to 30 °C.
Tags: Atacand
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