Angiakand tab 8mg 28 pc

Description

Composition
Active substance:
1 tablet contains: Candesartan cilexetil 8 mg, 16 mg or 32 mg.
Excipients:
Pregelatinized corn starch, sodium croscarmellose (primelloza), lactose monohydrate (milk sugar), magnesium stearate, povidone K30.
Description:
Tablets white or nearly so white color, round, biconcave.
Product form:
The tablets 8 mg, 16 mg and 32 mg.
At 7, 10, 20, 28 or 30 tablets in blisters of PVC film and aluminum foil printed patent.
1, 2, 3, 4, 8, contour cell packs 7 tablets or 1, 2, 3, 4, 5, 6 contour cell packs of 10 tablets, or 1, 2, 3 blisters with 20 tablets or 1, 2 blisters 28 tablets, or 1, 2 blisters of 30 tablets together with instructions for use placed in a pile of cardboard.
Contraindications
-Increased sensitivity candesartan or other components of the formulation; -defitsit lactase, lactose intolerance, glucose-galactose malabsorption; -pregnancy; is the period of lactation; Primordial hyperaldosteronism (resistance to therapy); -heavy human liver and / or cholestasis; -Age to 18 years.
Precautions: severe renal failure (creatinine clearance (CC) of less than 30 ml / min) and bilateral renal artery stenosis, renal artery stenosis single kidney after kidney transplantation in history, hemodynamically significant stenosis of aortic and mitral valve, cerebrovascular disease, ischemic heart disease , hypertrophic obstructive cardiomyopathy, decreased blood volume (CBV), hyperkalemia.
Dosage
8 mg
Indications
Arterial hypertension. Chronic heart failure and impaired left ventricular systolic function (decreased left ventricular ejection fraction less than 40%) as an adjunctive therapy to inhibitors of angiotensin converting enzyme (ACE) or intolerance to ACE inhibitors.
Interaction with other drugs
The combined application of candesartan hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinylestradiol / levonorgestrel), glibenclamide, nifedipine and enalapril clinically significant interactions not revealed.
With simultaneous use of drugs lithium with ACE inhibitors reported reversible increase the concentration of lithium in blood serum and the development of toxic reactions. Side reactions may occur and the application of angiotensin II receptor antagonists, and therefore, it is recommended to control blood serum level of lithium in the combined use of these drugs.
With simultaneous use of the angiotensin II receptor antagonists and non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2) and non-selective NSAIDs, such as acetylsalicylic acid, more than 3 g / d can be reduced hypotensive effect of candesartan. As in the case of ACE inhibitors, angiotensin II simultaneous application of receptor antagonists and NSAIDs increases the risk of loss of kidney function, until the development of renal failure, which leads to hyperkalemia in patients with impaired renal function. This combination should be used with caution, especially in elderly patients. All patients should receive adequate amounts of fluids. It is necessary to monitor renal function at initiation of therapy in the future.
Medications that affect the RAAS, may increase the concentration of urea and creatinine in the blood in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Diuretics and other antihypertensive drugs increase the risk of hypotension.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other drugs that may increase the serum potassium content (e.g., heparin), increase the risk of hyperkalemia.
Candesartan is metabolized in the liver to a small extent (isozyme CYP2C9). Studies on the interaction did not reveal the effect of candesartan on the isoenzymes CYP2C9 and CYP3A4. Effect on other cytochrome P450 isoenzymes is not known.
Overdose
Symptoms: marked reduction of blood pressure, dizziness, tachycardia.
Treatment: symptomatic patient lay on his back to lift the lower limbs above the head, if necessary – an increase of circulating blood volume (CBV) by infusion of 0.9% sodium chloride solution, the application of sympathomimetic. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Angiotensin II receptor antagonist.
Pharmacodynamics:
Candesartan – selective antagonist of angiotensin II receptor type 1 (AT1-receptor) forms a strong bond with them, followed by slow dissociation. It has vasodilating, hypotensive and diuretic effect. Does not exhibit agonist properties (not inhibit angiotensin converting enzyme (ACE) and does not lead to the accumulation of bradykinin or substance P, does not bind to receptors of other hormones, does not block the ionic channels involved in the regulation of cardiovascular function). As a result of blocking angiotensin II AT1-receptor occurs compensatory dose-dependent increase in renin concentration angiotensin I, angiotensin II and aldosterone decline in plasma concentration.
Arterial hypertension
The antihypertensive effect is due to a decrease in total peripheral vascular resistance (TPR), with no effect on heart rate (HR). No cases of severe hypotension after the first dose of the drug, as well as the syndrome of “cancellation” after the cessation of therapy. Starting antihypertensive action after the first dose usually develops within 2 hours. Against the background of continuing therapy with a fixed dose of the maximum reduction in blood pressure (BP) is usually achieved within 4 weeks and persists throughout the treatment.
Candesartan increases renal blood flow and does not change or increases glomerular filtration rate, whereas vascular resistance in the kidney and filtration fraction is reduced.
No effect on the concentration of glucose and the lipid profile in patients with hypertension and Type 2 diabetes. Provides smooth dose-dependent blood pressure reduction.
Age and gender do not influence the effectiveness of the drug.
Chronic heart failure
Patients with chronic heart failure and decreased left ventricular ejection fraction less than 40% candesartan helped reduce peripheral vascular resistance and pulmonary capillary pressure, increase the activity of renin and angiotensin II concentrations in the blood plasma, and reduce aldosterone concentrations.
Pharmacokinetics:
Candesartan is a prodrug for oral administration. Quickly (via ester hydrolysis) is converted into a pharmacologically active candesartan. The absolute bioavailability after oral administration of candesartan cilexetil candesartan solution is about 40%. The relative bioavailability of tablet formulation by comparison with the oral solution is approximately 34%. Thus, the calculated absolute bioavailability tableted forms – approximately 14% and is independent of mealtime. The maximum concentration (Cmax) in the blood serum is reached after 4.3 hours. The plasma concentration increases linearly with increasing doses in the therapeutic range (up to 32 mg). The volume of distribution – 0.13 L / kg. Communication with the plasma protein – 99.8%.
Slightly metabolized in the liver (20-30%) with the participation of cytochrome P450 CYP2C9 isozyme to form inactive derivative. Terminal half-life (T1 / 2) -. 9 h Not koumouliruet. Total clearance – 0.37 ml / min / kg, the renal clearance – about 0.19 ml / min / kg. Excreted by the kidneys and in bile mainly as unchanged, to a small extent – a metabolite: kidneys (by glomerular filtration and active tubular secretion) – 26% in the form of candesartan and 7%, – in the form of inactive metabolite to biliary – 56% 10%, respectively. After a single oral administration for 72 hours to return more than 90% of the dose.
In elderly patients (over 65 years) Cmax and area under the curve “concentration-time» (AUC) increased by 50% and 80%, respectively, compared with younger patients. However, the antihypertensive effect and frequency of side effects with the drug does not depend on the patients age.
In patients with mild and moderate renal disorders Cmax and AUC increased by 50% and 70%, respectively, whereas the T1 / 2 of the preparation does not change as compared with patients with normal renal function.
In patients with severely impaired renal function, Cmax and AUC increased by 50% and 110%, respectively, and T1 / 2 of the drug is increased by 2 times.
In patients with mild to moderate liver dysfunction observed increase in AUC by 23%.
Pregnancy and breast-feeding
In animal studies revealed damage to the kidney in the embryonic and neonatal periods when applying candesartan. It is assumed that the mechanism of damage caused by the pharmacological effects of the drug on the renin-angiotensin-aldosterone system (RAAS).
The human embryonic kidney blood supply system, which depends on the development of the RAAS, begins to form in the second trimester of pregnancy. Thus, the risk to the fetus increases when applying candesartan in the second and third trimesters of pregnancy. Drugs that have a direct effect on the RAAS may cause abnormalities of fetal development, or to have a negative effect on the newborn, including death, when using the drug in the second and third trimesters of pregnancy.
Angiakand should not be used during pregnancy. If pregnancy is detected during treatment with the drug, therapy should be discontinued as soon as possible.
It is not known whether candesartan is released into breast milk. Due to the potential adverse effects on infants, Angiakand should not be used during breastfeeding.
Conditions of supply of pharmacies
Prescription.
side effects
Arterial hypertension
The most common side effects (> 1/100,
Central nervous system: dizziness, weakness, headache;
On the part of the musculoskeletal system, connective tissue: back pain;
Other: respiratory infections;
Laboratory indicators: reduction of hemoglobin, hypercreatininemia, increasing the concentration of urea in the blood, hyperkalemia, hyponatremia, elevated alanine aminotransferase (ALT).
Chronic heart failure
The most common side effects (> 1/100,
Cardio-vascular system: marked reduction of blood pressure;
From the urinary system: renal function;
Laboratory changes: hypercreatininemia, increasing the concentration of urea in the blood, hyperkalemia.
During post-marketing reports of use of candesartan following side effects (frequency – less than 1/10 000):
From the side of hematopoiesis: leukopenia, neutropenia, and agranulocytosis;
Laboratory findings: hyperkalemia, hyponatremia;
Central nervous system: dizziness, weakness, headache;
From the digestive system: nausea;
Of the liver and biliary tract: increased activity “liver” transaminases, abnormal liver function and hepatitis;
Allergic reactions: angioedema, skin rashes, itching, urticaria;
On the part of the musculoskeletal system, connective tissue: back pain, arthralgia, myalgia;
From the urinary system: renal function, including acute renal failure in susceptible patients.
The respiratory system: cough.
special instructions
Before and during the treatment is necessary to monitor blood pressure, renal function (creatinine in blood plasma), a potassium content of lithium in blood serum (the combined use of drugs).
hypotension
In patients with chronic heart failure during therapy with the drug Angiakand may develop hypotension. As with other drugs that affect the RAAS, cause of hypotension in patients with hypertension may be a decrease in the bcc as observed in patients receiving high doses of diuretics. Therefore, at the beginning of therapy, caution should be exercised and, if necessary, to carry out the correction of hypovolemia.
Renal artery stenosis
In patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney drugs that affect the RAAS, such as ACE inhibitors, can cause increase in the concentration of urea and creatinine in serum. Similar effects can be expected when assigning angiotensin II receptor antagonists.
kidney transplant
Data on the use of candesartan in patients who have recently had a kidney transplant, no.
Renal function
Against the background of therapy with Angiakand as the use of other means of oppressing the RAAS, some patients may experience impaired renal function.
In applying Angiakand drug in patients with hypertension and renal failure to periodically monitor the potassium content and serum creatinine. Clinical experience of candesartan in patients with severe renal dysfunction or end-stage renal failure (creatinine clearance less than 15 mL / min) is limited.
In patients with chronic heart failure is necessary to periodically monitor renal function, especially in patients aged 75 years and older, as well as in patients with impaired renal function. With increasing doses of the drug Angiakand also recommended to control potassium, and creatinine in the blood plasma.
The combined use of ACE inhibitors in patients with chronic heart failure
In applying the drug Angiakand in combination with ACE inhibitors may increase the risk of side effects, especially of renal function and hyperkalaemia. In these cases, careful observation and monitoring of laboratory parameters.
General anesthesia and surgery
In patients receiving angiotensin II receptor antagonists during general anesthesia and surgical procedures can develop hypotension as a result of the blockade of the RAAS. Very rarely there are cases of severe hypotension requiring intravenous fluids and / or vasopressors.
Stenosis of the aortic and mitral valve (hypertrophic obstructive cardiomyopathy)
In applying the drug Angiakand as other vasodilators, in patients with hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis, aortic and / or mitral valve caution.
primary aldosteronism
Patients with primary hyperaldosteronism generally resistant to treatment with antihypertensive drugs that affect the activity of the RAAS. In connection with this drug Angiakand is not recommended in these patients.
hyperkalemia
Clinical experience with other drugs affecting RAAS reveals that the simultaneous use of candesartan, potassium-sparing diuretics, potassium supplements or substitutes salt containing potassium, or other drugs that may increase the content of potassium in the blood (e.g., heparin) can lead to hyperkalemia in hypertensive patients.
Are common
Patients with vascular tone and renal function is predominantly dependent on the activity of the RAAS (e.g., patients with severe congestive heart failure or renal diseases, including renal artery stenosis), are especially sensitive to drugs acting on the RAAS. The use of such funds in these patients is accompanied by a sharp arterial hypotension, azotemia, oliguria, and rarely – acute renal failure. The ability of these effects can not be excluded and the application of angiotensin II receptor antagonists. The sharp decline in blood pressure in patients with ischemic heart disease or cerebrovascular disease of ischemic origin, with the use of any antihypertensive drugs, can lead to myocardial infarction or stroke.
Effects on ability to drive vehicles, machinery.
In the period of treatment can be dizziness, weakness, so you must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Inside, regardless of meals, 1 time a day.
Arterial hypertension
The recommended initial and maintenance dose is 8 mg 1 time per day. Patients who require further blood pressure reduction, it is recommended to increase the dose up to 16 mg once a day. The maximum daily dose of the drug is 32 mg once a day.
The maximum antihypertensive effect occurs within 4 weeks after starting treatment.
If therapy with Angiakand not reduce blood pressure to optimal target level, it is recommended to add to the treatment of a thiazide diuretic. In elderly patients the initial dose adjustment is required. Patients with mild or moderate renal impairment (creatinine clearance of more than 30 ml / min) did not require changes in the initial dose. Пациенты с тяжелым нарушением функции почек (КК менее 30 мл/мин) и пациенты с нарушением функции печени легкой и средней степени: рекомендуемая начальная доза – 4 мг 1 раз в день (возможно применение препарата кандесартана в другой форме выпуска).
Chronic heart failure
Рекомендуемая начальная доза составляет 4 мг 1 раз в день (возможно применение препарата кандесартана в другой форме выпуска). Повышение дозы до 32 мг 1 раз в день или до максимально переносимой дозы проводится путем её удвоения с интервалом не менее 2 недель.
Пациентам пожилого возраста и пациентам с нарушением функции почек и/или печени не требуется изменение начальной дозы препарата.
Ангиаканд можно применять совместно с другими препаратами, применяемыми при терапии хронической сердечной недостаточности, например, ингибиторами АПФ, бета-адреноблокаторами, диуретиками и сердечными гликозидами.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist