Kardosal plus tab n / 12.5mg film about 20mg + 28 pcs


Kardosal plus tab n / 12.5mg film about 20mg + 28 pcs



Active substance:
Olmesartan medoxomil – 20.00 mg.
Microcrystalline Cellulose – 20.00 mg, giproloza (low-substituted) – 40.00 mg lactose monohydrate – 123.20 mg, giproloza (viscosity of 6-10 mPas.) – 5.00 mg magnesium stearate – 1, 80 mg.
Titanium dioxide (E 171) – 1.120 mg talc – 1.120 mg Hypromellose (viscosity of 5 mPa s.) – 5,760 mg.
White, round, biconvex tablets, film-coated, with the imprint “C14” on one side, with a barely perceptible characteristic odor.
Product form:
Tablets, film-coated, 20 mg.
14 tablets in blisters (blister) made from a laminated film (polyamide / aluminum / PVC) and aluminum foil.
1, 2, 4 or 7 blister together with instructions for use in a cardboard package.
– Accelerating sensitivity to the active agent or any of the excipients included in the formulation; – obstruction of the bile ducts; – severe renal failure severity (creatinine clearance (CC) of less than 20 ml / min) condition after kidney transplantation (no clinical experience); – hepatic insufficiency-severe (more than 9 points on the Child-Pugh, no clinical experience); – simultaneous application of aliskiren and aliskirensoderzhaschimi drugs in patients with diabetes mellitus and / or impaired renal function (creatinine clearance less than 60 mL / min); – pregnancy, breast-feeding; – the age of 18 years (effectiveness and safety have been established); – hereditary galactose intolerance, lactase deficiency and malabsorption syndrome, glucose and galactose.
Precautions – aortic stenosis or mitral valves; – hypertrophic obstructive cardiomyopathy; – primary aldosteronism; – hyperkalemia, hyponatremia (risk of dehydration, hypotension, renal failure); – mild renal insufficiency and moderate severity (QC more than 20 ml / min.); – Chronic heart failure; – renovascular hypertension (two-sided renal artery stenosis or stenosis of the artery to a solitary kidney); – coronary artery disease; – cerebrovascular disease; – old age (over 65 years); – hepatic insufficiency moderate (less than 9 points on the Child-Pugh); – state, accompanied by a decrease in blood volume (including diarrhea, vomiting), and the y – patients with a diet restriction salt; – while the use of diuretics; – while the use of drugs lithium.
12.5 mg + 20 mg
Interaction with other drugs
Not recommended simultaneous use of potassium-sparing diuretics, potassium preparations substitutes salts containing potassium, or other drugs that increase the content of potassium in the blood plasma (e.g., anti-inflammatory drugs (including selective inhibitors of cyclooxygenase – 2 (COX-2)), immunosuppressants (e.g. cyclosporin or tacrolimus), trimethoprim, angiotensin converting enzyme (ACE) inhibitors, heparin), because This can lead to increased potassium in the blood plasma (see. section Cautions).
The antihypertensive effect of therapy olmesartanom can be amplified in the combined use with other antihypertensives.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin doses of more than 3 g / day, and COX-2 inhibitors, and angiotensin II receptor antagonists may act synergistically to decrease glomerular filtration. With simultaneous use of NSAIDs and angiotensin II receptor antagonists may be risk of acute renal failure, it is recommended to monitor renal function at the beginning of treatment, and regular intake of a sufficient amount of liquid. However, simultaneous treatment can reduce the antihypertensive effect of angiotensin II receptor antagonists, resulting in a partial loss of therapeutic effectiveness.
When applied simultaneously with antacids (magnesium and aluminum hydroxide) may moderate decrease in bioavailability of olmesartan.
With simultaneous use of olmesartan medoxomil has no clinically significant effect on the pharmacokinetics and pharmacodynamics of warfarin, digoxin, hydrochlorothiazide, pravastatin and antacids (magnesium and aluminum hydroxide).
There are reports of increasing reversible lithium concentration in the blood serum and the manifestation of toxicity during the simultaneous application of drugs lithium with ACE inhibitors and angiotensin II receptor antagonist, olmesartan medoxomil therefore application in combination with lithium therapy is not recommended (see. Specific guidance section). If necessary, applying appropriate combination therapy recommended regular monitoring of lithium levels in serum.
Data from clinical studies indicate that dual blockade of the renin-angiotensin-aldosterone system (RAAS) by simultaneous application of ACE inhibitors, receptor antagonists of angiotensin II or aliskiren, is associated with a higher incidence of side effects such as arterial hypotension, hyperkalemia and decrease in renal function ( including the development of acute renal failure) than with only one drug acting on RAAS. Thus, the simultaneous use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is not recommended.
The simultaneous use of olmesartan Maddox and preparations containing aliskiren, contraindicated in patients with diabetes and renal failure (for glomerular filtration rate
Patients with diabetic nephropathy not be simultaneously used ACE inhibitors and angiotensin II receptor antagonists.
In the case where the simultaneous use of two agents acting on the RAAS is necessary, their use should be under the supervision of a physician and with regular monitoring of renal function, blood pressure indicators and concentration of electrolytes in the blood plasma. Clinically significant inhibitory effect of olmesartan at isoenzymes 1A1 / 2, 2A6, 2S8 / 9, 2C19, 2D6, 2E1 and 3A4 cytochrome P450 in vitro human not found regarding cytochrome P450 rats marked minimum or zero-inducing effect, suggesting absent clinically significant interactions while applying olmesartan Maddox and drugs metabolized involving the abovementioned isozymes of cytochrome P450.
There are limited data on cases of olmesartan medoxomil overdose in humans.
Symptoms: marked reduction of blood pressure.
Treatment: marked reduction of blood pressure is recommended to put the patient on his back, raised his legs. Recommended gastric lavage and / or administration of activated charcoal, therapy aimed at correcting disorders and dehydration of water-electrolyte metabolism, supplementation of circulating blood volume.
Withdrawal of olmesartan by dialysis has not been studied.
pharmachologic effect
Pharmacological group:
Angiotensin II receptor antagonist.
Olmesartan medoxomil – active substance preparation Kardosal® 20 – is a potent specific receptor antagonist angnotenzina II (AT1 type) for ingestion. Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system plays a significant role in the pathophysiology of hypertension by acting on the AT1-receptor. It is assumed that all blocks olmesartan action angnotenzina II, mediated by AT1 receptors regardless of the source and the path synthesis angnotenzina II. Specific antagonism olmesartan angiotensin II receptor (AT1 type) results in an increase in renin, angiotensin I and II in the blood plasma, and also reduces plasma concentrations of aldosterone.
When hypertension olmesartan causes a dose-dependent decrease in blood pressure for a long (BP). There is evidence of the development of hypotension after administration of the first dose of tachyphylaxis during long-term treatment or syndrome “cancel” (sharp increase in blood pressure following discontinuation).
Receiving olmesartan medoxomil 1 times a day and provides efficient mild decrease blood pressure within 24 hours, and the effect after a single dose similar to the effect of the drug twice a day in the same daily dose. The antihypertensive effect of olmesartan develops, usually in 2 weeks, and the maximum effect occurs in approximately 8 weeks after initiation of therapy.
Absorption and Distribution: olmesartan medoxomil is a prodrug. It is rapidly converted into a pharmacologically active metabolite olmesartan by enzymes in the intestinal mucosa and into the portal blood during absorption from the gastrointestinal tract. Olmesartan medoxomil in unchanged form in plasma can not be detected in the blood plasma and / or feces. The bioavailability of olmesartan average of 25.6%.
The maximum concentration (Cmax) in plasma olmesartan average reached after 2 h after administration of olmesartan medoxomil inwardly and increases approximately linearly with increasing single dose up to 80 mg.
Food intake has no significant effect on the bioavailability of olmesartan, olmesartan medoxomil therefore possible to accept regardless of the meal.
No clinically significant differences in pharmacokinetic parameters of olmesartan according to sex is not revealed.
Olmesartan binds to plasma proteins (99.7%), but the potential for a clinically significant displacement binding value with proteins in the interaction with other olmesartan vysokosvyazyvayuschimisya and simultaneously applied drugs is low (proved by the absence of clinically significant interaction between warfarin and olmesartanom). Communication olmesartan to blood cells is negligible. The mean volume of distribution after intravenous administration is low (16-29 L).
Metabolism and excretion: The total plasma clearance is typically 1,3 l / h (coefficient of variation of – 19%) and is relatively low in comparison with the hepatic blood flow (about 90 l / h). Withdrawal of olmesartan in two ways. After a single oral administration of olmesartan medoxomil isotopically labeled 14C, 10-16% of the radioactive substances excreted by the kidneys (most within 24 hours after administration of olmesartan medoxomil) and radioactive substance remaining allocated across the intestine. Given systemic bioavailability, equal to 25.6% can be calculated that approximately 40% of the dose absorbed olmesartan eliminated via the kidneys, and about 60% – in the hepatobiliary system. The liberated radioactive substance has been presented olmesartanom. Other metabolites were detected. Enterohepatic recycling of olmesartan is minimal. Since most of olmesartan is output through the liver, its use in patients with obstruction of the biliary tract contraindicated (see. Contraindications section).
Olmesartan half-life is 10-15 h. After repeated ingestion. The equilibrium state is reached after reception of the first few doses, and after 14 days of repeated application further accumulation is observed. Renal clearance is approximately 0.5-0.7 l / h and is independent of dose.
Pharmacokinetics in patients with renal insufficiency
In patients with renal insufficiency area under the curve “concentration-time» (AUC) was increased by about 62% in the equilibrium state, 82% and 179% in the case of a light failure, moderate to severe, respectively, compared with healthy volunteers.
Pharmacokinetics in patients with liver failure
After a single oral administration of olmesartan AUC values ​​were 6% and 65% higher in patients hepatic insufficiency mild or moderate, respectively, compared with healthy volunteers. Unbound fraction olmesartan 2 hours. Postdose formulation in healthy volunteers, patients with mild hepatic insufficiency and moderate severity was 0.26%, 0.34% and 0.41% respectively. With repeated ingestion AUC of olmesartan in patients with hepatic insufficiency mild to moderate severity was 65% higher than in healthy volunteers from the control group. Mean Cmax values ​​of olmesartan in patients with hepatic impairment and healthy subjects were similar. The pharmacokinetics of olmesartan medoxomil in patients with hepatic impairment has not been studied severe.
The pharmacokinetics in patients 65 years and older
Elderly patients (65-75 years) and elderly (75 years and older) with hypertension olmesartan AUC at steady state was greater than 35% and approximately 44%, respectively, compared with younger patients, which may be partially An age-related decline in kidney function.
Pregnancy and breast-feeding
Experience in the use of olmesartan medoxomil in pregnant women is absent. However, due to the available reports of severe teratogenic effects of drugs acting directly on the renin-angiotensin-aldosterone system, the drug Kardosal® 20 is contraindicated during pregnancy. In case of pregnancy during therapy with Kardosal® 20, the drug should be lifted immediately, and, if necessary, appoint an alternate treatment.
Patients planning pregnancy, it is recommended to transfer to other antihypertensive drugs groups, safety of which was proved during pregnancy, except in cases when angiotensin II receptor antagonists are used for health.
In the case of the angiotensin II receptor antagonist in the second and third trimesters of pregnancy necessary to conduct ultrasound to evaluate kidney function and bone ossification fetal skull. Newborns whose mothers have taken angiotensin II receptor antagonists should be monitored for the possible development of hypotension and renal dysfunction.
It is proved that olmesartan passes into breast milk of rats, but similar data for a person missing. If necessary, use Kardosal® 20 during lactation, breastfeeding must stop.
Conditions of supply of pharmacies
On prescription.
side effects
Possible side effects are listed below in descending frequency of occurrence: very often (> 1/10); often (> 1/100 to 1/1000, 1/10000,
From the blood and lymphatic system:
Uncommon: thrombocytopenia.
From the nervous system:
Common: dizziness, headache.
On the part of the organ of hearing and labyrinth disorders:
Uncommon: vertigo.
The respiratory system, thorax and mediastinum:
Common: pharyngitis, rhinitis, bronchitis, cough.
On the part of the digestive tract:
Common: diarrhea, dyspepsia, gastroenteritis, abdominal pain, nausea.
Uncommon: vomiting
Skin and subcutaneous tissue disorders:
Uncommon: rash, allergic dermatitis, urticaria, rash, pruritus.
Rare: angioedema.
On the part of the musculoskeletal system:
Common: back pain, bone pain, arthritis.
Uncommon: myalgia.
Rare: muscle cramps.
On the part of the kidney and urinary tract:
Often: hematuria, urinary tract infection.
Rare: acute renal failure, renal failure.
Cardio-vascular system:
Uncommon: angina pectoris.
Rare: marked reduction of blood pressure. *
On the part of metabolism and nutrition:
Often: increased plasma concentrations of triglycerides, increasing the concentration of uric acid in the blood.
Rare: elevated levels of potassium in the blood.
Immune system:
Uncommon: Anaphylactic reactions.
General disorders:
Common: chest pain, peripheral edema, flu-like symptoms, weakness.
Uncommon: swelling of the face, fatigue, malaise.
Rare: drowsiness.
Other violations
Often: increasing concentrations of urea in blood plasma, elevated liver enzymes, increased creatine kinase activity.
Rare: increases in creatinine concentration in blood plasma.
It was also reported isolated cases of rhabdomyolysis, which is the development time associated with the reception of AT-II receptor antagonists.
* Elderly patients marked reduction in blood pressure may occur slightly more often (from “rare” to “rare”).
special instructions
Symptomatic hypotension, especially after the first dose of drug may occur in patients with reduced circulating blood volume and / or reduced levels of sodium result of intensive diuretic therapy, restriction of salt intake from food at a dietary food, and also due to diarrhea or vomiting. Relevant factors should be eliminated before applying the 20 Kardosal® preparation.
In patients whose vascular tone and renal function depend heavily on the renin-angiotensin-aldosterone system (e.g., in patients with severe chronic heart failure or impaired renal function, including renal artery stenosis), treatment with other drugs acting on the this system, due to the possibility of acute hypotension, azotemia, oliguria or, rarely, acute renal failure. The ability of similar action can not be ruled out when using angiotensin II receptor antagonists.
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery only functioning kidney is receiving therapy drugs that affect the renin-angiotensin-aldosterone system.
При применении препарата Кардосал® 20 у пациентов с нарушением функции почек рекомендуется проводить периодический контроль содержания калия и креатинина в плазме крови. Опыт применения препарата Кардосал® 20 у пациентов с недавно проведенной трансплантацией почки или у пациентов с терминальной стадией нарушения функции почек (например, КК менее 12 мл/мин) отсутствует.
При применении антагонистов рецепторов ангиотензина II и ингибиторов АПФ возможно развитие гиперкалиемии, которая в отдельных случая может приводить к летальному исходу. Риск развития гиперкалиемии возрастает при одновременном применении с препаратами, которые повышают содержание калия в плазме крови (см. раздел Взаимодействие с другими лекарственными средствами), у пациентов пожилого возраста, при почечной недостаточности (в т.ч. при прогрессировании почечной недостаточности, остром нарушении функции почек, например, при инфекционных заболеваниях), сахарном диабете, дегидратации, острой декомпенсации сердечной деятельности, метаболическом ацидозе, состояниях, сопровождающихся массивным лизисом клеток (например, при острой ишемии конечностей, рабдомиолизе, обширных травмах). У пациентов этой группы риска рекомендуется контроль содержания калия в плазме крови.
Перед назначением одновременно с препаратом Кардосал® 20 других препаратов, влияющих на ренин-ангиотензин – альдостероновую систему, следует тщательно оценить соотношение «польза/риск» данной комбинации и рассмотреть другие варианты терапии.
Как и в случае других антагонистов рецепторов ангиотензина II, не рекомендуется комбинация препаратов лития и препарата Кардосал® 20 (см. раздел Взаимодействие с другими лекарственными средствами).
Как и в случае других антагонистов рецепторов ангиотензина II, у пациентов негроидной расы, с артериальной гипертензией, эффективность терапии препаратом Кардосал® 20 несколько ниже, чем у пациентов других рас, возможно, вследствие большей распространенности низкой активности ренина в плазме крови в данной популяции.
Как в случае любого гипотензивного средства, чрезмерное снижение АД у пациентов с ишемической болезнью сердца или с цереброваскулярной недостаточностью может привести к инфаркту миокарда или инсульту.
Препарат содержит лактозу, поэтому его применение у пациентов с наследственной непереносимостью галактозы, дефицитом лактазы и синдромом мальабсорбции глюкозы и галактозы противопоказано.
Effects on ability to drive vehicles and other mechanisms
Кардосал® 20 оказывает незначительное или умеренное влияние на способность к управлению транспортными средствами и другими механизмами. Поскольку в период лечения препаратом Кардосал® 20 возможны такие побочные эффекты, как сонливость и слабость, следует соблюдать осторожность при управлении транспортными средствами, другими механизмами и занятиях потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
Хранить при температуре не выше 30 ° С. Хранить в недоступном для детей месте!.
Dosing and Administration
Inside. Кардосал® 20 принимают в одно и то же время независимо от приема пищи 1 раз в сутки, не разжевывая, запивая достаточным количеством жидкости.
Для подбора необходимого режима дозирования целесообразно применять наиболее подходящую дозировку препарата – 10 мг, 20 мг или 40 мг (возможно применение препарата Кардосал® 10, Кардосал® 20 или Кардосал® 40, соответственно).
Рекомендуемая начальная доза олмесартана медоксомила составляет 10 мг один раз в сутки. В случае недостаточного снижения артериального давления, дозу можно увеличить до 20 мг один раз в сутки, при необходимости доза может быть увеличена до 40 мг в сутки.
The maximum daily dose is 40 mg.
Применение у пациентов 65 лет и старше
При применении препарата у пациентов старше 65 лет необходимо осуществлять регулярный контроль АД.
Use in patients with renal insufficiency
Максимальная доза препарата Кардосал® 20 у пациентов с почечной недостаточностью легкой и средней степени тяжести (клиренс креатинина 20 – 60 мл/мин) составляет 20 мг в сутки. Применение препарата Кардосал® 20 у пациентов с почечной недостаточностью тяжелой степени тяжести (клиренс креатинина
Use in patients with hepatic insufficiency
При печеночной недостаточности легкой степени тяжести коррекции дозы препарата не требуется. При печеночной недостаточности средней степени тяжести начальная доза препарата Кардосал® 20 составляет 10 мг один раз в сутки.
The maximum daily dose – 20 mg. При сопутствующей терапии диуретиками и/или другими гипотензивными препаратами пациентам с печеночной недостаточностью рекомендуется регулярный контроль АД и функции почек. Препарат Кардосал® 20 также противопоказано пациентам с обструкцией желчевыводящих путей (см. раздел Противопоказания).
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg

Berlin Chemie

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