Telzap tab 40mg 90 pc

$16.09

Telzap tab 40mg 90 pc

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Description

Composition
Active substance:
1 tablet contains: telmisartan – 40,000 mg or 80 mg.
Excipients:
Meglumine, sorbitol, sodium hydroxide, povidone 25 Magnesium stearate.
Description:
40 mg Tablets: oblong, biconvex tablets from nearly white to yellowish scored on both sides.
80 mg Tablets: oblong, biconvex tablets from nearly white to yellowish engraved “80” on one side.
Product form:
Tablets, 40 mg, 80 mg. 10 tablets in the blister of OPA / Alu / PVC / Alu. At 3, 6 or 9 placed in the blister pack carton along with instructions for use.
Contraindications
Hypersensitivity to the active agent or any of the excipients of the formulation; pregnancy and lactation; obstructive biliary tract disease; severe liver dysfunction (Class C classification Chayld- Social); combined use with aliskiren in patients with diabetes or severe renal impairment (glomerular filtration rate [GFR] less than 60 ml / min / 1.73 m 2 body surface area) (cm. Forums “Interaction with other drugs” and “Special instructions “); Hereditary fructose intolerance (due to the presence of sorbitol in the tablet); simultaneous application of inhibitors of angiotensin-converting enzyme (ACE) inhibitors in patients with diabetic nephropathy (see “Interaction with the other medicaments,” and “special instructions”.); age 18 years (effectiveness and safety have been established).
Carefully
TELZAP® drug should be prescribed with caution in the following conditions / diseases: bilateral renal artery stenosis or stenosis of the artery only functioning kidney; impaired renal function; light and moderate hepatic impairment; reduction in circulating blood volume (CBV) amid prior diuretics, restriction of salt intake, diarrhea or vomiting; hyponatremia; hyperkalemia; condition after kidney transplantation (application no experience); severe chronic heart failure; aortic stenosis and mitral valve; hypertrophic obstructive cardiomyopathy; primary hyperaldosteronism (effectiveness and safety installed); Use in patients blacks.
Dosage
40 mg
Indications
Essential hypertension; reduce mortality and the incidence of cardiovascular diseases in adult patients: cardiovascular diseases atherothrombotic origin (coronary heart disease, stroke or peripheral arterial disease in history); with type 2 diabetes with end-organ damage.
Interaction with other drugs
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal failure (GFR of less than 60 ml / min / 1.73 m 2 body surface area) and is not suitable for other patients. The simultaneous use of telmisartan and ACE contraindicated in patients with diabetic nephropathy inhibitors (see. The section “Contra ‘). Data from clinical studies have shown that dual blockade of the RAAS due to the combined use of ACE inhibitors, ARAII or aliskiren is associated with increased incidence of adverse effects, such as hypotension, hyperkalaemia and renal function (including acute renal failure) as compared with the use of only one drug, acting on the RAAS. The risk of hyperkalemia can increase when combined with other drugs capable of causing hyperkalemia (kalisodergaszczye supplements and salt substitutes containing potassium, potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene or amiloride), non-steroidal anti-inflammatory drugs (NSAIDs, including selective inhibitors cyclooxygenase-2 (COX-2)), heparin, immunosuppressants (cyclosporin or tacrolimus), and trimethoprim). If necessary, against the background of documented hypokalemia combined use of drugs should be undertaken with caution and regular monitoring of the content of potassium in the blood plasma
Digoxin: When telmisartan combined with digoxin has been observed increase in average Cmax of digoxin in the blood plasma of 49% and a minimum concentration of 20%. At the beginning of treatment, at dose selection and termination of treatment with telmisartan should carefully monitor the concentration of digoxin in the blood plasma to maintain it within the therapeutic range
Potassium-sparing diuretics or kalisodergaszczye supplements: angiotensin II receptor antagonists such as telmisartan, reduce the loss of potassium caused by diuretics. Potassium-sparing diuretics such as spironolactone, eplerenone, amiloride and triamterene, kalisodergaszczye supplements or salt substitutes can lead to significant increase of potassium in the blood plasma. If concomitant use is indicated because there is documented hypokalaemia, they should be used with caution and on a background of regular monitoring of potassium in the blood plasma.
of lithium drugs: when co-administered with lithium preparations and ACE inhibitors ARAII including telmisartan occurred reversible increases in serum lithium concentrations and toxic effect. If necessary, the application of this combination of drugs is recommended to carefully control the concentration of lithium in the blood plasma.
Nonsteroidal anti-inflammatory drugs (NSAIDs): NSAIDs (i.e., acetylsalicylic acid at doses used for anti-inflammatory treatment, COX-2 inhibitors and the nonselective NSAIDs) may reduce ARAII antihypertensive effect. In some patients with impaired renal function (e.g., patients with dehydration, elderly patients with impaired renal function) combined use ARAII and drugs which depress cyclooxygenase – 2, may lead to further deterioration of renal function, including the development of acute renal failure, which is usually It is reversible. Therefore, the combined use of drugs should be performed with caution, especially in elderly patients. It should ensure the appropriate flow of fluid, in addition, at the beginning of co-application and periodically thereafter should monitor renal function.
Diuretics (thiazide or “loop”): previous treatment with high doses of diuretics such as furosemide ( “loop” diuretics) and hydrochlorothiazide (thiazide diuretic) may lead to hypovolemia and hypotension risk of early treatment with telmisartan.
Other antihypertensive agents: the action of telmisartan may be increased by concomitant use of other antihypertensive drugs. Based on pharmacological properties, baclofen and amifostine can be assumed that they will enhance the therapeutic effect of antihypertensive agents including telmisartan. Furthermore, orthostatic hypotension may be exacerbated in patients receiving alcohol, barbiturates, narcotics or antidepressants.
Corticosteroids (for systemic use): corticosteroids weaken the effect of telmisartan.
Overdose
Symptoms: The most prominent manifestations of overdose have been a marked reduction in blood pressure and tachycardia also reported bradycardia, dizziness, increase in the concentration of serum creatinine, and acute renal failure.
Treatment: Telmisartan is not displayed by hemodialysis. You should carefully monitor the condition of patients and carry out symptomatic and supportive treatment. The approach to treatment depends on the time elapsed after administration, and the severity of symptoms the drug. Recommended actions include induced vomiting and / or gastric lavage, administration of activated charcoal expedient. Should regularly monitor the content of electrolytes and creatinine in the blood plasma. In the event of significant decrease in blood pressure, patients should take a horizontal position with raised legs, with the need to quickly fill the amount of BCC and electrolytes.
pharmachologic effect
Pharmacological group:
Angiotensin II receptor antagonist.
Pharmacodynamics:
Telmisartan is an angiotensin receptor specific antagonist II (ARAII) (type AT1), effective when taken orally. Telmisartan has a very high affinity for the AT1-receptor, which is realized through the action of angiotensin II. It displaces angiotensin II from binding with the receptor, having no agonist action against this receptor. Telmisartan is associated only with the subtype AT1 receptors of angiotensin II. Communication is sustainable. Telmisartan no affinity for other receptors, including to AT2 receptor and other less studied angiotensin receptors. The functional significance of these receptors, as well as their possible effect of excessive stimulation by angiotensin II, whose concentration increases with telmisartan, have not been studied. Telmisartan reduces the concentration of aldosterone in blood plasma renin activity does not reduce or block ion channels. Telmisartan does not inhibit angiotensin converting enzyme (ACE) inhibitors (kininazu II), which also catalyzes the breakdown of bradykinin. This avoids the adverse effects associated with the action of bradykinin (for example, dry cough).
Essential hypertension: telmisartan patients at a dose of 80 mg is completely blocked hypertensive action of angiotensin II. Starting antihypertensive effects observed for 3 hours after the first dose of telmisartan. Effect of the drug is maintained for 24 hours and is clinically significant to 48 hours. The marked antihypertensive effect usually develops within 4-8 weeks after regular reception. In patients suffering from hypertension, telmisartan reduces the systolic and diastolic blood pressure (BP), without affecting the heart rate (HR). In the event of an abrupt discontinuation of telmisartan, blood pressure for several days, gradually returned to baseline without the development of the syndrome of “cancellation”. As shown by the results of comparative clinical trials, telmisartan antihypertensive effect comparable to the effect of other classes of antihypertensive agents (amlodipine, atenolol, enalapril, lisinopril and hydrochlorothiazide). The incidence of dry cough was significantly lower with telmisartan in contrast to ACE inhibitors.
Prevention of cardiovascular disease: Patients aged 55 years or older with coronary heart disease, stroke, transient ischemic attack, peripheral artery disease, or complications of diabetes mellitus type 2 (eg retinopathy, left ventricular hypertrophy, macro- or microalbuminuria) in history, the risk of cardiovascular events, telmisartan has an effect similar to the effect of ramipril on reducing the combined endpoint: cardiovascular mortality infa rkta nonfatal infarction, non-fatal stroke, and hospitalization for congestive heart failure. Telmisartan was also effective as ramipril in reducing the frequency of the secondary points: cardiovascular death, myocardial infarction, non-fatal or non-fatal stroke. Dry cough and angioedema were less frequently described in patients receiving telmisartan, unlike ramipril, while hypotension occurred more often in patients receiving telmisartan.
Patients children and adolescents: the safety and efficacy of telmisartan in children and adolescents under 18 years have not been established.
Pharmacokinetics:
Absorption: Telmisartan ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability – 50%. When taken with food simultaneously decrease AUC (area under the curve “concentration-time”) ranges from 6% (at 40 mg) to 19% (at a dose of 160 mg). After 3 h after administration plasma concentration aligned independently telmisartan taken together with meals or not. There is a difference in plasma concentrations in men and women. Cmax (maximum concentration) and AUC were about 3 and 2 times, respectively, higher in women compared to men without significant effect on efficiency. There was no linear correlation between the dose and plasma drug concentration. Cmax and to a lesser extent, AUC increase disproportionately increasing dose at doses above 40 mg per day
Distribution: telmisartan binds strongly to plasma proteins (> 99.5%), mainly to albumin and alpha-1 acid glycoprotein. Middle apparent volume of distribution (Vdss) at steady state is about 500 liters.
Metabolism metabolized by conjugation with glucuronic acid. Conjugate does not possess pharmacological activity.
. Excretion: half-life (T1 / 2) is more than 20 hours is derived through the intestine in unaltered form by kidneys excretion – less than 1%. Total plasma clearance is high (about 1000 ml / min) compared with “liver” blood flow (about 1500 ml / min).
Special patient populations
Elderly patients: Pharmacokinetics of telmisartan in patients older than 65 years is no different from younger patients. Dose adjustment is not required.
Patients with impaired renal function: in patients with mild to moderate violation of renal function dose adjustment telmisartan is not required. For patients with severe renal failure and patients on hemodialysis, a lower recommended initial dose – 20 mg per day (see “Special instructions.”). Telmisartan does not rely on hemodialysis.
Patients with hepatic impairment: Patients with mild to moderate hepatic impairment (class A and B according to the classification Child-Pugh) daily dose should not exceed 40 mg.
Pregnancy and breast-feeding
Pregnancy: currently valid information on the safety of telmisartan in pregnant women is absent. In animal studies, reproductive toxicity of the drug was found. Use of the drug TELZAP® contraindicated during pregnancy (see. Section “Contraindications”). If necessary, long-term treatment with TELZAP® patients planning pregnancy should choose an alternative antihypertensive drug with a proven safety profile use during pregnancy. After establishing the fact of pregnancy TELZAP® drug treatment should be discontinued immediately and begin an alternative treatment if necessary. As shown by the results of clinical observations ARAII use in the second and third trimesters of pregnancy has toxic effects on the fetus (worsening renal function, oligohydramnios, delay of ossification of the skull) and newborn (renal failure, hypotension and hyperkalaemia). In applying ARAII during the second trimester of pregnancy recommended ultrasound kidney and fetal skull. Children whose mothers took ARAII during pregnancy should be carefully observed for hypotension.
Breastfeeding: Information on the use of telmisartan in the period of breast-feeding is not available. The drug TELZAP® breastfeeding period contraindicated (see. The section “Contra ‘) should be alternative hypotensive drug with a favorable safety profile, especially when feeding newborn or a premature baby.
Conditions of supply of pharmacies
Prescription.
side effects
According to the World Health Organization (WHO), undesirable effects are classified according to the frequency of their development as follows: very common (> 1/10), common (by> 1/100 to
special instructions
Abnormal liver function: use of the drug TELZAP® contraindicated in patients with cholestasis, biliary tract obstruction or severe hepatic impairment (class C Child-Pugh classification) (., See “Contra”) because telmisartan is mainly excreted in the bile. It is believed that in these patients reduced hepatic clearance of telmisartan. Patients with mild or moderate liver function abnormalities (grade A and B according to the classification Child-Pugh) TELZAP® drug should be used with caution (see. The section ”
Carefully “.
Renovascular hypertension: treatment with drugs acting on the RAAS in patients with bilateral renal artery stenosis or stenosis of the artery only functioning kidney is increased risk of severe hypotension and renal insufficiency.
Renal dysfunction and renal transplantation: The use of drug TELZAP® in patients with impaired renal function recommended periodic monitoring the potassium content and creatinine in blood plasma. Clinical experience TELZAP® drug in patients who have recently had a kidney transplant, is absent.
Reduced blood volume (CBV): symptomatic hypotension, especially after the first dose TELZAP® may occur in patients with reduced BCC and / or the sodium content in the blood plasma background prior treatment with diuretics, limiting reception salt, diarrhea or vomiting. Similar state (fluid deficiency and / or sodium) need to be resolved before receiving TELZAP® preparation.
Dual blockade of the renin-angiotensin-aldosterone system: concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal failure (GFR of less than 60 ml / min / 1.73 m 2 body surface area) (see “Contra.”). The simultaneous use of telmisartan and ACE contraindicated in patients with diabetic nephropathy inhibitors (see. The section “Contra ‘). В результате угнетения РААС были отмечены: артериальная гипотензия, обморок, гиперкалиемия и нарушение почечной функции (в том числе острая почечная недостаточность) у предрасположенных к этому пациентов, особенно при совместном применении нескольких лекарственных средств, так же действующих на эту систему. Поэтому двойная блокада РААС (например, на фоне приема телмисартана с другими антагонистами РААС) не рекомендована. В случаях зависимости сосудистого тонуса и функции почек преимущественно от активности РААС (например, у пациентов с хронической сердечной недостаточностью или заболеваниями почек, в том числе, при стенозе почечных артерий, или стенозе артерии единственной почки), назначение препаратов, влияющих на эту систему, может сопровождаться развитием острой артериальной гипотензии, гиперазотемии, олигурии, и в редких случаях острой почечной недостаточностью.
Первичный гиперальдостеронизм: у пациентов с первичным гиперальдостеронизмом лечение гипотензивными лекарственными средствами, действие которых осуществляется путем угнетения РААС, как правило, неэффективно. В связи с этим применение препарата ТЕЛЗАП® не рекомендовано.
Стеноз аортального и митрального клапанов, гипертрофическая обструктивная кардиомиопатия: как и в отношении других сосудорасширяющих средств, пациентам с аортальным или митральным стенозом, а также гипертрофической обструктивной кардиомиопатией при применении препарата ТЕЛЗАП® необходимо соблюдать особую осторожность.
Пациенты с сахарным диабетом, получавшие инсулин или гипогликемические средства для приема внутрь: на фоне лечения препаратом ТЕЛЗАП® у данных пациентов может возникать гипогликемия. У подобных пациентов следует усилить контроль гликемии, так как может возникнуть необходимость в коррекции дозы инсулина или гипогликемического средства.
Гиперкалиемия: прием лекарственных средств, действующих на РААС, может вызывать гиперкалиемию. У пациентов пожилого возраста, пациентов с почечной недостаточностью или сахарным диабетом, пациентов, также принимающих лекарственные препараты, способствующие повышению содержания калия в плазме крови, и/или пациентов с сопутствующими заболеваниями гиперкалиемия может привести к летальному исходу. При решении вопроса о сопутствующем применении лекарственных средств, действующих на РААС, необходимо оценить соотношение «риск-польза». Основными факторами риска развития гиперкалиемии, которые следует учитывать, являются: сахарный диабет, почечная недостаточность, возраст (пациенты старше 70 лет); сочетание с одним или более лекарственным средствами, действующими на РААС, и/или калийсодержащими пищевыми добавками. Лекарственными препаратами или терапевтическими классами лекарственных препаратов, которые могут вызывать гиперкалиемию, являются заменители соли, содержащие калий, калийсберегающие диуретики, ингибиторы АПФ, антагонисты рецептора ангиотензина II, нестероидные противовоспалительные препараты (НПВП, в том числе селективные ингибиторы ЦОГ-2), гепарин, иммунодепрессанты (циклоспорин или такролимус) и триметоприм; интеркуррентные заболевания, в особенности обезвоживание, острая сердечная недостаточность, метаболический ацидоз, нарушение функции почек, синдром цитолиза (например, острая ишемия конечностей, рабдомиолиз, обширная травма). Пациентам из группы риска рекомендуется тщательно контролировать содержание калия в плазме крови (см. раздел «Взаимодействие с другими лекарственными средствами»).
Сорбитол: данный лекарственный препарат содержит сорбитол (E420). Пациенты с редкой наследственной непереносимостью фруктозы не должны принимать препарат ТЕЛЗАП®.
Этнические различия: как отмечено для ингибиторов АПФ, телмисартан и другие АРАII, по- видимому, менее эффективно снижают артериальное давление у пациентов негроидной расы, чем у представителей других рас, возможно, вследствие большей предрасположенности к снижению активности ренина в популяции данных пациентов.
Прочее: как и при применении других гипотензивных средств, чрезмерное снижение уровня артериального давления у пациентов с ишемической кардиомиопатией или ишемической болезнью сердца может приводить к развитию инфаркта миокарда или инсульта.
Effects on ability to drive a vehicle, the mechanism
Специальных клинических исследований по изучению влияния препарата на способность управлять автомобилем и механизмами не проводилось. При управлении автомобилем и работе с механизмами, требующими повышенной концентрации внимания, следует соблюдать осторожность, так как на фоне приема препарата ТЕЛЗАП® редко могут возникать головокружение и сонливость.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Препарат ТЕЛЗАП® принимают внутрь один раз в сутки, запивая жидкостью, вне зависимости от приема пищи.
Артериальная гипертензия: начальная рекомендованная доза препарата ТЕЛЗАП® составляет 1 таблетка (40 мг) один раз в сутки. У некоторых пациентов может быть эффективным прием 20 мг в сутки. Дозу 20 мг можно получить путем разделения таблетки 40 мг пополам по риске. В случаях, когда терапевтический эффект не достигается, рекомендованная доза препарата ТЕЛЗАП® может быть увеличена до максимальной 80 мг один раз в сутки. В качестве альтернативы препарат Телзап® можно принимать в сочетании с тиазидными диуретиками, например, гидрохлоротиазидом, который при совместном применении оказывал дополнительное антигипертензивное действие. При решении вопроса об увеличении дозы следует принимать во внимание, что максимальный антигипертензивный эффект обычно достигается в течение 4- 8 недель после начала лечения.
Снижение смертности и частоты сердечно-сосудистых заболеваний: рекомендованная доза препарата ТЕЛЗАП® – 80 мг 1 раз в сутки. В начальный период лечения рекомендуется наблюдение за уровнем артериального давления (АД), может потребоваться коррекция гипотензивной терапии.
Особые популяции пациентов
Пациенты с нарушением функции почек: опыт применения телмисартана у пациентов с тяжелой почечной недостаточностью или пациентов, находящихся на гемодиализе, ограничен. Данным пациентам рекомендована более низкая начальная доза – 20 мг в сутки (см. раздел «Особые оказания»). Для пациентов с легким и умеренным нарушением функции почек коррекции дозы не требуется. Сопутствующее применение препарата ТЕЛЗАП® с алискиреном противопоказано пациентам с почечной недостаточностью (СКФ менее 60 мл/мин/1,73 м 2 площади поверхности тела) (см. раздел «Противопоказания»). Одновременное применение препарата ТЕЛЗАП® с иАПФ противопоказано у пациентов с диабетической нефропатией (см. раздел «Противопоказания»).
Пациенты с нарушением функции печени: препарат ТЕЛЗАП® противопоказан пациентам с тяжелой степенью печеночной недостаточности (класс С по классификации Чайлд-Пью) (см. раздел «Противопоказания»). У пациентов с легкой и умеренной степенью печеночной недостаточности (класс А и В по классификации Чайлд-Пью, соответственно) препарат назначается с осторожностью, доза не должна превышать 40 мг один раз в сутки (см. раздел «
Carefully “).
Пациенты пожилого возраста: для пациентов пожилого возраста не требуется коррекции дозы.
Детский и подростковый возраст: применение препарата ТЕЛЗАП® у детей и подростков младше 18 лет противопоказано из-за отсутствия данных по безопасности и эффективности (см. раздел «Противопоказания»).
Information
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
Manufacturer

SANOFI RUSSIA

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