Description
Latin name
TELZAP
Release form
Tablets from almost white to yellowish, oblong, biconvex, with an engraving of 80 on one side.
Pharmacological action of
Antihypertensive blocking ATII receptors.
Indications
– essential hypertension
– reduction in mortality and cardiovascular disease in adult patients with cardiovascular diseases of atherothrombotic origin (IHD, stroke or history of peripheral artery disease) and type 2 diabetes mellitus.
Contraindications
– obstructive biliary tract disease
– severe hepatic impairment (class C according to the Child-Pugh classification)
– co-administration with aliskiren in patients with diabetes mellitus or severe impaired renal function (GFR less than 60 ml / min / 1.73 m2 body surface area)
– concomitant use with ACE inhibitors in patients with diabetic nephropathy
– hereditary fructose intolerance (due to the presence of sorbitol in the preparation)
– pregnancy
– period gru when breastfeeding
– age up to 18 years (efficacy and safety have not been established)
– hypersensitivity to the active substance or any excipients of the drug.
Caution should be given to administering the drug in case of bilateral renal artery stenosis or artery stenosis of a single functioning kidney, impaired renal function and moderate liver dysfunction, decreased BCC compared to previous diuretics, restriction of sodium intake, diarrhea or vomiting hyponatremia hyperkalemia state after kidney transplantation (experience absent) severe chronic heart failure stenosis of the aortic and mitral valve hypertrophic st uktivnoy cardiomyopathy primary hyperaldosteronism (efficacy and safety have not been established) patients blacks.
Pregnancy and lactation
There is currently no reliable information on the safety of telmisartan in pregnant women. In animal studies, reproductive toxicity of the drug has been identified. The use of Telzap ® is contraindicated during pregnancy.
If long-term treatment with Telzap ® is necessary, patients planning a pregnancy should choose an alternative antihypertensive drug with a proven safety profile for use during pregnancy. After establishing the fact of pregnancy, treatment with Telzap ® should be stopped immediately and alternative treatment should be started if necessary.
As shown by the results of clinical observations, the use of angiotensin II receptor antagonists in the second and third trimesters of pregnancy has a toxic effect on the fetus (impaired renal function, oligohydramnios, delayed ossification of the skull) and the newborn (renal failure, arterial hypotension and hyperkalemia). When using angiotensin II receptor antagonists in the second trimester of pregnancy, ultrasound of the kidneys and skull of the fetus is recommended. Children whose mothers received angiotensin II receptor antagonists during pregnancy should be closely monitored to detect arterial hypotension.
Information on the use of telmisartan during breastfeeding is not available. The use of Telzap ® during breastfeeding is contraindicated. An alternative antihypertensive drug with a more favorable safety profile should be used. especially when feeding a newborn or premature baby.
Special instructions
Impaired liver function
The use of Telzap ® is contraindicated in patients with cholestasis, bile duct obstruction or severe hepatic impairment (Child-Pugh class C), since telmisartan is mainly excreted in the bile. It is believed that such patients have reduced hepatic clearance of telmisartan. In patients with mild or moderate hepatic impairment (Child-Pugh class A and B), Telzap ® should be used with caution.
Renovascular hypertension
In patients with bilateral renal artery stenosis or artery stenosis of a single functioning kidney, treatment with drugs acting on RAAS increases the risk of severe arterial hypotension and renal failure.
Impaired renal function and kidney transplantation
When using Telzap ® in patients with impaired renal function, periodic monitoring of potassium and creatinine in blood plasma is recommended. There is no clinical experience with Telzap ® in patients who have recently undergone kidney transplantation.
Decrease in bcc
Symptomatic arterial hypotension, especially after the first administration of Telzap ®, may occur in patients with reduced bcc and / or sodium in blood plasma against the background of previous treatment with diuretics, restriction of sodium chloride, diarrhea, or vomiting. Such conditions (fluid and / or sodium deficiency) should be eliminated before taking Telzap ®.
Double blockade of RAAS
Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR less than 60 ml / min / 1.73 m2 of body surface area).
The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.
As a result of inhibition of RAAS, arterial hypotension, fainting, hyperkalemia, and impaired renal function (including acute renal failure) were noted in susceptible patients, especially when combined with several drugs that also act on this system. Therefore, a double blockade of RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended.
In cases of dependence of vascular tone and renal function mainly on RAAS activity (for example, in patients with chronic heart failure or kidney disease, including with renal artery stenosis or stenosis of a single kidney artery), prescribing drugs that affect this system, may be accompanied by the development of acute arterial hypotension, hyperazotemia, oliguria, and in rare cases, acute renal failure.
Primary hyperaldosteronism
In patients with primary hyperaldosteronism, treatment with antihypertensive drugs, which act by suppressing RAAS, is usually ineffective. In this regard, the use of Telzap ® is not recommended.
Stenosis of the aortic and mitral valves, hypertrophic obstructive cardiomyopathy
As with other vasodilators, patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy, should be especially careful when using Telzap ®.
Patients with diabetes who received insulin or hypoglycemic agents for oral administration
Hypoglycemia may occur in these patients during treatment with Telzap ®. Glycemia control should be strengthened, as there may be a need for dose adjustment of insulin or a hypoglycemic agent.
Hyperkalemia
The use of drugs acting on the RAAS can cause hyperkalemia. In elderly patients, patients with renal failure or diabetes mellitus, patients taking medications that increase plasma potassium, and / or patients with concomitant diseases, hyperkalemia can be fatal.
When deciding on the concomitant use of drugs acting on the RAAS, it is necessary to assess the ratio of risk and benefit. The main risk factors for developing hyperkalemia that should be considered are:
– diabetes mellitus, renal failure, age (patients older than 70 years)
– combination with one or more drugs acting on RAAS, and / or potassium-containing food additives. Medications or therapeutic classes of medications that can cause hyperkalemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim
– intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, impaired renal function, syndrome cytolysis (e.g., acute limb ischemia, rhabdomyolysis, extensive trauma).
Patients at risk are advised to carefully monitor their potassium in the blood plasma.
Sorbitol
Telzap ® contains sorbitol (E420). Patients with rare hereditary fructose intolerance should not take the drug.
Ethnic differences
As noted for ACE inhibitors, telmisartan and other angiotensin II receptor antagonists seem to lower blood pressure less effectively in patients of the Negroid race. than representatives of other races, possibly due to a greater predisposition to a decrease in renin activity in the population of these patients.
Other
As with other antihypertensive drugs, an excessive decrease in blood pressure in patients with ischemic cardiomyopathy or coronary heart disease can lead to the development of myocardial infarction or stroke.
Influence on the ability to drive vehicles and control mechanisms
Special clinical studies to study the effect of the drug on the ability to drive a car and mechanisms have not been conducted. When driving and working with mechanisms that require increased concentration of attention, care should be taken, as dizziness and drowsiness may rarely occur with the use of Telzap ®.
Composition
1 tab. – telmisartan 80 mg.
Excipients: meglumine – 24 mg, sorbitol – 324.4 mg, sodium hydroxide – 6.8 mg, povidone 25 – 40 mg, magnesium stearate – 4.8 mg.
Side effects
According to the WHO, unwanted effects are classified according to their frequency of development as follows: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1/10 000 to < 1/1000), very rarely (<1/10 000) the frequency is unknown - according to the available data, it was not possible to establish the frequency of occurrence. Within each group, according to the frequency of occurrence, adverse reactions are presented in decreasing order of severity. Infectious and parasitic diseases: infrequently – urinary tract infections, including cystitis, upper respiratory tract infections, including pharyngitis and sinusitis, rarely – sepsis, incl. fatal. From the hemopoietic system: infrequently – anemia rarely – eosinophilia, thrombocytopenia. From the side of the immune system: rarely – anaphylactic reaction, hypersensitivity. From the side of metabolism: infrequently – hyperkalemia rarely – hypoglycemia (in patients with diabetes mellitus). Mental disorders: infrequently – insomnia, depression is rarely anxiety. From the nervous system: infrequently – fainting rarely – drowsiness. From the side of the organ of vision: rarely – visual disturbances. On the part of the organ of hearing and labyrinth disorders: infrequently – vertigo. From the cardiovascular system: infrequently – bradycardia, marked decrease in blood pressure, orthostatic hypotension rarely – tachycardia. From the respiratory system: infrequently – shortness of breath, cough very rarely – interstitial lung disease. From the gastrointestinal tract: infrequently – abdominal pain, diarrhea, dyspepsia, flatulence, vomiting rarely – dry mouth, discomfort in the stomach, violation of taste sensations. From the liver and biliary tract: rarely – impaired liver function / liver damage. From the skin and subcutaneous tissues: infrequently – skin itching, hyperhidrosis, rash rarely – angioedema (also fatal), eczema, erythema, urticaria, drug rash, toxic skin rash. From the musculoskeletal system: infrequently – sciatica, muscle cramps, myalgia rarely – arthralgia, pain in the extremities, tendon-like syndrome. From the urinary system: infrequently – impaired renal function, including acute renal failure. On the part of laboratory and instrumental studies: infrequently – an increase in plasma creatinine concentrations rarely – a decrease in hemoglobin, an increase in uric acid in blood plasma, an increase in the activity of liver enzymes and CPK. Other: infrequently – chest pain, asthenia rarely – flu-like syndrome. Drug interaction Double blockade of RAAS Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR less than 60 ml / min / 1.73 m2 of body surface area) and is not recommended for other patients. The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy. Clinical studies have shown that double blockade of RAAS due to the combined use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is associated with an increased incidence of adverse events such as arterial hypotension, hyperkalemia and impaired renal function (including acute renal failure) in comparison with the use of only one drug acting on RAAS. Hyperkalemia The risk of developing hyperkalemia may increase when used together with other medicines that can cause hyperkalemia (potassium-containing food supplements and salt substitutes containing potassium, potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride selective, -2), heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim). If necessary, against the background of documented hypokalemia, the combined use of drugs should be carried out with caution and regularly monitor the content of potassium in the blood plasma. Digoxin With the combined use of telmisartan with digoxin, an average increase in Cmax of digoxin in blood plasma by 49% and Cmin by 20% was noted. At the beginning of treatment, when selecting a dose and discontinuing treatment with telmisartan, the concentration of digoxin in blood plasma should be carefully monitored to maintain it within the therapeutic range. Potassium-sparing diuretics or potassium-containing food additives Angiotensin II receptor antagonists such as telmisartan reduce the loss of potassium caused by the diuretic. Potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamteren, or amiloride), potassium-containing food additives, or salt substitutes can lead to a significant increase in plasma potassium. If concomitant use is indicated because there is documented hypokalemia, they should be used with caution and against the background of regular monitoring of potassium in the blood plasma. Lithium preparations The combined use of lithium preparations with ACE inhibitors and angiotensin II receptor antagonists, including telmisartan, resulted in a reversible increase in the concentration of lithium in the blood plasma and its toxic effect. If you need to use this combination of drugs, it is recommended that you carefully monitor the concentration of lithium in blood plasma. NSAIDs NSAIDs (i.e., acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of angiotensin II receptor antagonists. Some patients with impaired renal function (e.g., patients with dehydration, elderly patients with impaired renal function) the combined use of angiotensin II receptor antagonists and drugs that inhibit COX-2 can lead to further deterioration of renal function, including the development of acute renal failure, which, as a rule, is reversible. Therefore, the combined use of drugs should be carried out with caution, especially in elderly patients. Adequate fluid intake should be ensured, in addition, at the beginning of joint use and periodically in the future, renal function indicators should be monitored. Diuretics (thiazide or loopback) Prior treatment with high-dose diuretics such as furosemide (loopback diuretic) and hydrochlorothiazide (thiazide diuretic), may lead to hypovolemia and the risk of developing hypotension at the start of telmisartan treatment. Other antihypertensive drugs The effect of telmisartan may be enhanced by the combined use of other antihypertensive drugs. Based on the pharmacological properties of baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all antihypertensive drugs, including telmisartan. In addition, orthostatic hypotension can be aggravated by the use of ethanol, barbiturates, drugs or antidepressants. Corticosteroids (for systemic use) Corticosteroids weaken the effect of telmisartan. overdose Symptoms: The most pronounced manifestations of overdose were marked BP and tachycardia also reported bradycardia, dizziness, increased serum creatinine and acute renal failure. Treatment: Patients should be carefully monitored and symptomatic as well as supportive treatment provided. The approach to treatment depends on the time elapsed after taking the drug and the severity of the symptoms. Recommended activities include vomiting and / or gastric lavage, activated charcoal is advisable. Electrolytes and creatinine in blood plasma should be monitored regularly. In case of excessive decrease in blood pressure, the patient should take a horizontal position with his legs elevated, while it is necessary to quickly compensate for BCC and lack of electrolytes. Telmisartan is not excreted by hemodialysis. Storage Conditions The product should be stored out of the reach of children at a temperature not exceeding 25 ° C. Shelf life 2 years. Do not use after the expiration date indicated on the package. Deystvuyushtee substance Telmisartan Terms and conditions prescription
