Telmisartan-Teva 80mg 28 tablets — Made in Hungary — Free Delivery

(Telmisartan-Teva)

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Description Telmisartan-Teva 80mg 28 tablets — Made in Hungary — Free Delivery

Pharmacological properties

Pharmacodynamics. Telmisartan is an oral specific angiotensin II receptor antagonist (at1 type). With high affinity telmisartan replaces angiotensin ii at the sites of its binding to a variety of at1 receptors, through which the action of angiotensin ii is mediated. Telmisartan does not show any partial agonistic effect on the at1 receptor.

Telmisartan selectively binds to the AT1 receptor for a long time, without even having a partial agonistic effect on it. The binding is long lasting.

Telmisartan is unrelated to other receptors, including AT2 receptors and other AT receptors. The functional role of these receptors has not been elucidated, as is the effect of their possible stimulation by angiotensin II, the levels of which are increased by telmisartan. Telmisartan reduces the level of aldosterone in the blood plasma, does not block ion channels and does not reduce the level of renin in the blood plasma. It does not inhibit angiotensin-converting enzyme (kininase II), an enzyme that also breaks down bradykinin. Therefore, bradykinin-mediated side effects are not expected.

In humans, a dose of 80 mg of telmisartan almost completely inhibits the increase in blood pressure caused by angiotensin II. The inhibitory effect lasts for a day and is determined up to 48 hours.

Pharmacokinetics. Telmisartan is rapidly absorbed, but the amount of the preparation that is absorbed varies. The average bioavailability of telmisartan is about 50%.

When telmisartan is used with food, the AUC for telmisartan decreases from about 6% (40 mg dose) to about 19% (160 mg dose). 3 hours after administration, the concentration in the blood plasma becomes the same as when using telmisartan without food. It is believed that a slight decrease in AUC does not reduce the therapeutic efficacy of the preparation. There is no linear relationship between dose and plasma level. Cmax and, to a lesser extent, AUC increase disproportionately at doses above 40 mg.

Telmisartan binds to a large extent with blood plasma proteins (more than 99.5%), mainly with albumin and α1-acid glycoprotein. The average volume of distribution (Vss) at equilibrium is approximately 500 liters.

Telmisartan is metabolized by conjugation to glucuronide of the parent compound, which has no pharmacological activity.

Telmisartan is characterized by a biexponential pharmacokinetic curve with a terminal T½ of more than 20 hours. Cmax in blood plasma and, to a lesser extent, AUC increases disproportionately to the dose. When using telmisartan in recommended doses, no clinically significant cumulation was detected. Plasma concentration was higher in women than in men, with no corresponding effect on efficacy.

After taking (and intravenous) administration, telmisartan is almost completely excreted in the feces, mainly unchanged. Cumulative urinary excretion is less than 1% of the dose taken. The total plasma clearance (CLtot) is high (about 1000 ml / min) compared to the blood flow through the liver (about 1500 ml / min).

Special categories of patients

Children. The pharmacokinetics of two doses of telmisartan was evaluated as a secondary target for hypertensive patients (n = 57) aged 6 to 18 years after taking telmisartan at a dose of 1 or 2 mg / kg body weight for 4 weeks of treatment. Pharmacokinetic goals included determining steady state telmisartan levels in children and adolescents and examining age-related differences. Although the study was insufficient to reliably evaluate the pharmacokinetics in children under 12 years of age, the results are broadly consistent with those obtained for adults and confirm the nonlinearity of telmisartan, in particular for Cmax.

Floor. Cmax and AUC in women are approximately 3 and 2 times higher, respectively, than in men.

Elderly patients. The pharmacokinetics of telmisartan do not differ in elderly patients and those under 65 years of age.

Patients with impaired renal function. In patients with moderate, moderate and severe renal failure, a 2-fold increase in plasma concentration was noted. However, in patients with renal insufficiency who are subject to dialysis, a low plasma concentration is detected. Telmisartan has a high affinity for plasma proteins in patients with renal insufficiency and cannot be removed by dialysis. In patients with renal insufficiency, T½ does not change.

Patients with impaired liver function. Pharmacokinetic studies in patients with hepatic impairment have shown an increase in bioavailability up to about 100%. In patients with hepatic impairment, T½ does not change.

Indications

Ag. treatment of essential ag in adults.

Prevention of cardiovascular diseases. Reducing the incidence of cardiovascular nosologies in patients with:

severe manifestations of atherothrombotic cardiovascular disease (coronary artery disease, stroke, or a history of peripheral arterial disease);

type II diabetes mellitus with diagnosed target organ damage.

Application

Telmisartan-teva should be taken orally once a day with a sufficient amount of liquid, regardless of food intake.

Treatment of hypertension. The recommended dose is 40 mg / day. For some patients, a dose of 20 mg / day will be sufficient. If the blood pressure does not decrease to the desired values, then the dose can be increased to a maximum of 80 mg once a day. Telmisartan-Teva can be given in combination with a thiazide diuretic such as hydrochlorothiazide, which has an additional blood pressure lowering effect when given together with telmisartan. When deciding whether to increase the dose, it should be borne in mind that the maximum hypotensive effect occurs 4–8 weeks after the start of treatment.

Prevention of cardiovascular diseases. The recommended dose is 80 mg once a day. It is not known whether the 80 mg dose of telmisartan is effective in reducing cardiovascular morbidity.

At the beginning of treatment with telmisartan, in order to reduce the risk of cardiovascular diseases, it is recommended to carry out careful monitoring of blood pressure. There may be a need for appropriate correction of regimens for the use of preparations that lower blood pressure.

Renal dysfunction. In patients with mild or moderate renal insufficiency, there is no need for dose adjustment. There is limited experience in patients with renal insufficiency or on hemodialysis. For these patients, the recommended low starting dose is 20 mg.

Liver dysfunction. For patients with mild to moderate hepatic dysfunction, the dose should not exceed 40 mg / day. The preparation is contraindicated in patients with severely impaired liver function.

Elderly patients. No dose adjustment is required.

Contraindications

Hypersensitivity to the active substance or any of the excipients of the preparation.

Pregnant women or women planning to become pregnant (see Use during pregnancy or lactation). Obstructive diseases of the bile ducts. Severe liver dysfunction. Children under the age of 18. The simultaneous use of telmisartan and aliskiren-containing preparations in patients with diabetes mellitus or impaired renal function (glomerular filtration rate 60 ml / min / 1.73 m2) is contraindicated.

Side effects

Serious side effects, including anaphylactic reactions and angioedema, are possible in some cases, opn was also observed.

Infectious diseases and invasions: infectious diseases of the upper respiratory tract (including pharyngitis and sinusitis), infectious diseases of the urinary tract (including cystitis), sepsis (including fatal) 1.

Disturbances from the blood and lymphatic system: anemia, thrombocytopenia, eosinophilia.

Immune system disorders: hypersensitivity, anaphylactic reactions.

Metabolic and metabolic disorders: hyperkalemia, hypoglycemia (in patients with diabetes mellitus).

Mental disorders: depression, insomnia, anxiety.

Neurological disorders: fainting, drowsiness.

Violations of the organ of vision: visual impairment.

Disturbances from the organ of hearing and vestibular apparatus: vertigo.

Disturbances from the cardiovascular system: bradycardia, tachycardia, arterial hypotension2, orthostatic hypotension.

Disturbances from the respiratory system, chest and mediastinal organs: shortness of breath, cough, interstitial lung disease.

Cases of interstitial lung disease have been reported temporarily with telmisartan during the post-marketing follow-up period. However, a causal relationship has not been established.

Digestive system disorders: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, stomach discomfort, dry mouth, dysgeusia.

Disorders of the hepatobiliary system: liver dysfunction / liver dysfunction. It has been reported that patients of Japanese origin are more susceptible to these adverse reactions.

Violations of the skin and subcutaneous tissue: hyperhidrosis, itching, rash, erythema, angioedema (including fatal), preparation dermatitis, toxic dermatitis, eczema, urticaria.

Musculoskeletal and connective tissue disorders: myalgia, back pain (eg sciatica), muscle cramps, arthralgia, limb pain, tendon pain (tendinitis-like symptoms).

Disorders of the urinary system: impaired renal function, including acute renal failure.

General disorders: chest pain, asthenia (weakness), flu-like symptoms.

Laboratory indicators: an increase in the level of creatinine in the blood, an increase in the level of uric acid in the blood, an increase in the level of liver enzymes, an increase in the level of CPK in the blood, a decrease in the level of hemoglobin.

Description of selected adverse reactions

Sepsis. It was reported that patients who took telmisartan had a higher incidence of sepsis compared with those who received placebo. This can be both an accident and a sign of a process, the essence of which is still unknown.

Hypotension. This adverse reaction has been reported frequently in patients with controlled blood pressure who were treated with telmisartan to reduce cardiovascular disease in addition to standard therapy.

Liver dysfunction / liver disorders. According to post-marketing data, the majority of cases of impaired liver function / hepatic disorders were observed in patients of Japanese nationality. Patients of Japanese origin are more susceptible to these adverse reactions.

Interstitial lung disease. Cases of interstitial lung disease were observed temporarily with the use of telmisartan during the post-marketing observation period. However, a causal relationship has not been established.

1 An increased incidence of sepsis has been reported with telmisartan compared to placebo. This phenomenon may be an accidental occurrence or related to a mechanism, the operation of which is currently unknown.

2 Reported as frequent in patients with controlled blood pressure treated with telmisartan to reduce cardiovascular morbidity in addition to standard therapy.

Special instructions

Pregnancy. Angiotensin II receptor antagonists should not be started during pregnancy. if continuation of therapy cannot be considered essential for a patient who is planning a pregnancy, she should switch to alternative antihypertensive therapy that has an established safety profile for use during pregnancy. when pregnancy is established, treatment with angiotensin II receptor antagonists should be stopped immediately and, if necessary, alternative treatment should be started (see contraindications and use during pregnancy or lactation).

Liver failure. Telmisartan-Teva should not be used in patients with cholestasis, obstructive diseases of the biliary system and severe hepatic insufficiency, since telmisartan is mainly excreted in the bile. In patients with these diseases, the hepatic clearance of telmisartan decreases. Telmisartan-Teva should be used with caution in patients with mild to moderate hepatic impairment.

Renovascular hypertension. There is a risk of severe arterial hypotension and renal failure in patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney when treated with preparations that affect the renin-angiotensin-aldosterone system.

Renal failure and kidney transplant. When using the preparation in patients with impaired renal function, it is recommended to periodically monitor the level of potassium and creatinine in the blood plasma. There is no experience of using the preparation in patients after kidney transplantation.

Decreased intravascular fluid volume. Symptomatic arterial hypotension, especially after the first dose of the preparation, may occur in patients with reduced BCC or hyponatremia, which have arisen as a result of intensive diuretic therapy, diet with limited salt or diarrhea and vomiting. Such conditions should be corrected before using the preparation. Before starting treatment, it is necessary to normalize the sodium level and the volume of intravascular fluid.

Double blockade of the renin-angiotensin-aldosterone system. There is evidence that the simultaneous use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalemia and reduces renal function (including ARF).

Therefore, a double blockade of the renin-angiotensin-aldosterone system when an ACE inhibitor is added to an angiotensin II receptor antagonist) is not recommended. If double blockade is considered absolutely necessary, it should only take place under the supervision of a specialist and subject to constant careful monitoring of kidney function, electrolytes and blood pressure.

ACE inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Other conditions accompanied by stimulation of the renin-angiotensin-aldosterone system. In patients whose vascular tone and renal function are highly dependent on the activity of the renin-angiotensin-aldosterone system (for example, in patients with severe congestive heart failure or severe kidney disease, including renal artery stenosis), treatment with preparations that also affect this system , can cause acute arterial hypotension, hyperazotemia, oliguria, or less often - acute renal failure.

Primary aldosteronism. Usually, patients with primary aldosteronism do not respond to antihypertensive preparations that suppress the renin-angiotensin system, therefore, it is not recommended to prescribe telmisartan to patients in this condition.

Stenosis of the mitral and aortic valves, obstructive hypertrophic cardiomyopathy. As with the use of other vasodilators, the preparation should be used with caution in patients with mitral and aortic stenosis or obstructive hypertrophic cardiomyopathy.

Hyperkalemia. The use of preparations that affect the renin-angiotensin-aldosterone system can cause hyperkalemia. In elderly patients, patients with renal insufficiency, patients with diabetes, patients who are simultaneously receiving other preparations that can increase the level of potassium, and / or in patients with intercurrent diseases, hyperkalemia can be fatal.

Before the simultaneous use of preparations that suppress the renin-angiotensin-aldosterone system, the balance of benefits and risks should be assessed.

The main risk factors for hyperkalemia to consider are:

diabetes mellitus, renal failure, age (70 years);

combination with one or more preparations that affect the renin-angiotensin-aldosterone system, and / or with food supplements containing potassium. Preparations or therapeutic classes of preparations that can provoke hyperkalemia include potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressants (cyclometrolimus); and

intercurrent manifestations, in particular dehydration, acute cardiac decompensation, metabolic acidosis, impaired renal function, unexpected deterioration of the kidney (eg, infectious diseases), cell lysis (eg, acute limb ischemia, rhabdomyolysis, severe trauma).

Careful monitoring of plasma potassium is recommended in patients at risk.

Sorbitol. The preparation contains sorbitol (E420), so it should not be administered to patients with hereditary fructose intolerance.

Ethnic differences. As has been found with the appointment of ACE inhibitors, telmisartan and other angiotensin receptor blockers are less effective in lowering blood pressure in black patients compared to representatives of other races, possibly because the level of renin in black patients with hypertension is lower than in representatives of other races ...

Others. As with the use of other antihypertensive preparations, an excessive decrease in blood pressure in patients with coronary artery disease and ischemic cardiopathy can lead to the development of myocardial infarction or stroke.

Diabetic patients who are treated with insulin or hypoglycemic preparations. Patients receiving insulin or antidiabetic preparations may experience hypoglycemia. In these patients, it is necessary to control the level of glucose in the blood, and this should also be taken into account when adjusting the dose of insulin or antidiabetic agents.

In patients with diabetes mellitus, cardiovascular risks (patients with diabetes mellitus, concomitant coronary artery disease), the risk of fatal myocardial infarction and sudden cardiovascular death may be higher when treated with antihypertensive preparations such as angiotensin II receptor antagonists and ACE inhibitors. In patients with diabetes mellitus, the course of concomitant diseases of the coronary arteries may be asymptomatic and therefore they may be undiagnosed. Diabetic patients should be carefully evaluated, for example, by stress testing, to identify and treat comorbid coronary artery disease before prescribing the preparation.

Use during pregnancy or lactation

Pregnancy. The preparation is contraindicated for use in pregnant women or women planning pregnancy. If pregnancy is confirmed by a preparation during treatment, its use should be discontinued immediately and, if necessary, replaced with another preparation approved for use in pregnant women.

There is insufficient data on the use of telmisartan in pregnant women.

The epidemiological justification of the risk of teratogenicity as a result of the use of ACE inhibitors in the first trimester of pregnancy was not convincing, but a slight increase in risk cannot be ruled out. Although there is no controlled epidemiological data on the risk of teratogenicity with the use of angiotensin II receptor antagonists, similar risks may exist for this class of preparations. When planning pregnancy, you should replace the preparation in advance with another antihypertensive agent with an established safety profile for use during pregnancy. When pregnancy is established, treatment with angiotensin II receptor antagonists should be discontinued immediately and, if necessary, alternative treatment should be initiated.

As you know, the use of angiotensin II receptor antagonists in the II and III trimester of pregnancy causes fetotoxicity in humans (impaired renal function, oligohydramnios, delayed formation of skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia). If the use of angiotensin II receptor antagonists was started from the second trimester of pregnancy, it is recommended to conduct an ultrasound of the function of the kidneys and skull bones of the fetus. The condition of newborns whose mothers took angiotensin II receptor antagonists should be carefully monitored for arterial hypotension.

Lactation. Since there is no information regarding the use of telmisartan during breastfeeding, its use is not recommended and alternative therapies with established safety profiles should be used during breastfeeding, especially in neonates or premature infants.

Fertility In the course of preclinical studies, no effect of telmisartan on fertility in men and women was revealed.

Children. The efficacy and safety of the preparation in children under the age of 18 have not been studied.

The ability to influence the reaction rate when driving or working with other mechanisms. Dizziness or drowsiness can sometimes occur with antihypertensive therapy. Therefore, if necessary, drive vehicles or work with other mechanisms, this should be taken into account.

Interactions

Digoxin. with the simultaneous use of telmisartan and digoxin, an average increase in the cmax of digoxin in blood plasma (by 49%) and minimum concentrations (by 20%) were noted. at the beginning of admission, in case of dose adjustment and discontinuation of telmisartan, the level of digoxin should be monitored to maintain them within the therapeutic range.

Like all medicines that affect the renin-angiotensin-aldosterone system, telmisartan can cause hyperkalemia. This risk may increase when combined with other preparations that can also provoke hyperkalemia (potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressants) or tacrol and trimethoprim).

The incidence of hyperkalemia depends on the associated risk factors. The risk is increased with the use of the aforementioned therapeutic combinations. This risk is especially high when combined with potassium-sparing diuretics and potassium-containing salt substitutes. The combination, for example, with ACE inhibitors or NSAIDs, creates less risk with strict adherence to caution in use.

Simultaneous use is not recommended

With potassium-sparing diuretics or potassium supplements. Angiotensin II receptor antagonists such as telmisartan reduce the potassium loss caused by diuretics. Potassium-sparing diuretics such as spironolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes can lead to significant increases in plasma potassium levels. If simultaneous use is indicated due to diagnosed hypokalemia, these preparations should be used with caution with frequent monitoring of plasma potassium.

With lithium. With the simultaneous use of lithium with ACE inhibitors and angiotensin II receptor antagonists, including telmisartan, a reversible increase in the concentration of lithium in the blood plasma and toxicity were noted. If the use of such a combination is necessary, careful monitoring of the level of lithium in the blood plasma is recommended.

Simultaneous use requiring caution

NSAIDs. NSAIDs (for example, acetylsalicylic acid in doses intended for the treatment of inflammation, COX-2 inhibitors and non-selective NSAIDs) can reduce the antihypertensive effect of angiotensin II receptor antagonists.

In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous use of angiotensin II receptor antagonists and COX depressants can lead to further deterioration of renal function, including possible ARF, which is usually reversible. Therefore, this combination should be used with caution, especially in elderly patients. Patients need to receive an adequate amount of fluid and should weigh the possibility of monitoring renal function after the start of concurrent treatment and periodically after it.

An almost 2.5-fold increase in AUC0-24 and Cmax was reported when used concomitantly with ramipril and ramiprilat. The clinical relevance of this message is unknown.

Diuretics (thiazide or loop). Pretreatment with high-dose diuretics, such as furosemide (a loop diuretic) and hydrochlorothiazide (a thiazide diuretic), may lead to dehydration and the risk of hypotension at the start of telmisartan treatment.

Should be considered with simultaneous use

Other antihypertensive preparations. The effect of telmisartan - lowering blood pressure - may increase when used simultaneously with other antihypertensive preparations.

Given the pharmacological properties, it can be expected that preparations such as baclofen, amifostine can cause the hypotensive effects of all antihypertensive preparations, including telmisartan. Orthostatic hypotension can also worsen with alcohol use, barbiturates, preparations, or antidepressants.

GCS (systemic use). Decreased antihypertensive effect.

Double blockade of the renin-angiotensin-aldosterone system. It has been demonstrated that double blockade of the renin-angiotensin-aldosterone system with the simultaneous use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is characterized by a higher incidence of adverse reactions such as arterial hypotension, hyperglycemia, decreased renal function (including ARF), compared with the use of monotherapy.

Overdose

Information on telmisartan overdose is limited.

The most pronounced symptoms of telmisartan overdose were arterial hypotension and tachycardia; bradycardia, dizziness, elevated plasma creatinine levels, and acute renal failure have also been reported.

Telmisartan is not eliminated from the body by hemodialysis. The patient should be closely monitored and symptomatic and supportive care should be given. Treatment depends on the time elapsed after the overdose and the severity of the symptoms. It is recommended to induce vomiting and / or gastric lavage. When treating an overdose, you can use activated carbon. Plasma electrolytes and creatinine levels should be monitored frequently. If arterial hypotension occurs, the patient should be given a supine position and the balance of fluid and salt in the body should be restored.

Storage conditions

Does not require special storage conditions.

Tags: Telmisartan

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