Telzap - Instructions For Use, Price, Reviews, Tablet Analogs

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Telzap

Telzap: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Telzap

ATX code: C09CA07

Active ingredient: telmisartan (telmisartan)

Manufacturer: Zentiva Saalyk Yuryunleri Sanayi ve Tijaret A. Sh. (Turkey)

Description and photo update: 2018-27-11

Prices in pharmacies: from 257 rubles.

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Telzap is an antihypertensive drug, angiotensin II receptor blocker.

Release form and composition

The drug is available in the form of film-coated tablets: from yellowish to almost white, oblong, biconvex; 40 mg - with a dividing line on each side, 80 mg - engraved "80" on one side (10 pieces in blisters, in a cardboard box of 3, 6 or 9 blisters and instructions for using Telzap).

1 tablet contains:

• active substance: telmisartan - 40 mg or 80 mg;
• auxiliary components: povidone 25, meglumine, sodium hydroxide, sorbitol, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Telzap is an antihypertensive drug, its active ingredient is telmisartan, a specific antagonist of angiotensin II receptors (AT ₁ subtype). Telmisartan has a high degree of affinity for AT ₁ (angiotensin) receptors, through which the action of angiotensin II is realized. Lacking the action of an agonist against the receptor, from the connection with it, it displaces angiotensin II and binds only to the subtype of AT ₁ -receptors of angiotensin II. To other angiotensin receptors (including AT ₂-receptors) telmisartan has no affinity. Their functional significance and the effect of possible overstimulation with angiotensin II have not been studied. Telmisartan reduces the level of aldosterone in the blood plasma, does not block ion channels, does not reduce the activity of renin, does not inhibit the action of the angiotensin-converting enzyme (kininase II), which catalyzes the destruction of bradykinin. This avoids the development of dry cough and other side effects due to the action of bradykinin.

With essential hypertension, taking Telzap at a dose of 80 mg blocks the hypertensive effect of angiotensin II. The hypotensive effect after the first dose of telmisartan occurs within 3 hours and lasts for 24 hours, remaining clinically significant up to 48 hours. A pronounced antihypertensive effect is achieved after 28–56 days of regular administration of the drug.

In hypertension, telmisartan lowers systolic and diastolic blood pressure (BP) without affecting the heart rate (HR).

Abrupt withdrawal of Telzap is not accompanied by the development of withdrawal syndrome, blood pressure gradually returns to baseline values over several days.

The antihypertensive effect of telmisartan is comparable to the action of antihypertensive drugs such as amlodipine, enalapril, hydrochlorothiazide, atenolol and lisinopril, but with the use of telmisartan there is a lower likelihood of dry cough, in contrast to angiotensin-converting enzyme (ACE) inhibitors.

The use of telmisartan for the prevention of cardiovascular diseases in adult patients (age 55 and older) with transient ischemic attack, coronary heart disease, peripheral arterial disease, stroke, or complications of type 2 diabetes mellitus (including retinopathy, left ventricular hypertrophy, macro- or microalbuminuria) in history contributed to a decrease in the combined endpoint of hospitalization for chronic heart failure, cardiovascular mortality, myocardial infarction or stroke without fatal outcome. Telmisartan has a similar effect to ramipril in reducing the frequency of secondary points: cardiovascular mortality, myocardial infarction or stroke without fatal outcome. In contrast to ramipril while taking telmisartan, the incidence of dry cough and angioedema is lower, and arterial hypotension is higher.

Pharmacokinetics

After oral administration, the absorption of telmisartan from the gastrointestinal tract occurs quickly, its bioavailability is 50%. Simultaneous food intake causes a decrease in AUC (total plasma concentration), but within three hours the concentration of telmisartan in blood plasma levels off.

Compared to men, in women, C _max (maximum concentration in blood plasma) is 3 times higher, and AUC is approximately 2 times higher, but this does not significantly affect the effectiveness of Telzap.

There is no linear relationship between dose and plasma concentration of the drug. When using daily doses above 40 mg, C _max and AUC change disproportionately to the dose increase.

Plasma protein binding (mainly albumin and alpha _1- acid glycoprotein) - more than 99.5%.

The average apparent volume of distribution is 500 liters.

Telmisartan metabolism occurs by conjugation with glucuronic acid, the conjugate has no pharmacological activity.

T _1/2 (half-life) - more than 20 hours. It is excreted unchanged mainly (99%) through the intestines, less than 1% is excreted by the kidneys.

Total plasma clearance is about 1000 ml / min, hepatic blood flow is up to 1500 ml / min.

With mild to moderate impairment of renal function, as well as in patients over the age of 65, the pharmacokinetics of telmisartan is not impaired, therefore, dose adjustment is not required.

In severe renal failure and for patients on hemodialysis, the initial dose should not exceed 20 mg per day.

Telmisartan is not excreted by hemodialysis.

For mild to moderate liver dysfunction (Child-Pugh classes A and B), a daily dose of up to 40 mg should be used.

Indications for use

• essential hypertension;
• a decrease in the incidence of cardiovascular diseases and mortality in adult patients with diseases of the cardiovascular system of atherothrombotic etiology (ischemic heart disease, peripheral arterial disease or stroke in history) and with target organ damage in type 2 diabetes mellitus.

Contraindications

• severe liver dysfunction (class C according to the Child-Pugh classification);
• obstructive diseases of the biliary tract, cholestasis;
• simultaneous use of aliskiren in severe renal dysfunction [GFR (glomerular filtration rate) less than 60 ml / min / 1.73 m ² of body surface] or in case of diabetes mellitus;
• concomitant therapy with angiotensin-converting enzyme (ACE) inhibitors in patients with diabetic nephropathy;
• hereditary fructose intolerance;
• period of pregnancy;
• breast-feeding;
• age up to 18 years;
• hypersensitivity to the components of the drug.

Telzap should be used with caution in severe chronic heart failure, hypertrophic obstructive cardiomyopathy, aortic and mitral stenosis, renal dysfunction, bilateral renal artery stenosis, artery stenosis of the only functioning kidney, mild to moderate liver dysfunction, decreased circulating blood volume (BCC) against the background of limited consumption of table salt, diarrhea, vomiting or taking diuretics, hyperkalemia, hyponatremia, primary hyperaldosteronism, in the period after kidney transplantation, use in patients of the Negroid race.

Telzap, application instruction: method and dosage

Telzap tablets are taken orally with a sufficient amount of liquid, regardless of the meal.

The frequency of taking the drug is 1 time per day.

Recommended daily dosage:

• arterial hypertension: initial dose - 20-40 mg. In the absence of a sufficient hypotensive effect after 28–56 days of therapy, the initial dose can be increased. The maximum daily dose is 80 mg. As an alternative, a combination of Telzap with thiazide diuretics (including hydrochlorothiazide) is indicated;
• reduction in mortality and the incidence of cardiovascular diseases: 80 mg, at the beginning of treatment it is necessary to control the level of blood pressure. If necessary, correction of antihypertensive therapy should be carried out.

In severe renal failure or patients on hemodialysis, it is recommended to use an initial daily dose of no more than 20 mg.

With mild to moderate renal impairment, dose adjustment is not required.

In case of mild to moderate hepatic impairment (classes A and B according to the Child-Pugh classification), the daily dose of Telzap should not exceed 40 mg.

Side effects

• general disorders: infrequently - asthenia, chest pain; rarely - flu-like syndrome;
• diseases of infectious and parasitic genesis: infrequently - urinary tract infections (including cystitis), upper respiratory tract infections (including sinusitis, pharyngitis); rarely - sepsis (including death);
• on the part of the cardiovascular system: infrequently - bradycardia, orthostatic hypotension, marked decrease in blood pressure; rarely - tachycardia;
• from the lymphatic system and blood: infrequently - anemia; rarely - thrombocytopenia, eosinophilia;
• from the immune system: rarely - hypersensitivity reactions, anaphylactic reactions;
• on the part of the psyche: infrequently - depression, insomnia; rarely - anxiety;
• from the side of metabolism and nutrition: infrequently - hyperkalemia; rarely - hypoglycemia against the background of diabetes mellitus;
• from the gastrointestinal tract: infrequently - abdominal pain, vomiting, dyspepsia, flatulence, diarrhea; rarely - dry mouth, impaired taste, discomfort in the stomach;
• from the hepatobiliary system: rarely - liver damage, liver functional disorders;
• from the nervous system: infrequently - fainting; rarely - drowsiness;
• on the part of the organ of hearing, labyrinth disorders: infrequently - vertigo;
• on the part of the organ of vision: visual disturbances;
• from the respiratory system, chest and mediastinal organs: infrequently - cough, shortness of breath; very rarely - interstitial lung disease;
• dermatological reactions: infrequently - itching, skin rash, hyperhidrosis; rarely - drug rash, urticaria, erythema, eczema, toxic skin rash, angioedema (including fatal);
• from the urinary system: infrequently - impaired renal function, acute renal failure;
• on the part of the musculoskeletal system and connective tissue: infrequently - muscle spasms, back pain (sciatica), myalgia; rarely - pain in the extremities, arthralgia, pain in the tendons (tendinitis-like syndrome);
• laboratory indicators: infrequently - an increase in the level of creatinine in the blood plasma; rarely - a decrease in the content of hemoglobin in the blood plasma, an increase in the activity of liver enzymes and creatine phosphokinase, an increase in the concentration of uric acid in the blood plasma.

Overdose

Symptoms: pronounced decrease in blood pressure, tachycardia, dizziness, bradycardia, increased serum creatinine concentration, acute renal failure.

Treatment: immediate gastric lavage, artificial vomiting, intake of activated carbon. The severity of symptoms and the patient's condition should be carefully monitored. Prescribe symptomatic and supportive therapy. It is important to ensure that blood is monitored regularly for electrolytes and plasma creatinine. With a pronounced decrease in blood pressure, the patient should be placed with his legs raised. Take measures to replenish BCC and electrolytes.

The use of hemodialysis is impractical.

special instructions

When prescribing Telzap to patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney, it should be borne in mind that taking the drug may increase the risk of severe arterial hypotension and renal failure.

Treatment with the drug should be started only after elimination of the existing deficiency of BCC and / or sodium content in blood plasma.

The use of Telzap in patients with impaired renal function is recommended to be accompanied by periodic monitoring of the content of potassium and creatinine in the blood plasma.

Inhibition of the RAAS (renin-aldosterone-angiotensin system) can occur in patients predisposed to this and while taking telmisartan with other RAAS antagonists. It can cause hypotension, fainting, hyperkalemia, and impaired renal function (including acute renal failure).

In chronic heart failure, kidney disease or other pathologies with a predominant dependence on the RAAS activity, the appointment of Telzap can cause the development of acute arterial hypotension, hyperazotemia, oliguria, in rare cases - acute renal failure.

In case of primary hyperaldosteronism, the use of the drug is ineffective.

During treatment with telmisartan, patients with diabetes mellitus receiving insulin or oral hypoglycemic agents may experience hypoglycemia, therefore, careful monitoring of blood glucose levels is required. If necessary, the dose of insulin or hypoglycemic agent should be adjusted.

It should be taken into account and special care should be taken when prescribing Telzap to patients with concomitant diseases such as renal failure, diabetes mellitus, patients on concomitant therapy with drugs that cause an increase in plasma potassium levels, elderly patients (over 70 years old), since these categories of patients are at high risk of developing hyperkalemia, including fatal ones.

During the period of drug treatment, concurrent administration of other drugs should be performed only as directed by the attending physician.

An excessive decrease in blood pressure in ischemic cardiomyopathy or coronary heart disease can lead to the development of myocardial infarction or stroke.

In patients of the black race, a less effective lowering of blood pressure is noted.

Influence on the ability to drive vehicles and complex mechanisms

During the period of taking Telzap, it is recommended to be careful when driving vehicles and mechanisms due to the possibility of dizziness and drowsiness.

Application during pregnancy and lactation

The use of Telzap tablets is contraindicated during the period of gestation and breastfeeding.

Patients taking Telzap, after establishing the fact of conception, should immediately stop therapy with telmisartan and switch to treatment with an alternative antihypertensive drug with an established safety profile of use during pregnancy and lactation.

Pediatric use

Due to the lack of information on the safety and efficacy of Telzap in childhood and adolescence, prescribing the drug to patients under 18 years of age is contraindicated.

With impaired renal function

The appointment of Telzap is contraindicated in patients with renal insufficiency (GFR less than 60 ml / min / 1.73 m ²), who are on concomitant therapy with aliskiren.

Telzap should be prescribed with caution in case of impaired renal function, bilateral renal artery stenosis, artery stenosis of the only functioning kidney.

In severe renal failure and patients on hemodialysis, it is recommended to use an initial daily dose of no more than 20 mg.

With mild to moderate renal impairment, dose adjustment is not required.

For violations of liver function

The appointment of Telzap is contraindicated for the treatment of patients with severe hepatic insufficiency (class C according to the Child-Pugh classification).

With caution, tablets should be taken with mild to moderate hepatic impairment (classes A and B according to the Child-Pugh classification). The daily dose of telmisartan should not exceed 40 mg.

Use in the elderly

No dose adjustment is required for elderly patients.

Drug interactions

With the simultaneous use of Telzap:

• aliskiren: in patients with renal failure or diabetes mellitus, combination therapy with telmisartan and aliskiren leads to a double blockade of the RAAS, as a result of which the incidence of adverse events in the form of arterial hypotension, hyperkalemia and renal dysfunction increases;
• ACE inhibitors: in patients with diabetic nephropathy on the background of concomitant therapy with ACE inhibitors, a double blockade of the RAAS occurs, therefore the combination of telmisartan and ACE inhibitors is contraindicated;
• potassium-sparing diuretics (including spironolactone, eplerenone, amiloride, triamterene), potassium-containing dietary supplements, potassium salt substitutes, nonsteroidal anti-inflammatory drugs (NSAIDs), heparin, cyclosporin, tacrolimus, trimethoprim: increase the likelihood of hyperkalemia. If necessary, joint use should regularly monitor the level of potassium concentration in the blood plasma;
• digoxin: there is an increase in the average concentration of digoxin in the blood plasma (C _max - by 49%, C _min - by 20%), therefore, when choosing a dose of telmisartan or stopping its intake, the level of digoxin in the blood plasma should be monitored, avoiding exceeding the limits of its therapeutic range;
• lithium preparations: it should be borne in mind that against the background of combination therapy with angiotensin II receptor antagonists and ACE inhibitors, the concentration of lithium in the blood plasma may increase to the level of its toxic effect;
• non-selective NSAIDs, acetylsalicylic acid (doses used for anti-inflammatory treatment), cyclooxygenase-2 (COX-2) inhibitors: help to weaken the hypotensive effect of telmisartan. In case of impaired renal function, the combination with COX-2 inhibitors can cause a reversible deterioration in renal function;
• diuretics: previous therapy with high doses of thiazide and loop diuretics increases the risk of hypovolemia and arterial hypotension at the beginning of telmisartan treatment;
• other antihypertensive drugs: enhance the effect of telmisartan;
• antidepressants, ethanol, barbiturates, narcotic drugs: increase the risk of orthostatic hypotension;
• corticosteroids for systemic use: cause a weakening of the hypotensive effect of Telzap.

Analogs

Telzap's analogues are: Telmista, Mikardis, Telsartan, Telpres.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Telzap

The few reviews about Telzap are positive. Patients indicate that taking the drug for arterial hypertension allows you to effectively control blood pressure.

Price for Telzap in pharmacies

The price of Telzap for a package containing 30 tablets at a dose of 80 mg can be from 337 rubles, 90 tablets at a dose of 80 mg - from 950 rubles, 30 tablets at a dose of 40 mg - from 346 rubles, 90 tablets at a dose of 40 mg - from 765 rubles.

Telzap: prices in online pharmacies

Drug name Price Pharmacy

Telzap 40 mg film-coated tablets 30 pcs. 257 r Buy

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Telzap 40 mg film-coated tablets 90 pcs. 666 RUB Buy

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Telzap tablets 80mg 90 pcs. 770 RUB Buy

Telzap 80 mg film-coated tablets 90 pcs. 770 RUB Buy

Telzap Plus 12.5 mg + 80 mg film-coated tablets 90 pcs. 979 r Buy

Telzap Plus tablets 80mg + 12.5mg 90 pcs. 996 RUB Buy

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!