Telzap is an antihypertensive drug that is often prescribed to patients with high blood pressure.
This drug has a number of advantages: high efficiency, safety, less pronounced side effects, affordable price.
This medicine for high blood pressure has a prolonged effect.
The result of treatment should be assessed after 4-6 weeks of use.
Letters from our readers
Topic: Grandma's blood pressure has returned to normal!
From: Christina ( [email protected] )
To: Administration otgipertonii.ru
Christina, Moscow
My grandmother’s hypertension is hereditary - most likely, I will have the same problems as I get older.
I accidentally found an article on the Internet that literally saved my grandmother. She was tormented by headaches and had a repeated crisis. I bought the course and monitored the correct treatment.
After 6 weeks she even started talking differently. She said that her head no longer hurts, but she still takes pills for blood pressure. I am sending a link to the article
Release form and composition
The drug is available in the form of film-coated tablets: 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 pack there are 3, 6 or 9 blisters and instructions for using Telzap).
1 tablet contains:
- active ingredient: telmisartan – 40 mg or 80 mg;
- auxiliary components: povidone 25, meglumine, sodium hydroxide, sorbitol, magnesium stearate.
Indications for use
According to the instructions for use, Telzap is prescribed to people with essential arterial hypertension.
It is also taken by patients with an increased risk of mortality from cardiovascular diseases:
- with type 2 diabetes mellitus, which is combined with myocardial damage;
- if there is a history of coronary heart disease of the 2nd degree, strokes, thrombosis of peripheral arteries.
It is recommended that you consult your doctor before taking this drug.
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Pharmacological properties
Pharmacodynamics
Telzap is an antihypertensive drug; its active ingredient is telmisartan, a specific angiotensin II receptor antagonist (AT1 subtype). Telmisartan has a high degree of affinity for AT1 (angiotensin) receptors, through which the action of angiotensin II is realized. Without having an agonist effect on the receptor, it displaces angiotensin II from its connection with it and binds only to the AT1 receptor subtype of angiotensin II. Telmisartan has no affinity for other angiotensin receptors (including AT2 receptors). Their functional significance and the effect of possible excessive stimulation 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 renin activity, and does not inhibit the action of angiotensin-converting enzyme (kininase II), which catalyzes the destruction of bradykinin. This allows you to avoid the development of a dry cough and other side effects caused by the action of bradykinin.
For 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 persists for 24 hours, remaining clinically significant for up to 48 hours. A pronounced antihypertensive effect is achieved after 28–56 days of regular use of the drug.
In arterial hypertension, telmisartan reduces systolic and diastolic blood pressure (BP) without affecting heart rate (HR).
Abrupt withdrawal of Telzap is not accompanied by the development of withdrawal syndrome; blood pressure gradually returns to its original values over several days.
The antihypertensive effect of telmisartan is comparable to the effect of such antihypertensive drugs 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 disease in adult patients (age 55 years and older) with transient ischemic attack, coronary artery disease, peripheral arterial disease, stroke, or complications of type 2 diabetes mellitus (including retinopathy, left ventricular hypertrophy, macro- or A history of microalbuminuria contributed to a reduction in the composite endpoint of hospitalization for chronic heart failure, cardiovascular mortality, myocardial infarction, or nonfatal stroke. Telmisartan also exhibits a similar effect to ramipril in reducing the incidence of secondary endpoints: cardiovascular mortality, myocardial infarction or non-fatal stroke. In contrast to ramipril, when taking telmisartan, the incidence of dry cough and angioedema is lower, and arterial hypotension is higher.
Pharmacokinetics
After oral administration, 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 Cmax (maximum concentration in blood plasma) is 3 times higher, and AUC is approximately 2 times higher, but this does not have a significant effect on the effectiveness of Telzap.
There is no linear relationship between the dose and plasma concentration of the drug. When using daily doses above 40 mg, Cmax and AUC change disproportionately with increasing dose.
Binding to blood plasma proteins (mainly albumin and alpha1-acid glycoprotein) is more than 99.5%.
The average apparent volume of distribution is 500 l.
Telmisartan is metabolized by conjugation with glucuronic acid; the conjugate has no pharmacological activity.
T1/2 (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.
In mild to moderate renal impairment, as well as in patients over 65 years of age, the pharmacokinetics of telmisartan are not affected, so no dose adjustment is required.
In severe renal failure and for patients on hemodialysis, the initial dose should not exceed 20 mg per day.
Telmisartan is not eliminated by hemodialysis.
For mild to moderate liver dysfunction (classes A and B according to the Child-Pugh classification), a daily dose of up to 40 mg should be used.
Effect on blood pressure
The action of this drug is aimed at a gentle and gradual reduction in blood pressure. This occurs due to the effect on angiotensin receptors of the ATI subtype.
The drug blocks specific proteins, eliminates the influence of aldosterone, but does not disrupt the exchange of potassium ions.
Telzap reduces both systolic and diastolic pressure, but does not interfere with heart function.
Telmisartan does not alter bradykinin metabolism. Therefore, an important advantage of the medicine is the absence of unpleasant side effects such as diarrhea and dry cough.
Withdrawal syndrome usually does not develop after abrupt cessation of use. However, within 2-3 days the pressure returns to its original level. This explains why blood pressure rises when Telzap 80 mg is excluded from the drug regimen.
Telmisartan is used only for long-term treatment (at least 4 weeks). It cannot be used to relieve symptoms of hypertensive crisis.
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 impairment [GFR (glomerular filtration rate) less than 60 ml/min/1.73 m2 body surface] or diabetes mellitus;
- concomitant therapy with angiotensin-converting enzyme (ACE) inhibitors in patients with diabetic nephropathy;
- hereditary fructose intolerance;
- pregnancy period;
- breast-feeding;
- age under 18 years;
- hypersensitivity to the components of the drug.
Telzap should be prescribed with caution in severe chronic heart failure, hypertrophic obstructive cardiomyopathy, aortic and mitral valve stenosis, renal dysfunction, bilateral renal artery stenosis, artery stenosis of the only functioning kidney, mild to moderate liver dysfunction, decreased circulating blood volume (CBV). ) 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.
Analogues of the drug Telzap
For treatment, analogues of the composition are prescribed:
- Prytor;
- Telsartan;
- Telsartan N;
- Telmisartan;
- Telpres;
- Teseo;
- Telmista;
- Tanidol;
- Telpres Plus;
- Micardis;
- MicardisPlus;
- Telzap Plus.
Analogs of angiotensin 2 receptor antagonists include:
- Sartavel;
- Presartan;
- Micardis;
- Losarel;
- Twinsta;
- Artinova;
- Exfotanz;
- Exforge;
- Firmasta;
- Irbesartan;
- Lorista;
- Telmisartan;
- Blocktran;
- Valz N;
- Ibertan;
- Kozaar;
- Renicard;
- Cardosten;
- Losartan;
- Naviten;
- Brozaar;
- Coaprovel;
- Lozap Plus;
- Walz;
- Lozap;
- Telsartan;
- Aprovel;
- Cardomine;
- Tareg;
- Telpres;
- Ordiss;
- Olimestra;
- Nortivan;
- Candecor;
- Duopress;
- Vasotens;
- Irsar;
- Gizaar;
- Zisakar;
- Edarby;
- Valsacor;
- Hyposart;
- Losartan N;
- Aprovask;
- Prytor;
- Candesartan;
- Diovan;
- Teveten;
- Eprosartan mesylate;
- Cardos;
- Cardosal;
- Co-Exforge;
- Carzartan;
- Xarten;
- Losakor;
- Valsartan;
- Tanidol;
- Atakand;
- Vamloset.
Telzap, instructions for use: method and dosage
Telzap tablets are taken orally with a sufficient amount of liquid, regardless of meals.
The frequency of taking the drug is 1 time per day.
Recommended daily dosage:
- arterial hypertension: initial dose – 20–40 mg. If there is no sufficient antihypertensive 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 incidence of cardiovascular diseases: 80 mg, at the beginning of treatment it is necessary to control blood pressure levels. If necessary, antihypertensive therapy should be adjusted.
In severe renal failure or patients on hemodialysis, it is recommended to use an initial daily dose of no more than 20 mg.
For mild to moderate renal impairment, no dose adjustment is required.
For mild to moderate liver failure (classes A and B according to the Child-Pugh classification), the daily dose of Telzapa should not exceed 40 mg.
Special conditions
If the following factors are present, only a qualified specialist can prescribe the drug and calculate its dosage:
- Serious kidney problems. For patients who have moderate functional renal impairment, no special dose adjustment is required. However, in case of severe renal impairment, the dosage should be reduced to 20 mg. If the patient is on hemodialysis, Telzap cannot be taken.
- Diabetes. The drug lowers blood glucose levels, so patients should constantly monitor their sugar levels.
- Cardiomyopathy, narrowing of the aortic or mitral valves. Telzap will expand the lumen of blood vessels, so patients with such diseases require special monitoring of drug therapy.
- Double blockade of the RAAS. Inhibition of the RAAS will lead to a strong decrease in blood pressure, increased potassium production and decreased renal function.
- Renovascular hypertension. Pathology appears when blood circulation is impaired due to stenosis of the renal vessels. When using the drug, kidney failure may occur.
- Functional liver disorders. For moderate liver dysfunction, no dose adjustment is required. In case of serious pathologies, taking pills is prohibited.
Side effects
- general disorders: infrequently – asthenia, chest pain; rarely – influenza-like syndrome;
- diseases of infectious and parasitic origin: uncommon - urinary tract infections (including cystitis), upper respiratory tract infections (including sinusitis, pharyngitis); rarely - sepsis (including death);
- from 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;
- from the mental side: infrequently – depression, insomnia; rarely – anxiety;
- on the part of metabolism and nutrition: infrequently – hyperkalemia; rarely – hypoglycemia due to 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, functional disorders of the liver;
- from the nervous system: infrequently – fainting; rarely - drowsiness;
- from the organ of hearing, labyrinthine disorders: infrequently – vertigo;
- from the organ of vision: visual disorders;
- from the respiratory system, chest and mediastinal organs: infrequently – cough, shortness of breath; very rarely - interstitial lung disease;
- dermatological reactions: uncommon – 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;
- from the musculoskeletal system and connective tissue: infrequently - muscle spasms, back pain (sciatica), myalgia; rarely – pain in the limbs, arthralgia, tendon pain (tendenitis-like syndrome);
- laboratory parameters: infrequently - increased creatinine levels in blood plasma; rarely - a decrease in hemoglobin content 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.
Telzap plus 80mg+12.5mg 30 pcs. zentiva tablets saalyk yurynleri sanayi ve tijaret a.sh.
pharmachologic effect
Combination antihypertensive agent (angiotensin II receptor antagonist + diuretic).
Composition and release form Telzap plus 80mg+12.5mg 30 pcs. zentiva tablets saalyk yurynleri sanayi ve tijaret a.sh.
Tablets - 1 tablet:
- active ingredients: hydrochlorothiazide - 12,500 mg; telmisartan - 80,000 mg;
- excipients: sorbitol, sodium hydroxide, povidone 25, magnesium stearate.
Tablets, 12.5 mg + 80 mg.
10 or 14 tablets in an Alu/Alu blister.
3 or 9 blisters (10 tablets each) or 1, 2, 4, 6 or 7 blisters (14 tablets each) are placed in a cardboard pack along with instructions for use.
Description of the dosage form
Oblong, biconvex tablets, white or almost white with a yellowish tint, engraved “81” on one side.
Directions for use and doses
Telzap® Plus is taken orally once a day with liquid, regardless of meals.
Patients whose blood pressure cannot be adequately controlled with telmisartan or hydrochlorothiazide monotherapy should take Telzap® Plus.
Before switching to a fixed-dose combination, individual titration of the dose of each component is recommended.
In some clinical situations, a direct switch from monotherapy to fixed-dose combination therapy may be considered.
Telzap® Plus, 12.5 mg + 80 mg, can be used once daily in patients whose blood pressure cannot be adequately controlled when taking telmisartan at a dose of 80 mg per day.
Special patient populations
Patients with impaired renal function
No dose adjustment is required in patients with mild or moderate renal impairment (creatinine clearance more than 30 ml/min). Periodic monitoring of kidney function indicators is recommended.
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal failure (GFR less than 60 ml/min/1.73 m2).
Patients with liver dysfunction
Telzap® Plus is contraindicated in patients with impaired liver function.
Elderly patients (over 70 years old)
For elderly patients, no dose adjustment is required.
Children and teenagers
Telzap® Plus is contraindicated for use in children and adolescents under 18 years of age due to the lack of data on safety and effectiveness.
Pharmacodynamics
Telzap Plus is a combination of telmisartan (an angiotensin II receptor antagonist (ARA II)) and hydrochlorothiazide (a thiazide diuretic). The combination of these components provides a more pronounced antihypertensive effect, while the level of blood pressure (BP) decreases more than with monotherapy with these components.
The drug, used once a day in therapeutic doses, effectively and gradually reduces blood pressure.
Telmisartan
Telmisartan is a specific angiotensin II receptor antagonist (AT1 subtype), effective when taken orally. Telmisartan has a high affinity for the AT1 receptor subtype of angiotensin II, through which the action of angiotensin II is realized. Telmisartan displaces angiotensin II from its connection with the receptor without exhibiting the properties of an AT1 receptor agonist. Telmisartan selectively and persistently binds to the AT1 receptor. Telmisartan has no affinity for other receptors, including AT2 and other less studied AT receptors. The functional role of these receptors, as well as the effect of their possible increased stimulation by angiotensin II, the concentration of which increases under the influence of telmisartan, have not been studied.
Telmisartan reduces the concentration of aldosterone in the blood plasma, does not inhibit renin and does not block ion channels.
Telmisartan does not inhibit angiotensin-converting enzyme (ACE, kininase II), which also destroys bradykinin. This avoids side effects associated with bradykinin.
In healthy people, telmisartan at a dose of 80 mg almost completely blocks the hypertensive effect of angiotensin II. The suppressive effect lasts more than 24 hours and persists up to 48 hours.
The onset of antihypertensive action is observed within the first 3 hours after oral administration of telmisartan. The duration of the therapeutic effect of the drug is more than 24 hours and includes the last 4 hours before taking the next dose according to 24-hour blood pressure monitoring. This is confirmed by measurements taken at the time of maximum effect and immediately before taking the next dose (the ratio of residual to maximum effect is above 80% for dosages of telmisartan 40 and 80 mg in placebo-controlled studies).
The maximum antihypertensive effect develops after 4-8 weeks of regular use of telmisartan and persists during long-term therapy.
In patients with arterial hypertension, telmisartan reduces both systolic and diastolic pressure without affecting heart rate (HR).
According to the results of clinical studies, the effectiveness of the antihypertensive effect of telmisartan is comparable to the therapeutic effect of drugs of other classes, such as amlodipine, atenolol, enalapril, hydrochlorothiazide and lisinopril.
In case of abrupt cessation of treatment with telmisartan, blood pressure gradually returns to initial values, without the development of hepatic coma syndrome.
There is no clinical experience with the combination of telmisartanhydrochlorothiazide in patients with impaired liver function.
Renovascular hypertension
When treated with drugs acting on the RAAS, in patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney, the risk of a significant decrease in blood pressure and the development of acute renal failure increases.
Double blockade of the RAAS
Data on the simultaneous use of ACE inhibitors with ARB II or with drugs containing aliskiren confirm an increased risk of a sharp decrease in blood pressure, the development of hyperkalemia and decreased renal function (including acute renal failure). The simultaneous use of ARA II with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 l ml/min/1.73 m2 body surface area) and is not recommended in other patients.
If it is necessary to carry out double blockade of the RAAS, each case should be considered individually and carefully monitor renal function, water-electrolyte balance and blood pressure.
Concomitant use of ARB II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.
Other conditions associated with stimulation of the RAAS
In patients whose vascular tone and renal function depend primarily on the activity of the RAAS (for example, patients with severe chronic heart failure or existing kidney disease, including renal artery stenosis), the use of drugs acting on this system, such as telmisartan, is associated with with the occurrence of an acute decrease in blood pressure, hyperazotemia, oliguria, or rarely with the development of acute renal failure).
Primary hyperaldosteronism
In patients with primary hyperaldosteronism, treatment with antihypertensive drugs that act by inhibiting the RAAS is usually ineffective. In this regard, the use of Telzap® Plus is not recommended.
Renal dysfunction and kidney transplantation
The use of Telzap® Plus is contraindicated in patients with severe renal impairment (CR
Since experience with the use of Telzap® Plus in patients with mild to moderate renal impairment is limited, it is recommended to periodically monitor the content of potassium, creatinine and uric acid in the blood plasma, as well as indicators of renal function. In patients with impaired renal function, azotemia may occur due to the use of thiazide diuretics.
Decrease in circulating blood volume (CBV)
A decrease in blood pressure, especially after the first dose of Telzap® Plus, may occur in patients with reduced blood volume and/or low sodium content in the blood plasma due to previous treatment with diuretics, restriction of salt intake, diarrhea or vomiting. Such conditions (fluid and/or sodium deficiency) must be eliminated before taking Telzap® Plus.
Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy
As with other vasodilators, patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy, should be especially careful.
Effect on metabolism and endocrine function
The use of hydrochlorothiazide may impair glucose tolerance, and in patients with diabetes mellitus hypoglycemia may develop during the simultaneous use of insulin or hypoglycemic agents and telmisartan. Dosage adjustment of hypoglycemic agents, including insulin, may be required.
During treatment with thiazides in patients with impaired glucose tolerance, the manifestation of latent diabetes mellitus is possible.
Treatment with thiazide diuretics is associated with an increase in the concentration of cholesterol and triglycerides in the blood plasma. However, when using a drug containing 12.5 mg of hydrochlorothiazide, this effect is minimal or absent.
Some patients using hydrochlorothiazide may develop hyperuricemia or a sudden onset of gout flare-up.
Water-electrolyte imbalance
When using the drug Telzap Plus, it is necessary to periodically monitor the content of electrolytes in the blood plasma.
Thiazides, including hydrochlorothiazide, can cause fluid and electrolyte imbalances (hypokalemia, hyponatremia and hypochloremic alkalosis) and changes in acid-base status.
Signs of water and electrolyte imbalance are: dry mouth, thirst, general weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle weakness, decreased blood pressure, oliguria, tachycardia and gastrointestinal disorders such as nausea and vomiting.
Hypokalemia
Although hypokalemia may occur due to the use of hydrochlorothiazide, concomitant therapy with telmisartan may compensate for the decrease in plasma potassium concentrations. The risk of hypokalemia increases in patients with cirrhosis, patients with severe diuresis, those on a salt-free diet, patients who do not adequately replace lost electrolytes, and also in patients receiving concomitant therapy with corticosteroids or ACTH.
Hyperkalemia
Taking telmisartan may cause the development of hyperkalemia. However, no clinically significant hyperkalemia was observed while taking Telzap® Plus.
The main risk factors for the development of hyperkalemia are:
- diabetes mellitus, renal failure, heart failure, old age (patients over 70 years of age);
- combination with one or more drugs acting on the RAAS and/or potassium supplements. Medicines that can cause hyperkalemia are potassium-sparing diuretics and ACE inhibitors. ARA II, NSAIDs, including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus), trimethoprim, and salt substitutes containing potassium;
- concomitant diseases, especially dehydration, acute heart failure, metabolic acidosis, acute renal failure (for example, in infectious diseases), cytolysis syndrome (for example, acute limb ischemia, rhabdomyolysis, major trauma).
Patients at risk are advised to carefully monitor plasma potassium levels.
Hyponatremia and hypochloremic alkalosis
There is no evidence that Telzap® Plus reduces or prevents the development of diuretic-induced hyponatremia. Minor chlorine deficiency usually does not require correction.
Hypercalcemia
Hydrochlorothiazide may reduce urinary calcium excretion and cause periodic and slight increases in plasma calcium in the absence of any disturbances in calcium metabolism. Severe hypercalcemia may be a sign of hidden hyperparathyroidism. Hydrochlorothiazide should be discontinued before parathyroid function tests are performed.
Hypomagnesemia
While taking hydrochlorothiazide, an increase in the excretion of magnesium in the urine was noted, which can lead to hypomagnesemia.
Ethnic differences
Like all other II receptor antagonists, telmisartan is less effective in lowering blood pressure in black patients than in other races, possibly due to a greater predisposition to decreased renin activity in these patient populations.
During post-marketing use, the majority of cases of hepatic dysfunction or liver injury occurred in Japanese subjects. The Japanese are more predisposed to developing these adverse reactions.
Coronary heart disease and cerebrovascular disease
As with any other antihypertensive drugs, an excessive decrease in blood pressure in patients with coronary heart disease or cerebrovascular disease can lead to the development of myocardial infarction or stroke.
Heart failure
As with other drugs that affect the RAAS, patients with heart failure (with or without renal impairment) are at risk of developing a significant decrease in blood pressure, as well as renal dysfunction (often acute).
General violations
Hypersensitivity reactions to hydrochlorothiazide are most likely to occur in patients with a history of allergic reactions or asthma. It is known that the use of thiazide diuretics, including hydrochlorothiazide, can lead to exacerbation or worsening of symptoms of systemic lupus erythematosus.
Photosensitivity reactions have been observed with the use of hydrochlorothiazide. If a photosensitivity reaction occurs, it is recommended to stop taking Telzap® Plus. If the use of diuretics is still necessary, it is recommended to protect exposed skin from exposure to sunlight or artificial ultraviolet irradiation.
Acute myopia and angle-closure glaucoma
Hydrochlorothiazide, being a sulfonamide derivative, can cause an idiosyncratic reaction leading to acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders include a sudden decrease in visual acuity or eye pain and usually occur between a few hours and a few weeks after starting treatment. If acute angle-closure glaucoma is not treated in a timely manner, it can lead to permanent vision loss.
First of all, you should immediately stop taking Telzap® Plus. If intraocular pressure is not controlled, emergency conservative or surgical treatment may be required. Risk factors for the development of acute angle-closure glaucoma include a history of an allergic reaction to sulfonamides or penicillin.
Anti-doping test
When using drugs containing hydrochlorothiazide, athletes may have a positive result during a doping test.
Sorbitol
This medicinal product contains sorbitol (E420). In patients with rare hereditary fructose intolerance, the use of Tslzap® Plus is contraindicated.
Impact on the ability to drive vehicles and operate machinery
When driving vehicles and engaging in potentially hazardous activities, it should be taken into account that dizziness and drowsiness may occur while taking Telzap® Plus, which requires caution.
Overdose
No cases of overdose have been identified. Possible symptoms consist of symptoms of an overdose of individual components.
Symptoms
The most pronounced manifestations of telmisartan overdose are arterial hypotension and tachycardia, and bradycardia, dizziness, vomiting, increased serum creatinine and acute renal failure have also been reported.
An overdose of hydrochlorothiazide is associated with a decrease in electrolyte levels (hypokalemia, hypochloremia) and hypovolemia due to excessive diuresis. The most common symptoms of overdose are nausea and drowsiness. Hypokalemia may lead to muscle spasm and/or exacerbation of arrhythmias when used concomitantly with cardiac glycosides or certain antiarrhythmic drugs.
Treatment
Telmisartan is not eliminated by hemodialysis. The extent of hydrochlorothiazide elimination by hemodialysis has not been established.
Patients should be carefully monitored and treated symptomatically as well as supportively. The treatment approach depends on the time elapsed after taking the drug and the severity of symptoms.
Recommended measures include inducing vomiting and/or gastric lavage; it is advisable to take activated charcoal. The patient should be placed on his back, legs elevated. If necessary, it is recommended to replenish the blood volume, for example, by intravenous administration of 0.9% sodium chloride solution. Sympathomimetic drugs may be prescribed.
Side effects Telzap plus 80mg+12.5mg 30 pcs. zentiva tablets saalyk yurynleri sanayi ve tijaret a.sh.
The most commonly reported adverse reaction with the combination telmisartanhydrochlorothiazide was dizziness.
Serious angioedema occurred rarely (≥ 1/10,000 -
The overall incidence of adverse reactions with the combination of telmisartan hydrochlorothiazide was comparable to that with telmisartan monotherapy.
The dependence of the development of adverse reactions on the dose of the drug has not been established; there was no relationship with the gender, age or race of patients.
Side effects are divided into systemic classes in accordance with the Medical Dictionary of Regulatory Activities (MedDRA).
The frequency of side effects was determined in accordance with the World Health Organization (WHO) classification: very often (≥1/10), often (≥1/100 -
Below are all the adverse reactions reported with telmisartan or hydrochlorothiazide monotherapy, or with the combination of telmisartan + hydrochlorothiazide.
Infectious and parasitic diseases: uncommon: upper respiratory tract infections, urinary tract infections, including cystitis; rarely: sepsis, including death, bronchitis, pharyngitis, sinusitis; frequency unknown: sialadenitis.
Blood and lymphatic system disorders: uncommon: anemia; rarely: eosinophilia, thrombocytopenia; frequency unknown: aplastic anemia, hemolytic anemia, bone marrow suppression, leukopenia, neutropenia, agranulocytopenia, thrombocytopenia.
Immune system disorders: rarely: increased symptoms or exacerbation of systemic lupus erythematosus (during post-marketing surveillance), hypersensitivity reactions, anaphylactic reactions.
Endocrine system disorders: frequency unknown: lack of adequate glycemic control in diabetes mellitus.
Metabolic and nutritional disorders: uncommon: hyperkalemia, hypokalemia; rarely: hypoglycemia (in patients with diabetes mellitus), hyperuricemia, hyponatremia; frequency unknown: anorexia, loss of appetite, water and electrolyte imbalance, hypovolemia, hyperglycemia.
Mental disorders: uncommon: anxiety; rarely: depression; frequency unknown: excited state.
Nervous system disorders: often: dizziness; uncommon: fainting, paresthesia; rarely: drowsiness, insomnia, sleep disturbance; frequency unknown: presyncope.
Visual disturbances: rarely: visual impairment, transient blurred vision; frequency unknown: xanthopsia, acute myopia, acute angle-closure glaucoma.
Hearing and labyrinthine disorders: uncommon: vertigo.
Cardiac disorders: uncommon: bradycardia, tachycardia, arrhythmia.
Vascular disorders: uncommon: arterial hypotension, orthostatic hypotension; frequency unknown: necrotizing vasculitis.
Disorders of the respiratory system, chest and mediastinal organs: uncommon: cough, shortness of breath; rarely: respiratory distress syndrome (including pneumonitis and pulmonary edema); very rare: interstitial lung disease.
Gastrointestinal disorders: uncommon: diarrhea, dry mouth, flatulence; rarely: discomfort in the stomach, abdominal pain, constipation, dyspepsia, vomiting, gastritis; frequency unknown: pancreatitis, discomfort in the stomach.
Disorders of the liver and biliary tract: rarely: impaired liver function/liver disease; frequency unknown: jaundice (parenchymal or cholestatic).
Skin and subcutaneous tissue disorders: rarely: eczema, drug rash, toxic skin rash, angioedema (also fatal), erythema, itching, skin rash, increased sweating, urticaria; frequency unknown: lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis (Lyell's syndrome).
Musculoskeletal and connective tissue disorders: uncommon: back pain, muscle spasms, myalgia; rarely: arthrosis, pain in the tendon area, joint pain, muscle cramps, pain in the limbs; frequency unknown: weakness.
Genital and breast disorders: uncommon: erectile dysfunction.
Renal and urinary tract disorders: uncommon: impaired renal function (including acute renal failure); frequency unknown: interstitial nephritis, renal dysfunction, glycosuria.
General disorders and disorders at the injection site: uncommon: asthenia, chest pain; rarely: flu-like syndrome, pain; frequency unknown: hyperthermia.
Impact on the results of laboratory and instrumental studies: rarely: decreased hemoglobin content, increased concentration of creatinine in the blood plasma, increased activity of creatine phosphokinase, increased activity of “liver” transaminases; frequency unknown: hypertriglyceridemia, hypercholesterolemia.
Description of selected adverse reactions
Interstitial lung disease
During post-registration use of the drug, cases of interstitial lung disease while taking telmisartan were described, but a cause-and-effect relationship was not established.
Drug interactions
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Concomitant use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR
The simultaneous use of ACE inhibitors with ARBs or drugs containing aliskiren is characterized by an increased risk of developing arterial hypotension, hyperkalemia and decreased renal function (including acute renal failure) in patients compared to the use of each drug separately.
In patients with diabetic nephropathy, the use of a combination of ACE inhibitors and ARB II is contraindicated.
Digoxin
With simultaneous use of telmisartan with digoxin, an average increase in peak plasma concentration (49%) and trough concentration (20%) of digoxin was noted. When co-administered, at the beginning of treatment, when selecting a dose and stopping treatment with telmisartan, the concentration of digoxin in the blood should be monitored to maintain it within the therapeutic range.
Drugs that cause potassium loss and hypokalemia
Other kaliuretic diuretics, laxatives, corticosteroids, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G sodium salt, salicylic acid and its derivatives. If it is necessary to use these drugs simultaneously with the telmisartan/hydrochlorothiazide combination, it is recommended to monitor the potassium level in the blood plasma. These drugs may increase potassium loss when used concomitantly with hydrochlorothiazide.
Medicines that cause an increase in potassium levels in the blood plasma
Like other drugs that act on the RAAS, the use of the telmisartan/hydrochlorothiazide combination may cause hyperkalemia. The risk may increase when used concomitantly with other drugs that can cause hyperkalemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, ARB II, nonsteroidal anti-inflammatory drugs (NSAIDs, including selective cyclooxygenase-2 [COX-2] inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim).
If precautions are strictly followed, combination with ACE inhibitors or NSAIDs is associated with less risk.
If it is necessary to use these drugs simultaneously with the telmisartan/hydrochlorothiazide combination, it is recommended to monitor the potassium level in the blood plasma.
Lithium
With the simultaneous use of lithium preparations with ACE inhibitors and rarely with ARA II, including the combination of telmisartan/hydrochlorothiazide, a reversible increase in the concentration of lithium in the blood plasma and its toxic effect was observed. When used simultaneously with lithium preparations, it is recommended to carefully monitor the concentration of lithium in the blood plasma.
Nonsteroidal anti-inflammatory drugs (NSAIDs)
NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment (not more than 3 g per day), COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of ARA II and weaken the diuretic, natriuretic effect of thiazide diuretics.
In some patients with impaired renal function (for example, in dehydrated patients with reduced volume of blood volume, elderly patients), the simultaneous use of ARB II and drugs that inhibit COX may lead to a further deterioration of renal function, up to the development of acute renal failure, which, as a rule, is reversible. Therefore, the simultaneous use of the combination of telmisartan/hydrochlorothiazide with NSAIDs should be used with caution, especially in elderly patients. It is necessary to ensure that patients receive adequate fluid intake, and renal function should be monitored at the beginning of simultaneous use and periodically thereafter.
When telmisartan was taken concomitantly with ibuprofen or paracetamol, no clinically significant interaction effect was observed.
Medicines whose action is influenced by changes in the potassium content in the blood plasma
It is recommended to periodically monitor the potassium content in the blood plasma and conduct an electrocardiographic study (ECG) during use with drugs whose effect depends on changes in the concentration of potassium in the blood plasma (for example, with cardiac glycosides, antiarrhythmic drugs), as well as after an attack of ventricular tachycardia, including those caused by drugs (including some antiarrhythmic drugs).
Hypokalemia was a provoking factor for the development of ventricular tachycardia of the “pirouette” type (torsade de pointes):
- Class Ia antiarrhythmic drugs (eg, quinidine, hydroquinidine, disopyramide)
- class III antiarrhythmic drugs (eg, amiodarone, sotalol, dofetilide, ibutilide);
- some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol);
- other drugs (eg, bepridil, cisapride, diphemanil, erythromycin [intravenous injection], halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine [intravenous injection]).
Cardiac glycosides
Hypokalemia or hypomagnesemia caused by hydrochlorothiazide may contribute to the occurrence of arrhythmia during therapy with cardiac glycosides.
Other antihypertensive drugs
Telmisartan may enhance the effect of other antihypertensive drugs.
Antidiabetic agents (oral medications and insulin)
Dosage adjustments of antidiabetic medications may be required.
Metformin
Metformin should be used with caution due to the risk of lactic acidosis caused by possible functional renal failure while taking hydrochlorothiazide.
Cholestyramine and colestipol
The absorption of hydrochlorothiazide is reduced in the presence of anion exchange resins.
Pressor amines (e.g. norepinephrine (norepinephrine))
The effect of vasopressor amines may be weakened.
Nondepolarizing skeletal muscle relaxants (eg, tubocurarine)
The effect of non-depolarizing muscle relaxants can be enhanced by hydrochlorothiazide.
Antigout medications (eg, probenecid, sulfinpyrazone, and allopurinol)
It may be necessary to adjust the dose of drugs that promote the removal of uric acid, since hydrochlorothiazide can increase the level of uric acid in the blood plasma. The dose of probenecid or sulfinpyrazone may need to be increased. Concomitant use of a thiazide diuretic may increase the incidence of hypersensitivity reactions to allopurinol.
Calcium salts
Hydrochlorothiazide may increase plasma calcium levels due to decreased calcium excretion. If calcium supplementation is necessary, plasma calcium concentrations should be monitored and the dose adjusted accordingly.
Due to their effect on calcium metabolism, thiazides may interfere with test results to assess parathyroid function.
β-adrenergic blockers and diazoxide
The hyperglycemic effect of β-adrenergic blockers and diazoxide can be enhanced by hydrochlorothiazide.
Anticholinergics (eg, atropine, biperiden)
Anticholinergics may increase the bioavailability of hydrochlorothiazide by decreasing gastrointestinal motility and the rate of gastric emptying.
Amantadine
Hydrochlorothiazide may increase the risk of adverse reactions caused by amantadine.
Glycyrrhizic acid
The interaction of hydrochlorothiazide and licorice root (glycyrrhizic acid) can lead to the development of hypokalemia.
Cytotoxic drugs (eg, cyclophosphamide, methotrexate)
Hydrochlorothiazide may reduce the renal excretion of cytotoxic drugs and enhance their myelosuppressive effect.
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 may be exacerbated by the use of alcohol, barbiturates, narcotics, or antidepressants.
Corticosteroids (for systemic use)
Corticosteroids weaken the antihypertensive effect of telmisartan.
Overdose
Symptoms: marked decrease in blood pressure, tachycardia, dizziness, bradycardia, increased serum creatinine concentration, acute renal failure.
Treatment: immediate gastric lavage, artificial vomiting, taking activated charcoal. The severity of symptoms and the patient's condition should be carefully monitored. Prescribe symptomatic and supportive therapy. It is important to ensure regular blood testing for electrolytes and plasma creatinine levels. If there is a pronounced decrease in blood pressure, the patient should be placed with his legs elevated. Carry out measures to replenish blood volume and electrolytes.
The use of hemodialysis is inappropriate.
special instructions
When prescribing Telzap to patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney, it should be taken into account that taking the drug may cause an increased risk of severe arterial hypotension and renal failure.
Treatment with the drug should be started only after the existing deficiency of bcc and/or sodium content in the blood plasma has been eliminated.
The use of Telzap in patients with impaired renal function is recommended to be accompanied by periodic monitoring of potassium and creatinine levels in the blood plasma.
Inhibition of the RAAS (renin-aldosterone-angiotensin system) may occur in patients predisposed to this and when telmisartan is taken concomitantly with other RAAS antagonists. It may cause hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure).
In chronic heart failure, kidney disease or other pathologies with a predominant dependence on the activity of the RAAS, the administration of Telzapa can cause the development of acute arterial hypotension, hyperazotemia, oliguria, and in rare cases, acute renal failure.
In case of primary hyperaldosteronism, the use of the drug is ineffective.
During treatment with telmisartan, hypoglycemia may occur in diabetic patients receiving insulin or oral hypoglycemic agents, so careful monitoring of blood glucose levels is required. If necessary, the dose of insulin or hypoglycemic agent should be adjusted.
Particular caution should be taken into account 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 potassium levels in the blood plasma, elderly patients (over 70 years of age), since these categories of patients are at high risk of developing hyperkalemia, including death.
During the period of treatment with the drug, simultaneous use of other medications should be carried out only as prescribed by the attending physician.
An excessive decrease in blood pressure due to ischemic cardiomyopathy or coronary heart disease can lead to the development of myocardial infarction or stroke.
In patients of the Negroid race, a less effective lowering of blood pressure is observed.
Impact on the ability to drive vehicles and complex mechanisms
While taking Telzap, it is recommended to be careful when driving vehicles and machinery due to the possibility of dizziness and drowsiness.
Side effects
Despite its high effectiveness, the blood pressure medicine Telzap has a number of side effects.
These include:
- decrease in the amount of hemoglobin and platelets;
- increased potassium levels in the blood;
- decreased glucose concentration;
- hearing impairment;
- decreased heart rate;
- allergic rashes, erythema, skin itching;
- pain in muscles and joints;
- digestive disorders, changes in taste, increased gas formation;
- mood lability, rarely – anxiety;
- changes in the normal functioning of the kidneys and liver;
- drowsiness;
- dizziness, short-term loss of consciousness.
The patient needs to carefully monitor his condition. The appearance of any negative changes in the body may indicate the ineffectiveness of therapy.
For impaired renal function
The use of Telzap is contraindicated in patients with renal failure (GFR less than 60 ml/min/1.73 m2) who are on concomitant therapy with aliskiren.
Telzap should be prescribed with caution in case of impaired renal function, bilateral renal artery stenosis, or stenosis of the artery of a single 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.
For mild to moderate renal impairment, no dose adjustment is required.
Drug interactions
With simultaneous use of Telzap:
- aliskiren: in patients with renal failure or diabetes mellitus, combination therapy with telmisartan and aliskiren leads to double blockade of the RAAS, resulting in an increased incidence of adverse events such as arterial hypotension, hyperkalemia and renal dysfunction;
- ACE inhibitors: in patients with diabetic nephropathy, during concomitant therapy with ACE inhibitors, 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-containing salt substitutes, nonsteroidal anti-inflammatory drugs (NSAIDs), heparin, cyclosporine, tacrolimus, trimethoprim: increase the likelihood of developing hyperkalemia. If combined use is necessary, the level of potassium concentration in the blood plasma should be regularly monitored;
- digoxin: there is an increase in the average concentration of digoxin in the blood plasma (Cmax - by 49%, Cmin - by 20%), therefore, when selecting the dose of telmisartan or stopping its use, the level of digoxin in the blood plasma should be monitored, not allowing it to exceed its therapeutic range;
- lithium preparations: it should be taken into account that during 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 weaken the hypotensive effect of telmisartan. If renal function is impaired, combination with COX-2 inhibitors may cause a reversible deterioration of 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 treatment with telmisartan;
- other antihypertensive drugs: enhance the effect of telmisartan;
- antidepressants, ethanol, barbiturates, narcotic drugs: increase the risk of developing orthostatic hypotension;
- corticosteroids for systemic use: cause a weakening of the hypotensive effect of Telzap.
Analogs
There are a number of medicines whose active ingredient is also telmisartan:
- Telsartan;
- Telmista;
- Telpres;
- Mikardis.
You can replace Telzap with analogues only after consulting a doctor!
