TELZAP PILLS 80MG

Clinico-pharmacological group:

Angiotensin II Receptor Antagonist

Pharmaco-therapeutic group:

Angiotensin II receptor antagonist

Indications

- essential hypertension;
- reduction of mortality and frequency of cardiovascular diseases in adult patients with cardiovascular diseases of atherothrombotic genesis (coronary artery disease, stroke or peripheral arterial disease in history) and diabetes mellitus type 2 with target organ damage.

Dosage and administration

The drug is taken orally, 1 time / day, regardless of the meal; pills should be washed down with liquid.

Arterial hypertension
The initial recommended dose of Telzap is 40 mg (1 tab.) 1 time / day. In some patients, it may be effective to take the drug at a dose of 20 mg / day. A dose of 20 mg can be obtained by dividing a 40 mg pill in half over the risk. In cases where the therapeutic effect is not achieved, the recommended dose of Telzap can be increased to a maximum of 80 mg 1 time / day.

Alternatively, Telzap can be taken in combination with thiazide diuretics, for example, hydrochlorothiazide, which, when used together, had an additional antihypertensive effect. When deciding whether to increase the dose should be taken into account that the maximum antihypertensive effect is usually achieved within 4-8 weeks after the start of treatment.

Reduced mortality and cardiovascular disease
The recommended dose of Telzap is 80 mg 1 time / day. In the initial period of treatment, monitoring of the level of blood pressure is recommended; correction of antihypertensive therapy may be required.

Experience with telmisartan in patients with severe renal failure or patients on hemodialysis is limited. These patients recommended a lower initial dose of 20 mg / day. For patients with mild and moderate renal impairment, dose adjustment is not required.

Concomitant use of the drug Telzap with aliskiren is contraindicated in patients with renal insufficiency (GFR less than 60 ml / min / 1.73 m2 surface area of ​​the body).
The simultaneous use of the drug Telzap with ACE inhibitors is contraindicated in patients with diabetic nephropathy.
Patients with mild and moderate degrees of liver failure (class A and B according to Child-Pugh classification) should be prescribed the drug with caution, the dose should not exceed 40 mg 1 time / day. Telzap is contraindicated in patients with severe hepatic insufficiency (Child-Pugh class C).
Elderly patients do not require dose adjustment.
The use of Telzap in children and adolescents under the age of 18 years is contraindicated due to the lack of data on safety and efficacy.

Side effect

According to the WHO, undesirable effects are classified according to the frequency of their development as follows: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100 ) rarely (from ≥1 / 10,000 to <1/1000),very rarely (<1/10 000); frequency is unknown - according to the available data it was not possible to establish the frequency of occurrence.
Within each group, according to the frequency of occurrence, undesirable reactions are presented in order of decreasing severity.
Infectious and parasitic diseases: infrequently - urinary tract infections, including cystitis, upper respiratory tract infections, including pharyngitis and sinusitis; rarely - sepsis, incl. with a fatal outcome.
From the hemopoietic system: infrequently - anemia; rarely - eosinophilia, thrombocytopenia.
On the part of the immune system: rarely - anaphylactic reaction, hypersensitivity.
On the part of metabolism: infrequently - hyperkalemia; rarely - hypoglycemia (in patients with diabetes).
Mental disorders: infrequently - insomnia, depression; rarely anxiety.
On the part of the nervous system: infrequently - fainting; rarely - drowsiness.
On the part of the organ of vision: rarely - visual disorders.
On the part of the organ of hearing and labyrinth disturbances: infrequently - vertigo.
Since the cardiovascular system: infrequently - bradycardia, excessive decrease in blood pressure, orthostatic hypotension; rarely - tachycardia.
On the part of the respiratory system: infrequently - shortness of breath, cough; very rarely - interstitial lung disease.
On the part of the gastrointestinal tract: infrequently - abdominal pain, diarrhea, dyspepsia, flatulence, vomiting; rarely - dry mouth, discomfort in the stomach, a violation of taste.
On the part of the liver and biliary tract: rarely - abnormal liver function / liver damage.
From the skin and subcutaneous tissues: infrequently - pruritus, hyperhidrosis, rash; rarely - angioedema (also fatal), eczema, erythema, urticaria, drug rash, toxic skin rash.
From the musculoskeletal system: infrequently - sciatica, muscle spasms, myalgia; rarely - arthralgia, pain in the extremities, tendente-like syndrome.
On the part of the urinary system: infrequently - impaired renal function, including acute renal failure.
From the laboratory and instrumental studies: infrequently - increasing the concentration of creatinine in the blood plasma; rarely - a decrease in hemoglobin, an increase in the content of uric acid in the blood plasma, an increase in the activity of liver enzymes and CPK.
Other: infrequently - chest pain, asthenia; rarely flu-like syndrome.

Contraindications

- obstructive diseases of the biliary tract;
- severe liver dysfunction (Child-Pugh class C);
- combined use with aliskiren in patients with diabetes mellitus or severe renal dysfunction (GFR less than 60 ml / min / 1.73 m2 surface area of ​​the body);
- simultaneous use with ACE inhibitors in patients with diabetic nephropathy;
- hereditary intolerance to fructose (due to the presence of sorbitol in the composition of the drug);
- pregnancy;
- breastfeeding period;
- age up to 18 years (efficacy and safety have not been established);
- hypersensitivity to the active substance or any excipients of the drug.

Precautions should be prescribed in case of bilateral renal artery stenosis or arterial stenosis of the only functioning kidney; renal dysfunction; mild and moderate liver dysfunction; lower bcc on the background of previous diuretic intake, restriction of salt, diarrhea or vomiting; hyponatremia; hyperkalemia; condition after kidney transplantation (no experience); severe chronic heart failure; stenosis of the aortic and mitral valve; hypertrophic obstructive cardiomyopathy; primary hyperaldosteronism (efficacy and safety have not been established); Negroid patients.

Use during pregnancy and lactation

Currently, there is no reliable information about the safety of telmisartan in pregnant women. In animal studies revealed reproductive toxicity of the drug. The use of the drug Telzap contraindicated during pregnancy.
If you need long-term treatment with Telzap, patients planning pregnancy should choose an alternative antihypertensive drug with a proven safety profile during pregnancy. After the establishment of the fact of pregnancy, treatment with Telzap should be immediately discontinued and, if necessary, alternative treatment can be started.
The results of clinical observations showed that the use of angiotensin II receptor antagonists in the second and third trimesters of pregnancy has a toxic effect on the fetus (deterioration of renal function, oligohydramnios, delayed ossification of the skull) and of the newborn (renal failure, arterial hypotension and hyperkalemia). When using angiotensin II receptor antagonists in the second trimester of pregnancy, an ultrasound scan of the kidney and fetal skull is recommended. Children whose mothers took angiotensin II receptor antagonists during pregnancy should be carefully monitored to detect hypotension.
Information on the use of telmisartan during breastfeeding is not available. The use of the drug Telzap during breastfeeding is contraindicated. An alternative antihypertensive drug with a more favorable safety profile should be used, especially when feeding a newborn or premature baby.

Application for violations of the liver
Contraindicated use of the drug for obstructive diseases of the biliary tract; severe liver dysfunction (Child-Pugh class C).
Precautions should be prescribed the drug for mild and moderate liver dysfunction.

Application for violations of kidney function
Precautions should be prescribed in case of bilateral renal artery stenosis or arterial stenosis of the only functioning kidney; renal dysfunction; condition after kidney transplantation (no experience).

Use in children
The drug is contraindicated at the age of 18 years (efficacy and safety have not been established).

Use in elderly patients
Elderly patients do not require dose adjustment.

special instructions

Liver dysfunction
The use of Telzap is contraindicated in patients with cholestasis, obstruction of the biliary tract or severe liver dysfunction (Child-Pugh class C), since telmisartan is mainly excreted in the bile. It is believed that in these patients the hepatic clearance of telmisartan is reduced. In patients with a mild or moderate degree of abnormal liver function (class A and B according to Child-Pugh classification), Telzap should be used with caution.
Renovascular hypertension
When treating drugs that act on the RAAS, in patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney, the risk of severe hypotension and renal failure increases.
Impaired renal function and kidney transplantation
When using the drug Telzap in patients with impaired renal function, periodic monitoring of the content of potassium and creatinine in blood plasma is recommended. There is no experience with the clinical use of Telzap in patients who have recently undergone a kidney transplant.
Lower bcc
Symptomatic arterial hypotension,especially after the first intake, Telzap may occur in patients with lowered BCC and / or sodium in the blood plasma on the background of prior diuretic treatment, restrictions on salt, diarrhea or vomiting. Such conditions (lack of liquid and / or sodium) should be eliminated before taking Telzap.
Double blockade of RAAS
Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal failure (GFR less than 60 ml / min / 1.73 m2 surface area of ​​the body).
Simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.
As a result of inhibition of the RAAS, arterial hypotension, syncope, hyperkalemia and impaired renal function (including acute renal failure) were noted in susceptible patients, especially when several drugs were used together, also acting on this system. Therefore, a double blockade of the RAAS (for example, against the background of receiving telmisartan with other RAAS antagonists) is not recommended.
In cases of dependence of the vascular tone and kidney function, mainly on the activity of the RAAS (for example, in patients with chronic heart failure or kidney disease, including stenosis of the renal arteries or stenosis of the artery of a single kidney), the administration of drugs affecting this system can accompanied by the development of acute arterial hypotension, hyperasotemia, oliguria, and in rare cases acute renal failure.
Primary hyperaldosteronism
In patients with primary hyperaldosteronism, treatment with antihypertensive drugs, which are mediated by inhibition of the RAAS, is usually ineffective. In this regard, the use of the drug Telzap is not recommended.
Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy
As with other vasodilators, patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy, when using Telzap, it is necessary to take special care.
Patients with diabetes who received insulin or hypoglycemic agents for oral administration
During treatment with Telzap, hypoglycemia may occur in these patients. Glycemic control should be enhanced, since It may be necessary to adjust the dose of insulin or hypoglycemic agent.
Hyperkalemia
The use of drugs acting on the RAAS can cause hyperkalemia. In elderly patients, patients with renal insufficiency or diabetes mellitus, patients taking medications that increase the plasma content of potassium, and / or patients with concomitant diseases, hyperkalemia can be fatal.
When deciding on the concomitant use of drugs acting on the RAAS, it is necessary to assess the balance of risk and benefit.The main risk factors for the development of hyperkalemia that should be considered are:
- diabetes, renal failure, age (patients older than 70 years);
- combination with one or more drugs acting on the RAAS, and / or potassium-containing food additives. Drugs or therapeutic classes of drugs that can cause hyperkalemia are salt substitutes containing potassium, potassium-saving diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inhibitors), Heparin, immunosuppressants (cyclosporin or tacrolimus) and trimethoprim;
- intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, impaired renal function, cytolysis syndrome (for example, acute limb ischemia, rhabdomyolysis, extensive trauma).
Patients at risk are advised to carefully monitor plasma potassium levels.
Sorbitol
Telzap contains sorbitol (E420). Patients with a rare hereditary fructose intolerance should not take the drug.
Ethnic differences
As noted for ACE inhibitors, telmisartan and other angiotensin II receptor antagonists seem to be less effective in lowering blood pressure in patients of the Negroid race than in other races, possibly due to a greater susceptibility to a decrease in renin activity in the patient population.
Other
As with the use of other antihypertensive drugs, an excessive decrease in blood pressure in patients with ischemic cardiomyopathy or ischemic heart disease can lead to the development of myocardial infarction or stroke.

Special clinical studies on the effect of the drug on the ability to drive and mechanisms were not conducted. When driving and working with mechanisms that require high concentration of attention, caution should be exercised, because while Telzap is used, dizziness and drowsiness can seldom occur.

Overdose

Symptoms: The most pronounced manifestations of overdose were excessive reduction of blood pressure and tachycardia; also reported bradycardia, dizziness, increased serum creatinine concentrations, and acute renal failure.

Treatment: Patients should be carefully monitored and symptomatic as well as supportive treatment should be carried out. The approach to treatment depends on the time elapsed after taking the drug, and the severity of symptoms. Recommended activities include provoking vomiting and / or gastric lavage, it is advisable to receive activated charcoal. It should regularly monitor the content of electrolytes and creatinine in the blood plasma. With an excessive decrease in blood pressure, the patient should take a horizontal position with raised legs, while it is necessary to quickly fill the BCC and the lack of electrolytes. Telmisartan is not excreted by hemodialysis.

Drug interaction

Double blockade of RAAS
Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal failure (GFR less than 60 ml / min / 1.73 m2 surface area of ​​the body) and is not recommended for other patients.
Simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.
Data from clinical studies have shown that double blockade of RAAS due to the combined use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is associated with an increased incidence of adverse events such as hypotension, hyperkalemia and impaired renal function (including acute renal failure) compared to using only one medicinal product acting on the RAAS.
Hyperkalemia
The risk of developing hyperkalemia may increase when used together with other drugs that can cause hyperkalemia (potassium-containing dietary supplements and salt substitutes containing potassium, potassium-sparing diuretics (for example, spironolactone, eplerenone, triamterene, or amiloride), NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim). If necessary, against the background of documented hypokalemia, the combined use of drugs should be carried out with caution and regularly monitor the content of potassium in the blood plasma.
Digoxin
When telmisartan was co-administered with digoxin, a moderate increase in C was observed.maxdigoxin in plasma by 49% and Cmin by 20%. At the beginning of treatment, when selecting a dose and stopping treatment with telmisartan, the concentration of digoxin in the blood plasma should be carefully controlled to maintain it within the therapeutic range.
Potassium-sparing diuretics or potassium-containing dietary supplements
Angiotensin II receptor antagonists, such as telmisartan, reduce diuretic-induced potassium loss. Potassium-sparing diuretics (for example, spironolactone, eplerenone, triamterene, or amiloride), potassium-containing dietary supplements or salt substitutes can lead to a significant increase in plasma potassium. If concomitant use is indicated, since there is documented hypokalemia, they should be used with caution and against the background of regular monitoring of the content of potassium in the blood plasma.
Lithium preparations
The combined use of lithium preparations with ACE inhibitors and angiotensin II receptor antagonists, including telmisartan, resulted in a reversible increase in plasma concentration of lithium and its toxic action. If necessary, the use of this combination of drugs is recommended to carefully monitor the concentration of lithium in the blood plasma.
NSAIDs
NSAIDs (ie, Acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of angiotensin II receptor antagonists.In some patients with impaired renal function (for example, patients with dehydration, elderly patients with impaired renal function), the combined use of angiotensin II receptor antagonists and drugs that depress COX-2 can lead to a further deterioration in renal function, including the development of acute renal failure, which is usually reversible. Therefore, the joint use of drugs should be carried out with caution, especially in elderly patients. Adequate fluid intake should be ensured, in addition, at the beginning of the joint application and periodically in the future should be monitored indicators of renal function.
Diuretics (thiazide or "loop")
Prior treatment with high-dose diuretics, such as Furosemide (“loop” diuretic) and hydrochlorothiazide (thiazide diuretic), can lead to hypovolemia and the risk of arterial hypotension at the beginning of treatment with telmisartan.
Other antihypertensive drugs
The effect of telmisartan may be enhanced by the combined use of other antihypertensive drugs.
Based on the pharmacological properties of Baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all antihypertensive drugs, including telmisartan. In addition, orthostatic hypotension may increase with the use of ethanol, barbiturates, narcotic drugs or antidepressants.
Corticosteroids (for systemic use)
Corticosteroids weaken the effect of telmisartan.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.