Telsartan N, tablets 12.5mg+40 mg pcs

Pharmacodynamics
Telsartan® N is a combination of telmisartan (angiotensin II receptor antagonist) and hydrochlorothiazide – thiazide diuretic. Simultaneous use of these components leads to a greater antihypertensive effect than the use of each of them separately. Administration of Telsartan® H once daily leads to a significant gradual decrease in blood pressure (BP).

Telmisartan

Telmisartan is a specific angiotensin receptor antagonist (ARA) II, effective when taken orally. It has a high affinity for the AT1 subtype of angiotensin II receptors, through which the action of angiotensin II is realized.

It displaces angiotensin II from binding to the receptor without exhibiting agonist properties against this receptor. Telmisartan binds only to the AT1 subtype of the angiotensin II receptor. The binding is long-lasting. It has no affinity for other receptors, including AT2 receptor and other less studied angiotensin receptors.

The functional significance of these receptors as well as the effect of their possible overstimulation by angiotensin II, the concentration of which increases with telmisartan administration, has not been studied. Telmisartan reduces plasma aldosterone concentration, does not inhibit plasma renin and does not block ion channels. Telmisartan does not inhibit angiotensin-converting enzyme (kininase II), which also catalyzes bradykinin degradation. Therefore, an increase in bradykinin-induced side effects is not expected.

In patients with arterial hypertension, telmisartan at a dose of 80 mg completely blocks the hypertensive effects of angiotensin II. Initiation of antihypertensive action is observed within 3 hours after the first oral administration of telmisartan. The action of the drug persists for 24 hours and remains significant up to 48 hours. Apparent antihypertensive effect usually develops 4 weeks after regular drug intake.

In patients with arterial hypertension telmisartan reduces systolic and diastolic BP without affecting heart rate (HR).

In the case of abrupt telmisartan withdrawal, BP gradually returns to baseline levels without the development of “withdrawal” syndrome.

The study with telmisartan evaluated cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke or hospitalization due to chronic heart failure.

It has been shown to reduce cardiovascular morbidity and mortality in patients at high cardiovascular risk (with coronary artery disease, stroke, peripheral artery disease or diabetes with concomitant target organ damage such as retinopathy, left ventricular hypertrophy, macro- or microalbuminuria in the history) over 55 years of age.

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect electrolyte reabsorption in the renal tubules by directly increasing sodium and chloride excretion (approximately equivalent amounts).

Diuretic effect of hydrochlorothiazide leads to a decrease in circulating blood volume (RBC), increased plasma renin activity, increased secretion of aldosterone with a subsequent increase in urinary potassium and hydrocarbonates and, consequently, a decrease in plasma potassium.

In concomitant administration with telmisartan there is a tendency to stop potassium loss caused by these diuretics, presumably due to blockade of the renin-angiotensin-aldosterone system (RAAS).

After oral administration diuresis increases after 2 hours, and the maximum effect is observed after about 4 hours. Diuretic effect of the drug lasts for about 6-12 hours.

Long-term use of hydrochlorthiazide reduces the risk of cardiovascular disease complications and mortality from them.

The maximal antihypertensive effect of Telsartan® H is usually achieved 4 weeks after initiation of treatment.

Pharmacokinetics

Indications

Hypertension (high blood pressure)Arterial hypertension (if telmisartan or hydrochlorothiazide is ineffective in monotherapy).

Active ingredient

Hydrochlorothiazide, Telmisartan

Composition

1 tablet 12.5 mg+40 mg contains:

The active ingredients:

• Hydrochlorothiazide 12.50 mg
• Telmisartan 40.00 mg

Associates:

• Meglumine
• Sodium hydroxide
• Povidone K30
• Polysorbate-80
• Mannitol
• Lactose monohydrate
• Magnesium stearate
• Red iron oxide dye (E172).

.

How to take, the dosage

Orally, regardless of meals.

Telsartan® N should be taken once daily
.
Telsartan® N (12.5 mg + 40 mg) may be administered to patients in whom monotherapy with telmisartan 40 mg or hydrochlorothiazide monotherapy does not adequately control BP.

Telsartan® N (12.5 mg + 80 mg) may be administered to patients in whom monotherapy with telmisartan at a dose of 80 mg or Telsartan® N (12.5 mg + 40 mg) does not adequately control BP.

In patients with severe arterial hypertension the maximum daily dose of telmisartan is 160 mg/day. This dose was well tolerated and effective.

Renal dysfunction

Available limited experience with the combination of hydrochlorothiazide and telmisartan in patients with mild to moderately marked renal dysfunction does not require changes in drug dose in these cases. In such patients renal function should be monitored (if creatinine clearance is less than 30 ml/min, see section “Contraindications”).

Hepatic disorders

In patients with mild to moderate hepatic dysfunction (Child-Pugh Class A and B) the daily dose of Telsartan® H should not exceed 12.5 mg + 40 mg per day (see section “Pharmacokinetics and Pharmacokinetics”).

Elderly patients

The dosing regimen does not require modification.

Interaction

Telmisartan

Hypotensive agents

An increase in the antihypertensive effect is possible. One study observed a 2.5-fold increase in AUC0-24 and Cmax of ramipril and ramiprilat when telmisartan and ramipril were combined. The clinical significance of this interaction has not been established.

In an analysis of adverse events leading to discontinuation of treatment and an analysis of serious adverse events from a clinical trial, it was found that cough and angioedema were more frequently seen on ramipril therapy, whereas arterial hypotension was more frequently seen on telmisartan therapy.

Hyperkalemia, renal failure, arterial hypotension, and syncope were significantly more common with telmisartan and ramipril.

Lithium preparations

There have been reversible increases in plasma lithium concentrations accompanied by toxic effects with ACE inhibitors.

In rare cases such changes have been reported with the use of angiotensin II receptor antagonists, particularly telmisartan. When concomitant use of lithium preparations and angiotensin II receptor antagonists, determination of lithium content in blood is recommended.

Non-steroidal anti-inflammatory drugs (NSAIDs)

. NSAIDs, including acetylsalicylic acid in doses used as an anti-inflammatory agent, cyclooxygenase-2 (COX-2) inhibitors and non-selective NSAIDs, may cause acute renal failure in patients with decreased RBC.

The drugs affecting the RAAS may have a synergistic effect. In patients receiving NSAIDs and telmisartan, the BCC should be compensated and renal function should be monitored at the beginning of treatment.

A decreased effect of hypotensive agents such as telmisartan through inhibition of the vasodilatory effect of prostaglandins has been noted when coadministered with NSAIDs. No clinically significant effect has been observed when telmisartan is taken concomitantly with ibuprofen or paracetamol.

Digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine

There were no clinically significant interactions. There was an increase in the average plasma concentration of digoxin by an average of 20% (in one case by 39%). When concomitant use of telmisartan and digoxin, periodic determination of plasma concentrations of digoxin is advisable.

Aliskiren, aliskiren-containing drugs

. Clinical data have shown that dual RAAS blockade, by coadministration with ACE inhibitors, angiotensin II receptor blockers, or aliskiren is associated with a high incidence of side effects such as hypotension, hyperkalemia, and decreased renal function (including acute renal failure) compared with the use of a single active RAAS blocker.

Hydrochlorothiazide

Ethanol, barbiturates or narcotic analgesics

Risk of orthostatic hypotension.

Hypoglycemic oral agents and insulin

The dose of hypoglycemic oral agents and insulin may need to be adjusted.

Metformin

Risk of lactic acidosis.

Colestyramine and colestipol

In the presence of anion exchange resins, the absorption of hydrochlorothiazide is impaired.

Cardiac glycosides

Risk of hypokalemia or hypomagnesemia caused by thiazide diuretics, development of arrhythmias caused by taking cardiac glycosides.

Pressor amines (e.g., norepinephrine)

The effects of pressor amines may be impaired.

Nondepolarizing myorelaxants (e.g., tubocurarine chloride)

Hydrochlorothiazide may increase the effect of nondepolarizing myorelaxants.

Antipodagric agents

The concentration of uric acid in the blood serum may increase, and therefore it may be necessary to change the dose of uricosuric agents. The use of thiazide diuretics increases the incidence of hypersensitivity reactions to allopurinol.

Calcium preparations and vitamin D

Thiazide diuretics may increase serum calcium levels due to reduced renal excretion. If it is necessary to use calcium preparations, serum calcium levels should be monitored regularly, and the dose of calcium preparations should be changed, if necessary.

Beta-adrenoblockers and diazoxide

Tiazide diuretics may increase the hyperglycemia caused by beta-adrenoblockers and diazoxide.

M-cholinoblockers (e.g., atropine, biperiden)

Decrease gastrointestinal motility, increase bioavailability of thiazide diuretics.

Amantadine

The clearance of amantadine may be decreased by hydrochlorothiazide, which leads to increased plasma concentrations of amantadine and possible toxicity.

Cytotoxic agents (e.g., cyclophosphamide, methotrexate)

Decrease renal excretion of cytotoxic agents and increase their myelosuppressive effect.

NSAIDs

Concomitant use with thiazide diuretics may lead to decreased diuretic and antihypertensive effects.

Medications that lead to potassium excretion and hypokalemia

Medications such as potassium excretion diuretics; laxatives; Glucocorticosteroids; calcitonin; adrenocorticotropic hormone (ACTH); glycyrrhizic acid (found in licorice root); amphotericin B; carbenoxolone; benzylpenicillin: Acetylsalicylic acid derivatives) may lead to increased hypokalemic effects. Hypokalemia caused by hydrochlorothiazide is compensated by the potassium-saving effect of telmisartan.

Theophylline

An increased risk of hypokalemia.

Amiodarone

Simultaneous use with thiazide diuretics may lead to an increased risk of arrhythmias associated with hypokalemia.

Potassium-saving diuretics, potassium preparations, other agents that can increase serum potassium levels (e.g., heparin)

These agents, as well as replacement of sodium in table salt with potassium salts, can lead to hyperkalemia.

Periodic monitoring of plasma potassium is recommended during concomitant use of Telsartan® N with drugs that may cause hypokalemia as well as with drugs that may increase serum potassium.

Special Instructions

Conditions that contribute to increased RAAS activity

In some patients, due to suppression of RAAS activity, especially when concomitant administration of drugs acting on this system, renal function is impaired (including acute renal failure). Therefore, therapy accompanied by such dual RAAS blockade (e.g., when adding angiotensin-converting enzyme inhibitor (ACEI) or direct renin-aliskiren inhibitor to angiotensin II receptor antagonists) should be performed on a strictly individual basis and with regular monitoring of renal function, including periodic monitoring of serum potassium and creatinine.
The use of thiazide diuretics in patients with impaired renal function may lead to azotemia.

Recommended periodic monitoring of renal function.

Renovascular hypertension

. In patients with bilateral renal artery stenosis or artery stenosis of the only functioning kidney, the use of drugs affecting the RAAS increases the risk of severe arterial hypotension and renal failure.

Hepatic disorders

In patients with hepatic dysfunction or advanced liver disease, the drug containing hydrochlorothiazide and telmisartan should be used with caution because even small changes in the water-electrolyte balance may contribute to the development of “hepatic” coma.

Influence on metabolism and endocrine function

In patients with diabetes mellitus it may be necessary to change the dose of insulin or oral hypoglycemic agents. During therapy with thiazide diuretics, latent diabetes mellitus may manifest.

In some cases, the use of thiazide diuretics may lead to hyperuricemia and aggravation of the course of gout.

Diabetes mellitus

. Patients with diabetes and additional cardiovascular risk, such as those with diabetes and coronary heart disease (CHD), may have an increased risk of myocardial infarction and sudden cardiovascular death when using blood pressure-lowering drugs such as angiotensin II receptor antagonists (ARA II) or ACE inhibitors.

In patients with diabetes mellitus, CHD may be asymptomatic and therefore may be undiagnosed.

In patients with diabetes mellitus, appropriate diagnostic tests, including exercise testing, should be performed prior to initiating use of the drug containing hydrochlorothiazide and telmisartan to detect and treat CHD.

Acute myopia and secondary closed-angle glaucoma

Hydrochlorothiazide, as a sulfonamide derivative, may cause an idiosyncratic reaction in the form of acute transient myopia and acute closed-angle glaucoma. Symptoms of these disorders are sudden decrease in visual acuity or pain in the eyes, which in typical cases occur within a few hours to a few weeks after the start of drug administration.

If left untreated, acute closed angle glaucoma can lead to loss of vision. The main treatment is to withdraw hydrochlorothiazide as quickly as possible. Keep in mind that if the intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be necessary. A history of allergy to sulfonamides or penicillin may be a risk factor for acute closed angle glaucoma.

Water-electrolyte balance disorders

When using the drug containing hydrochlorothiazide and telmisartan, as in the case of diuretic therapy, periodic monitoring of serum electrolytes is required. Thiazide diuretics, including hydrochlorothiazide, may cause disorders of water-electrolyte balance and acid-base status (hypokalemia, hyponatremia and hypochloremic alkalosis).

Warning signs for these disorders are dry oral mucosa, thirst, general weakness, drowsiness, restlessness, myalgia or twitching of the calf muscles, muscle weakness, marked decrease in BP, oliguria, tachycardia and gastrointestinal disorders such as nausea or vomiting.

Hypokalemia may occur with thiazide diuretics, but concomitant use of telmisartan may increase blood potassium levels. The risk of hypokalemia is most increased in patients with cirrhosis, with increased diuresis, with a salt-free diet, as well as in case of simultaneous use
with glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (contained in licorice root).

Telmisartan®, in contrast, may lead to hyperkalemia due to antagonism to angiotensin II receptors (AT1 subtype). Although clinically significant hyperkalemia has not been reported with the combination of hydrochlorothiazide and telmisartan, it should be taken into account that risk factors for this include renal and/or heart failure and diabetes.

There is no evidence that the drug containing hydrochlorothiazide and telmisartan can reduce or prevent the hyponatremia caused by diuretics. Hypochloremia is usually mild and does not require treatment.

Thiazide diuretics may decrease renal calcium excretion and cause (in the absence of overt calcium metabolism disorders) a transient and small increase in serum calcium. More pronounced hypercalcemia may be a sign of hidden hyperparathyroidism. Thiazide diuretics should be discontinued before parathyroid function is evaluated. Thiazide diuretics have been shown to increase magnesium excretion by the kidneys, which may lead to hypomagnesemia.

In patients with coronary heart disease, use of any hypotensive agent, if the BP is reduced excessively, may lead to myocardial infarction or stroke.

Increased monitoring of patients with impaired uric acid metabolism is required; thiazides may decrease the amount of iodine bound to serum proteins without evidence of thyroid dysfunction; there is information about cases of photosensitivity when taking thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to suspend treatment.

If it is decided to resume diuretic administration, it is necessary to protect body areas that may be exposed to sunlight or ultraviolet type A rays and avoid sun exposure; hydrochlorothiazide may increase the concentration of cholesterol and triglycerides in blood; hydrochlorothiazide may give positive results in doping control.

There have been reports of the development of systemic lupus erythematosus when using thiazide diuretics.
Telsartan® H may be combined with other hypotensive agents if necessary.
Drugs containing hydrochlorothiazide and telmisartan are less effective in non-Hispanic patients.

No special clinical studies have been performed to evaluate the effect of Telsartan® N on the ability to drive vehicles and work with mechanisms requiring increased attention. However, the possibility of dizziness and drowsiness should be taken into account when driving motor vehicles and engaging in hazardous activities, which requires caution.

Synopsis

Oval-shaped, biconvex, bilayered tablets, one layer of light pink to pink, the other layer of white to almost white with possible pink flecks.

On the white surface of tablets has the risk and embossed “T” and “1” on either side of it.

Contraindications

• High sensitivity to the active substances or excipients of the drug or other sulfonamide derivatives.

• obstructive diseases of the biliary tract.

• Severe hepatic impairment (Child-Pugh class C).

• Severe renal impairment (creatinine clearance less than 30 ml/min).

• Refractory hypokalemia, hypercalcemia.

• Concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes and/or moderate to severe renal function impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 body surface area).

• Simultaneous use with angiotensin-converting enzyme (ACE) inhibitors in patients with diabetic nephropathy.

• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

• Pregnancy.

• Breast-feeding period.

• Age under 18 years (efficacy and safety not established).

With caution:

• Bilateral renal artery stenosis or stenosis of the artery of the single kidney (see Speciality
• Cautious.

• Cautions).

• Liver dysfunction or advanced liver disease (Child-Pugh grades A and B) (see “Special Instructions”).

• Decreased BOD due to previous therapy with diuretics, restricted intake of table salt, diarrhea, or vomiting.

• Hyperkalemia.

• Condition after kidney transplantation (no experience of use).

• Chronic heart failure (CHF) class III-IV functional class (FC) according to the classification of the New York Heart Association (NYHA).

• Hypercalcemia.

• Hypertriglyceridemia.

• Coronary heart disease.

• Progressive liver disease (risk of hepatic coma).

• Aortic and mitral valve stenosis.

• Idiopathic hypertrophic subaortic stenosis.

• Hypertrophic obstructive cardiomyopathy (HCMP).

• Diabetes mellitus.

• Primary aldosteronism.

• Gout, hyperuricemia.

• Systemic lupus erythematosus.

• Secondary closed-angle glaucoma (due to the presence of hydrochlorothiazide).

• Application in non-gracial patients.

• Experience of use in patients with renal impairment (creatinine clearance greater than 30 mL/min) is limited, but no evidence of renal side effects and no dose adjustment is required.

Side effects

Side effects reported with the combination of telmisartan and hydrochlorothiazide
The overall incidence of side effects reported with the combination of telmisartan and hydrochlorothiazide was comparable to the incidence of side effects observed with telmisartan monotherapy in controlled trials involving 1471 patients randomized to groups of patients receiving telmisartan + hydrochlorothiazide (835 patients) or patients receiving telmisartan alone (636). No dependence of side effects on dose, sex, age, or race of patients has been established.

All side effects occurring with the combination of telmisartan and hydrochlorothiazide with a frequency greater than that of placebo (p≤0.05) are presented below according to system-organ classes.

Frequency: very common (≥1/10); common (≥1/100 to < 1/10); infrequent (≥1/1000 to < 1/100); rare (≥1/10000 to < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data). Adverse reactions are presented in descending order of severity.

Infectious and parasitic diseases

Rare: bronchitis, pharyngitis, sinusitis.

Disorders of the immune system

Rarely: exacerbation or worsening of symptoms of systemic lupus erythematosus1.

Disorders of metabolism and nutrition

Infrequent: hypokalemia.
Rare: hyperuricemia, hyponatremia.

Mental disorders

Infrequent: anxiety.
Rarely: depression.

Nervous system disorders

Infrequent: syncope/fainting spells, paresthesias.
Rare: insomnia, sleep disorders.

Visual disorders

Rare: visual impairment, transient blurred vision.

Hearing organ and labyrinth disorders

Infrequent: vertigo.

Cardiac disorders

Infrequent: tachycardia, arrhythmia.

Vascular disorders

Infrequent: hypotension, orthostatic hypotension.

Disorders of the respiratory system, thorax and mediastinum organs

Infrequent: dyspnea.
Rare: respiratory distress syndrome (including pneumonia and noncardiogenic pulmonary edema).

Gastrointestinal disorders

Infrequent: diarrhea, dry mouth, flatulence.
Rare: abdominal pain, constipation, dyspepsia, vomiting, gastritis.

Liver and biliary tract disorders

Rare: liver function disorder2.

Dermatological and subcutaneous tissue disorders
Rare: angioedema (including cases with lethal outcome), erythema, skin itching, rash, increased sweating, urticaria.

Muscular and connective tissue disorders

Infrequent: back pain, muscle cramps, myalgia.
Rare: arthralgia, muscle cramps, pain in the calf muscles.

Gender and mammary gland disorders

Infrequent: erectile dysfunction.

General disorders and disorders at the site of administration

Infrequent: chest pain.
Rarely: flu-like syndrome, pain.

Laboratory and instrumental data

Infrequent: increased plasma uric acid concentration.
Rare: increased concentration of creatinine in plasma, increased activity of creatinphosphokinase in plasma, increased activity of “liver” enzymes.
1 – based on the experience of post-marketing use.
2 – see subsection “Description of individual adverse reactions”.

Additional information on experience with individual active ingredients

Adverse reactions previously observed with each component of the drug may potentially be observed with the combination of telmisartan and hydrochlorothiazide, even if they were not observed when the specified combination was studied.

Telmisartan

The incidence of side effects with telmisartan is similar to that with placebo.
In placebo-controlled studies, the overall incidence of side effects observed with telmisartan (41.4%) is generally comparable to the incidence of side effects with placebo (43.9%). The side effects listed below are from all clinical trials with patients receiving telmisartan for arterial hypertension or telmisartan in patients 50 years and older at high risk for cardiovascular events.

Infectious and parasitic diseases

Infrequent: Upper respiratory tract infections, urinary tract infections including cystitis.
Rare: sepsis, including cases with fatal outcome.

Disorders of the blood and lymphatic system

Infrequent: anemia.
Rare: eosinophilia, thrombocytopenia.

Disorders of the immune system

Rare: hypersensitivity reactions, anaphylactic reactions.

Disorders of metabolism and nutrition

Infrequent: hyperkalemia.
Rare: hyperglycemia (in patients with diabetes).

Cardiac disorders

Infrequent: bradycardia.

Nervous system disorders

Rare: drowsiness.
Disorders of the respiratory system, thorax and mediastinum organs

Infrequent: cough.
Very common: interstitial lung disease3.

Gastrointestinal tract disorders

Rare: feeling of discomfort in the stomach.

Dermatological and subcutaneous tissue disorders

Rarely: eczema, drug and toxic rash.

Muscular and connective tissue disorders

Rare: arthrosis, tendon pain.

Renal and urinary tract disorders

Infrequent: renal dysfunction (including acute renal failure).

General disorders and disorders at the site of administration

Infrequent: Asthenia.

Laboratory and instrumental data

Rare: decreased hemoglobin levels.
3 – see subsection “Description of individual adverse reactions”.

Hydrochlorothiazide

The use of hydrochlorothiazide may lead to the occurrence or exacerbation of hypovolemia, which may cause electrolyte imbalance.

The following are adverse reactions noted when using hydrochlorothiazide in monotherapy. It is not possible to determine the frequency of such reactions.

Infectious and parasitic diseases

Sialoadenitis.

Disorders of the blood and lymphatic system

Aplastic anemia, hemolytic anemia, bone marrow dysfunction, leukopenia, neutropenia, agranulocytosis, thrombocytopenia.

Disorders of the immune system

Anaphylactic reactions, hypersensitivity.

Endocrine system disorders


Uncontrolled diabetes.

Disorders of metabolism and nutrition

Anorexia, decreased appetite, electrolyte imbalance, hypercholesterolemia, hyperglycemia, hypovolemia.

Mental disorders

Indisposition.

Nervous system disorders

Mild dizziness.

Xanthopsia, acute myopia, acute closed-angle glaucoma.

Vascular disorders

Necrotizing vasculitis.

Gastrointestinal tract disorders

Pancreatitis, feeling of discomfort in the stomach.

Liver and biliary tract disorders

Hepatic jaundice, cholestatic jaundice.

Dermatological and subcutaneous tissue disorders

Lupus-like syndrome, photosensitivity reactions, cutaneous vasculitis, toxic epidermal necrolysis.

Muscular and connective tissue disorders

Weakness.

Renal and urinary tract disorders

Interstitial nephritis, impaired renal function, glucosuria.

General disorders and disorders at the site of administration

Pyrexia.

Laboratory and instrumental findings

Elevated triglyceride levels.

Description of individual adverse reactions

Liver function impairment

Most cases of liver function impairment during post-registration use of telmisartan are described in patients in Japan. Apparently, these adverse effects are more common in this group of patients.

Sepsis

In the PRoFESS study, an increased incidence of sepsis was observed with telmisartan compared to placebo. The findings may be considered an incidental finding, as the mechanism of the relationship is unknown.

Interstitial lung disease

Cases of interstitial lung disease were reported during post-registration use of telmisartan and coincided with the period of its administration. However, a causal relationship between these events has not been established.

Overdose

No cases of overdose have been identified.

Possible symptoms of overdose consist of symptoms from the individual components of the drug.

Telmisartan – marked BP decrease, tachycardia, bradycardia.

Hydrochlorothiazide – disorders of water-electrolyte balance of the blood (hypokalemia, hypochloremia), reduction of the blood circulation, which may lead to muscle spasms and/or exacerbate cardiovascular disorders: arrhythmias caused by simultaneous use of cardiac glycosides or some antiarrhythmic drugs.

Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of hydrochlorothiazide removal during hemodialysis has not been established. Regular monitoring of electrolytes and serum creatinine concentration is necessary.

Pregnancy use

Telsartan® N is contraindicated during pregnancy.

Telmisartan

The use of angiotensin II receptor antagonists during the first trimester of pregnancy is not recommended and these drugs should not be prescribed during pregnancy. If pregnancy is diagnosed, the drug should be discontinued immediately.

If necessary, alternative therapy (other classes of hypotensive drugs approved for use during pregnancy) should be used.

The use of angiotensin II receptor antagonists during the second and third trimesters of pregnancy is contraindicated.

In preclinical studies telmisartan teratogenic effect was not noted, but fetotoxicity was established.

It is known that exposure to angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes fetotoxicity in humans (reduced renal function, oligohydramnion, delayed ossification of cranial bones) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia).

Patients planning pregnancy should be prescribed alternative therapy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, an ultrasound examination of the fetal kidneys and skull bones is recommended.

Newborns whose mothers received angiotensin II receptor antagonists should be closely monitored for arterial hypotension.

Hydrochlorothiazide

Experience with hydrochlorothiazide during pregnancy, especially during the first trimester, is limited.
Hydrochlorothiazide penetrates the placental barrier. Given the pharmacological mechanism of action of hydrochlorothiazide, it is assumed that its use during the second and third trimesters of pregnancy may disrupt feto-placental perfusion and cause changes in the embryo and fetus such as jaundice, electrolyte-water balance disorders and thrombocytopenia.

Hydrochlorothiazide should not be used in pregnant women with edema, pregnant women with arterial hypertension or during preeclampsia, as there is a risk of decreased plasma volume and reduced placental perfusion, and there is no beneficial effect in these clinical situations.

Hydrochlorothiazide should not be used to treat essential hypertension in pregnant women except in those rare situations where other treatments cannot be used.

Therapy with Telsartan® H is contraindicated during breastfeeding.

No effect of telmisartan and hydrochlorothiazide on fertility has been observed in animal studies. Studies on the effect on human fertility have not been conducted.

Similarities

Mycardis Plus, Telprez, Telzap Plus, Telprez Plus, Telmista N, Mikafor