Telsartan H tabs 12.5mg + 80mg #28

Telsartan H instruction

You can buy Telsartan H here

Composition

1 tablet 12.5 mg + 40 mg contains:
Active ingredients: hydrochlorothiazide 12.50 mg telmisartan 40.00 mg
Excipients:
meglumine 12.00 mg, sodium hydroxide 3.36 mg, povidone K30 13.55 mg, polysorbate-80 0.65 mg, mannitol 235.94 mg, lactose monohydrate 43.75 mg, magnesium stearate 6.07 mg, iron dye red oxide (E172) 0.18 mg.
1 tablet of 12.5 mg + 80 mg contains:
Active ingredients: hydrochlorothiazide 12.50 mg telmisartan 80.00 mg
Excipients:
meglumine 24.00 mg, sodium hydroxide 6.72 mg, povidone K30 27.10 mg, polysorbate-80 1.30 mg, mannitol 479.38 mg, lactose monohydrate 92.50 mg, magnesium stearate 12.15 mg, iron dye red oxide (E172) 0.35 mg.
Description:
Tablets 12.5 mg + 40 mg
Oval-shaped, biconvex, bilayer tablets, one layer from light pink to pink, another layer from white to almost white with possible blotches of pink. On the white surface of the tablets there is a risk and embossing "T" and "1" on either side of it.
Tablets 12.5 mg + 80 mg
Oval-shaped, biconvex, bilayer tablets, one layer from light pink to pink, another layer from white to almost white with possible blotches of pink. On the white surface of the tablets there is a risk and embossing "T" and "2" on opposite sides of it.

Packaging

On 7 tablets in the blister from (PVC / Al / PA) foil / aluminum foil. On 2 or 4 blisters together with the application instruction in a pack cardboard.
On 6 or 10 tablets in the blister from (PVC / Al / PА) foil / aluminum foil. On 3 blisters together with the application instruction in a pack cardboard.

pharmachologic effect

Pharmacotherapeutic group:
Combined antihypertensive agent (angiotensin II receptor antagonist + diuretic agent)
ATC:
C.09.D.A.07 Telmisartan in combination with diuretics

Pharmacodynamics

Telsartan N is a combination of telmisartan (angiotensin II receptor antagonist) and hydrochlorothiazide, a thiazide diuretic. The simultaneous use of these components leads to a greater antihypertensive effect than the use of each of them separately. Taking the drug Telsartan N once a day leads to a significant gradual decrease in blood pressure (BP).

Telmisartan

Telmisartan is a specific angiotensin II receptor antagonist (type AT1), 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. Displaces angiotensin II from its association with the receptor, without showing the properties of an agonist with respect to this receptor. Telmisartan binds only to the angiotensin II receptor subtype AT1. Communication is long lasting. It has no affinity for other receptors, including the AT2 receptor and other less studied angiotensin receptors. The functional significance of these receptors, as well as the effect of their possible over-stimulation with angiotensin II, the concentration of which increases with the administration of telmisartan, has not been studied. Telmisartan reduces the concentration of aldosterone in the blood plasma, does not inhibit renin in the blood plasma and does not block the ion channels. Telmisartan does not inhibit angiotensin-converting enzyme (kininase II), which also catalyzes the degradation of bradykinin. Therefore, the enhancement of bradykinin-induced side effects is not expected.
In patients with arterial hypertension, telmisartan at a dose of 80 mg completely blocks the hypertensive effect of angiotensin II. The onset of the antihypertensive effect is noted within 3 hours after the first intake of telmisartan inside. The effect of Telsartan H lasts for 24 hours and remains significant up to 48 hours. A pronounced antihypertensive effect usually develops 4 weeks after regular use of the drug.
In patients with arterial hypertension, telmisartan reduces systolic and diastolic blood pressure without affecting the heart rate (HR).
In the case of abrupt cancellation of telmisartan, blood pressure gradually returns to its original level without the development of the "cancellation" syndrome.
In a study with telmisartan, cases of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke or hospitalization due to chronic heart failure were evaluated. It has been shown to reduce cardiovascular morbidity and mortality in high-risk cardiovascular patients (with coronary artery disease, stroke, peripheral artery disease, or diabetes mellitus with concomitant damage to target organs such as retinopathy, left ventricular hypertrophy, macro- or microalbuminuria in anamnesis ) over the age of 55 years.

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect electrolyte reabsorption in the renal tubules, directly increasing the excretion of sodium and chloride (approximately in equivalent amounts). The diuretic effect of hydrochlorothiazide leads to a decrease in circulating blood volume (BCC), an increase in plasma renin activity, an increase in aldosterone secretion, followed by an increase in potassium and bicarbonate in urine and, as a result, a decrease in plasma potassium. When taken simultaneously with telmisartan, there is a tendency to stop the loss of potassium caused by these diuretics, presumably due to the blockade of the renin-angiotensin-aldosterone system (RAAS). After ingestion diuresis increases after 2 hours, and the maximum effect is observed after about 4 hours. The diuretic effect of Telsartan H lasts for about 6-12 hours.
Prolonged use of hydrochlorothiazide reduces the risk of developing complications of cardiovascular diseases and mortality from them.
The maximum antihypertensive effect of Telsartan H is usually achieved 4 weeks after the start of treatment.

Pharmacokinetics

The combined use of telmisartan and hydrochlorothiazide does not affect the pharmacokinetics of each of the components of the drug.

Telmisartan

When ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability is approximately 50%. Peak concentration occurs in about 0.5-1.5 hours. When taken simultaneously with food, the reduction in area under the concentration-time pharmacokinetic curve (AUC) ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). 3 hours after ingestion, plasma concentration levels off regardless of the meal. There is a difference in plasma concentrations of telmisartan in men and women. The maximum plasma concentration (C max) is approximately 3 times and AUC is approximately 2 times higher in women compared to men without significant effect on efficacy. However, there is no increase in the hypotensive effect in women.
Communication with plasma proteins is significant (more than 99.5%), mainly with albumin and alpha 1-acid glycoprotein. The distribution volume is approximately 500 liters. Telmisartan is metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive. The half-life (T1 / 2) is more than 20 hours. Excreted through the intestine unchanged, the excretion by the kidneys - less than 2%. Total plasma clearance is high (about 900 ml / min).

Elderly patients

The pharmacokinetics of telmisartan in elderly patients is not different from younger patients. Dose adjustment is not required.

Patients with renal failure

Changing the dose of telmisartan in patients with renal insufficiency is not required, including patients on hemodialysis. Telmisartan is not removed by hemodialysis.

Patients with liver failure

Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of almost 100%. When liver failure T1 / 2 does not change {see section "Dosage and administration").

Hydrochlorothiazide

After ingestion of the drug Telsartan H, the maximum plasma concentrations of hydrochlorothiazide are reached within 1-3 hours. Absolute bioavailability is about 60% (based on total excretion by the kidneys). 64% of hydrochlorothiazide is bound by plasma proteins, and the volume of distribution is 0.8 ± 0.3 l / kg.
Hydrochlorothiazide is not metabolized in the body and excreted by the kidneys practically unchanged. About 60% of the ingested dose is eliminated within 48 hours. Renal clearance of about 250-300 ml / min. T1 / 2 hydrochlorothiazide is 10-15 hours.
There is a difference in plasma concentrations in men and women. In women, the concentration of telmisartan in plasma is 2-3 times higher than in men; women also tend to have a clinically insignificant increase in plasma concentrations of hydrochlorothiazide.

Patients with renal failure

In patients with impaired renal function, the rate of elimination of hydrochlorothiazide is reduced.
Studies conducted with patients with creatinine clearance of 90 ml / min showed that T1 / 2 hydrochlorothiazide increases. In patients with reduced T1 / 2 kidney function, about 34 hours.

Telsartan H, indications for use

Arterial hypertension (in case of failure of telmisartan or hydrochlorothiazide in monotherapy).

Contraindications

- Hypersensitivity to the active substances or auxiliary components of Telsartan H or other sulfonamide derivatives.
- Pregnancy.
- breastfeeding period
- Obstructive diseases of the biliary tract.
- Severe abnormal liver function (Child-Pugh class C).
- Severe renal dysfunction (creatinine clearance less than 30 ml / min).
- Refractory hypokalemia, hypercalcemia.
- Simultaneous therapy with aliskiren in patients with diabetes and renal failure (glomerular filtration rate (GFR)
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.
- Age up to 18 years (efficacy and safety have not been established).

Carefully

- Bilateral renal artery stenosis or arterial stenosis of a single kidney (see section "Special Instructions").
- Liver dysfunction or progressive liver disease (class A and B on the Child-Pugh scale) (see the section "Special Instructions").
- Reduction of BCC due to previous diuretic therapy, restriction of salt, diarrhea or vomiting.
- Hyperkalemia.
- Condition after kidney transplantation (no experience).
- Chronic heart failure (CHF) III-IV functional class (FC) according to the classification of the New York Heart Association (NYHA).
- Hypercalcemia.
- Hypercholesterolemia.
- Hypertriglyceridemia.
- Coronary heart disease.
- Progressive liver disease (risk of developing hepatic coma).
- Aortic stenosis and mitral valve.
- Idiopathic hypertrophic subaortic stenosis.
- Hypertrophic obstructive cardiomyopathy (GOKMP).
- Diabetes.
- Primary aldosteronism.
- Gout, hyperuricemia.
- Systemic lupus erythematosus.
- Secondary angle-closure glaucoma (due to the presence of hydrochlorothiazide in the composition).
- Use in patients of the Negroid race.
- Experience of use in patients with renal insufficiency (creatinine clearance more than 30 ml / min) is limited, but does not confirm the development of side effects from the kidneys and dose adjustment is not required.

Dosage and administration

Inside, regardless of the meal.
Telsartan H must be taken 1 time per day.
- Telsartan H (12.5 mg + 40 mg) may be prescribed to patients in whom monotherapy with telmisartan at a dose of 40 mg or hydrotherapy with hydrochlorothiazide does not lead to adequate control of blood pressure.
- Telsartan H (12.5 mg + 80 mg) may be prescribed to patients in whom monotherapy with telmisartan at a dose of 80 mg or with Tulsartan® N (12.5 mg + 40 mg) does not lead to adequate blood pressure control.
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

The limited experience of using the combination of hydrochlorothiazide and telmisartan in patients with small or moderately severe renal impairment does not require changes in the dose of the drug in these cases. In such patients, renal function should be monitored (for creatinine clearance less than 30 ml / min. See “Contraindications” section).

Liver function disorders

In patients with mild and moderate liver dysfunction (Child-Pugh class A and B), the daily dose of Telsartan H should not exceed 12.5 mg / 40 mg per day (see the Pharmacokinetics section).

Elderly patients

Dosing regimen does not require changes.

Use during pregnancy and lactation

Use of the drug Telsartan H is contraindicated during pregnancy.

Telmisartan

The use of angiotensin II receptor antagonists during the first trimester of pregnancy is not recommended; these drugs should not be prescribed during pregnancy. When diagnosing pregnancy, taking Telsartan H should be stopped immediately. If necessary, alternative therapy should be applied (other classes of antihypertensive drugs approved for use during pregnancy). The use of angiotensin II receptor antagonists during the second and third trimesters of pregnancy is contraindicated.
In preclinical studies of telmisartan, no teratogenic effect was 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 a person (decreased kidney function, oligohydramnion, slowing down ossification of the skull bones), as well as neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). Patients who are planning a pregnancy should be given alternative therapy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, an ultrasound examination of the kidneys and bones of the fetal skull is recommended.
Newborns whose mothers received angiotensin II receptor antagonists should be carefully 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 can disrupt fetoplacental perfusion and cause such changes in the embryo and fetus as jaundice, impaired water electrolyte balance and thrombocytopenia.
Hydrochlorothiazide should not be used for edema of pregnant women, for hypertension of pregnant women or during pre-eclampsia, as there is a risk of reducing blood plasma volume and reducing placental perfusion, and there is no favorable effect in these clinical situations.
Hydrochlorothiazide should not be used to treat essential hypertension in pregnant women, with the exception of those rare situations when other types of treatment cannot be used.
Therapy with Telsartan H is contraindicated during breastfeeding.
In animal studies, the effects of telmisartan and hydrochlorothiazide on fertility were not observed. Studies on the effect on human fertility were not conducted.

Side effects of Telsartan H

Side effects reported when using a 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 studies in 1471 patients randomized to groups of patients receiving telmisartan + hydrochlorothiazide (835 patients) or patients who received only telmisartan (636). The dependence of side effects on the dose, gender, age or race of patients has not been established.
All side effects that occur when using a combination of telmisartan and hydrochlorothiazide with a frequency greater than the placebo frequency (p
Frequency of occurrence: very often (≥1 / 10); often (≥1 / 100 -
Infectious and parasitic diseases
Rarely: bronchitis, pharyngitis, sinusitis.
Immune system disorders
Seldom: exacerbation or aggravation of symptoms of systemic lupus erythematosus1.
Metabolic and nutritional disorders
Infrequently: hypokalemia.
Rarely: hyperuricemia, hyponatremia.
Mental disorders
Infrequently: anxiety.
Rarely: depression.
Nervous system disorders
Often: dizziness.
Infrequently: syncope / syncope, paresthesias.
Rarely: insomnia, sleep disorders.
Violations by the organ of vision
Rarely: blurred vision, transient blurred vision.
Disturbances from an organ of hearing and labyrinth disturbances
Infrequently: vertigo.
Heart disorders
Infrequently: tachycardia, arrhythmia.
Vascular disorders
Infrequently: hypotension, orthostatic hypotension.
Disorders of the respiratory system, chest and mediastinum
Infrequently: shortness of breath.
Seldom: respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema.
Disorders of the gastrointestinal tract
Infrequently: diarrhea, dry mouth, flatulence.
Rarely: abdominal pain, constipation, dyspepsia, vomiting, gastritis.
Disorders of the liver and biliary tract
Seldom: abnormal liver function2.
Violations of the rut and subcutaneous tissue
Rarely: angioedema (including cases with a fatal outcome), erythema, pruritus, rash, sweating, urticaria.
Disorders of the musculoskeletal and connective tissue
Infrequently: back pain, muscle spasms, myalgia.
Rarely: arthralgia, muscle cramps, pain in the calf muscles.
Violations of the genital and breast
Infrequently: erectile dysfunction.
General disorders and disorders at the site of administration
Infrequently: pain in the chest.
Rarely: flu-like syndrome, pain.
Laboratory and instrumental data
Infrequently: increase in concentration of uric acid in a blood plasma.
Rarely: an increase in the concentration of creatinine in the blood plasma, an increase in the activity of creatine phosphokinase in the blood plasma, an increase in the activity of "liver" enzymes.
1- Based on post-marketing experience.
2- see the subsection "Description of individual undesirable reactions".
Additional information on the experience of using individual active ingredients.
Adverse reactions observed previously with each of the components of the drug, can potentially be observed when using a combination of telmisartan and hydrochlorothiazide, even if they were not observed when studying the specified combination.
Telmisartan
The frequency 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 usually comparable to the incidence of side effects when taking placebo (43.9%). The side effects listed below are based on the results of all clinical studies involving patients receiving telmisartan for hypertension or using telmisartan in patients 50 years and older with a high risk of developing cardiovascular events.
Infectious and parasitic diseases
Infrequently: upper respiratory tract infections, urinary tract infections, including cystitis.
Rarely: sepsis, including fatal cases.
Violations of the blood and lymphatic system
Infrequently: anemia.
Rarely: eosinophilia, thrombocytopenia.
Immune system disorders
Seldom: hypersensitivity reactions, anaphylactic reactions
Metabolic and nutritional disorders
Infrequently: hyperkalemia.
Rarely: hyperglycemia (in patients with diabetes mellitus).
Heart disorders
Infrequently: bradycardia.
Nervous system disorders
Seldom: drowsiness.
Disorders of the respiratory system, chest and mediastinum
Infrequently: cough.
Very often: interstitial lung disease3.
Disorders of the gastrointestinal tract
Seldom: feeling of discomfort in the field of a stomach.
Violations of the skin and subcutaneous tissues
Rarely: eczema, drug and toxic rash.
Disorders of the musculoskeletal and connective tissue
Rarely: arthrosis, pain in the tendons.
Kidney and urinary tract disorders
Infrequently: renal failure (including acute renal failure).
General disorders and disorders at the site of administration
Infrequently: asthenia.
Laboratory and instrumental data
Seldom: decrease in level of hemoglobin.
3- see the subsection "Description of individual undesirable reactions."
Hydrochlorothiazide
The use of hydrochlorothiazide can cause or exacerbate hypovolemia, which can cause electrolyte imbalance.
The following are the adverse reactions noted when using hydrochlorothiazide in monotherapy. The frequency of such reactions is not possible to determine.
Infectious and parasitic diseases
Sialadenitis
Violations of the blood and lymphatic system
Aplastic anemia, hemolytic anemia, impaired bone marrow function, leukopenia, neutropenia, agranulocytosis, thrombocytopenia.
Immune system disorders
Anaphylactic reactions, hypersensitivity.
Endocrine Disorders
Uncontrolled diabetes.
Metabolic and nutritional disorders
Anorexia, loss of appetite, electrolyte imbalance, hypercholesterolemia, hyperglycemia, hypovolemia.
Mental disorders
Restlessness
Nervous system disorders
Slight dizziness.
Violations by the organ of vision
Xantopsia, acute myopia, acute angle-closure glaucoma.
Vascular disorders
Necrotizing vasculitis.
Disorders of the gastrointestinal tract
Pancreatitis, a feeling of discomfort in the stomach.
Disorders of the liver and biliary tract
Hepatic jaundice, cholestatic jaundice.
Violations of the rut and subcutaneous tissue
Lupus-like syndrome, photosensitivity reactions, cutaneous vasculitis, toxic epidermal necrolysis.
Disorders of the musculoskeletal system and connective tissue
Weakness.
Kidney and urinary tract disorders
Interstitial nephritis, renal dysfunction, glycosuria.
General disorders and disorders at the site of administration
Pyrexia.
Laboratory and instrumental data
Increased triglyceride levels.
Description of individual unwanted reactions
Liver dysfunction
Most cases of abnormal liver function in post-registration use of telmisartan are described in patients in Japan. Apparently, these undesirable effects are more characteristic of this group of patients.
Sepsis
In the study PRoFESS, an increased incidence of sepsis was observed with telmisartan versus placebo. The data obtained can be considered a random finding, since the mechanism of interrelation is unknown.
Interstitial lung disease
Cases of interstitial lung disease were recorded with the post-registration use of telmisartan and coincided with the period of its appointment. However, a causal relationship between these events has not been established.

special instructions

States contributing to increased activity of the RAAS
In some patients, due to the suppression of the activity of the RAAS, especially with the simultaneous use of drugs acting on this system, renal function is impaired (including acute renal failure). Therefore, therapy accompanied by a similar double blockade of RAAS (for example, by adding ACE inhibitors or a direct renin inhibitor — aliskiren to antagonists of angiotensin II receptors) should be carried out strictly individually and with regular monitoring of renal function, including periodic monitoring of potassium and creatinine concentrations in serum (see section "Contraindications").
The use of thiazide diuretics in patients with impaired renal function can lead to azotemia. Periodic monitoring of renal function is recommended.

Renovascular hypertension

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

Liver dysfunction

In patients with impaired liver function or progressive liver disease, the combination of hydrochlorothiazide and telmisartan should be used with caution, since even small changes in water-electrolyte balance may contribute to the development of "hepatic" coma.

Impact on the metabolism and function of the endocrine glands

Patients with diabetes may need to change the dose of insulin or hypoglycemic agents for oral administration. During treatment with thiazide diuretics, latent diabetes can manifest itself.
In some cases, the use of thiazide diuretics may develop hyperuricemia and exacerbation of the flow of gout.

Diabetes

Patients with diabetes mellitus and additional cardiovascular risk, for example, patients with diabetes mellitus and coronary heart disease (CHD), in the case of the use of drugs that reduce blood pressure, such as antagonists of angiotensin II receptors or ACE inhibitors, may increase the risk of a fatal heart attack myocardial and sudden cardiovascular death. In patients with diabetes, IHD may be asymptomatic and therefore may be undiagnosed. In patients with diabetes mellitus, before using the drug Telsartan N for the detection and treatment of coronary artery disease, appropriate diagnostic studies should be conducted, including exercise tests.

Acute myopia and secondary angle-closure glaucoma

Hydrochlorothiazide, a derivative of sulfonamide, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders are an unexpected decrease in visual acuity or pain in the eyes, which occurs within a few hours to several weeks after the start of Telsartan H. If not treated, acute angle-closure glaucoma can result in loss of vision. The main treatment is, as quickly as possible, the abolition of hydrochlorothiazide. It must be borne in mind that if intraocular pressure remains uncontrolled, emergency conservative or surgical treatment may be required. The risk factors for the development of acute angle-closure glaucoma include information on allergies to sulfonamides or penicillin in history.

Disorders of water and electrolyte balance

At use of the drug Telsartan N, as well as in case of carrying out diuretic therapy, periodic control of content of electrolytes in blood serum is necessary. Thiazide diuretics, including hydrochlorothiazide, can cause disturbances in the water electrolyte balance and acid-base status (hypokalemia, hyponatremia, and hypochloraemic alkalosis). Signs that are alarming for these disorders are dryness of the oral mucosa, thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the gastrocnemius muscles (cramp), muscle weakness, marked reduction of blood pressure, oliguria, tachycardia and such gastrointestinal intestinal disturbances like nausea or vomiting.
When using thiazide diuretics, hypokalemia may develop, but at the same time using telmisartan may increase the content of potassium in the blood serum. The risk of hypokalemia increases in patients with cirrhosis of the liver, with enhanced diuresis, with a salt-free diet, as well as in the case of simultaneous use with glucocorticosteroids, calcitonin, ACTH, glycyrrhizic acid. Telmisartan, which is part of the drug Telsartan N, on the contrary, can lead to hyperkalemia due to antagonism to angiotensin II receptors (subtype AT1). Although using a combination of hydrochlorothiazide and telmisartan, clinically significant hyperkalemia was not registered, it should be taken into account that the risk factors for its development include renal and / or heart failure and diabetes mellitus.
There is no evidence that Telsartan H can reduce or prevent hyponatremia caused by diuretic therapy. Hypochloremia is usually minor and does not require treatment.
Thiazide diuretics can reduce calcium excretion by the kidneys and cause (in the absence of obvious disturbances in calcium metabolism) a transient and slight increase in serum calcium levels. More pronounced hypercalcemia may be a sign of latent hyperparathyroidism. Thiazide diuretics should be canceled before evaluating the function of the parathyroid glands.
Thiazide diuretics have been shown to increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia.
In patients with coronary artery disease, the use of any antihypertensive drug, in the event of an excessive decrease in blood pressure, can lead to myocardial infarction or stroke.
Requires enhanced monitoring of patients with impaired uric acid metabolism. Thiazides can reduce the amount of iodine that binds to serum proteins without showing signs of dysfunction of the thyroid gland.
There is information about the development of photosensitivity reactions when taking thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If a decision is made to resume diuretic intake, it is necessary to protect areas of the body that may be exposed to sunlight or ultraviolet A rays and avoid exposure to the sun.
Hydrochlorothiazide can increase the concentration of cholesterol and triglycerides in the blood serum, hydrochlorothiazide can give a positive result during the doping control.
There are reports of the development of systemic lupus erythematosus with the use of thiazide diuretics. The drug Telsartan N can, if necessary, be used together with other antihypertensive drugs. Liver dysfunction in the appointment of telmisartan in most cases was observed in the inhabitants of Japan. The drug Telsartan H is less effective in patients of the Negroid race.

Impact on the ability to drive trans. Wed and fur .:

Special clinical studies to assess the effect of the drug Telsartan H on the ability to drive vehicles and work with mechanisms requiring increased attention have not been conducted. However, when driving and pursuing hazardous activities, the possibility of developing dizziness and drowsiness should be taken into account, which requires caution.

Interaction

Telmisartan

Antihypertensive drugs
Perhaps increased antihypertensive effect. In one study, there was an increase in AUC0-24 and Cmax of ramipril and ramiprilat 2.5 times with the combined use of telmisartan and ramipril. The clinical significance of this interaction has not been established.
When analyzing adverse events leading to discontinuation of treatment and analyzing serious adverse events obtained during a clinical study, it was found that cough and angioedema was more frequently observed with ramipril therapy, while arterial hypotension was more common with Telmisartan therapy. Cases of hyperkalemia, renal failure, arterial hypotension and syncope were observed significantly more often with the combined use of telmisartan and ramipril.
Lithium preparations
It was noted a reversible increase in the concentration of lithium in the blood plasma, accompanied by toxic effects when taking ACE inhibitors. In rare cases, such changes have been reported with the use of angiotensin II receptor antagonists, in particular, telmisartan. With simultaneous use of lithium preparations and angiotensin II receptor antagonists, it is recommended to determine the content of lithium in the blood.
Nonsteroidal anti-inflammatory drugs (NSAIDs)
NSAIDs, including acetylsalicylic acid in doses used as an anti-inflammatory agent, cyclooxygenase-2 inhibitors (COX-2) and non-selective NSAIDs can cause the development of acute renal failure in patients with reduced BCC. Drugs that affect RAAS may have a synergistic effect. In patients receiving NSAIDs and telmisartan, at the beginning of treatment, BCC should be compensated and renal function should be monitored.
Reducing the effect of antihypertensive drugs, such as telmisartan, by inhibiting the vasodilator effect of prostaglandins has been observed when used together with NSAIDs. While taking telmisartan with ibuprofen or paracetamol, there was no clinically significant effect.
Digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine
No clinically significant interaction found. An increase in the average concentration of digoxin in the blood plasma was noted on average by 20% (in one case by 39%). With simultaneous use of telmisartan and digoxin, it is advisable to periodically determine the concentration of digoxin in the blood plasma.
Aliskiren, aliskiren-containing drugs
Clinical data have shown that double blockade of RAAS, through joint use with ACE inhibitors, angiotensin II receptor blockers or aliskiren, is associated with a high incidence of side effects, such as hypotension, hyperkalemia, reduced renal function (including acute renal failure), compared with using one active RAAS blocker.

Hydrochlorothiazide

Ethanol, barbiturates or narcotic analgesics
Risk of orthostatic hypotension.
Hypoglycemic agents for oral administration and insulin
You may need a dose adjustment hypoglycemic agents for oral and insulin.
Metformin
The risk of developing lactic acidosis.
Kolestiramin and Kolestipol
In the presence of anionic exchange resins, hydrochlorothiazide absorption is impaired.
Cardiac glycosides
The risk of hypokalemia or hypomagnesemia caused by thiazide diuretics, the development of arrhythmias caused by the intake of cardiac glycosides.
Pressor amines (for example, norepinephrine)
Perhaps the weakening effect of pressor amines.
Non-polarizing muscle relaxants (for example, tubocurarine chloride)
Hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants.
Anti-gout agents
The concentration of uric acid in the serum may increase, and therefore, changes in the dose of uricosuric drugs may be required. The use of thiazide diuretics increases the frequency of hypersensitivity reactions to allopurinol.
Calcium and Vitamin D
Thiazide diuretics may increase serum calcium levels due to a decrease in kidney clearance. If you want to use calcium supplements, you should regularly monitor the calcium content in the serum and, if necessary, change the dose of calcium supplements.
Beta blockers and diazoxide
Thiazide diuretics can enhance hyperglycemia caused by beta-blockers and diazoxide.
M-holinoblokatory (for example, atropine, biperiden)
Reduced motility of the gastrointestinal tract, increased bioavailability of thiazide diuretics.
Amantadine
The clearance of amantadine can be reduced by hydrochlorothiazide, which leads to an increase in plasma concentration of amantadine and possible toxicity.
Cytotoxic drugs (for example, cyclophosphamide, methotrexate)
Reduction of renal excretion of cytotoxic agents and enhancement of their myelosuppressive action.
NSAIDs
Simultaneous use with thiazide diuretics can lead to a decrease in diuretic and antihypertensive effect.
Drugs that cause potassium excretion and hypokalemia
Means such as diuretics, excreting potassium; laxatives; glucocorticosteroids; calcitonin; adrenocorticotropic hormone (ACTH); glycyrrhizinic acid (found in licorice root); amphotericin B; carbenoxolone; benzylpenicillin: derivatives of acetylsalicylic acid) can lead to increased hypokalemic effect. The hypokalemia caused by hydrochlorothiazide is compensated by the potassium-saving effect of telmisartan.
Theophylline
Increased risk of hypokalemia.
Amiodarone
Simultaneous use with thiazide diuretics can lead to an increased risk of arrhythmias associated with hypokalemia.
Potassium-sparing diuretics, potassium preparations, other drugs that can increase the content of potassium in the blood serum (for example, heparin)
These drugs, as well as the replacement of sodium in sodium chloride with potassium salts, can lead to hyperkalemia.
It is recommended to periodically monitor the content of potassium in the blood plasma with simultaneous use of the drug Telsartan H with drugs that can cause hypokalemia, as well as with drugs that can increase the content of potassium in the blood serum.

Overdose

No overdose cases have been identified. Possible symptoms of overdose consist of symptoms from the individual components of Telsartan H.
Telmisartan - marked reduction in blood pressure, tachycardia, bradycardia.
Hydrochlorothiazide is a violation of the water-electrolyte balance of the blood (hypokalemia, hypochloremia), a decrease in the BCC, which can lead to muscle spasms and / or increase cardiovascular disorders: arrhythmias caused by the simultaneous use of cardiac glycosides or some antiarrhythmic drugs.
Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis has not been established. Regular monitoring of electrolyte and serum creatinine levels is necessary.

Storage conditions

At a temperature not higher than 25 ° С.
Keep out of the reach of children!

Shelf life - 2 years.
Do not use after the expiration date.

Terms of sell

You can buy Telsartan H without a prescription.