Telsartan N, tablets 12.5 mg+80 mg 28 pcs.
€15.34 €12.79
Pharmacodynamics
Telsartan® H is a combination of telmisartan (angiotensin II receptor antagonist) and hydrochlorothiazide, a 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 results in a significant gradual decrease in blood pressure (BP).
Telmisartan
Telmisartan is a specific angiotensin receptor antagonist (ARA) II, effective when taken orally. It has high affinity to 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. The onset of antihypertensive action is observed within 3 hours after the first oral administration of telmisartan.
The action of the drug lasts for 24 hours and remains significant up to 48 hours. Expressed 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 renin-angiotensin-aldosterone system (RAAS).
After oral administration diuresis increases after 2 hours, and the maximum effect is observed after about 4 hours. The diuretic effect of the drug persists for approximately 6-12 hours.
Long-term use of hydrochlorthiazide reduces the risk of cardiovascular complications and mortality from them.
Maximum antihypertensive effect of Telsartan® N is usually achieved 4 weeks after the start of treatment.
Pharmacokinetics
The co-administration of Telmisartan and hydrochlorothiazide has no effect on the pharmacokinetics of either drug component.
Telmisartan
When taken orally, it is rapidly absorbed from the gastrointestinal tract.
Bioavailability is approximately 50%. Concentration peaks after about 0.5-1.5 hours. Administration with food decreases area under pharmacokinetic curve “concentration-time” (AUC) from 6% (with a dose of 40 mg) to 19% (with a dose of 160 mg). In 3 hours after oral administration, plasma concentrations level off regardless of food intake.
There is a difference in plasma concentrations of telmisartan in men and women. Maximum plasma concentrations (Cmax) are approximately 3 times and AUC approximately 2 times higher in women compared to men with no significant effect on efficacy. Nevertheless, increase of hypotensive effect is not observed in women.
The binding to plasma proteins is significant (more than 99.5%), mainly to albumin and alpha1-acid glycoprotein. The volume of distribution is approximately 500 liters.
Telmisartan is metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive. The elimination half-life (T1/2) is more than 20 hours. It is excreted unchanged in the intestine, renal excretion is less than 2%. Total plasma clearance is high (about 900 ml/min).
Elderly patients
Pharmacokinetics of telmisartan in elderly patients does not differ from younger patients. No dose adjustment is required.
Patients with renal impairment
No change in telmisartan dose is required in patients with renal impairment, including patients on hemodialysis. Telmisartan is not eliminated by hemodialysis.
Patients with hepatic impairment
Pharmacokinetic studies in patients with hepatic impairment have shown increased absolute bioavailability to nearly 100%. In patients with hepatic insufficiency the T1/2 is not changed (see section “Dosage and administration”).
Hydrochlorothiazide
After oral administration of Telsartan® H, the maximum plasma concentrations of hydrochlorothiazide are reached within 1-3 hours. Absolute bioavailability is about 60% (based on total renal excretion). Plasma proteins bind 64% of hydrochlorothiazide, and the volume of distribution is 0.8±0.3 l/kg.
Hydrochlorothiazide is not metabolized in the body and is excreted by the kidneys almost unchanged. About 60% of the oral dose is eliminated within 48 hours. Renal clearance is about 250-300 ml/min. T1/2 of hydrochlorothiazide is 10-15 hours.
There is a difference in plasma concentrations in men and women. In women telmisartan plasma concentrations are 2-3 times higher than in men; also in women there is a tendency for clinically insignificant increase in plasma concentrations of hydrochlorothiazide.
Patients with renal impairment
In patients with impaired renal function the excretion rate of hydrochlorothiazide is reduced.
Studies conducted with patients with a creatinine clearance of 90 ml/min have shown that the T1/2 of hydrochlorothiazide is increased. In patients with decreased renal function, the T1/2 is approximately 34 hours.
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+80 mg contains:
The active ingredients:
- hydrochlorothiazide 12.50 mg
- telmisartan 80.00 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”).
Liver function disorders
In patients with mild to moderate hepatic function disorders (Child-Pugh grades A and B) the daily dose of Telsartan® N should not exceed 12.5 mg + 40 mg per day (see sect.
Elderly patients
The dosing regimen does not need to be changed.
Interaction
Telmisartan
Hypotensive agents
Antihypertensive effects may be enhanced. 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 the clinical trial, it was found that cough and angioedema were more frequently observed on ramipril therapy, while arterial hypotension occurred more frequently on telmisartan therapy.
Cases of hyperkalemia, renal failure, arterial hypotension, and syncope were significantly more frequently observed when telmisartan and ramipril were used together.
Lithium drugs
There was a reversible increase in plasma lithium concentration 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. When concomitant use of lithium preparations and angiotensin II receptor antagonists it is recommended to determine lithium content in blood.
Non-steroidal anti-inflammatory drugs (NSAIDs)
NSAIDs, including acetylsalicylic acid in doses used as anti-inflammatory drugs, cyclooxygenase-2 inhibitors (COX-2) and non-selective NSAIDs may cause acute renal failure in patients with decreased RBC. 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.
Reduction in the effect of hypotensive agents such as telmisartan by inhibiting
vasodilatory effects of prostaglandins has been observed when coadministered with NSAIDs. When telmisartan is concomitantly administered with ibuprofen or paracetamol no clinically significant effect has been found.
Digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine
No clinically significant interaction was found. There was an increase in the average plasma concentration of digoxin by an average of 20% (in one case by 39%). In concomitant use of telmisartan and digoxin it is advisable to conduct periodic determination of plasma digoxin concentration.
Aliskiren, aliskiren-containing drugs
Clinical data have shown that dual RAAS blockade, through co-administration with ACE inhibitors, angiotensin II receptor blockers or aliskiren is associated with a high frequency of adverse effects such as hypotension, hyperkalemia, 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.
Oral hypoglycemic agents and insulin
Dose adjustment of oral hypoglycemic agents and insulin may be required.
Metformin
Risk of lactic acidosis.
Colestiramine and colestipol
In the presence of anion exchange resins, hydrochlorothiazide absorption is impaired.
Cardiac glycosides
Risk of hypokalemia or hypomagnesemia caused by thiazide diuretics, development of arrhythmias caused by cardiac glycosides.
Pressor amines (e.g., norepinephrine)
The effect 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 serum may increase, and therefore it may be necessary to change the dose of uricosuric agents. Thiazide diuretics use increases the frequency of hypersensitivity reactions to allopurinol.
Calcium preparations and vitamin D
Thiazide diuretics may increase serum calcium content due to its reduced excretion by the kidneys. If calcium preparations are required, the serum calcium content should be monitored regularly and, if necessary, the dose of calcium preparations should be changed.
Beta-adrenoblockers and diazoxide
Thiazide diuretics may increase the hyperglycemia caused by beta-adrenoblockers and diazoxide.
M-cholinoblockers (e.g., atropine, biperidine)
Decreased gastrointestinal motility, increased bioavailability of thiazide diuretics.
Amantadine
Amantadine clearance may be reduced by hydrochlorothiazide, resulting in increased plasma amantadine concentrations and possible toxicity.
Cytotoxic agents (e.g., cyclophosphamide, methotrexate)
Reduced renal excretion of cytotoxic agents and increased myelosuppressive effects.
NSAIDs
Simultaneous use with thiazide diuretics may lead to decreased diuretic and antihypertensive effect.
Drugs that lead to potassium excretion and hypokalemia
Drugs such as potassium withdrawing 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 offset by the potassium-saving effect of telmisartan.
Theophylline
Increased risk of hypokalemia.
Amiodarone
Concomitant use with thiazide diuretics may lead to an increased risk of arrhythmias associated with hypokalemia.
Potassium-saving diuretics, potassium preparations, other drugs that can increase potassium content in blood serum (e.g., heparin)
The indicated drugs as well as replacement of sodium in table salt with potassium salts may lead to hyperkalemia.
Periodic monitoring of plasma potassium is recommended during concomitant use of Telsartan® H with drugs that may cause hypokalemia as well as with drugs that may increase serum potassium.
Special Instructions
Conditions that contribute to the increase of the RAAS activity
In some patients, due to the suppression of the 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 an 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. Periodic monitoring of renal function is recommended.
Renovascular hypertension
In patients with bilateral renal artery stenosis or artery stenosis of the only functioning kidney when using drugs that affect the RAAS, the risk of severe arterial hypotension and renal failure increases.
Hepatic disorders
In patients with hepatic dysfunction or advanced liver disease, the drug containing hydrochlorothiazide and telmisartan should be used with caution, since even small changes in the water-electrolyte balance may contribute to the development of a “hepatic” coma.
Effect 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 the therapy with thiazide diuretics latent diabetes mellitus may manifest.
In some cases, the use of thiazide diuretics may lead to the development of hyperuricemia and aggravation of the course of gout.
Diabetes mellitus
. Patients with diabetes mellitus and additional cardiovascular risk, such as those with diabetes mellitus 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 before initiating the use of the drug containing hydrochlorothiazide and telmisartan to detect and treat CHD.
Acute myopia and secondary closed-angle glaucoma
Hydrochlorothiazide, being 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 a sudden decrease in visual acuity or eye pain, which in typical cases occur within a few hours to a few weeks after starting the drug. If left untreated, acute closed-angle glaucoma can lead to loss of vision. The main treatment is to withdraw hydrochlorothiazide as soon as possible.
Keep in mind that if the intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be necessary. Risk factors for acute closed angle glaucoma include a history of allergy to sulfonamides or penicillin.
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, sleepiness, restlessness, myalgia or twitching of the calf muscles, muscle weakness, marked BP decrease, 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, at maintenance of salt-free diet, as well as in case of concurrent 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 evaluation of parathyroid function. 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 that the diuretic should be resumed, areas of the body that may be exposed to sunlight or type A ultraviolet rays should be protected and sun exposure avoided; hydrochlorothiazide may increase blood cholesterol and triglyceride concentrations; hydrochlorothiazide may test positive for doping control.
There have been reports of the development of systemic lupus erythematosus when using thiazide diuretics.
Telsartan® H may be used in combination 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 considered when driving motor vehicles and engaging in hazardous activities, which requires caution.
Contraindications
- High sensitivity to the active substances or excipients of the drug or other sulfonamide derivatives.
- Obstructive diseases of the biliary tract.
- Severe liver dysfunction (Child-Pugh class C).
- Severe renal dysfunction (creatinine clearance less than 30 ml/min).
- Refractory hypokalemia, hypercalcemia.
- Simultaneous 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.
- Breastfeeding period.
- Age under 18 years of age (efficacy and safety not established).
With caution:
- Bilateral stenosis of the renal arteries or stenosis of the artery of the solitary kidney (see “Cautionary Note.
- Hepatic impairment or advanced liver disease (Child-Pugh grades A and B) (see Special Instructions).
- Hyperkalemia
- Decreased RBC due to previous diuretic therapy, restricted intake of table salt, diarrhea, or vomiting
- Hyperkalemia
- After renal transplantation (no experience of use).
- Cronic heart failure (CHF) New York Heart Association (NYHA) functional class III-IV.
- Hypercalcemia.
- Hypercholesterolemia.
- Hypertriglyceridemia.
- Ischemic heart disease.
- Progressive liver disease (risk of hepatic coma).
- Aortic and mitral valve stenosis.
- Idiopathic hypertrophic subaortic stenosis.
- Hypertrophic obstructive cardiomyopathy (HOCMP).
- Diabetes mellitus.
- Primary aldosteronism.
- Gout, hyperuricemia.
- Systemic lupus erythematosus.
- Secondary closed-angle glaucoma (due to the presence of hydrochlorothiazide).
- Application in non-human 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.
Immune system disorders
Rare: exacerbation or exacerbation of symptoms of systemic lupus erythematosus1.
Metabolic and nutritional disorders
Infrequent: hypokalemia.
Rare: hyperuricemia, hyponatremia.
Mental disorders
Infrequent: anxiety.
Rare: depression.
Nervous system disorders
Often: dizziness.
Infrequent: syncope/fainting spells, paresthesias.
Rare: insomnia, sleep disturbances.
Visual organ disorders
Rare: visual disturbances, transient blurred vision.
Hearing organ and labyrinth disturbances
Infrequent: vertigo.
Heart disorders
Infrequent: tachycardia, arrhythmia.
Vascular disorders
Infrequent: hypotension, orthostatic hypotension.
Respiratory system, thorax and mediastinum disorders
Infrequent: dyspnea.
Rare: respiratory distress syndrome (including pneumonia and noncardiac pulmonary edema).
Gastrointestinal tract disorders
Infrequent: diarrhea, dry mouth, flatulence.
Rare: abdominal pain, constipation, dyspepsia, vomiting, gastritis.
Disorders of the liver and biliary tract
Rare: impairment of liver function2.
Skin and subcutaneous tissue disorders
Rare: angioedema (including cases with lethal outcome), erythema, skin itching, rash, increased sweating, urticaria.
Musculoskeletal and connective tissue disorders
Infrequent: back pain, muscle cramps, myalgia.
Rare: arthralgia, muscle cramps, calf pain.
Genital and breast disorders
Infrequent: erectile dysfunction.
General disorders and disorders at the site of administration
Infrequent: pain in the chest.
Rarely: flu-like syndrome, pain.
Laboratory and instrumental data
Infrequent: increase in 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 the experience of using individual active ingredients
Adverse reactions previously observed with the use of each of the drug components may potentially be observed with the combination of telmisartan and hydrochlorothiazide, even if they were not observed in the study of the specified combination.
Telmisartan
The incidence of adverse events 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 studies involving patients who received telmisartan for arterial hypertension or telmisartan in patients 50 years of age and older with a high risk of cardiovascular events.
Infectious and parasitic diseases
Infrequent: upper respiratory tract infections, urinary tract infections including cystitis.
Rare: sepsis, including cases with fatal outcome.
Blood and lymphatic system disorders
Infrequent: anemia.
Rare: eosinophilia, thrombocytopenia.
Immune system disorders
Rare: hypersensitivity reactions, anaphylactic reactions.
Metabolic and nutritional disorders
Infrequent: hyperkalemia.
Rare: hyperglycemia (in patients with diabetes).
Heart disorders
Infrequent: bradycardia.
Nervous system disorders
Rare: somnolence.
Respiratory system, thoracic and mediastinal organs
Infrequent: cough.
Very common: interstitial lung disease3.
Gastrointestinal tract disorders
Rare: feeling of discomfort in the stomach.
Skin and subcutaneous tissue disorders
Rare: eczema, drug and toxic rash.
Musculoskeletal and connective tissue disorders
Rare: arthrosis, tendon pain.
Renal and urinary tract disorders
Infrequent: impaired renal function (including acute renal failure).
General disorders and disorders at the site of administration
Infrequent: asthenia.
Laboratory and instrumental data
Rare: decrease in hemoglobin.
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 these reactions.
Infectious and parasitic diseases
Sialoadenitis.
Blood and lymphatic system disorders
Aplastic anemia, hemolytic anemia, bone marrow disorders, leukopenia, neutropenia, agranulocytosis, thrombocytopenia.
Immune system disorders
Anaphylactic reactions, hypersensitivity.
Endocrine system disorders
Uncontrolled diabetes.
Metabolism and nutrition disorders
Anorexia, reduced appetite, electrolyte imbalance, hypercholesterolemia, hyperglycemia, hypovolemia.
Mental disorders
Indolence.
Nervous system disorders
Mild dizziness.
Visual organ disorders
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.
Skin and subcutaneous tissue disorders
Lupus-like syndrome, photosensitivity reactions, cutaneous vasculitis, toxic epidermal necrolysis.
Musculoskeletal system 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 data
Elevation of triglycerides.
Description of individual adverse reactions
Liver function impairment
Most cases of liver function impairment during post-registration use of telmisartan have been 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 are symptoms of the individual components of the drug.
Telmisartan – marked BP decrease, tachycardia, bradycardia.
Hydrochlorothiazide – disorders of water-electrolyte balance of blood (hypokalemia, hypochloremia), decreased blood pressure that 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
The use of 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 fetus 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
Weight | 0.040 kg |
---|---|
Shelf life | 1 year |
Conditions of storage | At a temperature not exceeding 25 ° C. Keep out of reach of children! |
Manufacturer | Dr. Reddy's, India |
Medication form | pills |
Brand | Dr. Reddy's |
Related products
Buy Telsartan N, tablets 12.5 mg+80 mg 28 pcs. with delivery to USA, UK, Europe and over 120 other countries.