Telzap Plus 12.5mg + 80mg #90

Telzap Plus instruction

You can buy Telzap Plus here

Composition

1 tab .:
Telmisartan 80 mg
hydrochlorothiazide 12.5 mg
Excipients: sorbitol - 348.3 mg, sodium hydroxide - 6.8 mg, povidone 25-40 mg, magnesium stearate - 4.9 mg.

pharmachologic effect

Telzap Plus is a combination of telmisartan (angiotensin II receptor antagonist (APA II)) and hydrochlorothiazide (thiazide diuretic). The combination of these components provides a more pronounced antihypertensive effect, while the level of blood pressure decreases more than against the background of monotherapy with these components.
The drug, used 1 time / day in therapeutic doses, effectively and gradually reduces blood pressure.

Telmisartan

Telmisartan is a specific angiotensin II receptor antagonist (subtype AT1), effective when taken orally. Telmisartan has a high affinity for the AT1 receptor subtype angiotensin II, through which the action of angiotensin II is realized. Telmisartan displaces angiotensin II from its association with the receptor, without showing the properties of an AT1 receptor agonist. Telmisartan is selectively and firmly associated with the AT1 receptor. Telmisartan has no affinity for other receptors, including AT2 and other less studied AT receptors. The functional role of these receptors, as well as the effect of their possible increased stimulation with angiotensin II, the concentration of which increases under the action of telmisartan, has not been studied. Telmisartan reduces the concentration of aldosterone in the blood plasma, does not inhibit renin and does not block ion channels. Telmisartan does not inhibit ACE (Kininase II), which also destroys bradykinin. This avoids the side effects associated with the action of bradykinin.
In healthy people, telmisartan at a dose of 80 mg almost completely blocks the hypertensive effect of angiotensin II. The overwhelming effect lasts more than 24 hours and lasts up to 48 hours.
The onset of the antihypertensive effect is observed within the first 3 hours after ingestion of telmisartan inside. The duration of the therapeutic effect of Telzap Plus is more than 24 hours and includes the last 4 hours before taking the next dose according to the daily monitoring of blood pressure. This is confirmed by measurements made at the time of maximum effect and immediately before taking the next dose (the ratio of the residual effect to the maximum above 80% for dosages of 40 and 80 mg of telmisartan in placebo-controlled studies). The maximum antihypertensive effect develops after 4-8 weeks of regular intake of telmisartan and persists during long-term therapy.
In patients with arterial hypertension, telmisartan reduces both systolic and diastolic pressure without affecting heart rate. According to the results of clinical studies, the effectiveness of the antihypertensive effect of telmisartan is comparable to the therapeutic effect of other classes of drugs, such as amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril. In the case of abrupt cessation of treatment with telmisartan, blood pressure gradually returns to baseline, without the development of the syndrome of "cancellation"
The incidence of dry cough was significantly lower compared with the use of telmisartan, in contrast to ACE inhibitors.

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect electrolyte reabsorption in the renal tubules, thereby increasing the excretion of sodium ions and chlorides in approximately equivalent amounts. The diuretic effect of hydrochlorothiazide leads to a decrease in BCC, an increase in plasma renin activity, an increase in aldosterone production, with a consequent increase in potassium and bicarbonate levels in the urine and a decrease in the potassium content in blood plasma. The simultaneous use of telmisartan helps to reduce the loss of potassium caused by this diuretic, probably due to the blockade of the RAAS. After taking hydrochlorothiazide diuresis increases after 2 hours, the maximum effect develops after about 4 hours, the effect lasts about 6-12 hours.
In epidemiological studies, it has been established that prolonged therapy with hydrochlorothiazide reduces the risk of cardiovascular morbidity and mortality.

Patients of childhood and adolescence

The safety and efficacy of telmisartan in children and adolescents under the age of 18 years has not been established.

Telzap Plus, indications for use

- arterial hypertension (in the absence of the effectiveness of monotherapy with telmisartan or hydrochlorothiazide).

Contraindications

- cholestasis and obstructive diseases of the biliary tract;
- abnormal liver function;
- severe renal dysfunction (CC less than 30 ml / min);
- simultaneous use with drugs containing aliskiren in patients with diabetes or renal failure (GFR less than 60 ml / min / 1.73 m2);
- simultaneous use with ACE inhibitors in patients with diabetic nephropathy;
- refractory hypokalemia, hypercalcemia;
- hereditary intolerance to fructose (contains sorbitol).
- pregnancy;
- breastfeeding period;
- age up to 18 years (efficacy and safety have not been established);
- hypersensitivity to the active substance or any excipients of the drug and to other sulfonamide derivatives.
With caution, you should prescribe Telzap Plus for bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, severe renal impairment; reduction of BCC in the background of previous diuretic therapy, restrictions on the use of table salt, diarrhea or vomiting; hyperkalemia; condition after kidney transplantation (no experience); chronic heart failure III-IV FC according to the NYHA classification; stenosis of the aortic and mitral valves; idiopathic hypertrophic subaortic stenosis; hypertrophic obstructive cardiomyopathy; IHD and cerebrovascular diseases; diabetes; primary hyperaldosteronism; gout; violations of water and electrolyte balance (including hypokalemia, hyponatremia, hypochloraemic alkalosis, hypomagnesemia); hyperuricemia; angle-closure glaucoma (due to the presence of hydrochlorothiazide in the composition); systemic lupus erythematosus; in patients of the Negroid race; elderly patients (over 70 years).
The experience of use in patients with renal insufficiency (CC more than 30 ml / min) is limited, but does not confirm the development of side effects from the kidneys, dose adjustment is not required.

Dosage and administration

The drug is taken orally 1 time / day, squeezed fluid, regardless of the meal.
Patients whose blood pressure cannot be adequately controlled using monotherapy with telmisartan or hydrochlorothiazide should be given Telzap Plus drug. Before switching to a fixed dose combination, an individual dose titration of each component is recommended. In some clinical situations, a direct transition from monotherapy to treatment with a fixed-dose combination can be considered.
Telzap Plus, 80 mg + 12.5 mg, can be used 1 time / day in patients whose blood pressure cannot be adequately controlled when receiving telmisartan at a dose of 80 mg / day.
Dose adjustment in patients with impaired renal function of mild or moderate severity (CC more than 30 ml / min) is not required. Recommended periodic monitoring of indicators of renal function.
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal insufficiency (GFR less than 60 ml / min / 1.73 m2).
Telzap Plus is contraindicated in patients with impaired liver function.
For elderly patients (over 70 years), dose adjustment is not required.
Telzap Plus is contraindicated for use in children and adolescents under the age of 18 years due to the lack of data on safety and efficacy.

Use during pregnancy and lactation

Pregnancy

Treatment of ARA II during pregnancy is contraindicated. The use of ARA II is not recommended in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy.
Telmisartan
There is no adequate data on the use of the drug telmisartan in pregnant women. Animal studies have discovered its reproductive toxicity. Epidemiological evidence of the risk of teratogenic effects after taking ACE inhibitors in the first trimester of pregnancy was not conclusive, however, this risk cannot be excluded. Until data from controlled epidemiological studies have been received regarding the risk of taking APA II, a similar risk may exist for this class of drugs. With the exception of the urgent need for long-term treatment of ARA II, patients planning a pregnancy should choose an alternative antihypertensive drug with a confirmed safety profile during pregnancy. After the establishment of the fact of pregnancy, the treatment of APA II should be stopped immediately and, if necessary, alternative treatment should be started.
Treatment of ARA II in the II and III trimesters of pregnancy has a toxic effect on the fetus (deterioration of renal function, oligohydramnios, delayed ossification of the skull) and the newborn (renal failure, arterial hypotension and hyperkalemia). In the application of ARA II with the II trimester of pregnancy, an ultrasound scan of the kidneys and fetal skull is recommended. Children whose mothers took ARA II should be carefully examined for hypotension.
Hydrochlorothiazide
The experience of using hydrochlorothiazide during pregnancy, especially in the first trimester, is limited. Hydrochlorothiazide penetrates through the BBB. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use in the second and third trimesters may worsen the placental blood flow and cause jaundice in the fetus / newborn, impaired water-electrolyte balance and thrombocytopenia. Hydrochlorothiazide should not be used to treat pregnancy edema, pregnant hypertension or pre-eclampsia due to the risk of lowering the BCC and deterioration of placental blood flow without adequate therapeutic effect on the course of the disease.
Do not use hydrochlorothiazide for the treatment of essential hypertension in pregnant women, except in rare cases where other treatment is not possible.

Breastfeeding period

Taking Telzap Plus during breastfeeding is contraindicated; alternative treatment with more favorable safety profiles should be used.

Fertility

The study of the effect of the combination of telmisartan and hydrochlorothiazide on human fertility has not been conducted.

Side effects

The most commonly reported adverse events were dizziness. Severe angioedema rarely occurred (≥1 / 10,000,
Telzap Plus 80 mg + 12.5 mg: the overall incidence of adverse reactions was comparable to that on the background of telmisartan monotherapy. The dependence of the development of adverse reactions on the dose of Telzap Plus has not been established, there was no correlation with gender, age or race of patients.
Adverse reactions are divided into system-organ classes according to MedDRA. The frequency of side effects was determined in accordance with the WHO classification: very often (≥1 / 10), often (≥1 / 100,
Infectious and parasitic diseases: rarely - bronchitis, pharyngitis, sinusitis.
On the part of the immune system: rarely - increased symptoms or exacerbation of systemic lupus erythematosus (during post-registration observation).
Metabolism and nutrition: infrequently - hypokalemia; rarely - hyperuricemia, hyponatremia.
Mental disorders: infrequently - anxiety; rarely - depression.
On the part of the nervous system: often - dizziness; infrequently - fainting, paresthesias; rarely - insomnia, sleep disturbance.
On the part of the organ of vision: rarely - visual impairment, transient visual disturbance.
On the part of the organ of hearing: infrequently - vertigo.
Since the cardiovascular system: infrequently - tachycardia, arrhythmia, arterial hypotension, orthostatic hypotension.
On the part of the respiratory system: infrequently - shortness of breath; rarely, respiratory distress syndrome (including pneumonitis and pulmonary edema).
On the part of the digestive system: infrequently - diarrhea, dry mouth, flatulence; rarely - abdominal pain, constipation, dyspepsia, vomiting, gastritis.
On the part of the liver and biliary tract: rarely - impaired liver function, liver disease.
On the part of the skin and subcutaneous tissues: rarely - angioedema (also fatal), erythema, pruritus, skin rash, increased sweating, urticaria.
On the part of the musculoskeletal system and connective tissue: infrequently - back pain, muscle spasms, myalgia; rarely - pain in the joints, muscle spasms, pain in the limbs.
On the part of the genital organs and the mammary gland: infrequently - erectile dysfunction.
General disorders and disorders at the injection site: infrequently - chest pain; rarely - flu-like syndrome, pain.
From the laboratory and instrumental studies: rarely - increasing the concentration of creatinine in the blood plasma, increasing the activity of CPK, increasing the activity of hepatic transaminases.

Additional information about individual components

The side effects noted when using one of the components, the development of which can be expected when using a combination of telmisartan and hydrochlorothiazide.

Telmisartan

The incidence of adverse reactions with telmisartan, registered in controlled clinical trials, was comparable to the incidence of adverse reactions noted in the placebo group (41.4% and 43.9%, respectively). The following adverse reactions were reported during a clinical trial of telmisartan, including a high-risk cardiovascular patient group over the age of 50 years.
Infectious and parasitic diseases: infrequently - upper respiratory tract infections, urinary tract infections, including cystitis; rarely - sepsis, incl. fatal.
From the hemopoietic system: infrequently - anemia; rarely - eosinophilia, thrombocytopenia.
On the part of the immune system: rarely - hypersensitivity reactions, anaphylactic reactions.
On the part of metabolism and nutrition: infrequently - hyperkalemia; rarely - hypoglycemia (in patients with diabetes).
On the part of the nervous system: rarely - drowsiness.
Since the cardiovascular system: infrequently - bradycardia.
On the part of the respiratory system: Infrequently - cough; very rarely - interstitial lung disease.
On the part of the digestive system: rarely - a feeling of discomfort in the stomach.
On the part of the skin and subcutaneous tissues: rarely - eczema, drug rash, toxic skin rash.
From the musculoskeletal system: rarely - arthrosis, pain in the tendon.
From the urinary system: infrequently - impaired renal function (including acute renal failure).
General disorders and disorders at the injection site: infrequently - asthenia.
From the laboratory and instrumental studies: rarely - a decrease in hemoglobin content.

Hydrochlorothiazide

Hydrochlorothiazide can cause or increase hypovolemia, which can lead to disruption of water and electrolyte balance. The adverse reactions reported with hydrochlorothiazide are listed below.
Infectious and parasitic diseases: frequency unknown - sialadenitis.
On the part of the hematopoietic system: the frequency is unknown - aplastic anemia, hemolytic anemia, bone marrow suppression, leukopenia, neutropenia, agranulocytosis, thrombocytopenia.
On the part of the immune system: the frequency is unknown - anaphylactic reactions, hypersensitivity reactions.
On the part of the endocrine system: the frequency is unknown - the lack of proper glycemic control in diabetes mellitus.
Metabolism and nutrition: the frequency is unknown - anorexia, loss of appetite, impaired water and electrolyte balance, hypovolemia.
Mental disorders: frequency unknown - excited state.
On the part of the nervous system: the frequency is unknown - pre-unconscious state.
On the part of the organ of vision: the frequency is unknown - xantopsia, acute myopia, acute angle-closure glaucoma.
On the part of the vessels: the frequency is unknown - necrotizing vasculitis.
On the part of the digestive system: the frequency is unknown - pancreatitis, a feeling of discomfort in the stomach.
On the part of the liver and biliary tract: the frequency is unknown - jaundice (parenchymal or cholestatic).
On the part of the skin and subcutaneous tissues: the frequency is unknown - lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis (Lyell's syndrome).
On the part of the urinary system: the frequency is unknown - interstitial nephritis, renal dysfunction, glycosuria.
On the part of the musculoskeletal system and connective tissue: the frequency is unknown - weakness.
General disorders and disorders at the injection site: frequency unknown - hyperthermia.
From the laboratory and instrumental studies: the frequency is unknown - hypertriglyceridemia, hypercholesterolemia, hyperglycemia.

special instructions for Telzap Plus

Liver dysfunction

The use of Telzap Plus is contraindicated in patients with cholestasis, obstruction of the biliary tract and / or abnormal liver function, since telmisartan is mainly excreted in the bile. There is reason to believe that these patients lowered the hepatic clearance of telmisartan.

Renovascular hypertension

When treating drugs acting on the RAAS, in patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney, the risk of a significant reduction in blood pressure and the development of acute renal failure increases.

Double blockade of RAAS

Data on the simultaneous use of ACE inhibitors with ARA II or with drugs containing aliskiren confirm an increased risk of a sharp decrease in blood pressure, the development of hyperkalemia and a decrease in renal function (including acute renal failure). Therefore, the use of this drug combination is contraindicated. If necessary, the implementation of a double blockade of the RAAS should consider each case individually and carefully monitor kidney function, water and electrolyte balance and blood pressure indicators.
In patients with diabetic nephropathy, the use of a combination of ACE inhibitors and APA II is contraindicated.

Other conditions associated with stimulation of the RAAS

In patients whose vascular tone and renal function depend mainly on the activity of the RAAS (for example, patients with severe chronic heart failure or existing kidney disease, including renal artery stenosis), the use of drugs acting on this system, such as telmisartan , is associated with the occurrence of an acute decrease in blood pressure, hyperasotemia, oliguria, or rarely with the development of acute renal failure.

Primary hyperaldosteronism

In patients with primary hyper aldosteronism, treatment with antihypertensive drugs, which are mediated by the suppression of the RAAS, is usually ineffective. In this regard, the use of the drug Telzap Plus is not recommended.

Impaired renal function and kidney transplantation

The use of Telzap Plus is contraindicated in patients with severely impaired renal function (CK® Plus in patients with impaired mild to moderately severe renal function, it is recommended to periodically monitor the content of potassium, creatinine and uric acid in the blood plasma, as well as indicators of renal function Azotemia associated with the use of thiazide diuretics may occur in patients with impaired renal function.

Lower bcc

Decreased blood pressure, especially after the first dose of Telzap Plus, can occur in patients with reduced BCC and / or low sodium in the blood plasma on the background of prior diuretic treatment, limitation of salt, diarrhea or vomiting. Similar conditions (lack of liquid and / or sodium) should be eliminated before taking Telzap Plus.

Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilators, patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy, should be especially careful.

Effect on metabolism and endocrine function

The use of hydrochlorothiazide may interfere with glucose tolerance, while in patients with diabetes mellitus hypoglycemia may develop along with the simultaneous use of insulin or hypoglycemic agents and telmisartan. May require dose adjustment of hypoglycemic agents, incl. insulin. During treatment with thiazides in patients with impaired glucose tolerance, latent diabetes mellitus may manifest. An increase in plasma cholesterol and triglyceride concentrations is associated with treatment with thiazide diuretics. However, when using a preparation containing 12.5 mg of hydrochlorothiazide, this effect is minimal or absent. Some patients using hydrochlorothiazide may develop hyperuricemia or a sudden onset of exacerbation of gout.

Disruption of water and electrolyte balance

At use of the drug Telzap Plus it is necessary to carry out periodic control of content of electrolytes in a blood plasma.
Thiazides, including hydrochlorothiazide, can cause disturbances in water and electrolyte balance (hypokalemia, hyponatremia, and hypochloraemic alkalosis) and changes in the acid-base state. Signs of impaired water and electrolyte balance are: dry mouth, thirst, general weakness, lethargy, drowsiness, anxiety, pain or muscle cramps, muscle weakness, decreased blood pressure, oliguria, tachycardia, and disorders of the gastrointestinal tract, such as nausea and vomiting.

Hypokalemia

Although hypokalemia may develop due to the use of hydrochlorothiazide, concomitant therapy with telmisartan may compensate for a decrease in plasma potassium concentration. The risk of hypokalemia increases in patients with cirrhosis of the liver, patients with severe diuresis, with a salt-free diet, in patients who do not adequately replenish electrolyte loss, as well as in patients receiving concomitant corticosteroids or ACTH.

Hyperkalemia

Taking Telmisartan can cause hyperkalemia. However, there was no clinically significant hyperkalemia in patients receiving Telzap Plus. The main risk factors for the development of hyperkalemia are:
- diabetes mellitus, renal failure, heart failure, old age (patients over 70 years old);
- combination with one or more drugs acting on the RAAS, and / or supplements containing potassium. Drugs that can cause hyperkalemia are potassium-sparing diuretics, ACE inhibitors, ARA II, NSAIDs, incl. selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporin or tacrolimus), trimethoprim, as well as potassium-containing salt substitutes;
- comorbidities, especially dehydration, acute heart failure, metabolic acidosis, acute renal failure (for example, in infectious diseases), cytolysis syndrome (for example, acute limb ischemia, rhabdomyolysis, extensive trauma).
Patients at risk are advised to carefully monitor plasma potassium levels.

Hyponatremia and hypochloremic alkalosis

There is no evidence that Telzap Plus reduces or prevents the development of hyponatremia caused by diuretics. Minor chlorine deficiency does not usually require correction.

Hypercalcemia

Hydrochlorothiazide can reduce urinary calcium excretion and cause a periodic and insignificant increase in plasma calcium in the absence of any calcium metabolism disorders. Severe hypercalcemia can be a sign of latent hyperparathyroidism. Receiving hydrochlorothiazide should be discontinued before the parathyroid function is analyzed.

Hypomagnesemia

While taking hydrochlorothiazide, an increase in magnesium excretion in the urine was noted, which can lead to hypomagnesaemia.

Sorbitol

This drug contains sorbitol (E420). In patients with rare hereditary fructose intolerance, the use of Telzap Plus is contraindicated.

Ethnic differences

Like all other ARA II, telmisartan less effectively reduces blood pressure in patients of the Negroid race than in other races, possibly due to a greater propensity to decrease renin activity in the population of these patients. During post-registration use, most cases of functional impairment of liver function or liver damage have occurred in the Japanese. The Japanese are more prone to the development of these undesirable reactions.

CHD and cerebrovascular disease

As with any other antihypertensive drugs, an excessive decrease in blood pressure in patients with IHD or cerebrovascular disease can lead to the development of myocardial infarction or stroke.

Heart failure

As with the use of other drugs that affect the RAAS, patients with heart failure (accompanied or not accompanied by impaired renal function) are at risk of developing a significant reduction in blood pressure, as well as renal impairment (often acute).

General violations

Hypersensitivity reactions to hydrochlorothiazide are most likely to occur in patients with a history of allergic reactions or bronchial asthma. It is known that the use of thiazide diuretics, including hydrochlorothiazide, may exacerbate or exacerbate the symptoms of systemic lupus erythematosus. When using hydrochlorothiazide, photosensitivity reactions were noted. In the event of a photosensitivity reaction, it is recommended to stop taking Telzap Plus. If the use of diuretics is still necessary, it is recommended to protect exposed skin from exposure to sunlight or artificial ultraviolet radiation.

Acute myopia and angle-closure glaucoma

Receiving hydrochlorothiazide may cause an idiosyncratic reaction, leading to acute transient myopia and acute angle-closure glaucoma. The symptoms of these disorders are a sudden decrease in visual acuity or eye pain and, as a rule, occurring from a few hours to several weeks after the start of treatment. In a timely manner, uncorrected acute angle-closure glaucoma can lead to persistent loss of vision. First of all, you should immediately stop taking Telzap Plus. In the absence of control of intraocular pressure, emergency conservative or surgical treatment may be required. Risk factors for the development of acute angle-closure glaucoma are an allergic reaction to a sulfonamide or penicillin in history.

Interstitial lung disease

During clinical use, cases of interstitial lung disease have been described while receiving telmisartan.

Influence on ability to drive motor transport and control mechanisms

When driving and taking on potentially hazardous activities, it should be taken into account that while taking Telzap Plus, dizziness and drowsiness may occur, which requires caution.

Interaction

Double blockade of RAAS

The simultaneous use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR2) and is not recommended for other patients.
The simultaneous use of ACE inhibitors with ARA II or drugs containing aliskiren is characterized by an increased risk of arterial hypotension, hyperkalemia and decreased renal function (including acute renal failure) in patients compared with the use of each drug separately.
In patients with diabetic nephropathy, the use of a combination of ACE inhibitors and APA II is contraindicated.

Digoxin

With simultaneous use of telmisartan with digoxin, an average increase in peak plasma concentration (49%) and minimum concentration (20%) of digoxin was noted. With simultaneous appointment, at the beginning of treatment, when selecting the dose and stopping treatment with telmisartan, the concentration of digoxin in the blood should be monitored to maintain it within the therapeutic range.

Drugs that cause potassium loss and hypokalemia

Other potassium uretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium salt, salicylic acid and its derivatives. If necessary, the simultaneous use of these drugs with a combination of telmisartan / hydrochlorothiazide is recommended to monitor the content of potassium in the blood plasma. These drugs can increase the loss of potassium while using it with hydrochlorothiazide.

Drugs that cause an increase in plasma potassium

Like other drugs acting on the RAAS, the use of the telmisartan / hydrochlorothiazide combination can cause hyperkalemia. The risk may increase with simultaneous use with other drugs that can cause hyperkalemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, ARA II, NSAIDs, including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus), and cyclosporine or tacrolimus). ).
With strict precautions, combining with ACE inhibitors or NSAIDs is less dangerous.
If necessary, the simultaneous use of these drugs with a combination of telmisartan / hydrochlorothiazide is recommended to monitor the content of potassium in the blood plasma.

Lithium

With simultaneous use of lithium preparations with ACE inhibitors and rarely with ARA II, including the telmisartan / hydrochlorothiazide combination, there was a reversible increase in plasma lithium concentration and its toxic effect. With their simultaneous use with lithium preparations, it is recommended to carefully control the concentration of lithium in the blood plasma.

NSAIDs

NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment (no more than 3 g / day), COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of ARA II and weaken the diuretic, natriuretic effect of thiazide diuretics.
In some patients with impaired renal function (for example, in dehydrated patients with reduced BCC, elderly patients), the simultaneous use of ARA II and drugs that depress COX may lead to a further deterioration in renal function, up to the development of acute renal failure, which, as a rule, is reversible. Therefore, the simultaneous use of a combination of telmisartan / hydrochlorothiazide with NSAIDs should be carried out with caution, especially for elderly patients. It is necessary to provide patients with proper fluid intake, in addition, at the beginning of simultaneous use and periodically in the future should be monitored renal function.
While taking telmisartan with ibuprofen or paracetamol, there was no clinically significant interaction effect.

Drugs that are affected by changes in the content of potassium in the blood plasma

It is recommended to periodically monitor the content of potassium in the blood plasma and conduct an ECG on the background of use with drugs whose effect depends on changes in the concentration of potassium in the blood plasma (for example, with cardiac glycosides, antiarrhythmic drugs), and also after an attack of ventricular tachycardia, including . caused by drugs (including some antiarrhythmic drugs). Hypokalemia was a provoking factor for the development of ventricular tachycardia like "pirouette" (torsade de pointes):
- class antiarrhythmic drugs IA (for example, quinidine, hydroquinidine, disopyramide);
- Class III antiarrhythmic drugs (for example, amiodarone, sotalol, dofetilide, ibutilide);
- some neuroleptics (for example, thioridazine, chlorpromazine, levomepromazine, trifluoperazin, cyamemazine, sulpiride, sultopride, amisulpride, tiaprid, pimozide, haloperidol, droperidol);
- other drugs (for example, bepridil, cisapride, difemanil, erythromycin [in / in injections], halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincammine [in / in injections]).

Cardiac glycosides

Hypokalemia or hypomagnesemia, caused by taking hydrochlorothiazide, may contribute to the occurrence of arrhythmias during therapy with cardiac glycosides.

Other antihypertensive drugs

Telmisartan may enhance the effect of other antihypertensive drugs.

Anti-diabetic agents (oral and insulin preparations)

Correction of doses of antidiabetic drugs may be required.

Metformin

Metformin should be used with caution because of the risk of lactic acidosis caused by possible functional renal failure in patients receiving hydrochlorothiazide.

Cholestyramine and colestipol

Hydrochlorothiazide absorption is reduced in the presence of anion exchange resins.

Pressor amines (for example, norepinephrine (norepinephrine))

The action of vasopressor amines may be weakened.

Non-depolarizing skeletal muscle relaxants (for example, tubocurarine)

The action of non-depolarizing muscle relaxants can be enhanced by hydrochlorothiazide.

Anti-gouty agents (eg, probenecid, sulfinpyrazone, and allopurinol)

It may be necessary to adjust the dose of drugs that promote the excretion of uric acid, since hydrochlorothiazide may increase the content of uric acid in the blood plasma. You may need to increase the dose of probenecid or sulfinpyrazone. The simultaneous use of thiazide diuretic can increase the frequency of hypersensitivity reactions to allopurinol.

Calcium salts

Hydrochlorothiazide may increase calcium in blood plasma due to a decrease in its excretion. If necessary, the appointment of calcium supplements should control the concentration of calcium in the blood plasma and, accordingly, correct the dose.
Due to the effect on calcium metabolism, thiazides may distort test results to evaluate the function of the parathyroid glands.

Β-adrenoreceptor blockers and diazoxide

The hyperglycemic effect of β-adrenoreceptor blockers and diazoxide can be enhanced by hydrochlorothiazide.

Cholinolytic agents (for example, atropine, biperiden)

Cholinolytic agents can increase the bioavailability of hydrochlorothiazide by reducing gastrointestinal motility and the rate of gastric emptying.

Amantadine

Hydrochlorothiazide may increase the risk of unwanted reactions caused by amantadine.

Glycyrrhizinic acid

The interaction of hydrochlorothiazide and licorice root (glycyrrhizic acid) can lead to the development of hypokalemia.

Cytotoxic drugs (eg, cyclophosphamide, methotrexate)

Hydrochlorothiazide can reduce the excretion of cytotoxic drugs by the kidneys and increase their myelosuppressive effect.
Based on the pharmacological properties of baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all antihypertensive drugs, including telmisartan.
In addition, orthostatic hypotension may increase with alcohol intake, barbiturates, narcotic drugs or antidepressants.

Corticosteroids (for systemic use)

Corticosteroids weaken the antihypertensive effect of telmisartan.

Overdose

No overdose cases have been identified. Possible symptoms consist of the symptoms of an overdose of individual components.

Symptoms

The most pronounced manifestations of telmisartan overdose are arterial hypotension and tachycardia, bradycardia, dizziness, vomiting, increased serum creatinine and acute renal failure have also been reported.
Hydrochlorothiazide overdose is associated with a decrease in electrolyte content (hypokalemia, hypochloraemia) and hypovolemia due to excessive diuresis. The most common symptoms of an overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasm and / or exacerbation of arrhythmias when used simultaneously with cardiac glycosides or certain antiarrhythmic drugs.

Treatment

Telmisartan is not excreted by hemodialysis. The degree of elimination of hydrochlorothiazide by hemodialysis has not been established. Patients should be carefully monitored and symptomatic as well as supportive treatment should be carried out. The approach to treatment depends on the time elapsed after taking Telzap Plus, and the severity of symptoms. Recommended interventions include provoking vomiting and / or gastric lavage, it is advisable to receive activated charcoal. The patient should be laid on his back, legs raised. If necessary, it is recommended to replenish the BCC, for example, by intravenous administration of a 0.9% solution of sodium chloride. Sympathomimetic drugs may be prescribed.

Shelf life

2 years. Do not use after the expiration date printed on the package.

Storage conditions

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

Terms of sell

You can buy Telzap Plus without a prescription.