Telpres Plus pills 80mg+12.5mg, 56pcs

Composition

Active ingredients:

Hydrochlorothiazide-12.50 mg, telmisartan-80.00 mg;

Auxiliary substances:

Mannitol – 327,70 mg, povidone-To 25 – 21,60 mg crospovidone – 12,00 mg, magnesium stearate – of 8.50 mg, meglumin – 24,00 mg, sodium hydroxide – of 6.70 g, lactose monohydrate – 49,84 mg, microcrystalline cellulose – of 32.00 mg, hypromellose – 3,00 mg, carboximetilkrahmal sodium type a – 2,00 mg, iron oxide red (E 172) and 0.17 mg

Pharmacological action

Angiotensin II receptor antagonist. 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 binding to the receptor, without having an agonist effect on this receptor. Telmisartan binds only to the AT1 subtype of angiotensin II receptors. The relationship is long-term. It has no affinity for other receptors, including the AT2 receptor and other less well-studied angiotensin receptors. The functional significance of these receptors, as well as the effect of their possible overstimulation with angiotensin II, the concentration of which increases with the appointment of telmisartan, have not been studied. Reduces the concentration of aldosterone in the blood, does not inhibit renin in the blood plasma and does not block ion channels. Telmisartan does not inhibit the angiotensin-converting enzyme (kininase II) (an enzyme that also breaks down bradykinin). Therefore, an increase in the side effects caused by bradykinin 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 antihypertensive action is noted within 3 hours after the first oral use of telmisartan. The effect of the drug persists for 24 hours and remains significant for up to 48 hours. A pronounced antihypertensive effect usually develops 4 weeks after regular use of the drug. In patients with hypertension, telmisartan reduces systolic and diastolic blood pressure( BP) without affecting the heart rate (HR). In the case of abrupt withdrawal of telmisartan, blood pressure gradually returns to its original level without the development of “withdrawal”syndrome.

Indications

-Arterial hypertension;

– Reduction of cardiovascular morbidity and mortality in patients aged 55 years and older with a high risk of cardiovascular diseases.

Contraindications

– Hypersensitivity to the Active ingredient or auxiliary components of the drug;

– Pregnancy;

– the Period of breastfeeding;

– Obstructive disease of the biliary tract;

Severe disturbances of liver function (class C child-Pugh);

– Simultaneous use of the drug Telpas with aliskiren in patients with diabetes mellitus and/or impaired renal function (glomerular filtration rate less than 60 ml/min/1.73 m 2 );

– Simultaneous use of ACE inhibitors in patients with diabetic nephropathy;

– Age up to 18 years (efficacy and safety have not been established).

With caution:

– Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney;

– Disorders of liver function and/or kidney (see “Special instructions”);

– Condition after kidney transplantation (experience of missing);

– Reduced volume of circulating blood (BCC) as a result of prior diuretic therapy, restriction of salt, diarrhoea, or vomiting;

– Hyponatremia;

– Hyperkalemia;

– Chronic heart failure;

Ischemic heart disease;

– stenosis of the aortic and mitral valve;

– Idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy);

– Primary aldosteronism (efficacy and safety not established);

– the Simultaneous use of ACE inhibitors or aliskiren;

– Simultaneous use with potassium supplements, potassium-sparing diuretics;

– diabetes.

Side effects

The most commonly reported side effect is dizziness. In rare cases (less than 1 case per 1000 patients), serious angioedema is possible.

Fixed-dose combination

No dose-dependent side effects have been established, and these effects were not related to gender, age, or race.

Adverse events reported in all clinical trials that occurred more frequently (p < 0.05) with telmisartan plus hydrochlorothiazide than with placebo are listed below according to organ system classes. Side effects that were observed with the use of each component separately, but which did not appear during clinical studies, may appear during treatment with Telpres Plus.

In each group, adverse reactions are presented in descending order of severity.

Infections and infestations: rarely-bronchitis, pharyngitis, sinusitis.

Immune system disorders: rarely-exacerbation or activation of systemic lupus erythematosus.

From the side of metabolism: infrequently-hypokalemia rarely-hyperuricemia, hyponatremia.

From the side of the psyche: infrequently-anxiety; rarely-depression.

From the nervous system: often – dizziness infrequently-fainting spells, paresthesia; rarely-insomnia, sleep disorders.

From the side of the organ of vision: rarely-visual impairment, blurred vision.

From the side of the hearing organs: infrequently-vertigo.

From the cardiovascular system: infrequently-tachycardia, arrhythmia, hypotension, orthostatic hypotension.

From the respiratory system: infrequently – shortness of breath; rarely-respiratory distress syndrome (including pneumonitis and pulmonary edema).

From the digestive tract: rarely-diarrhea, dry mouth, flatulence rarely-abdominal pain, constipation, dyspepsia, vomiting, gastritis.

From the digestive system: rarely-impaired liver function / liver disease.

From the skin and subcutaneous tissue: rarely-angioedema (also fatal), erythema, pruritus, rash, hyperhidrosis, urticaria.

Musculoskeletal disorders: infrequently-back pain, muscle spasms, myalgia rarely-arthralgia, muscle cramps, leg pain.

From the reproductive system: infrequently-erectile dysfunction.

Common disorders: infrequently-chest pain; rarely-flu-like symptoms, pain.

Laboratory parameters: infrequently-increased uric acid level rarely-increased creatinine level, increased blood CK level, increased level of liver enzymes.

Additional information on individual components.

Side effects that have previously been reported in connection with the use of one of the components may occur with the use of a combination of telmisartan / hydrochlorothiazide, even if they were not observed in clinical studies of this combination.

Sepsis. In the PRoFESS study, patients treated with telmisartan had a higher incidence of sepsis than those treated with placebo. This phenomenon can be either accidental or related to a mechanism, the essence of which is still unknown.

Interaction

The interaction study was conducted only with the participation of adults.

Lithium. With simultaneous use of lithium with ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and an increase in its toxicity were recorded. Such rare interactions have also been reported with angiotensin II receptor antagonists (including telmisartan / hydrochlorothiazide). Concomitant use of lithium and Telpres Plus is not recommended. If this combination is proven to be effective, careful monitoring of serum lithium levels is recommended.

Medications associated with potassium loss and hypokalemia (e. g. other potassium-removing diuretics, laxatives, corticosteroids, ACTH (ACTH), amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives)

When using these drugs together with the combination of telmisartan / hydrochlorothiazide, monitoring of blood potassium levels is recommended.

These drugs may increase the effect of hydrochlorothiazide on the level of potassium in the blood plasma.

Medications that may increase sodium levels and cause hyperkalemia (for example, medications that inhibit the renin-angiotensin system, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporine, or other medications such as sodium heparin)

When using these drugs together with the combination of telmisartan / hydrochlorothiazide, it is recommended to monitor the level of potassium in the blood plasma. Given the experience of using other drugs that inhibit the renin-angiotensin system, the simultaneous use of these drugs may lead to an increase in serum potassium levels and is therefore not recommended.

Medications that cause impaired serum potassium levels

It is recommended to monitor the level of potassium in the blood serum and ECG in use of the drug Telpas Plus with drugs that cause disturbance in the level of potassium in the serum (e. g., digitalis glycosides, antiarrhythmic agents), and drugs that stimulate paroxysmal tachycardia type torsades de pointes (including some antiarrhythmics), hypokalemia, which is a provocative factor for torsades de pointes :

• antiarrhythmic drugs of class Ia (e. g. quinidine, gedragingen, disopyramide)
• Class III antiarrhythmic drugs (e. g. amiodarone, sotalol, dofetelide, ibutilide)
• some antipsychotic agents (e. g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultoprid, amisulpride, tiapride, pimozide, haloperidol, droperidol)
• others (e. g. bepridil, cisapride, difemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine iv).

Digitalis glycosides. Hypokalemia or hypomagnesemia caused by thiazides contributes to the occurrence of digitalis-induced cardiac arrhythmia.

Digoxin. When telmisartan was co-administered with digoxin, an increase in the average peak (49%) and minimum (20%) digoxin concentrations in blood plasma was noted.

At the beginning of therapy, during dose adjustment, and when telmisartan therapy is discontinued, digoxin levels should be monitored to maintain the level within therapeutic limits.

Other antihypertensive medications

Telmisartan may increase the antihypertensive effect of other antihypertensive agents.

Double blockade of renin-angiotensin(RAAS) with a combination of ACE inhibitors, angiotensin II receptor blockers, or aliskiren has been reported to be associated with a higher incidence of side effects such as hypotension, hyperkalemia, and decreased renal function (including acute renal failure) compared to the use of a single RAAS-active agent.

Antidiabetic medications (oral medications and insulin)

It may be necessary to adjust the dose of antidiabetic agents.

Metformin should be used with caution due to the risk of lactic acidosis caused by possible functional renal failure, when used concomitantly with hydrochlorothiazide.

Colestyramic and cholestipolic resins. Absorption of hydrochlorothiazide is impaired in the presence of anion exchange resins.

Nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs (in particular acetylsalicylic acid in anti-inflammatory doses, COX-2 inhibitors, non-selective NSAIDs) can reduce the diuretic, natriuretic and hypotensive effects of thiazide diuretics and the antihypertensive effect of angiotensin II receptor antagonists. In some patients with impaired renal function (dehydrated patients or elderly patients with impaired renal function), concomitant use of angiotensin II receptor antagonists and agents that inhibit COX may cause deterioration of renal function, including acute renal failure, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and carefully monitored for renal function after starting therapy with a combination of medications and periodically thereafter.

In one study, concomitant use of telmisartan and ramipril resulted in a 2.5-fold increase in the AUC 0-24 and cmax of ramipril and ramiprilate.

The clinical significance of this observation remains unknown.

Vasopressor amines (e. g. norepinephrine)

The effect of vasopressor amines may be reduced.

Non-depolarizing skeletal muscle relaxants (e. g. tubocurarine)

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

Medications used to treat gout (e. g. probenecid, sulfinpyrazone, and allopurinol)

It may be necessary to adjust the dose of drugs that promote the elimination of uric acid, since hydrochlorothiazide can increase the level of uric acid in the blood serum. You may need to increase the dose of probenecid or sulfinpyrazone. Concomitant use of thiazide may increase the incidence of hypersensitivity reactions to allopurinol.

Calcium salts. Thiazide diuretics may increase serum calcium levels due to decreased excretion. If calcium supplementation is necessary, serum calcium levels should be monitored and the dose adjusted accordingly.

beta-blockers and diazoxide. The hyperglycemic effect of beta-blockers and diazoxide may be enhanced by thiazides.

Anticholinergic drugs (e. g. atropine, biperidene) may increase the bioavailability of thiazide diuretics by reducing gastrointestinal motility and the degree of gastric emptying.

Amantadine. Thiazides increase the risk of side effects of amantadine.

Cytotoxic drugs (e. g. cyclophosphamide, methotrexate)

Thiazides can reduce the renal excretion of cytotoxic drugs and enhance their myelosuppressive effect.

Based on their pharmacological properties, it is expected that baclofen and amifostine may enhance the antihypertensive effect of all antihypertensive drugs, including telmisartan.

In addition, orthostatic hypotension may be aggravated by the use of alcohol, barbiturates, narcotic drugs or antidepressants.

Salicylates. When high doses of salicylates are used, hydrochlorothiazide may increase their toxic effects on the central nervous system.

Methyldopa. Isolated cases of hemolytic anemia have been reported with concomitant use of hydrochlorothiazide and methyldopa.

Cyclosporine. Concomitant use of cyclosporine may increase hyperuricemia and increase the risk of complications such as gout.

The effect of drugs on the results of laboratory tests

Through the effect on calcium metabolism, thiazides can affect the results of evaluating the function of the parathyroid glands.

Carbamazepine. Given the risk of symptomatic hyponatremia, clinical and biological monitoring is necessary.

Iodine-containing contrast agents. In the case of diuretic-induced dehydration, the risk of acute renal failure increases, especially when using high doses of iodine-containing contrast agents. Patients need rehydration prior to use of iodine-containing drugs.

Amphotericin B (for parenteral use), corticosteroids, ACTH, and stimulant laxatives. Hydrochlorothiazide increases electrolyte imbalance, mainly hypokalemia.

How to take, course of use and dosage

Inside, regardless of the meal.

Arterial hypertension

The initial recommended dose of Telpres is 1 tablet. (40 mg) once a day. In cases where the therapeutic effect is not achieved, the maximum recommended dose of Telpres can be increased to 80 mg once a day. When deciding whether to increase the dose, it should be taken into account that the maximum antihypertensive effect is usually achieved within 4-8 weeks after the start of treatment.

Reduction of cardiovascular morbidity and mortality

The recommended dose is 1 tablet of Telpres 80 mg once a day.

During the initial period of treatment, monitoring of blood pressure (BP) is recommended, and correction of antihypertensive therapy may be required.

Impaired renal function

In patients with severe renal impairment and patients undergoing hemodialysis, experience with the drug is limited.

In such patients, the recommended starting dose is 20 mg per day. No dose adjustment is required in patients with mild to moderate renal impairment.

Impaired liver function

In patients with mild to moderate hepatic impairment (Child-Pugh class A and B, respectively), the daily dose of Telpres should not exceed 40 mg.

Elderly patients

No dose adjustment is required in elderly patients.

Overdose

Information on telmisartan overdose in humans is limited. The level of withdrawal of hydrochlorothiazide by hemodialysis has not been established.

Symptoms.

In the case of telmisartan overdose, the most pronounced manifestations were hypotension and tachycardia, bradycardia, dizziness, vomiting, increased serum creatinine levels and acute renal failure were also reported. An overdose of hydrochlorothiazide is associated with a decrease in the concentration of electrolytes (hypokalemia, hypochloremia) and hypovolemia due to excessive diuresis.

The most common symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasms and / or exacerbation of cardiac arrhythmia when digitalis glycosides or certain antiarrhythmic drugs are used concomitantly.

Treatment.

Telmisartan is not removed by hemodialysis. Patients should be closely monitored and receive symptomatic and supportive care. Therapy depends on the time elapsed after taking the drug and the severity of symptoms. Recommended activities include inducing vomiting and / or gastric lavage. In the treatment of overdose, you can use activated charcoal. It is necessary to monitor the level of electrolytes and creatinine in the serum. If hypotension occurs, the patient should be placed on his back and help to quickly replenish the volume of fluid and salt in the body.

Special instructions

Pregnancy. Angiotensin II receptor antagonist therapy should not be initiated during pregnancy. Until therapy with angiotensin II receptor antagonists is considered appropriate, patients planning pregnancy should be transferred to alternative antihypertensive medications that have an established safety profile for use during pregnancy. If pregnancy is established, angiotensin II receptor antagonists should be discontinued immediately and alternative therapy should be initiated if necessary.

Impaired liver function. Telpres Plus should not be used in patients with cholestasis, obstructive bile duct diseases, or severe hepatic insufficiency, since telmisartan is mainly excreted in the bile. In such patients, a decrease in the hepatic clearance of telmisartan can be expected. In addition, Telpres Plus should be used with caution in patients with impaired liver function or progressive liver disease, since even minor changes in the water-electrolyte balance can cause hepatic coma.

There is no clinical experience of using Telpres Plus in patients with hepatic insufficiency.

Renovascular hypertension. There is an increased risk of severe hypotension and renal failure if patients with bilateral renal artery stenosis or stenosis of the renal artery of a single kidney take medications that affect the renin-angiotensin-aldosterone system.

Kidney failure and kidney transplantation. Telpres Plus should not be used in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min). There is no experience of using Telpres Plus in patients who have recently had a kidney transplant. Since the experience of using Telpres Plus in patients with mild to moderate renal impairment is small, it is recommended to periodically monitor the level of potassium, creatinine and uric acid in the blood serum. Patients with impaired renal function may experience azotemia associated with thiazide diuretics.

BCC reduction. Patients with a lack of sodium and / or circulating blood volume in the body through powerful diuretic therapy, salt restriction in the diet, diarrhea or vomiting may experience symptomatic hypotension, especially after the first dose. Therefore, before prescribing the drug Telpres Plus, you should correct the above conditions.

Double blockade of renin-angiotensin-(RAAS). There is evidence that concomitant use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren increases the risk of hypotension, hyperkalemia, and decreased renal function (including acute renal failure).

Therefore, double blockade of the RAAS by the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended.

If a double blockade is considered absolutely necessary, it is carried out only under the supervision of a specialist and subject to constant careful monitoring of kidney function, electrolytes and blood pressure.

ACE inhibitors and angiotensin II receptor blockers should not be used simultaneously in patients with diabetic nephropathy.

In patients whose vascular tone and renal function depend mainly on the activity of renin-angiotensin-(for example, patients with severe congestive heart failure or kidney diseases, including:

Patients with stenosis of the renal arteries), treatment with drugs that affect this system can cause acute arterial hypotension, hyperazotemia, oliguria, and occasionally acute renal failure.

Primary aldosteronism. Patients with primary aldosteronism usually do not respond to antihypertensive drugs, the action of which involves the suppression of the renin-angiotensin system, so the use of Telpres Plus in such patients is not recommended.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy. As with other vasodilators, special care should be taken when treating patients suffering from aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy.

Metabolic and endocrine effects. Treatment with thiazides may reduce glucose tolerance. For patients with diabetes mellitus, it may be necessary to adjust the dose of insulin or oral antidiabetic drugs. Latent diabetes mellitus may occur during thiazide therapy. Increased cholesterol and triglyceride levels are associated with treatment with thiazide diuretics. However, the 12.5 mg dose contained in Telpres Plus has no such effect or this effect is only minimal. Some patients receiving thiazide medications may develop hyperuricemia or overt gout.

Electrolyte imbalance. In any patient treated with diuretics, the level of serum electrolytes should be determined at certain intervals.

Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalances (in particular hypokalemia, hyponatremia, and hypochloremic alkalosis). Signs of fluid electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disorders such as nausea and vomiting.

Hypokalemia. Although hypokalemia may occur as a result of thiazide diuretics, concomitant therapy with telmisartan may reduce diuretic-induced hypokalemia.

The risk of hypokalemia is higher in patients with cirrhosis of the liver, in patients with significant diuresis, in patients whose oral electrolyte intake does not meet their needs, and in patients receiving corticosteroid or ACTH therapy.

Hyperkalemia. Hyperkalemia may occur due to angiotensin II (AT1) receptor antagonism associated with telmisartan, a component of Telpres Plus. Clinically significant hyperkalemia due to Telpres Plus has not been documented. Risk factors for hyperkalemia include kidney failure and / or heart failure and diabetes mellitus. Potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium should be administered with caution simultaneously with the combination of telmisartan / hydrochlorothiazide.

Hypercalcemia. Thiazides can reduce the excretion of calcium in the urine and cause a periodic and slight increase in serum calcium levels in the absence of calcium metabolism disorders. Significant hypercalcemia may be a sign of latent hyperparathyroidism. You should stop taking thiazides before performing parathyroid function tests.

Hypomagnesemia. Thiazides cause increased urinary magnesium excretion, which can lead to hypomagnesemia.

Ethnic differences. Like all other angiotensin II receptor antagonists, telmisartan is clearly less effective in lowering blood pressure in black patients than in non-black patients. This may be due to the high prevalence of conditions with low renin levels in black patients suffering from arterial hypertension.

Other states. As with any other antihypertensive medication, excessive lowering of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease can lead to myocardial infarction or stroke.

General disorders. Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with a history of allergies or asthma.

It is known that the use of thiazide diuretics, including hydrochlorothiazide, can lead to an exacerbation of systemic lupus erythematosus.

Photosensitivity reactions have been reported with thiazide diuretics. If photosensitization occurs during treatment, it is recommended to stop using the drug. If repeated use of diuretics is considered necessary, it is recommended to protect exposed areas of the body from exposure to the sun or artificial ultraviolet radiation.

Acute myopia and secondary glaucoma. Medications containing sulfonamide or its derivatives can cause idiosyncrasy, which leads to transient myopia and acute angle-closure glaucoma. Hydrochlorothiazide is a derivative of sulfonamides, but so far only isolated cases of acute angle-closure glaucoma have been reported with the use of hydrochlorothiazide. Symptoms of this condition include acute loss of visual acuity or pain in the eyes. Typically, these symptoms develop within a few hours or a few weeks after starting therapy with this drug. If acute angle-closure glaucoma is left untreated, it can lead to permanent vision loss in the patient. If such a symptom is detected, first of all, therapy with this drug should be discontinued as soon as possible. If after this, intraocular pressure remains uncontrolled, medical or surgical treatment may be considered. Risk factors for acute angle-closure glaucoma may include a history of allergy to sulfonamide or penicillin.

The drug may affect the results of laboratory tests:

the drug may reduce the level of protein-bound iodine in the blood plasma

treatment should be discontinued before conducting a laboratory examination to assess the function of the parathyroid glands

the drug can increase the concentration of free bilirubin in the blood serum.

Active ingredient

Hydrochlorothiazide, Telmisartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension