Tanidol tabs 80mg #30

Tanidol instruction

You can buy Tanidol here

The composition of 1 tablet

Dosage 40 mg
Active ingredient: Telmisartan 40 mg.
Excipients: sodium hydroxide 3.35 mg, povidone-K25 12.00 mg, meglumine 12.00 mg, lactose monohydrate 217.35 mg, crospovidone 12.00 mg, iron dye yellow oxide 0.30 mg, magnesium stearate 3, 00 mg.
Film coating (opadry yellow *) 9.00 mg: hypromellose-5cP 5.409 mg, titanium dioxide 2.704 mg, macrogol-400 0.541 mg, talc 0.173 mg, iron dye yellow oxide 0.173 mg.
Dosage 80 mg
Active ingredient: Telmisartan 80 mg.
Excipients: sodium hydroxide 6.70 mg, povidon-K25 24.00 mg, meglumine 24.00 mg, lactose monohydrate 434.70 mg, crospovidone 24.00 mg, iron dye yellow oxide 0.60 mg, magnesium stearate 6, 00 mg.
Film casing (yellow yellow *) 18.00 mg: hypromellose-5cP 10.817 mg, titanium dioxide 5.409 mg, macrogol-400 1.082 mg, talc 0.346 mg, iron dye yellow oxide 0.346 mg.
* code 02B82506
Description
Dosage 40 mg
Capsule tablets, film-coated yellow, with the engraving "40" on one side and the engraving "T" on the other side.
Dosage 80 mg
Capsule tablets, film-coated yellow, engraved with “80” on one side and engraved with “T” on the other side.
Pharmacotherapeutic group:
Angiotensin II receptor antagonist.
ATC code: C09CA07

Pharmacodynamics

Telmisartan, a specific angiotensin II receptor antagonist (type AT1), has
high affinity for the AT1 receptor angiotensin II subtype, through which
action of angiotensin II. Telmisartan does not show any activity as an AT1 receptor agonist. Telmisartan binds selectively to the AT1 receptor. Tying wears long character. Telmisartan does not show affinity for other receptors, including the AT2 receptor and other less studied angiotensin receptors. The functional role of these receptors unknown, the effect of their possible increased stimulation is also unknown angiotensin II, the level of which increases under the action of telmisartan. Telmisartan reduces the concentration of aldosterone in the blood plasma, does not reduce the activity of renin in the plasma blood and does not block the ion channels. Telmisartan does not inhibit angiotensin-converting enzyme (kininase II), which also catalyzes the degradation of bradykinin. This avoids the side effects associated with the action of bradykinin.
Telmisartan in a dose of 80 mg completely blocks the hypertensive effect of angiotensin II in patients. The effective effect of Tanidol lasts more than 24 hours and is still noticeable after 48 hours.
After the first use of telmisartan, the onset of the antihypertensive effect is noted within three hours. The maximum reduction in blood pressure is usually achieved 4 to 8 weeks after the start of treatment and persists with long-term treatment. Antihypertensive effect persists for more than 24 hours after taking the drug.
In patients with arterial hypertension, telmisartan reduces both systolic and diastolic blood pressure without affecting the heart rate.
In the case of abrupt withdrawal of telmisartan, blood pressure gradually (within a few days) returns to baseline values ​​without the development of the “withdrawal” syndrome.
In comparative clinical studies, the incidence of dry cough was significantly lower in patients who received telmisartan compared with those who received angiotensin-converting enzyme inhibitors.
The efficacy of reducing the risk of cardiovascular mortality with doses of telmisartan less than 80 mg has not been studied.

Pharmacokinetics

Suction

After ingestion, Telmisartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 50%. When taking telmisartan along with food, the reduction in area under the concentration-time curve (AUC) for telmisartan varies from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). 3 hours after taking Tanidol, the concentrations of telmisartan in the blood plasma are equal, regardless of whether the drug is taken on an empty stomach or with food.

Linearity / nonlinearity

It is not intended that a slight decrease in AUC may cause a decrease in therapeutic efficacy. There is no linear relationship between the dose and the concentration of Tanidol in the blood plasma. At doses greater than 40 mg, the maximum plasma concentration (Cmax) and, to a lesser extent, AUC increase disproportionately.

Distribution

Telmisartan is actively associated with plasma proteins (more than 99.5%), mainly with albumin and alpha-1 acid glycoprotein. The average value of the apparent volume of distribution in the equilibrium stage (Vdss) is approximately 500 liters.

Metabolism

Telmisartan is metabolized by conjugation of the starting material with the glucuronide. Pharmacological activity of the conjugate is not detected.

Removal

Telmisartan is characterized by the pharmacokinetics of biexponential decay with a final half-life of more than 20 hours. The maximum plasma concentration (Cmax) and, to a lesser extent, the area under the concentration-time curve (AUC) increase disproportionately with the dose. There is no evidence that accumulation of telmisartan when taken in recommended doses has clinical significance. Plasma concentrations were higher in women compared to men, but there was no corresponding effect on efficacy.
After administration of the drug inside (and intravenously), telmisartan is eliminated almost exclusively through the intestines, mostly unchanged. The total amount excreted by the kidneys is less than 1% of the dose. The total plasma clearance (Cltot) is high (about 1000 ml / min) compared with hepatic blood flow (about 1500 ml / min).

Pharmacokinetics in Special Patient Groups

Gender Differences

Differences in plasma concentrations of Cmax and AUC in women compared with men were observed, they were about 3 and 2 times higher, respectively.

Elderly patients

The pharmacokinetics of telmisartan in elderly patients and patients younger than 65 years old is no different.

Patients with renal failure

Changing the dose in patients with renal insufficiency is not required, including patients on hemodialysis. Telmisartan is actively associated with plasma proteins in patients with renal insufficiency and is not eliminated during dialysis. The half-life in patients with renal insufficiency does not change.

Patients with hepatic impairment

Pharmacokinetic studies involving patients with hepatic insufficiency revealed an increase in absolute bioavailability of almost 100%. The half-life in patients with hepatic insufficiency does not change.

Indications for use

- Arterial hypertension;
- Reduced cardiovascular morbidity and mortality in patients aged 55 years and older with a high risk of cardiovascular disease.

Contraindications

    Hypersensitivity to the active substance or other components of Tanidol;
    Pregnancy and lactation;
    Obstructive biliary tract disease;
    Children's age (up to 18 years);
    Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
    Severe abnormal liver function (class C on the Child-Pugh scale (10-15 points));
    Primary aldosteronism.

Carefully

Bilateral renal artery stenosis, arterial stenosis of a single kidney, impaired kidney and / or liver function, a condition after kidney transplantation (no experience), a decrease in circulating blood volume due to previous diuretic therapy, limitation of salt, diarrhea or vomiting, hyponatremia, hyperkalemia, chronic heart failure, aortic and / or mitral valve stenosis, hypertrophic obstructive cardiomyopathy, ischemic heart disease.

Use during pregnancy and lactation

Pregnancy

Adequate data on the use of telmisartan in pregnant women are not available. In preclinical studies revealed no teratogenic effect of the drug, however, fetotoxic effect (decrease in renal function, oligohydramnios, delayed ossification of the skull) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia) were noted.
Use of the drug Tanidol is contraindicated in pregnancy.

Lactation period

There is no information about whether telmisartan is excreted into breast milk. Tanidol is preferably replaced with a drug with the best safety profile, especially when feeding newborns or premature babies.

Dosage and administration

Inside, regardless of the meal.

Arterial hypertension

The initial dose is usually 40 mg once a day. In case of failure to achieve blood pressure targets, the dose of Tanidol can be increased to a maximum (80 mg) once a day. As an alternative, Tanidol can be used in combination with thiazide diuretics, such as hydrochlorothiazide, which, when used simultaneously, has demonstrated an additive antihypertensive effect. If necessary, increase the dose should be borne in mind that the maximum antihypertensive effect usually develops after 4-8 weeks after the start of treatment (see the Pharmacodynamics section).

Reduced cardiovascular morbidity and mortality

The recommended dose is 80 mg once a day. Regular monitoring of blood pressure and, if necessary, adjusting the dose of drugs that lower blood pressure are recommended.

Special patient populations

Renal Failure: Dose adjustment is not required in patients with mild to moderate renal failure. The experience of use in patients with severe renal failure or patients requiring hemodialysis is limited.
Hepatic impairment: in patients with mild or moderate hepatic impairment, the daily dose of the drug should not exceed 40 mg (see section "Special instructions").

Elderly patients

For elderly patients, dose adjustment is not required.

Children

Tanidol is not recommended for use in children under 18 years of age due to the lack of sufficient data on safety and efficacy.

Side effect of Tanidol

In general, the incidence of adverse events, noted for telmisartan (41.4%), is comparable to that for placebo (43.9%). The frequency of occurrence of adverse events did not depend on the dose and did not correlate with the sex, age or race of the patients.
Adverse adverse reactions are presented according to the frequency of occurrence: very often (≥ 1/10); often (from ≥ 1/100 to <1/10); infrequently (from ≥ 1/1000 to <1/100); rarely (from ≥ 1/10000 to <1/1000); very rarely (<1/10000), an unknown frequency (based on the available data it is impossible to assess).
In each frequency group, adverse side reactions are presented in order of decreasing severity.

Infections and invasions

Infrequently: an infection of the upper respiratory tract, including pharyngitis and sinusitis, urinary tract infection, including cystitis; Unknown frequency: sepsis, including fatal.
Violations of the blood and lymphatic system
Infrequently: anemia; Rarely: thrombocytopenia; Unknown frequency: eosinophilia.
Immune system disorders
Rarely: hypersensitivity;
Unknown frequency: anaphylactic reaction.
Nutrition and Metabolism Disorders
Infrequently: hyperkalemia.
Mental disorders
Infrequently: depression, insomnia;
Seldom: anxiety.
Nervous system disorders
Infrequently: syncope.
Violations by the organ of vision
Rarely: visual impairment.
Violations of the organ of hearing and balance
Infrequently: vertigo.
Violations of the cardiovascular system
Infrequently: bradycardia, marked reduction in blood pressure *, orthostatic hypotension;
Rarely: tachycardia.
* Often observed in patients with controlled blood pressure who received treatment with telmisartan to reduce the risk of cardiovascular mortality in addition to standard treatment.
Disorders of the respiratory system, chest and mediastinum
Infrequently: shortness of breath.
Disorders of the digestive system
Infrequently: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting;
Rarely: indigestion, discomfort, dryness of the oral mucosa.
Violations of the hepatobiliary system
Rarely: liver dysfunction / liver disease.
Violations of the skin and subcutaneous tissue
Infrequently: hyperhidrosis, skin itch, rash; Rarely: erythema, angioedema (including fatal), drug rash, toxic skin rash, eczema; Unknown frequency: urticaria.
Violations of the musculoskeletal system and connective tissue
Infrequently: myalgia, back pain (eg, sciatica), muscle spasms; Rarely: arthralgia, pain in the limbs; Unknown frequency: pain in the tendon area (tendinitis-like symptoms).
Violations of the urinary system
Infrequently: renal failure, including acute renal failure.
System disorders
Infrequently: chest pain, asthenia (weakness); Seldom: a flu-like state.
Laboratory values
Infrequently: increase in concentration of creatinine in blood; Rarely: an increase in the concentration of uric acid in the blood, “liver” enzymes, serum creatine phosphokinase activity; decreased hemoglobin; hypoglycemia (in patients with diabetes).

Overdose

Information regarding overdose is limited.
Symptoms: the most significant - marked reduction in blood pressure and tachycardia; bradycardia, dizziness, increased serum creatinine levels and acute renal failure may also occur.
Treatment: treatment should be symptomatic and supportive. The proposed measures include: induction of vomiting and / or gastric lavage, intake of activated carbon, and replenishment of lack of fluid and salt. Serum electrolytes and creatinine levels should be monitored continuously. Hemodialysis is not effective.

Interaction with other drugs

Angiotensin-converting enzyme (ACE) inhibitors, potassium-sparing diuretics
With the simultaneous appointment of ACE inhibitors, potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride) and other drugs that can increase the content of potassium in the blood serum, as well as potassium-containing dietary supplements, especially in patients with renal insufficiency, the risk of hyperkalemia increases. Requires regular monitoring of potassium in the serum. Combined use is not recommended.

Lithium preparations

While taking lithium preparations with ACE inhibitors and angiotensin II receptor antagonists, including telmisartan, there was a reversible increase in serum lithium concentrations. It is recommended to carefully monitor the concentration of lithium in the serum. Combined use requires caution.

Digoxin

Telmisartan increases the concentration of digoxin by an average of 20% (in one case, by 39%); it is necessary to determine the concentration of digoxin with simultaneous use.

Warfarin

Against the background of receiving telmisartan, the concentration of warfarin in the blood plasma decreases (slightly).

Risperidone

Enhances the antihypertensive effect of telmisartan.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

NSAIDs (for example, acetylsalicylic acid in doses that have anti-inflammatory effects, cyclooxygenase inhibitors (COX-2) and non-selective non-steroidal anti-inflammatory drugs) can reduce the antihypertensive effect of Tanidol. In patients with impaired renal function (for example, patients with reduced circulating blood volume (BCC) or elderly patients with impaired renal function), simultaneous use of the drug Tanidol and drugs inhibiting cyclooxygenase may cause further deterioration in renal function, including possible acute renal failure, which is usually reversible. At the same time, care should be taken, especially in elderly patients. Renal function should be monitored after the start of combination therapy and periodically thereafter.

Diuretics (thiazide or "loop" diuretics)

Preliminary therapy with high doses of diuretics, such as furosemide (“loopback” diuretic) and hydrochlorothiazide (thiazide-type diuretic), can lead to a decrease in body fluid and increase the risk of arterial hypotension at the start of treatment with Tanidol.

Other antihypertensive drugs

The antihypertensive effect of Tanidol can be enhanced by combined use with other antihypertensives. On the basis of data on pharmacological properties, it can be assumed that the following drugs can enhance the antihypertensive effect of all antihypertensive drugs, including telmisartan: baclofen, amifosten.
Ethanol, barbiturates, narcotic drugs, or antidepressants may increase orthostatic hypotension.

Corticosteroids (systemic action)

Reduced antihypertensive action of telmisartan.

special instructions

Before and during treatment with Tanidol, control of blood pressure, kidney function, and potassium content in blood serum is necessary. Transient arterial hypotension is not a contraindication for further treatment with Tanidol after blood pressure has stabilized. In the case of recurrence of severe hypotension, reduce the dose or discontinue Tanidol. In the presence of renal failure treatment is carried out with caution under the control of the concentration of creatinine in the serum.

Liver failure

Tanidol should not be used in patients with cholestasis, biliary tract obstruction or acute liver failure (see the “Contraindications” section), since telmisartan is mainly excreted in bile. It is assumed that in these patients the hepatic clearance of telmisartan is reduced. Tanidol should be used with extreme caution in patients with mild or moderate hepatic insufficiency.

Renovascular hypertension

When treating drugs acting on the renin-angiotensin-aldosterone system (RAAS), in patients with bilateral renal artery stenosis and single kidney artery stenosis, the risk of severe hypotension and renal failure increases.

Kidney failure and kidney transplantation

When using the drug Tanidol in patients with impaired renal function, periodic monitoring of serum potassium and creatinine is recommended. There is no clinical experience with Tanidol in patients who have recently had a kidney transplant.

Decreased circulating blood volume (BCC)

In patients with reduced BCC and / or sodium content, prior symptomatic diuretic therapy, restriction of salt, diarrhea or vomiting can cause symptomatic hypotension, especially after the first dose of Tanidol. Such conditions must be eliminated before it is taken. Deficit of liquid and / or sodium should be eliminated before taking the drug Tanidol.

Double blockade of the renin-angiotensin-aldosterone system

As the consequences of inhibition of the RAAS were noted: the occurrence of arterial hypotension, fainting, hyperkalemia and impaired renal function (including acute renal failure) in susceptible patients, especially when used in combination with drugs also acting on this system. Double blocking of the RAAS, for example, by adding an ACE inhibitor (angiotensin-converting enzyme) to the angiotensin II receptor antagonist, is not recommended for patients with already controlled blood pressure and should be limited to individual cases with enhanced control of renal function.

Other diseases characterized by stimulation of the RAAS

In patients whose vascular tone and renal function depend primarily on the activity of the RAAS (for example, patients with chronic heart failure or kidney disease, including renal artery stenosis), the use of drugs acting on this system, such as telmisartan, has been associated with the occurrence of acute arterial hypotension, hyperasotemia, oliguria, or rarely with acute renal failure (see the “Adverse Effects” section).

Primary aldosteronism

Patients with primary aldosteronism, as a rule, do not respond to treatment with antihypertensive drugs, the action of which is manifested by inhibition of the RAAS. In this regard, the use of the drug Tanidol in these cases is not recommended.

Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy

As with other vasodilators, for patients with aortic imitral stenosis or hypertrophic obstructive cardiomyopathy, special precautions have been observed.

Hyperkalemia

The use of drugs acting on the RAAS can cause hyperkalemia.
For elderly patients, patients with renal insufficiency, patients with diabetes mellitus and also with arterial hypertension and coronary heart disease (CHD), patients receiving concomitant medication that may cause an increase in potassium, and / or patients with concomitant disease hyperkalemia can be fatal.
Before considering the possibility of concomitant use of drugs acting on the RAAS, it is necessary to evaluate the “benefit-risk” ratio.
The main risk factors that should be considered are:
- Diabetes mellitus, renal failure, age (patients older than 70 years).
- A combination with one or more drugs acting on the RAAS and / or an increase in serum potassium. Drugs or therapeutic classes of drugs that can cause hyperkalemia are salt substitutes containing potassium, potassium-saving diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroid drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressants ( cyclosporine or tacrolimus) and trimethoprim.
- Intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, impaired renal function, a sharp deterioration of the kidneys (eg, infectious diseases), cytolysis syndrome (eg, acute limb ischemia, rhabdomyolysis, severe injury). For patients at risk, regular monitoring of serum potassium is recommended (see the section "Interaction with other drugs").

Lactose

This drug contains lactose monohydrate. Patients with rare hereditary diseases, such as galactose intolerance, Lapp's lactase deficiency, or glucose-galactose dysfunction, should not take this drug.

Racial differences

As noted for inhibitors of angiotensin-converting enzyme (ACE), Tanidol and other angiotensin II receptor antagonists seem to be less effective in lowering blood pressure in patients of the Negroid race than in other races, possibly due to a greater predisposition to a decrease in renin activity of the patient population Negroid race, patients with diabetes mellitus and also with arterial hypertension and IHD.

Other

As with the use of other antihypertensive drugs, excessive lowering of blood pressure in patients suffering from ischemic cardiopathy, or patients with diabetes mellitus and also with arterial hypertension and ischemic heart disease can lead to the development of myocardial infarction or cerebral circulation.

Impact on the ability to drive and work with technology

Special studies on the effect of Tanidol on the ability to drive and to work with the equipment have not been conducted Care must be taken when driving, as well as when working with equipment (the risk of dizziness and drowsiness).

Release form

Tablets, film coated, 40 mg, 80 mg. On 7 tablets in the blister from Al / Al foil. On 2, 4 or 8 blisters in a cardboard pack together with the application instruction. 10 tablets per blister of Al / Al foil. On 3 or 9 blisters together with the application instruction in a cardboard pack.

Storage conditions

At a temperature not higher than 30 ° C. Keep out of the reach of children!

Shelf life - 3 years.
Do not use after the expiration date printed on the package.

Pharmacy sales terms

You don't need a prescription to buy Tanidol.