Mikardis

Mikardis is the antagonist of receptors of angiotensin II, anti-hypertensive drug.

Form of release and structure

Dosage form – tablets: oblong shape, almost white or white color, on one party – an engraving "51H" (tablets of 40 mg) or "52H" (tablets of 80 mg), on another – a symbol of firm (on 7 pieces in the blister, in a cardboard pack 2 or 4 blisters with tablets of 40 mg or 2, 4 or 8 blisters with tablets of 80 mg).

Active ingredient: телмисартан, its contents in 1 tablet makes 40 or 80 mg.

Excipients: sodium hydroxide, поливидон (коллидон 25), sorbitol, Megluminum, magnesium stearate.

Indications to use

Mikardis – drug for treatment of arterial hypertension.

Also medicine is applied to decrease in cardiovascular incidence and, respectively, mortality at people is more senior than 55 years with high risk of development of diseases of cardiovascular system.

Contraindications

Absolute:

• Hereditary intolerance of fructose (because of the content of sorbitol);
• The expressed abnormal liver functions (a class C according to a scale of Chayld-Pyyu);
• Obstructive diseases of biliary tract;
• Primary aldosteronism;
• Age up to 18 years;
• Period of pregnancy and lactation;
• Hypersensitivity to drug components.

Relative:

• Hyperpotassemia;
• Hyponatremia;
• Coronary Heart Disease (CHD);
• Chronic heart failure;
• Idiopathic hypertrophic subaortal stenosis;
• Stenosis of the aortal and mitral valve;
• Decrease in volume of the circulating blood owing to diarrhea or vomiting, restriction of reception of table salt and/or the previous therapy with diuretics;
• Abnormal liver functions and/or kidneys;
• Bilateral stenosis of renal arteries or stenosis of an artery of the only kidney;
• States after transplantation of a kidney.

Route of administration and dosage

Mikardis it is necessary to accept inside. Meal does not influence efficiency of drug.

At arterial hypertension treatment is recommended to begin with a daily dose 40 mg in 1 reception. At insufficiency of therapeutic effect the daily dose is increased to 80 mg in 1 reception, at the same time it is necessary to consider that the maximum hypotensive effect of drug develops within 4-8 weeks after the beginning of therapy.

For decrease in risk of cardiovascular incidence recommend to accept 80 mg of 1 times a day. In an initiation of treatment additional correction of arterial pressure can be required.

The daily dose for patients with abnormal liver functions of easy and average degree (the classes A and B on a scale of Chayld-Pyyu) should not exceed 40 mg.

Side effects

• Infections: upper respiratory tract infections, infections of urinary tract (including cystitis), sepsis (including with a lethal outcome);
• System of a hemopoiesis: decrease in concentration of hemoglobin, eosinophilia, anemia, thrombocytopenia;
• Respiratory system: asthma;
• Central nervous system: depression, uneasiness, faint, sleeplessness, вертиго;
• Cardiovascular system: the expressed lowering of arterial pressure, bradycardia, orthostatic hypotension, tachycardia;
• Alimentary system: increase in activity of liver enzymes, discomfort in a stomach, dyspepsia, dryness in a mouth, diarrhea, a meteorism, an abdominal pain, vomiting, and also abnormal liver functions or diseases of a liver (in post-marketing observations these disturbances were revealed at patients from Japan);
• Urinary system: increase in concentration of uric acid and creatinine in blood, a renal failure (including an acute renal failure);
• Musculoskeletal system: spasms of gastrocnemius muscles, dorsodynia, sinews and lower extremities, mialgiya, arthralgia;
• Organ of sight: visual frustration;
• Skin and hypodermic fabrics: hyperhidrosis;
• Allergic reactions: rash (including medicinal), a skin itch, eczema, toxic rash, hypersensitivity (a small tortoiseshell, an erythema, a Quincke's disease), anaphylactic reactions, a Quincke's disease (including from the death);
• Others: adynamy, grippopodobny syndrome, thorax pain;
• Laboratory indicators: increase in level of a kreatinfosfokinaza of blood, hyperpotassemia; a hypoglycemia at patients with a diabetes mellitus.

Special instructions

Some patients owing to suppression have a renin-angiotenzinovoy of system (RAAS), especially at simultaneous use of several means having effect on this system function of kidneys is broken, up to an acute renal failure. For this reason the therapy which is followed by double blockade of RAAS (for example, Mikardis's combination with inhibitors of an angiotensin-converting enzyme or direct inhibitor of a renin), has to be carried out individually and under the careful control of function of kidneys including monitoring of concentration of creatinine and potassium in blood serum.

If the vascular tone and function of kidneys depend preferential on activity of RAAS (for example, at chronic heart failure or diseases of kidneys, including a stenosis of a renal artery(arteries)), use of the drugs influencing this system can lead to development of acute arterial hypotension, an oliguria, hyperazotemia and even an acute renal failure.

In case of simultaneous use of Mikardis with kaliysoderzhashchy additives, kaliysberegayushchy diuretics, kaliysoderzhashchy edible salt or any other means which increase potassium concentration in blood it is necessary to control this indicator in the course of treatment.

At patients with a diabetes mellitus with existence of the accompanying additional cardiovascular risks (for example, coronary heart disease) the probability of a fatal myocardial infarction and sudden cardiovascular death increases. At the same time the ischemic heart disease at patients with a diabetes mellitus can proceed asymptomatically and to be not diagnosed. For this reason, for early detection and treatment of an ischemic heart disease, before Mikardis's appointment patients with a diabetes mellitus need to conduct the corresponding diagnostic testings including an exercise tolerance test.

Telmisartan is less effective at patients of negroid race.

Special clinical trials concerning Mikardis's influence on ability to concentration of attention and speed of reactions were not carried out. However considering probability of development of such side effects as drowsiness and dizziness, it is recommended to be careful at control of motor transport and work with potentially dangerous mechanisms.

Medicinal interaction

• Other anti-hypertensive means: their action amplifies;
• Digoxin: its concentration in a blood plasma increases;
• Ramipril: raises its maximum and total (during the whole time of observation) concentration by 2,5 times, however the clinical importance of such interaction is not established;
• Lithium drugs: the reversible increase in their concentration in blood which is followed by toxic action is noted;
• Non-steroidal anti-inflammatory drugs (NPVP), including acetylsalicylic acid, non-selective NPVP and inhibitors of cyclooxygenase 2 types: the risk of development of an acute renal failure in patients with dehydration increases (before purpose of such combination it is necessary to conduct a research of function of kidneys and to compensate the volume of the circulating blood). Decrease in anti-hypertensive action of a telmisartan is also possible.

Terms and storage conditions

To store in the place, unavailable to children, protected from moisture at a temperature up to 30 ºС.

Period of validity – 4 years.