Mikardis - a drug used to treat hypertension.
Release form and composition
Mikardis is produced in the form of tablets: oblong, almost white or white, on one side - engraved "51N" or "52N" (40 or 80 mg, respectively), on the other - the symbol of the company (7 pieces in blisters, 2, 4, 8 or 14 blisters in a carton box).
The composition of 1 tablet includes:
- Active ingredient: Telmisartan - 40 or 80 mg;
- Auxiliary components (40/80 mg, respectively): magnesium stearate - 4/8 mg; sodium hydroxide - 3,36 / 6,72 mg; meglumine - 12/24 mg; polyvidone (collidon 25) - 12/24 mg; sorbitol - 168.64 / 337.28 mg.
Indications for use
Mikardis prescribed in the treatment of hypertension.
Also, the drug is used to reduce cardiovascular morbidity and mortality in patients from 55 years of age who are at high risk of developing cardiovascular diseases.
- Obstructive diseases of the biliary tract;
- Severe functional disorders of the liver (Child-Pugh - class C);
- Fructose intolerance and sucrase / isomaltase deficiency syndrome or glucose / galactose absorption disorders;
- Simultaneous use with aliskiren in patients with renal insufficiency or diabetes mellitus (with glomerular filtration rate <60 ml / min / 1.73 m²);
- Age up to 18 years (efficacy and safety of Mikardis use in this age group of patients have not been established);
- Pregnancy and lactation;
- Hypersensitivity to the drug.
Mikardis should be taken with caution in the presence of the following diseases / conditions:
- Single renal artery stenosis or bilateral renal artery stenosis;
- Functional disorders of the kidneys and / or liver;
- Idiopathic hypertrophic subaortic stenosis;
- Decreased circulating blood volume associated with prior diuretic treatment, limiting salt intake, vomiting, or diarrhea;
- Conditions after kidney transplantation (due to lack of experience with Mikardis);
- Aortic and mitral valve stenosis;
- Chronic heart failure;
- Coronary heart disease.
Dosing and Administration
Mikardis is taken orally, regardless of the meal.
The drug is taken 1 time per day.
The initial daily dose of Mikardis in the treatment of hypertension is 40 mg. If necessary, you can increase the dose by 2 times, while it should be borne in mind that the maximum antihypertensive effect is achieved within 1-2 months after the start of therapy.
The recommended daily dose of Mikardis to reduce cardiovascular morbidity and mortality is 80 mg. At the beginning of treatment, additional blood pressure correction may be required.
Patients with renal insufficiency (including patients on hemodialysis) do not require dose adjustment.
The daily dose of the drug for functional disorders of the liver of the medium and mild degree (on the Child-Pugh scale - class A and B) should not be more than 40 mg.
Adjust the dosage regimen in elderly patients should not be.
During the use of Mikardisa the following side effects may occur:
- Cardiovascular system: orthostatic hypotension, marked lowering of blood pressure, tachycardia, bradycardia;
- Respiratory system: shortness of breath;
- Central nervous system: anxiety, insomnia, syncope, depression, vertigo;
- Urinary system: functional disorders of the kidneys (including acute renal failure), an increase in the concentration of creatinine, uric acid in the blood;
- Musculoskeletal system: pain in the lower extremities, back and tendons (symptoms similar to those of tendinitis), arthralgia, muscle spasms (convulsions of calf muscles), myalgia;
- The digestive system: dyspepsia, abdominal pain, dry mouth, diarrhea, discomfort in the stomach, flatulence, vomiting, increased activity of liver enzymes, abnormal liver function and its diseases;
- Hematopoietic system: eosinophilia, anemia, thrombocytopenia, decrease in hemoglobin concentration;
- Infections: infections of the upper respiratory tract and urinary tract (including cystitis), sepsis (including fatal sepsis);
- Subcutaneous tissue and skin: hyperhidrosis;
- Visual organ: visual disturbances;
- Laboratory indicators: increased blood creatine phosphokinase level, hyperkalemia, hypoglycemia (in patients with diabetes mellitus);
- Allergic reactions: toxic rash, pruritus, urticaria, erythema, angioedema, anaphylactic reactions, eczema, angioedema;
- Other: flu-like syndrome, chest pain, asthenia (weakness).
In some patients, renal function (including the development of acute renal failure) is impaired due to the suppression of the Renin-angiotensin system (RAAS), especially when using a combination of drugs acting on this system. Therefore, treatment accompanied by a similar double blockade of the RAAS (for example, adding inhibitors of angiotensin-converting enzyme or a direct inhibitor of renin-aliskiren to blockers of angiotensin II receptor antagonists), should be strictly individually and carefully monitoring kidney function (including periodic monitoring of serum creatinine and potassium concentrations) .
When kidney function and vascular tone are predominantly dependent on the activity of the RAAS (for example, in patients with kidney disease or chronic heart failure, including stenosis of the renal arteries or stenosis of the artery of a single kidney), the prescription of drugs affecting this system, may be accompanied by the development of oliguria, hyperazotemia, acute hypotension, and, in some cases, acute renal failure. With the simultaneous appointment of Mikardis with potassium-sparing diuretics, potassium-containing supplements, potassium-containing edible salt, other means that increase the concentration of potassium in the blood (for example, heparin), this indicator should be monitored in patients.
In patients with diabetes mellitus and additional cardiovascular risk (for example, coronary heart disease), with the use of drugs that lower blood pressure, the risk of fatal myocardial infarction and sudden cardiovascular death may increase. Coronary heart disease in patients with diabetes mellitus may be asymptomatic, as a result of which it may be undiagnosed. Before starting the use of Mikardis in patients with diabetes mellitus, to identify and treat coronary heart disease, it is necessary to conduct appropriate diagnostic studies, including an exercise test.
Mikardis as an alternative can be used simultaneously with thiazide diuretics (for example, with hydrochlorothiazide), which have an additional hypotensive effect.
Care should be taken when taking Mikardis in patients with mitral or aortic stenosis or with hypertrophic obstructive cardiomyopathy.
In patients with hepatic insufficiency or obstructive diseases of the biliary tract may reduce the clearance of the drug.
In most cases, the development of functional disorders of the liver in the appointment of Mikardisa was observed in Japan. In patients of the Negroid race, the drug is less effective.
When driving and working with machinery, it is necessary to take into account the possibility of drowsiness and dizziness, which requires caution.
With the simultaneous use of Mikardisa with certain drugs, undesirable effects may occur:
- Antihypertensive drugs: an increase in the hypotensive effect;
- Angiotensin-converting enzyme inhibitors and lithium preparations: a reversible increase in the concentration of lithium in the blood, which is accompanied by a toxic effect;
- Nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, COX-2 inhibitors and non-selective nonsteroidal anti-inflammatory drugs: the development of acute renal failure in patients with dehydration;
- Drugs that affect the RAAS: the development of a synergistic effect.
With the simultaneous use of Mikardisa with non-steroidal anti-inflammatory drugs at the beginning of therapy, it is necessary to compensate for the volume of circulating blood and to conduct a study of renal function. Also, when using such a combination, due to the inhibition of the vasodilator effect of prostaglandins, the Mikardis effect may be reduced.
Terms and conditions of storage
Store in a dark, dry place inaccessible to children at temperature up to 30 ° C.
Shelf life - 4 years.