Mikardis tab 80mg 28 pc

Description

Composition
Active substance:
1 tablet contains: telmisartan 40 mg or 80 mg ;.
Excipients:
Sodium hydroxide 3.36 mg / 6.72 mg Polyvidone (Kollidon 25) 12 mg / 24 mg, meglumine 12 mg / 24 mg Sorbitol 168.64 mg / 337.28 mg Magnesium stearate 4 mg / 8 mg.
Description:
40 mg Tablets
White or almost white oblong tablets, engraved on one side “51H”, on the other side – the symbol of the company.
80 mg Tablets
White or almost white oblong tablets, engraved on one side “52H”, on the other side – the symbol of the company.
Product form:
Tablets of 40 mg and 80 mg. 7 tablets in the blister of polyamide / aluminum / PVC. 2 or 4 blisters with instructions for use in a cardboard box (for a dosage of 40 mg). 2, 4 or 8 blisters with instructions for use in a cardboard box (for a dosage of 80 mg).
Contraindications
Hypersensitivity to the active substance or auxiliary components of the preparation
Pregnancy
Period breastfeeding
Biliary obstructive disorders
Serious liver function (class C Child-Pugh)
Simultaneous use of the drug MIKARDIS with aliskiren in patients with diabetes or renal failure (glomerular filtration rate (GFR)
Age 18 years (effectiveness and safety have been established)
Carefully
Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
Disturbances of liver and / or kidney (see. Specific guidance section)
Reduced blood volume (CBV) due to prior diuretic therapy restrictions reception salt, diarrhea or vomiting
hyponatremia
hyperkalemia
Condition after kidney transplantation (application no experience)
Chronic heart failure
Stenosis of the aortic and mitral valves
Idiopathic hypertrophic subaortic stenosis
Primary aldosteronism (effectiveness and safety have been established).
Dosage
80 mg
Indications
Arterial hypertension.
Reduction in cardiovascular morbidity and mortality in patients aged 55 years or older at high risk of cardiovascular disease.
Interaction with other drugs
Telmisartan may enhance the hypotensive effect of other antihypertensives. Other types of interactions with clinical significance have been identified. Interactions with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine does not cause a clinically significant interaction. An increasing average digoxin concentration in the blood plasma of an average of 20% (in one case by 39%). When concomitant administration of telmisartan and digoxin expedient periodic determination of digoxin concentration in the blood. With simultaneous use of telmisartan and ramipril observed increase in AUC0-24 and Cmax of ramipril and ramiprilat 2.5 times. The clinical relevance of this effect has not been established. When concomitant administration of angiotensin converting enzyme inhibitors (ACE) and lithium preparations mentioned reversible increase the concentration of lithium in the blood, accompanied by toxic effects. In rare cases, such changes are registered in the appointment of angiotensin II receptor antagonists. When concomitant administration of drugs lithium and angiotensin II receptor antagonists recommended determining the concentration of lithium in the blood. Treatment of non-steroidal antiinflammatory drugs (NSAIDs), including aspirin, cyclooxygenase-2 (COX-2) and non-selective NSAIDs may cause the development of acute renal failure in dehydrated patients. Drugs that act on the renin-angiotensin-aldosterone system (RAAS), may have a synergistic effect. In patients receiving NSAIDs and telmisartan, at the beginning of treatment should be compensated for BCC and conducted monitoring of renal function. Reducing the Effects of antihypertensive agents such as telmisartan, by inhibiting prostaglandins sosuudorasshiryayuschego effect observed when co-treatment with NSAIDs.
Overdose
Cases of overdose have been identified.
Symptoms: marked reduction of blood pressure, tachycardia, bradycardia.
Treatment: symptomatic therapy, hemodialysis is not effective.
pharmachologic effect
Pharmacological group:
Angiotensin II receptor antagonist.
Pharmacodynamics:
Telmisartan – specific antagonist of the angiotensin II receptor (type AT1), effective when taken orally. It has high affinity for the AT1 subtype angiotensin II receptor, which is realized through the action of angiotensin II. Displaces angiotensin II from binding with the receptor, having no agonist action against this receptor. Telmisartan binds only to the AT1 subtype angiotensin II receptor. Relationship is long-term nature. No affinity for other receptors, including AT2 receptor and other less-studied receptors of angiotensin. The functional significance of these receptors, as well as their possible effect of excessive stimulation by angiotensin II, whose concentration increases with telmisartan, have not been studied. Reduces the concentration of aldosterone in the blood, does not inhibit renin in plasma and does not block the ion channels. Telmisartan does not inhibit the angiotensin converting enzyme (kininaza II) (an enzyme which also destroys bradykinin). Therefore, enhancement of bradykinin-induced side effects are not expected. Patients telmisartan 80 mg completely blocks the hypertensive effect of angiotensin II. Starting hypotensive effect observed for 3 hours after the first dose of telmisartan. Effect of the drug is maintained for 24 hours and remains significant up to 48 hours. Pronounced hypotensive effect usually develops within 4-8 weeks after the regular admission. In patients suffering from hypertension, telmisartan reduces the systolic and diastolic blood pressure (BP), without affecting the heart rate (HR). In the case of abrupt withdrawal of telmisartan, blood pressure gradually returned to baseline without the development of the syndrome of “cancellation”.
Pharmacokinetics:
If ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability – 50%. When taken with food simultaneously decrease AUC (area under “concentration-time” curve) ranges from 6% (at 40 mg) to 19% (at a dose of 160 mg). After 3 hours after dosing plasma concentration equalized regardless of mealtime. There is a difference in plasma concentrations in men and women. Cmax (maximum concentration) and AUC were about 3 and 2 times, respectively, higher in women compared to men without significant effect on efficiency. Communication with plasma proteins – 99.5%, mainly to albumin and alpha-1 glycoprotein. The mean value of the apparent distribution volume in the equilibrium concentration – 500 l. It is metabolized by conjugation with glucuronic acid. The metabolites are pharmacologically inactive. The half-life (T 1/2) – more than 20 hours. Is output through the intestine unaltered, renal excretion – less than 2% of the dose. Total plasma clearance is high (900 mL / min) compared with “liver” blood flow (about 1500 ml / min.).
Elderly patients: Pharmacokinetics of telmisartan in elderly patients does not differ from younger patients. Dose adjustment is not required.
Patients with renal impairment: change the dose in patients with renal insufficiency is not required, including patients on hemodialysis. Telmisartan is not removed by dialysis.
Patients with liver failure: patients with mild to moderate impairment of liver function (class A and B Child-Pugh) daily dose should not exceed 40 mg.
Pediatric use: The main pharmacokinetics of telmisartan in children aged 6 to 18 years after telmisartan in a dose of 1 mg / kg or 2 mg / kg for 4 weeks, generally comparable to those obtained in the treatment of adults and confirm the nonlinearity of the pharmacokinetics of telmisartan, particularly with respect to Cmax.
Pregnancy and breast-feeding
Use of the drug MIKARDIS contraindicated during pregnancy. The use of angiotensin II receptor antagonists during the first trimester of pregnancy is not recommended, these drugs should not be administered during pregnancy. In the diagnosis of pregnancy the drug should be discontinued immediately. alternative therapy should be administered, if necessary (the other classes of antihypertensive drugs permitted for use during pregnancy). Use of an angiotensin II receptor antagonist in the second and third trimesters of pregnancy contraindicated. In preclinical studies of telmisartan teratogenic effects have been identified, but is set fetotoxicity. It is known that the effect of angiotensin II receptor antagonists in the second and third trimesters of pregnancy causes human fetotoxicity (decreased renal function, oligogidroamnion slowing skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Patients planning pregnancy should be prescribed an alternative therapy. If treatment of angiotensin II receptor antagonists occurred during the second trimester of pregnancy, it is recommended ultrasonic inspection method renal function and status of the skull of the fetus. Newborns whose mothers received angiotensin II receptor antagonists should be closely observed for hypotension. MIKARDIS drug therapy is contraindicated during breast-feeding. Studies of the effect on human fertility have not been conducted.
Conditions of supply of pharmacies
On prescription.
side effects
The observed incidence of side effects did not correlate with gender, age or race of patients.
Infections: sepsis, sepsis, including fatalities, urinary tract infections (including cystitis), upper respiratory tract infection.
On the part of the blood and lymphatic system: anemia, eosinophilia, thrombocytopenia.
On the part of the central nervous system: anxiety, insomnia, depression, fainting, vertigo.
On the part of the organ of vision: visual disturbances
With the cardiovascular system: bradycardia, tachycardia, marked reduction in blood pressure, orthostatic hypotension.
The respiratory system: dyspnea.
From the digestive system: abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, stomach discomfort, vomiting, abnormal liver / liver disease function * (* as a result of postmarketing observations, in most cases, violations of the liver / liver disease features were were detected in patients in Japan).
Allergic reactions: anaphylactic reactions, hypersensitivity (erythema, urticaria, angioneurotic edema), eczema, pruritus, rash (including dosage), angioedema (fatal), hyperhidrosis, toxic eruption.
On the part of the musculoskeletal system: arthralgia, back pain, muscle spasms (leg cramps), pain in the lower extremities, myalgia, pain in the tendons (symptoms similar to the manifestation of tendinitis).
The kidneys and the urinary tract: renal failure including acute renal failure.
Common: chest pain, flu-like symptoms, fatigue, hyperkalemia, hypoglycemia (in patients with diabetes).
Laboratory parameters: decrease in hemoglobin concentration, increasing the concentration of uric acid, creatinine in blood, increased activity “liver” enzyme, increasing the concentration of creatine phosphokinase (CPK).
special instructions
In some patients, due to suppress the RAAS, especially when using combinations of means acting on this system is disturbed renal function (including acute renal failure). Therefore, therapy, accompanied by such dual blockade of the RAAS (e.g., adding an ACE inhibitor or direct renin inhibitor aliskiren to blockers of angiotensin II receptor antagonists) should be carried out strictly individually and with careful monitoring of renal function (including periodic monitoring of the concentration of potassium, and creatinine in the serum ). In cases depending vascular tone and renal function primarily on the activity of the RAAS (e.g., patients with chronic heart failure, or renal disease, including, when bilateral renal artery stenosis, or stenosis of the artery only kidneys), designation drugs affecting this system may be accompanied by the development of acute hypotension, hyperasotemia, oliguria, and in rare cases acute renal failure. Based on the experience of other means influencing the RAAS when coadministered drug MIKARDIS and potassium-sparing diuretics, potassium-containing additives, potassium-containing edible salt other means to increase the content of potassium in the blood (e.g., heparin), this figure should be monitored in patients. Patients with diabetes mellitus and additional cardiovascular risk, such as patients with diabetes mellitus and coronary heart disease (CHD) in the case of drugs that lower blood pressure, such as angiotensin II receptor antagonists (APAII) or ACE inhibitors may increase the risk of fatal myocardial infarction and sudden cardiovascular death. In patients with ischemic heart disease with diabetes mellitus may be asymptomatic and therefore may be undiagnosed. In patients with diabetes before the drug MIKARDIS for the detection and treatment of coronary heart disease should be appropriate diagnostic studies, including exercise tests. Alternatively MIKARDIS preparation may be used in combination with a thiazide diuretic, such as hydrochlorothiazide, which additionally have a hypotensive effect (e.g., a drug MIKARDISPLYUS 40 mg / 12.5 mg, 80 mg / 12.5 mg). Patients with primary aldosteronism antihypertensive drugs mechanism of action which consists in the inhibition of the renin-angiotensin system aldosteronovoy- usually not effective. Care must be taken when applying MIKARDIS preparation (as well as other vasodilators) in patients with aortic or mitral stenosis, or in hypertrophic obstructive cardiomyopathy. Telmisartan is derived mainly from the bile. Patients with obstructive biliary tract disease or hepatic insufficiency can expect a decrease in drug clearance. In patients with severe hypertension telmisartan dose of 160 mg / day, in combination with hydrochlorothiazide 12.5-25 mg was well tolerated and effective. Human liver with telmisartan in most cases were observed among residents of Japan. MIKARDIS less effective in blacks patients.
Effects on ability to drive and use machines
Special clinical studies of the effect of the drug on the ability to drive and not carried out mechanisms. However, when driving and operating machinery should take into account the possibility of dizziness and drowsiness, which requires compliance with caution.
Storage conditions
Store at a temperature not higher than 30 ° C, in the original package.
Keep out of the reach of children!.
Dosing and Administration
Inside, regardless of meals.
Arterial hypertension
Starting Mikardis® recommended dose is 1 tablet formulation. (40 mg) once a day. In cases where the therapeutic effect is not achieved, the maximum recommended dose Mikardis® drug can be increased to 80 mg once a day. In deciding whether to increase the dose should be taken into account that the maximum antihypertensive effect is usually achieved within 4-8 weeks after starting treatment.
Reduction in cardiovascular morbidity and mortality
The recommended dose – 1 tablet formulation Mikardis® 80 mg, 1 times a day. In the initial period of treatment may require additional correction of blood pressure.
Renal function
In patients with renal insufficiency, including patients on hemodialysis, the correct dosing regimen is required.
Abnormal liver function
Patients with mild to moderate hepatic impairment (class A and B Child-Pugh, respectively) Mikardis® daily dose of the drug should not exceed 40 mg
elderly patients
The dosage regimen does not require modification.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist