Micardis 80mg 28 tablets — Made in Greece — Free Delivery
(Micardis 80mg)
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Description Micardis 80mg 28 tablets — Made in Greece — Free Delivery
Pharmacological properties
Pharmacodynamics. Telmisartan is a specific and effective antagonist of angiotensin II receptors (AT1 type). Telmisartan replaces angiotensin II with a very high degree of affinity at the sites of its binding to the at1 receptors responsible for the physiological effects of angiotensin II. Telmisartan does not show partial agonist activity against the at1 receptors. Telmisartan binds selectively to the at1 receptor. the binding is lengthy. Telmisartan does not have an affinity for other receptors, including AT2 - and other less studied AT receptors. the functional role of these receptors is unknown, as the effect of their possible "overstimulation" with angiotensin II, the level of which increases under the influence of telmisartan, has not been revealed. telmisartan reduces plasma aldosterone levels. Telmisartan does not inhibit renin in human blood plasma, does not block ion channels. Telmisartan does not inhibit the angiotensin-converting enzyme (kininase II), an enzyme that also degrades bradykinin. therefore, one should not expect potentiation of the bradykinin-accompanying side effects.
In humans, telmisartan at a dose of 80 mg almost completely inhibits the increase in blood pressure caused by angiotensin II. The blocking effect lasts for 24 hours and remains noticeable for up to 48 hours.
Pharmacokinetics. Suction. The absorption of telmisartan is rapid, although the amounts absorbed are different. The average absolute bioavailability is about 50%. If Mikardis is taken with meals, the decrease in the AUC value varies from 6% (when taken at a dose of 40 mg) to 19% (when taken at a dose of 160 mg). 3 hours after taking the preparation, the concentration in the blood plasma is the same and does not depend on whether telmisartan was taken on an empty stomach or with food.
Linearity / non-linearity. It is believed that a small decrease in AUC does not cause a decrease in therapeutic efficacy. There is no linear relationship between dose and plasma level. Cmax and, to a lesser extent, AUC increase disproportionately at doses above 40 mg.
Distribution. Telmisartan binds to a large extent with blood plasma proteins (99.5%), mainly albumin and alpha-1-acid glycoprotein. The volume of distribution at equilibrium is about 500 liters.
Metabolism. Telmisartan is metabolized by conjugation with glucuronide. The pharmacological activity of the conjugate has not been established.
Excretion. Telmisartan is characterized by a biexponential pharmacokinetic profile with T½ in the terminal phase for more than 20 hours. Cmax in blood plasma and AUC increase disproportionately to the dose. There are no data on clinically significant cumulation in the body when used in recommended doses. Plasma concentration is higher in women than in men, with no change in efficacy.
After oral administration, telmisartan is almost completely excreted in the feces, usually unchanged. Cumulative renal excretion is 1% of the dose. The total plasma clearance (Сltot) is high (about 1000 ml / min) compared to the hepatic blood flow (about 1500 ml / min).
Special categories of patients
Floor. Plasma concentrations Cmax and AUC in women are approximately 3 and 2 times higher, respectively, than in men.
Elderly patients. The pharmacokinetics of telmisartan in the elderly and under the age of 65 does not differ.
Patients with impaired renal function. In patients with moderate to moderate and severe renal failure, a 2-fold increase in plasma concentration was noted. However, in patients with renal insufficiency who are subject to dialysis, a low plasma concentration is detected. Telmisartan has a high affinity for blood plasma proteins in patients with renal insufficiency and cannot be cleared by dialysis. In patients with renal insufficiency, T½ does not change.
Patients with impaired liver function. Pharmacokinetic studies in patients with hepatic impairment have shown an increase in bioavailability up to about 100%. In patients with hepatic impairment, T½ does not change.
Indications
- Hypertension
- Treatment of essential hypertension in adults.
- Prevention of cardiovascular disease
Reducing the incidence of cardiovascular disease in patients:
- with overt atherothrombotic cardiovascular disease (coronary artery disease, stroke, or a history of peripheral arterial disease);
- type II diabetes mellitus with documented target organ damage.
Application
Treatment of ag. the usual effective dose is 40 mg / day. in some patients, a dose of 20 mg / day may be sufficient. in cases where the level of the desired blood pressure is not reached, the dose of telmisartan can be increased to 80 mg / day. alternatively, telmisartan can be used in combination with thiazide diuretics (hydrochlorothiazide), which have shown an additional decrease in blood pressure when used concomitantly with telmisartan. when deciding whether to increase the dose, it should be borne in mind that the maximum antihypertensive effect develops 4–8 weeks after the start of treatment.
Prevention of cardiovascular diseases. The recommended dose is 80 mg once a day. The efficacy of telmisartan 80 mg in the prevention of cardiovascular disease is unknown.
When starting treatment with telmisartan in order to prevent cardiovascular diseases, it is recommended to monitor blood pressure and, if necessary, adjust the intake of preparations that lower blood pressure.
The preparation is taken regardless of food.
Special patient groups
Impaired renal function. Experience in treating patients with renal insufficiency or patients on hemodialysis is limited. In such patients, it is recommended to start treatment with a low dose of 20 mg (see SPECIAL INSTRUCTIONS). For patients with mild to moderate renal insufficiency, there is no need for dose adjustment.
Liver dysfunction. Mikardis is contraindicated in patients with severely impaired liver function.
In patients with mild or moderate liver dysfunction, the daily dose should not exceed 40 mg 1 time per day (see SPECIAL INSTRUCTIONS).
Elderly patients. No dose adjustment is required in the elderly.
Contraindications
Hypersensitivity to preparation components; ii and iii trimester of pregnancy; obstructive biliary disorders; severe liver dysfunction.
Side effects
Serious side effects, which include anaphylactic reactions and angioedema, are possible in isolated cases (≥1 / 10,000, 1/1000), also noted opn.
The overall incidence of side effects in patients with hypertension in controlled clinical trials with telmisartan was usually comparable to taking placebo (41.4% versus 43.9%). The frequency of side effects is independent of dose and has no relationship with gender, age or race of patients. The data on the safety of Mikardis in the prevention of cardiovascular diseases correlated with the data in the treatment of hypertension.
The following adverse reactions to the preparation were noted in controlled clinical trials with the participation of patients with hypertension, as well as according to post-marketing reports. This list also includes serious adverse reactions and adverse reactions that led to discontinuation of treatment and were identified during 3 clinical long-term studies with the participation of 21,642 patients who received telmisartan for the prevention of cardiovascular disease and mortality for 6 years.
Side effects are stated in terms of frequency using the following designations: very often (≥1 / 10); often (from 1/100 to 1/10); infrequently (from 1/1000 to 1/100); rarely (from 1/10 000 to 1/1000); very rare (1/10 000).
In each group, side effects are presented in decreasing order of severity.
Infections and invasions: infrequently - upper respiratory tract infections, including pharyngitis and sinusitis, urinary tract infections, including cystitis; rarely - sepsis, including fatal1.
On the part of the blood and lymphatic system: infrequently - anemia; rarely - thrombocytopenia, eosinophilia.
From the immune system: rarely - hypersensitivity, anaphylactic reaction.
Metabolic disorders: infrequently - hyperkalemia; rarely - hypoglycemia (in diabetic patients).
Mental disorders: infrequently - insomnia, depression; rarely - anxiety.
From the side of the central nervous system: infrequently - syncope; rarely, drowsiness.
From the side of the organ of vision: rarely - visual impairment.
From the side of the vestibular apparatus: infrequently - vertigo.
From the side of the heart: infrequently - bradycardia; rarely - tachycardia.
From the side of the vessels: infrequently - arterial hypotension2, orthostatic hypotension.
From the respiratory system, chest and mediastinal organs: infrequently - dyspnea, cough; very rarely - interstitial lung disease 4.
From the gastrointestinal tract: infrequently - abdominal pain, diarrhea, dyspepsia, flatulence, vomiting; rarely - stomach discomfort, dry mouth.
From the hepatobiliary system: rarely - impaired liver function / hepatic impairment 3.
On the part of the skin and subcutaneous tissue: infrequently - increased sweating, itching, rash; rarely - erythema, angioedema (including fatal), preparation dermatitis, toxic dermatitis, eczema, urticaria.
From the musculoskeletal system and connective tissue: infrequently - myalgia, back pain (eg sciatica), muscle cramps; rarely, arthralgia, pain in the limbs, pain in the tendon (symptoms similar to tendonitis).
From the urinary system: infrequently - impaired renal function, including acute renal failure.
General disorders: infrequently - chest pain, asthenia (weakness); rarely, flu-like symptoms.
Laboratory data: infrequently - increased blood creatinine; rarely - an increase in uric acid in the blood, an increase in hepatic enzymes, an increase in the level of CPK in the blood, a decrease in hemoglobin.
1 Sepsis. In the PRoFESS study, patients who took telmisartan had a higher incidence of sepsis compared with those who received placebo. This can be both an accident and a sign of a process, the essence of which is still unknown.
2 Hypotension. This adverse reaction has been reported frequently in patients with controlled blood pressure who took telmisartan to reduce the severity of cardiovascular disease in addition to standard therapy.
3 Impaired liver function / hepatic disorders. According to postmarketing data, most cases of liver dysfunction / liver disorders were observed in patients of Japanese nationality. Patients of Japanese origin are more susceptible to these adverse reactions.
4 Interstitial lung disease. Cases of interstitial lung disease have been reported temporarily with telmisartan during the post-marketing follow-up period. However, a causal relationship has not been established.
Special instructions
Pregnancy. during pregnancy, do not start treatment with angiotensin receptor antagonists ii. if continued therapy with angiotensin II receptor antagonists is not considered essential for a patient planning a pregnancy, she should switch to alternative antihypertensive therapy that has an established safety profile for use during pregnancy. when pregnancy is established, treatment with angiogenesis II receptor antagonists should be stopped urgently and, if necessary, alternative treatment should be started (see contraindications and use during pregnancy and lactation).
Liver failure. Mikardis should not be prescribed to patients with cholestasis, obstructive diseases of the bile ducts and severe hepatic insufficiency (see CONTRAINDICATIONS), since telmisartan is excreted mainly in the bile. In such patients, a decrease in hepatic clearance of telmisartan can be expected. Mikardis should be used with caution in patients with moderate to moderate hepatic impairment.
Renovascular hypertension. There is an increased risk of severe hypotension and renal failure if patients with bilateral renal artery stenosis or stenosis of a solitary kidney are treated with preparations that affect the renin-angiotensin-aldosterone system.
Renal failure and kidney transplant. When Mikardis is prescribed to patients with impaired renal function, periodic monitoring of serum potassium and creatinine levels is recommended. There is no experience of using Mikardis in patients with recent kidney transplantation.
Decrease in BCC. Symptomatic hypotension, especially after the first dose of Micardis, can occur in patients with reduced BCC and / or sodium levels, which occurs as a result of diuretic therapy, restriction of salt intake from food, diarrhea or vomiting. Before taking Mikardis, it is necessary to correct such conditions, especially a decrease in intravascular volume and / or sodium level.
Double blockade of the renin-angiotensin-aldosterone system. As a result of inhibition of the renin-angiotensin-aldosterone system, more sensitive patients had arterial hypotension, syncope, hyperkalemia and changes in renal function (including ARF), especially if the combination therapy included preparations that affect this system. Therefore, double blockade of the renin-angiotensin-aldosterone system (for example, the use of telmisartan with other blockers of the renin-angiotensin-aldosterone system) is not recommended. If necessary, simultaneous use is recommended careful monitoring of renal function.
Other conditions requiring stimulation of the renin-angiotensin-aldosterone system
In patients in whom vascular tone and renal function depend mainly on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe congestive heart failure or severe kidney disease, including renal artery stenosis), taking Mikardis with other medicines that affect the renin-angiotensin-aldosterone system was associated with acute arterial hypotension, hyperazotemia, oliguria, and occasionally with acute renal failure (see SIDE EFFECTS).
Primary hyperaldosteronism. Patients with primary hyperaldosteronism generally do not respond to antihypertensive preparations that act by blocking the renin-angiotensin system. Therefore, the appointment of telmisartan is not recommended for them.
Stenosis of the aorta and mitral valve, obstructive hypertrophic cardiomyopathy. As with other vasodilators, Mikardis is prescribed with extreme caution in patients diagnosed with stenosis of the aorta, mitral valve, or obstructive hypertrophic cardiomyopathy.
Patients with diabetes mellitus who are treated with insulin or antidiabetic preparations
During treatment with telmisartan, these patients may develop hypoglycemia. Consideration should be given to the need for appropriate monitoring of blood glucose levels in these patients. According to the indications, it may be necessary to adjust the dose of insulin or antidiabetic preparations.
In diabetic patients with cardiovascular risks (patients with diabetes mellitus and concomitant coronary artery disease), the risk of fatal myocardial infarction and sudden cardiovascular death may be higher when treated with antihypertensive preparations such as angiotensin II receptor antagonists and ACE inhibitors. In patients with diabetes mellitus, the course of concomitant diseases of the coronary arteries may be asymptomatic, and therefore they may be undiagnosed. Patients with diabetes mellitus should be carefully evaluated, for example by stress testing, to identify and treat comorbid coronary artery disease before prescribing the preparation.
Hyperkalemia. During the entire intake of preparations that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur.
In the elderly, in patients with renal failure, diabetes mellitus, in patients concurrently taking other preparations that can cause an increase in potassium levels, and / or with concomitant diseases, hyperkalemia can be fatal.
Before considering the issue of the simultaneous use of preparations that inhibit the renin-angiotensin system, it is necessary to assess the balance of benefits and risks.
The main risk factors for hyperkalemia to look out for are:
diabetes mellitus, renal failure, age (over 70 years);
combination therapy with one or more drugs that affect the renin-angiotensin system, and / or potassium supplements. Preparations or therapeutic groups of preparations that can provoke hyperkalemia include salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, including selective COX-2 inhibitors, heparin, immunosuppressants (cyclophenylamine) and tacimetrolimusorin ;
comorbidities, especially dehydration, acute cardiac decompensation, metabolic acidosis, impaired renal function, severe deterioration of the kidneys (infectious diseases), cell lysis (eg, acute limb ischemia, acute skeletal muscle necrosis, extensive trauma).
Patients at risk should be closely monitored for serum potassium levels (see INTERACTIONS).
Sorbitol. The medicinal product contains sorbitol (E420). Patients with rare hereditary disorders of fructose intolerance should not take this preparation.
Ethnic differences. Like all other angiotensin II receptor antagonists, telmisartan is clearly less effective in lowering blood pressure in black patients than in other races. Perhaps this is due to the high prevalence of low renin states in patients of the Negroid race with hypertension.
Other. As with any other antihypertensive preparation, a significant decrease in blood pressure in patients with ischemic cardiopathy or ischemic cardiovascular disease can lead to myocardial infarction or stroke.
Use during pregnancy and lactation. The use of angiotensin II receptor antagonists is not recommended in the first trimester of pregnancy (see SPECIAL INSTRUCTIONS). The use of angiotensin II receptor antagonists is contraindicated in the II and III trimester of pregnancy (see CONTRAINDICATIONS and SPECIAL INSTRUCTIONS).
There is insufficient data on the use of Mikardis in pregnant women.
The epidemiological justification of the risk of teratogenicity due to the use of ACE inhibitors in the first trimester of pregnancy was not convincing, but a slight increase in risk cannot be ruled out. Despite the lack of controlled epidemiological data regarding the risk of teratogenicity with the use of angiotensin II receptor antagonists, similar risks may exist for this class of preparations. If continued therapy with angiotensin II receptor antagonists is not considered essential, patients planning a pregnancy should switch to antihypertensive preparations that have an established safety profile for use during pregnancy. When pregnancy is established, treatment with angiotensin II receptor antagonists should be stopped urgently and, if necessary, alternative treatment should be started. In the II and III trimester of pregnancy, angiotensin II receptor antagonists are known to cause fetotoxicity (decreased renal function, oligohydramnios, delayed formation of skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia). If the use of angiotensin II receptor antagonists began in the second trimester of pregnancy, it is recommended to conduct an ultrasound of the function of the kidneys and skull bones. Children whose mothers took angiotensin II receptor antagonists should be carefully examined for arterial hypotension (see CONTRAINDICATIONS and SPECIAL INSTRUCTIONS).
Due to the lack of information, the use of the preparation Mikardis during breastfeeding is not recommended. Alternative treatments with a better known safety profile are preferred, especially when breastfeeding a newborn or premature baby.
In the course of preclinical studies, no effect of Mikardis on fertility in men and women was revealed.
Children. The safety and efficacy of Mikardis has not been studied in children (under the age of 18). No data available.
Influence on the reaction rate when driving or working with other mechanisms. When driving a car and mechanisms, it is necessary to take into account the possibility of dizziness or hypersomnia during antihypertensive therapy, including the preparation Mikardis.
Interactions
Like other preparations that inhibit the renin-angiotensin system, telmisartan can cause hyperkalemia (see special instructions). the risk may be increased with treatment in combination with other preparations that can also provoke hyperkalemia (salt substitutes containing potassium, potassium-sparing diuretics, APF inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective Tsog-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim).
The incidence of hyperkalemia depends on the associated risk factors. The risk is increased with the above therapeutic combinations. The risk is especially high when combined with potassium-sparing diuretics and in combination with salt substitutes containing potassium. The combination with ACE inhibitors or NSAIDs causes less risk, provided that precautionary measures are strictly observed during use.
Concomitant use is not recommended
Potassium-sparing diuretics or potassium supplements. Angiotensin II receptor antagonists such as telmisartan mitigate diuretic-induced potassium loss. Potassium-sparing diuretics such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements, or potassium-containing salt substitutes can cause significant increases in serum potassium. If concomitant use is indicated due to documented hypokalemia, it should be taken with caution, often monitoring serum potassium levels.
Lithium. There are cases of a reversible increase in the concentration of lithium in the blood serum and an increase in toxicity during concomitant administration of lithium with ACE inhibitors and angiotensin II receptor antagonists, including telmisartan. If the appointment of this combination is necessary, during concomitant use, the level of lithium in the blood serum should be closely monitored.
Concomitant use requiring caution
NSAIDs (acetylsalicylic acid in anti-inflammatory regimens, COX-2 inhibitors and non-selective NSAIDs) can reduce the severity of the antihypertensive effect of angiotensin II receptor antagonists.
In some patients with impaired renal function (for example, patients with dehydration or elderly patients with impaired renal function), the combination of angiotensin II receptor antagonists and COX inhibitors may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, this combination should be administered with caution, especially in the elderly. Patients should be provided with adequate hydration; in addition, after the start of combination therapy, as well as periodically in the future, it is necessary to monitor renal function.
One study reported that the combined use of telmisartan and ramipril led to a 2.5-fold increase in the AUC0-24 and Cmax of rampiril and ramiprilat. The clinical relevance of this observation is unknown.
Diuretics (thiazide or loop). Previous treatment with high doses of diuretics such as furosemide (a loop diuretic) and hydrochlorothiazide (a thiazide diuretic) may result in volume loss and risk of hypotension if telmisartan is started.
Pay attention to concomitant use
Other antihypertensive preparations. The ability of telmisartan to lower blood pressure may be increased by the concomitant use of other antihypertensive preparations.
Based on the pharmacological properties of baclofen and amifostine, these preparations can be expected to potentiate the antihypertensive effect of all antihypertensive agents, including telmisartan. In addition, orthostatic hypotension can be worsened by alcohol, barbiturates, preparations, and antidepressants.
Corticosteroids (systemic use). Decreased antihypertensive action.
Overdose
Information regarding overdose in humans is limited.
Symptoms The most significant manifestations in telmisartan overdose were arterial hypotension and tachycardia, and bradycardia, dizziness, increased serum creatinine concentration and ARF were reported.
Therapy. Telmisartan is not excreted by hemodialysis.
Patients should be closely monitored and receive symptomatic and supportive therapy. Therapy depends on the time the preparation was taken and the severity of the symptoms. Recommended measures include induction of vomiting and / or gastric lavage. When treating an overdose, activated charcoal can be used. It is necessary to frequently monitor the level of electrolytes and serum creatinine. If arterial hypotension occurs, the patient should be given a horizontal position and assistance should be provided to quickly replenish the volume of fluid and salt in the body.
Storage conditions
Store in a dry place in its original packaging at a temperature not exceeding 30 ° C.
Tags: Micardis
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