Canarb (Kanarb)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFimasartanFimasartan
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  • Canarb
    pills inwards 
    R-PHARM, CJSC     Russia
    • Dosage form: & nbsptfilm-covered laths
    Composition:

    One tablet contains:

    active substance: fumasartan potassium trihydrate 66.01 / 132.02 mg in terms of potassium fumasartan 60.0 / 120.0 mg;

    Excipients: lactose monohydrate 43.99 / 87.98 mg, microcrystalline cellulose 11.75 / 23.50 mg, croscarmellose sodium 22.50 / 45.0 mg, hydroxypropylcellulose 3.50 / 7.0 mg, magnesium stearate 2.25 / 4.50 mg;

    shell: * Opaprai 03V62599 yellow 3.75 mg (hypromellose (E464) 62.50%, titanium dioxide (E171) 25.52%, macrogol (E1521) 6.25%, food grade tartrazine dye (E102) 3.00%, iron dye oxide yellow (E172) 2.70%, dye brilliant blue (E133) 0.02%, dye red charming (E129) 0.01%); ** Opapray 03B63253 orange 7.50 mg (hypromellose (E464) 62.50%, titanium dioxide (E171) 25.23%, macrogol (E1521) 6.25%, coloring sunset yellow sunset yellow (E110) 6.00% iron dye oxide black (E172) 0.01%, iron dye oxide yellow (E172) 0.01%); carnauba wax (E 903) 0.25 / 0.50 mg.

    * osadrai 03V62599 yellow - tablets of 60 mg

    ** osadrai 03V63253 orange - tablets 120 mg

    Description:

    Tablets 60 mg: hexagonal biconvex tablets, covered with a film coating of yellow color with a risk for division and engraving "B |R"on the one hand and"FMS 6 "on the other: two layers are visible on the cross section: the core is white and the shell is yellow.

    Tablets 120 mg: hexagon biconvex tablets, covered with a film shell of orange color with a risk for division and engraving "B |R"on the one hand and"FMS 12 "on the other: two layers are visible on the cross section: the core is white and the shell is orange.

    Pharmacotherapeutic group:Angiotensin II receptor antagonist
    ATX: & nbsp

    C.09.C.A.10   Fimasartan

    Pharmacodynamics:

    Fimasartan is a non-peptide antagonist of angiotensin receptors II (type AT1) for oral administration.

    Angiotensin II is a key effector compound of the renin-angiotensin-aldosterone system (RAAS), which plays an important role in regulating arterial pressure and the pathogenesis of hypertension.

    Angiotensin II increases arterial pressure due to pronounced vasoconstrictive effect and increase in total peripheral vascular resistance, activation of epinephrine production, aldosterone release, effect on sodium reabsorption in the distal sections of renal tubules and increase in circulating blood volume. Its action is carried out through specific angiotensin receptors, while the main physiological effects, including unfavorable ones, are mediated AT1receptors. The effect of fimasartan is due to selective binding to AT1angiotensin receptors II: fimasartan does not have a partial agonistic effect on angiotensin receptors II, which is typical for peptide blockers of angiotensin receptors II (e.g., saralazine). When studying various animal models fimasartan after a single or repeated oral and intravenous administration, effectively and dose-dependent decreased blood pressure.

    In the human body fimasartan increased plasma renin activity in combination with an increase in angiotensin concentration I and II, which confirms the specific blockade of angiotensin receptors II. Thus, after a single oral administration at a dose fimasartana from 20 to 480 mg, it caused an increase in plasma renin, angiotensin I and angiotensin II the maximum magnification, typically between 6 and 8 hours after dosing, which persisted long (up to 48 h after administration). In this drug-related changes in the activity of angiotensin converting enzyme inhibitors and aldosterone were observed. Fimasartan increased plasma renin activity and angiotensin concentration II after repeated, during 7 days, use of 120 and 360 mg per day. The maximum increase in these parameters was noted, as a rule, 6-8 hours after application, was preserved for a long time (up to 24 hours after administration). A decrease in the plasma level of aldosterone was observed with a longer duration of admission of fimasartan (within 28 days).

    The efficacy of fimasartan at therapeutic doses of 60 and 120 mg with respect to lowering blood pressure was demonstrated in comparative randomized clinical trials. It was found that the blood pressure when taking the drug is reduced within 2 weeks from the start of treatment, the maximum effect is observed approximately in 8-12 weeks.

    Fimasartan acts on blood pressure for 24 hours, providing a stable and smooth profile of blood pressure, which is also facilitated by taking fimasartan at the same time of day (to minimize pressure fluctuations). When appointing fimasartan for a long period (24 weeks), tolerance did not develop.

    Pharmacokinetics:

    Suction

    Fimasartan is rapidly absorbed after oral administration: the time interval until the peak concentration (TCmOh) in blood plasma after admission in healthy individuals and patients with hypertension was 0.5-3 hours and 0.5-1.3 hours, respectively. When studying the pharmacokinetic characteristics of the drug directly in the population of Russian patients with arterial hypertension TSmOh was also determined in the range from 0.5 to 4 hours (with a single dose of 60 mg).

    After reaching CmOh a two-phase decrease in the concentration of fimasartan in the plasma was observed, with the onset of the elimination phase observed 2.5 to 8 hours after the drug was administered to all patients. Quantitatively determined concentrations of fimasartan in plasma were observed up to the last time point of collection of samples 24 hours after drug administration in the range from 1.33 to 11.2 ng / ml. Variability of indicators between patients (geometric mean CV%), was high, while the values ​​for AUC0-tlast, AUC0-∞ and Cmax amounted to 50.1%, 53.9% and 86.8% respectively.

    In the Russian study №СС09042014 pharmacokinetics were obtained in female patients. Comparison of data with the population of healthy male volunteers showed that after a single dose of fumasartan in a dose of 60 mg in healthy volunteers, the time to reach the peak concentration of the drug (TCmax) came on 2 hours later in comparison with patients with arterial hypertension. Peak systemic exposure (CmOh) was 1.4 times higher in patients with arterial hypertension. In this case, the overall systemic effect (AUC0-∞ and AUC0-tlast) was comparable in both populations.

    A comparison of the data with the Korean population of patients with hypertension showed that after a single intake of fimasartan inside at a dose of 60 mg of the median TSmax in the populations of Russian and Korean patients was approximately 1 hour with an individual range of values ​​from 0.5 to 4.0 hours and from 0.5 to 6.0 hours after taking the drug, respectively. Peak Systemic Impact (FROMmax) and the overall systemic effect (AUC0-∞ and AUC0-tlast) fimasartan are comparable in populations of Russian and Korean patients.

    Absolute bioavailability of fimasartan in healthy subjects with oral intake of 60 mg is about 19%.

    Distribution and binding to proteins

    In preclinical studies, a limited distribution of the drug following oral administration was shown.

    Mri concentrations of fimasartan from 0.01 to 100 μg / ml in vitro binding to a protein in human blood plasma is 95.6 to 97.2% and is dose independent.

    Metabolism

    CYP3A4 was the main enzyme metabolizing fimasartan. However, the role of metabolism in the process of removing fimasartan is negligible, since the initial drug is ≥85% of the forms of fimasartan found in human blood plasma, in addition, the level of systemic exposure to fimasartan is slightly increased by specific inhibitors CYP3A4. Desulfo-fimsartan and fimasartan - S-oxide were identified as the most common circulating metabolites of fimasartan in plasma in healthy men. Fimasartan is not an inducer or inhibitor of other enzymes of the cytochrome P450 family.

    Excretion

    After a single dose of fimasartan in a dose of 20 to 480 mg in healthy subjects, the elimination half-life (t1/2) is from 5 to 16 hours, in the Korean population of patients with essential hypertension when doses ranging from 20 to 180 mg t1/2 was in the range of 7 to 10 hours, in a population of Russian patients with hypertension - from 4.4 to 7.9 hours with a single dose of 60 mg. The systemic effect is evaluated as linear in a wide range of doses. The accumulation index ranged from 1.20 to 1.26 in healthy individuals and from 1.02 to 1.08 in persons with arterial hypertension.In the evaluation of healthy men and patients with hypertension for 24 or 144 hours after oral administration in urine, approximately 3-5% of the administered dose of fimasartan was detected. Thus, the involvement of the kidney in the excretion of fimasartan is insignificant. The main way of excretion is with feces. Thus, after oral administration of a single dose of 120 mg of radiolabeled C14 fimasartan in the group of 6 healthy men, the average total excretion of radioactive material in feces and urine was about 86% of the prescribed dose, with urinary excretion of about 4.6%.

    Pharmacokinetics in specific patient groups

    Elderly people

    In elderly patients (that is, in patients over the age of 65 years) the systemic effect of the drug is 1.69 times more pronounced than in young people. However, the increase in systemic exposure in elderly patients does not appear to result in a more significant decrease in blood pressure, as the activity of RAAS in this population is generally lower than in young people.

    Persons with renal insufficiency

    Pharmacokinetic parameters of fimasartan were studied in patients with renal insufficiency; patients on hemodialysis were excluded from the study.When taking the drug at a dose of 120 mg with severe renal dysfunction (the estimated glomerular filtration rate (GFR) is less than 30 ml / min / 1.73 m2 surface area of ​​the body) peak concentration (CmOh) and the area under the curve "concentration in plasma - time" (AUC) were compared with those of healthy volunteers: Cmax and AUC in patients with renal failure increased in 1.87 and 1.73 times, respectively. When assessing the safety profile in the two groups, there were no differences. For patients with severe renal insufficiency (creatinine clearance <30 ml / min) dose adjustment is required (see sections "Dosage and administration", "With caution").

    Persons with hepatic impairment

    Fimasartan at a dose of 120 mg was given to patients with hepatic insufficiency (class A and B on the Child-Pugh scale). FROMmOh and AUC compared with the same indicators in healthy volunteers. Geometric mean ratios of the ratio CmOh and AUC were 0.77 and 1.10, respectively, in the calculation of indicators for patients with hepatic insufficiency of class A and healthy volunteers. When calculating the indices in groups of patients with hepatic insufficiency of class B and healthy volunteers - 6.55 for CmOh and 5.2 for AUC. There were no significant differences in blood pressure and safety profile between the three groups. For patients with mild hepatic insufficiency, initial dose adjustment is not required. In patients with moderate and severe hepatic insufficiency, the drug is not recommended for use (see section "Dosing and Administration", "Contraindications" and "With caution").

    Indications:

    Hypertension 1 and 2 degrees.

    Contraindications:

    1) Ppatients with hypersensitivity to any of the components of the drug;

    2) pregnant women and women in the period of breastfeeding, women planning pregnancy (see the section on "Application during pregnancy and during breastfeeding");

    3) patients who are on hemodialysis (there is no experience of using the drug in this population of patients);

    4) moderate and severe violations of the liver (more than 7 points on the scale Child-Pugh);

    5) patients with bile duct obstruction;

    6) simultaneous use with aliskiren and preparations containing aliskiren, in patients with diabetes mellitus and / or moderate or severe renal dysfunction (glomerular filtration rate (GFR) of less than 60 ml / min / 1.73 m2 surface area of ​​the body);

    7) patients with diabetic nephropathy who take angiotensin-converting enzyme (ACE inhibitors) inhibitors (see section "Interaction with Other Drugs");

    8) patients with genetic disorders, such as galactose intolerance, congenital insufficiency of lactase or glucose malabsorption syndrome and galactose (the preparation contains lactose);

    9) age to 18 years.

    Carefully:

    Special precautions should be taken when using fimasartan in patients with the following conditions / conditions:

    1) Reduction of circulating fluid volume or salt depletion: in these patients (eg, patients receiving high doses of diuretics) with activated RAAS, symptomatic hypotension may occur at the beginning of fimasartan therapy or with an increase in the dose of the drug. Such patients need careful monitoring.

    2) Renal failure: in patients with increased sensitivity to inhibition of RAAS, changes in renal function may occur. The use of both ACE or angiotensin receptor antagonists II may be accompanied by the development of oliguria, progressive uraemia and, in rare cases,acute renal failure or fatal outcome in patients in whom renal function depends on RAAS activity (eg, in patients with chronic heart failure, IV functional class by classification NYHA).

    3) Renovascular hypertension: in patients with unilateral or bilateral stenosis of the renal artery, there is an increased risk of developing severe hypotension or renal failure while taking medications that affect RAAS, such as fimasargan (see section "Specific guidance").

    4) As with other vasodilators, special care should be taken when treating patients with stenosis of the aortic or mitral valve, obstructive or hypertrophic cardiomyopathy.

    5) Primary hyperaldosteronism: the use of drugs that inhibit the renin-angiotensin system is usually not effective. Therefore, it is not recommended to prescribe fimasratan to such patients.

    6) Hyperkalemia.

    7) Elderly age.

    8) Simultaneous use of lithium preparations.

    9) Cardiac ischemia.

    10) Cerebrovascular disease.

    Pregnancy and lactation:

    Pregnant women

    The use of Canarb during pregnancy is contraindicated.

    Drugs that have a direct effect on RAAS can cause disease and death of the fetus and newborn in the case of therapy with a pregnant woman. The use of drugs that have a direct effect on RAAS in the second and third trimesters of pregnancy has been associated with adverse effects on the fetus and the newborn, including the development of hypotension, neonatal hypoplasia of the skull bones, anuria, reversible and irreversible renal failure and lethal outcomes. Also described was low-water, presumably as a result of impaired fetal kidney function. The malignancy was associated with the development of limb contractures in the fetus, deformation of the bones of the facial skull and lung hypoplasia. In addition, there have been cases of prematurity, intrauterine growth retardation of the fetus and open ductus arteriosus, although it is not clear whether these disorders were caused by the effects of the drug.

    The use of Canarb is contraindicated in women planning pregnancy. In case of pregnancy fimasartan it is necessary to cancel as soon as possible. Such undesirable phenomena do not appear to be the result of intrauterine exposure limited to the first trimester. You should inform the woman receiving the angiotensin II receptor antagonist during the first trimester of pregnancy. Nevertheless, when a pregnancy occurs, the doctor should cancel the drug as soon as possible. Newborns exposed to intrauterine effects of angiotensin II receptor antagonists should be closely monitored for hypotension, oliguria, and hyperkalemia.

    During breastfeeding

    It is not known whether fimasartan with breast milk of women, but it was revealed that fimasartan is excreted with the milk of lactating rats. Therefore, lactating mothers are not recommended to use fimasartan. It is necessary to decide whether to stop breastfeeding or cancel fimasartan, considering the importance of therapy with the drug for the mother.

    Dosing and Administration:

    The recommended initial dose of fimasartan is 60 mg once a day, regardless of the time of ingestion.

    If the blood pressure can not be adequately controlled against the background of the drug at a dose of 60 mg, the dose of fimasartan can be increased to 120 mg once a day. If possible, it is recommended to take fimasartan at the same time of the day (for example, in the morning).

    The antihypertensive effect of fimasartan generally develops within 2 weeks, the maximum reduction is usually achieved through 8-12 weeks of therapy.

    The efficacy of Canarb for more than 24 weeks has not been studied in clinical studies.

    Special patient groups

    Elderly patients

    In a study to compare pharmacokinetics in elderly healthy volunteers aged 65 years or older and in young volunteers, AUC fimasartan in older patients increased by 69%. However, differences in efficacy and safety between the elderly and younger patients in comparing 21 elderly patients (≥65 years, 9.3%) of the 226 patients who received fimasartan in clinical studies of phase III, it was not revealed. Therefore, dose adjustment in elderly patients (age ≥65 years) is not required, although we can not exclude a somewhat higher susceptibility in some elderly patients.

    Patients with renal insufficiency

    For patients with mild or moderate renal insufficiency (creatinine clearance 30-80 ml / min), initial dose adjustment is not required. For patients with severe renal insufficiency (creatinine clearance <30 ml / min), the recommended initial dose is 30 mg once a day, the daily dose of the drug should not exceed 60 mg. When appointing a dose of 30 mg of fimasartan should be taken 1/2 part of the 60 mg tablet, dividing it along the fault line.

    Patients with renal failure receiving aliskiren, also to patients who undergo hemodialysis, the drug is not shown (see the sections "Contraindications" and "With caution").

    Patients with hepatic insufficiency

    For patients with mild hepatic insufficiency, initial dose adjustment is not required. The use of fimasartan is not recommended in patients with moderate or severe hepatic insufficiency (see the sections "Contraindications" and "With caution").

    Patients of childhood

    The efficacy and safety of fimasartan in patients aged 18 years or less have not been established.

    Patients with a reduced intravascular volume of circulating fluid (eg, patients receiving high doses of diuretics)

    For patients with an increased risk of hypotension, for example, due to a decrease in the intravascular volume of the circulating fluid, the recommended initial dose of the drug is 30 mg once daily (see the section "With caution").

    Side effects:

    The safety of fimasartan in the Korean population was studied in 406 patients from 852 patients with essential hypertension who received fimasartan in doses from 60 to 120 mg during 4-12 weeks, and which were included in the clinical studies and selected for safety analysis (ie the information on which the safety database was compiled). 85 patients received fimasartan for 6 months or more. The majority of these adverse events were mild to moderate and of a transient nature, the incidence rate was independent of the dose of the drug. The most common adverse events were headache and dizziness.

    Table 1 lists undesirable reactions (ie, undesirable events regarded as specifically related, probably related or possibly associated with the use of fimasartan) according to the WHO classification of adverse reactions in frequency of occurrence,Registered in clinical trials using fimasartan in Korea.

    Table 1. Undesirable reactions due to the use of fimasartan1)

    Classification by classes of organ systems

    Frequency emergence2)

    Symptoms

    Disturbances from the nervous system

    Often

    Headache, dizziness

    Infrequently

    Fainting, sedation. migraine

    Disorders from the gastrointestinal tract

    Infrequently

    Dyspepsia, nausea, vomiting, pain in the upper abdomen

    General disorders and disorders at the site of administration

    Infrequently

    Asthenia, sensation of foreign body

    Laboratory and instrumental data (deviations of laboratory indicators)

    Infrequently

    Increased ALT activity3), increased ACT activity4), thrombocytopenia, increased activity of CK5) in blood

    Disturbances from the respiratory system, chest and mediastinal organs

    Infrequently

    Cough

    Disturbances from musculoskeletal and connective tissue

    Infrequently

    Muscular twitching, muscle stiffness

    Disturbances from the skin and subcutaneous tissues

    Infrequently

    Skin itching, localized urticaria

    Vascular disorders

    Infrequently

    Flushing, congestion

    Violations of the genitals and mammary gland

    Infrequently

    erectile disfunction

    1) undesirable phenomena for which the relationship with the use of fimasartan was specific, probable, or possible.

    2) very often occurring (≥1 / 10); often occurring (≥1 / 100, <1/10); infrequently occurring (≥1 / 1000, <1/100); rarely occurring (≥1 / 10000, <1/1000); very rare (<1/10000); frequency of occurrence is not known (can not be determined from available information).

    3) ALT = alanine aminotransferase.

    4) ACT aspartate aminotransferase.

    5) CKF = creatine phosphokinase.

    In the Russian population, the safety of fimasartan was studied in 89 of 179 patients with arterial hypertension I-II degrees received fimasartan in a dose of 60 to 120 mg for 12 weeks in a study using lozaratap as a reference preparation. In this study, the following undesirable reactions caused by the use of fimasartan were observed: nausea in 4 (4.5%) patients, increased activity ACT 1 (1.1%) patients, increased ALT activity in 1 (1.1%) patients, dizziness in 1 (1.1%) patients, headache in 4 (4.5%) patients, pruritus in 1 (1.1%) patients. In the Russian patient population, undesirable phenomena have been identified,whose connection with the administration of the drug has not been established (anemia, diarrhea, and elevated levels of total cholesterol and LDL cholesterol in the blood, a decrease in creatinine clearance).

    Overdose:

    There is no data on overdose of fimasartan in humans. The most likely manifestations of an overdose may be arterial hypotension and tachycardia. Bradycardia can arise as a result of stimulation of the parasympathetic nervous system (vagus nerve). In case of symptomatic arterial hypotension, maintenance therapy is necessary. It is not known whether fimasartan from the plasma by means of hemodialysis.

    Interaction:

    1) Potassium-sparing diuretics and potassium-containing drugs. With simultaneous application fimasartana as other drugs that affect the RAAS and potassium-sparing diuretics (e.g., spironolactone), additives containing potassium salt substitute containing potassium and drugs which can increase the serum potassium level (e.g., heparin), it is possible to increase the potassium level in the serum.

    2) Reduction of arterial pressure when taking fimasartan can be enhanced with simultaneous use with other antihypertensive drugs, including diuretics. With the previous use of high doses of diuretics, the onset of fimasartan may be accompanied by an excessive decrease in blood pressure due to a decrease in the intravascular volume of the circulating fluid (see the sections "With caution" and "Dosage and administration").

    3) Lithium preparations. A reversible increase in serum lithium concentration and toxic manifestations were noted in the appointment of lithium with ACE inhibitors. In the case of combined use of lithium preparations with angiotensin II receptor antagonists, such reactions were very rare. Although simultaneous use of fimasartan with lithium preparations is usually not recommended, if necessary, such therapy should be carefully monitored the level of lithium in the blood.

    4) Non-steroidal anti-inflammatory drugs (NSAIDs). With the simultaneous use of NSAIDs (eg, cyclooxygenase-2 (COX-2) inhibitors, acetylsalicylic acid at a dose of ≤3 g / day) with angiotensin II receptor antagonists, weakening of the hypotensive effect may be observed.Against the background of the use of angiotensin II receptor antagonists in combination with a cyclooxygenase inhibitor, in some patients with renal insufficiency (for example, in patients with dehydration and in elderly patients with impaired renal function), the severity of impaired excretory function (including the development of acute renal failure, although reversible). Therefore, care should be taken when using fimasartan with NSAIDs, especially in elderly patients. In these cases, sufficient hydration and careful monitoring of kidney function is necessary.

    5) Hydrochlorothiazide. With the simultaneous use of fimasartan and hydrochlorothiazide, no significant pharmacokinetic drug interaction was observed.

    6) Amlodipine. With the simultaneous use of fimasartan and amlodipine no significant pharmacokinetic drug interaction was observed.

    7) Ketoconazole. The level of systemic exposure to fimasartan. determined by the area under the curve "concentration - time" (AUC), against the background of the concomitant use of ketoconazole increased by approximately two times.Caution should be exercised while using fimasartan and ketoconazole.

    8) Rifampicin or other inhibitors of protein-carriers of organic anions (OATP1B1, OAT1). Fimasartan is not a substrate for the ABC transport system, but is a substrate for OAT1 and OART1B1 carriers. With the simultaneous use of fimasartan with rifampicin (inhibitor of OATP1B1), an increase in the AUC of fimasartan was approximately 4.6-fold. Therefore, simultaneous use of fimasartan with rifampicin is not recommended. When combined with other inhibitors of the OATP1B1 transporter (eg, cyclosporin), an increase in systemic exposure to fimasartan may also occur, so these combinations should be administered with caution.

    9) Warfarin. Simultaneous use of fimasartan did not significantly affect the pharmacokinetics and pharmacodynamics of warfarin.

    10) Atorvastatin. Simultaneous use of fimasartan did not affect the AUC of atorvastatin and its active metabolites. FROMmOh atorvastatin and its active metabolites in plasma increased 1.9 and 2.5 times, respectively. There is no data on the clinical significance of this interaction.

    11) Digoxin. Simultaneous use of fimasartan did not affect the pharmacokinetics and clearance of digoxin, except for an increase in CmOh digoxin by 30%. Combined therapy may require careful monitoring of digoxin concentrations.

    12) Other angiotensin receptor antagonists, ACE inhibitors or aliskiren. Dual blockade of the renin-angiotensin system, angiotensin II receptor blockers, ACE aliskiren or accompanied by a higher risk of arterial hypotension, syncope, hyperkalaemia and changes in renal function (including acute renal failure) than in the monotherapy. As a rule, joint use of inhibitors of the renin-angiotensin system should be avoided. Do not use aliskiren and fimasartan in patients with diabetes mellitus or impaired sleep function (GFR <60 mL / min / 1.73 m2 surface area of ​​the body). It is not recommended to simultaneously use ACE inhibitors and fimasartanAnd in patients with diabetic nephropathy simultaneous use of ACE inhibitors and fimasartana should be avoided (see. Section "Contraindications").

    13) Other cases of drug interactions. Fimasartan does not inhibit or induce the enzymes of the CYP450 system.

    Special instructions:

    1) Arterial hypotension and disturbance of water-electrolyte balance: in patients with reduced circulating fluid volume or salt exhaustion (for example, in patients receiving high doses of diuretics that adhere to a diet with limited salt intake in patients with diarrhea or vomiting) symptomatic hypotension may occur, especially if fimasartan is started or when increasing the dose of the drug. Reduction of intravascular volume of circulating fluid or salt depletion should be adjusted before the beginning of therapy with fimasartan, or it is necessary to start therapy with a lower dose and then increase it. This requires careful monitoring of the patients' condition.

    If symptomatic arterial hypotension occurs, the patient should be placed in a horizontal position and, if necessary, begin infusion therapy. The intake of fimasartan can be resumed after the stabilization of blood pressure.

    2) Hyperkalemia: drugs that affect RAAS can cause hyperkalemia in patients with chronic heart failure or renal insufficiency.In the case of fimsartan in these patients, regular monitoring of blood potassium levels is recommended.

    3) Renovascular hypertension: in patients with unilateral or bilateral reninvascular hypertension, there have been cases of increased serum creatinine and urea nitrogen levels when angiotensin II receptor antagonists have been used, such as fimasartan. Although, in fact fimasartan was not used in patients with unilateral or bilateral reninvascular hypertension, in the case of such use, similar effects may arise.

    4) Double inhibition of RAAS: when taking drugs that inhibit the RAAS system, especially when used simultaneously with drugs that can also affect RAAS, a change in renal function, including the development of acute renal failure in patients with hypersensitivity to these drugs, is possible. Therefore, double inhibition of RAAS, i.e., simultaneous use of an angiotensin II receptor antagonist and an angiotensin-converting enzyme inhibitor is generally not recommended. However, if necessary, such therapy can be performed in a number of patients after confirmation of itsecurity.

    5) On the background of fimasartan therapy may occur transient symptomatic arterial hypotension (for example, shock, loss of consciousness, dyspnea). If these symptoms appear, you should cancel the drug and begin the necessary symptomatic therapy.

    6) Arterial hypotension may also develop in patients receiving an angiotensin II receptor antagonist during anesthesia (anesthesia) and surgical interventions by inhibiting RAAS. In very rare cases, severe arterial hypotension may occur, requiring infusion therapy and the use of vasopressors.

    7) As with other hypotensive drugs, a marked decrease in blood pressure in patients with ischemic heart disease or cerebral vascular ischemia may worsen the course of the underlying disease. When treating this patient population, special care must be taken.

    8) There is no experience of using Canarb in patients after kidney transplantation.

    9) Patients Negroid race there was a decrease in the antihypertensive efficacy of angiotensin II receptor antagonists.

    Effect on the ability to drive transp. cf. and fur:

    The effect of fimasartan on the ability to drive vehicles and mechanisms has not been studied. However, sometimes, hypotensive drugs may cause drowsiness and dizziness, so patients taking fimasartan, it is necessary to warn about the existence of such a risk.

    Form release / dosage:Film-coated tablets are 60 mg and 120 mg.
    Packaging:

    For 10 tablets in a contour mesh package made of a white opaque three-layer PVC / PE / PVDX film and aluminum foil for sealing.

    For 1, 2 or 3 contour mesh packages, together with instructions for medical use, are placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003962
    Date of registration:15.11.2016
    Expiration Date:15.11.2021
    The owner of the registration certificate:R-PHARM, CJSC R-PHARM, CJSC Russia
    Manufacturer: & nbsp
    Boryung Pharmaceutical Co Ltd The Republic of Korea
    Representation: & nbspR-PHARM, JSC R-PHARM, JSC Russia
    Information update date: & nbsp22.11.2017
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