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  • Availability date:
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STRUCTURE:


active ingredients: olmesartan medoxomil; amlodipine besilate; hydrochlorothiazide;


1 coated tablet contains olmesartan medoxomil 20 mg, amlodipine besilate 6,944 mg, which is equivalent to amlodipine 5 mg and hydrochlorothiazide 12.5 mg


or olmesartan medoxomil 40 mg, amlodipine besilate 6,944 mg, which is equivalent to amlodipine 5 mg and hydrochlorothiazide 12.5 mg


or olmesartan medoxomil 40 mg, amlodipine besilate 6,944 mg, which is equivalent to amlodipine 5 mg and hydrochlorothiazide 25 mg


or olmesartan medoxomil 40 mg, amlodipine besilate 13,888 mg, which is equivalent to amlodipine 10 mg, and hydrochlorothiazide 12.5 mg


or olmesartan medoxomil 40 mg, amlodipine besilate 13,888 mg, which is equivalent to amlodipine 10 mg, and hydrochlorothiazide 25 mg


corn starch, microcrystalline cellulose silicate (contains 98% microcrystalline cellulose (Ph. Eur.) and 2% colloidal anhydrous silicon dioxide (Ph. Eur.)), sodium croscarmellose, magnesium stearate (of vegetable origin);


the film shell contains Opadray II 85F24118 or Opadray II 85F32331, or Opadray II 85F25437 (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E 172)).


DOSAGE FORM


Film-coated tablets.


BASIC PHYSICAL AND CHEMICAL PROPERTIES:


for dosing 20 mg / 5 mg / 12.5 mg: light orange round tablets, coated with a film shell, 8 mm in size, with the "C51" embossed on one side;


for dosage of 40 mg / 5 mg / 12.5 mg: light yellow round tablets, coated with a film shell, 9.5 mm in size, with the "C53" embossed on one side;


for dosing 40 mg / 10 mg / 12.5 mg gray-red round tablets, film-coated, 9.5 mm in size, with the "C55" embossed on one side;


for dosage of 40 mg / 5 mg / 25 mg: light yellow oval tablets, film-coated, 15 × 7 mm in size, with the "C54" embossed on one side;


for dosing 40 mg / 10 mg / 25 mg, gray-red oval tablets, coated with a film shell, 15 × 7 mm in size, with the "C57" embossed on one side.


PHARMACOLOGICAL GROUP


The cardiovascular system. Drugs that affect the renin-angiotensin system. Angiotensin II antagonists in combination with other drugs. Olmesartan medoxomil, amlodipine and hydrochlorothiazide . The ATX code is C09DX03.

INDICATIONS


Treatment of essential hypertension.


Additional therapy.


The drug Sevicar HCT is prescribed to patients whose blood pressure is insufficiently controlled by the use of a combination of olmesartan medoxomil and amlodipine as a two-component drug.


Substitution therapy.


Sevicar NST is prescribed as an alternative therapy for adult patients whose blood pressure is normally controlled by using a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide as two-component drugs (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and single-component drugs (hydrochlorothiazide or amlodipine).


CONTRAINDICATIONS


Hypersensitivity to active substances, to dihydropyridine derivatives or to sulfonamide substances (since hydrochlorothiazide is a sulfonamide preparation) or to any of the excipients.


- severe renal dysfunction (see the section "Application features", "Pharmacological properties").


- Persistent hypokalemia, hypercalcemia, hyponatremia and clinically pronounced hyperuricemia.


- severe liver dysfunction, cholestasis and obstructive diseases of the bile ducts.


- II and III trimester of pregnancy (see the section "Features of use", "Use during pregnancy or lactation").


The combined use of the drug Sevikar HCT and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR <60 ml / min / 1.73 m2) (see the sections "Interaction with other drugs and other types of interactions" , "Pharmacological properties".


Due to the content of amlodipine in the drug as an active substance, Sevicar HCT is contraindicated in patients with:


- shock (including cardiogenic shock)


- severe hypotension;


- violation of the outflow of blood from the left ventricle (for example, severe aortic stenosis);


- hemodynamically unstable heart failure after acute myocardial infarction.


INTERACTION WITH OTHER DRUGS AND OTHER TYPES OF INTERACTIONS


Simultaneous use

of lithium preparations is not recommended

With the simultaneous use of lithium preparations with ACE inhibitors and sometimes with angiotensin II receptor blockers, a reversible increase in the concentration of lithium in the blood serum and its toxic effect was observed. In addition, in the presence of thiazides, renal clearance decreases, so the risk of its toxic effect against the background of the use of hydrochlorothiazide may increase. In this regard, the use of the drug Sevikar HCT in combination with lithium is not recommended. In patients who need to be prescribed these drugs simultaneously, it is recommended to carefully monitor the concentration of lithium in the blood plasma during treatment.


Joint use with the following medicines requires caution


Baclofen

It is possible to increase the antihypertensive effect.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

NSAIDs (for example, acetylsalicylic acid (> 3 g / day), COX-2 inhibitors and non-selective NSAIDs) can weaken the hypotensive effect of thiazide diuretics and angiotensin II receptor blockers. In some patients with impaired renal function (dehydrated patients or elderly people with impaired renal function), the simultaneous use of angiotensin II receptor antagonists and cyclooxygenase inhibitors may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. Patients should be sufficiently hydrated. It is necessary to monitor kidney function after the start of joint therapy and periodically during the course of treatment.

It should be taken into account when using it simultaneously

Amphostin

The antihypertensive effect may increase. 

Other antihypertensive agents.


The antihypertensive effect of the drug Sevikar HCT may be enhanced if it is used simultaneously with other drugs that reduce blood pressure.


Ethyl alcohol, barbiturates, narcotic analgesics and antidepressants.


The manifestations of orthostatic hypotension may increase.


Potential interactions with olmesartan medoxomil.


Simultaneous use is not recommended


ACE inhibitors, angiotensin II receptor blockers or aliskiren.


Clinical studies have shown that double blockade of renin-angiotensin-aldosterone (RAAS) with the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse effects, such as hypotension, hyperkalemia and decreased renal function ( including acute renal failure), compared with the use of one RAAS-effective agent.

Medications that affect the concentration of potassium in the blood

Simultaneous use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that can increase the level of potassium in the blood serum (for example, heparin, ACE inhibitors) may lead to an increase in the content of potassium in the blood (see the section " application features "). It is recommended to monitor the level of potassium in the blood serum, if drugs that affect the level of potassium are prescribed in combination with the drug Sevikar HCT.

Additional information

The drug is kolesevelam, which binds bile acids.


The combined use of colesevelam hydrochloride, which binds bile acids, reduces the systemic exposure and peak concentration of olmesartan in plasma, and also reduces the half-life. Taking olmesartan medoxomil at least 4: 00 before taking kolesevelam hydrochloride reduced the effect of drug interaction. You should consider taking olmesartan medoxomil at least 4: 00 before taking kolesevelam hydrochloride (see the section "Pharmacological properties").


After treatment with an antacid (aluminum hydroxide, magnesium hydroxide), a moderate decrease in the bioavailability of olmesartan was observed.

Olmesartan medoxomil has no significant effect on the pharmacokinetics or pharmacodynamics of warfarin or on the pharmacokinetics of digoxin.

The simultaneous use of olmesartan medoxomil and pravastatin has no clinically significant effect on the pharmacokinetics of any of the components in healthy volunteers.

In the invitro studies, there was no clinically significant inhibition of the activity of cytochrome P450 isoenzymes 1A1 / 2, 2A6, 2C8 / 9, 2C19, 2D6, 2E1 and 3A4 by olmesartan in humans; with respect to cytochrome P450 isoenzymes in animals, olmesartan either had a minor inducing effect, or did not have any. Thus, clinically significant interactions between olmesartan and drugs that are metabolized with the participation of these cytochrome P450 isoenzymes are not expected.


Potential interactions with amlodipine


Simultaneous use of drugs requires caution

The effect of other drugs on the effect of amlodipine

CYP3A4 inhibitors

Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole fungicides, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) may lead to a significant increase in amlodipine exposure. The clinical manifestation of these pharmacokinetic variations may be more pronounced in elderly patients. Thus, clinical monitoring and dose adjustment may be required.


CYP3A4 inducers


Simultaneous administration with CYP3A4 inducers may reduce the concentration of amlodipine in plasma. Therefore, during and after the simultaneous use of amlodipine with CYP3A4 inducers (such as rifampicin, St. John's wort), careful monitoring of the patient and dose adjustment is necessary.  


Taking amlodipine together with grapefruit or grapefruit juice is not recommended, since in some patients the bioavailability of the drug may increase, manifested in an increase in its hypotonic effect.


Dantrolene (infusion)


During studies on laboratory animals after taking verapamil and the introduction of dantrolene, ventricular fibrillation and cardiovascular insufficiency with a fatal outcome were observed due to the development of hyperkalemia. Due to the risk of hyperkalemia in patients prone to malignant hyperthermia, as well as against the background of therapy for malignant hyperthermia, it is recommended to avoid simultaneous administration of calcium channel blockers, such as amlodipine.


The effect of amlodipine on other medications


The hypotensive effect of amlodipine is applied to the hypotensive effect of other drugs that reduce blood pressure.


In clinical studies of drug interactions, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin and warfarin.


Simvastatin


Simultaneous administration of multiple doses of amlodipine (10 mg) and simvastatin (80 mg) leads to an increase in simvastatin exposure by 77% compared to taking simvastatin alone. The dose of simvastatin for patients taking amlodipine should not exceed 20 mg per day.


Tacrolimus


There is a risk of increased levels of tacrolimus in the blood when used simultaneously with amlodipine. To avoid the toxicity of tacrolimus with the simultaneous use of amlodipine, regular monitoring of the level of tacrolimus in the blood is necessary and, if necessary, dose adjustment.

USE DURING PREGNANCY OR LACTATION


Pregnancy.


The use of the drug Sevikar HCT is contraindicated during the II and III trimesters of pregnancy (see the sections "Contraindications", "Features of use"). Taking into account the effect of the active substances in the combined drug Sevicar HCT on pregnancy, the use of the drug Sevicar HCT is not recommended during the first trimester of pregnancy (see the section "Application features").

Olmesartan medoxomil.


The use of angiotensin II receptor antagonists is not recommended in the first trimester of pregnancy. The use of angiotensin II antagonists is contraindicated in the second and third trimesters of pregnancy.


Epidemiological data on the risk of teratogenicity caused by exposure to ACE inhibitors during the first trimester of pregnancy were not decisive; however, a slight increase in risk cannot be excluded. Although there is no epidemiological information about the risk of using angiotensin II receptor antagonists, such risks cannot be excluded. If it is necessary to continue therapy with angiotensin receptor antagonists in patients who are planning pregnancy, it is necessary to switch to alternative antihypertensive drugs that have an established safety profile for use during pregnancy. When pregnancy has already been diagnosed, treatment with angiotensin II antagonists should be stopped immediately and, if necessary, alternative therapy should be started.

In the second and third trimesters, angiotensin II receptor antagonists have a toxic effect on the fetus (inhibition of kidney function, oligohydramnion, delayed ossification of the skull bones) and the newborn (renal failure, arterial hypotension, hyperkalemia).


If the effect of angiotensin II receptor antagonists began from the 2nd trimester of pregnancy, ultrasound examination of kidney and skull function is recommended. 

It is necessary to carefully examine the hypotension of infants whose mothers took angiotensin II receptor antagonists (see the section "Contraindications", "Features of use").

Hydrochlorothiazide.


The experience of using hydrochlorothiazide during pregnancy, especially in the first trimester, is limited. The results of experimental studies on animals are insufficient. Hydrochlorothiazide penetrates the placental barrier. Taking into account the mechanism of action of hydrochlorothiazide, its use in the II and III trimesters of pregnancy can cause a violation of fetoplacental blood flow and adverse effects on the fetus and newborn, causing jaundice, electrolyte disorders and thrombocytopenia.


Hydrochlorothiazide is not intended for the treatment of dropsy in pregnant women, arterial hypertension of pregnant women or preeclampsia, since it can cause a decrease in plasma volume and hypoperfusion of the placenta and at the same time not bring proper benefits for the treatment of the disease.


Hydrochlorothiazide is also not recommended for the treatment of essential hypertension in pregnant women, except in rare cases when other drugs cannot be prescribed.


Amlodipine.


The data obtained during observations of a limited number of pregnant women did not show that amlodipine or other calcium receptor antagonists have a harmful effect on fetal health. However, there is a risk of increasing the duration of labor.


The period of breast-feeding.


Since there is no information on the use of the drug Sevikar HCT during lactation, the drug Sevikar HCT is not recommended for women who are breastfeeding. It is recommended to use other alternative methods of treatment with a better established safety profile during breastfeeding, especially during feeding of newborns or premature babies.

Olmesartan penetrates into the milk of lactating rats. However, it is not known whether olmesartan penetrates into breast milk. It is not known whether amlodipine penetrates into breast milk. Similar calcium channel blockers such as dihydropyridine are secreted into breast milk. Hydrochlorothiazide penetrates into breast milk in small amounts. The use of thiazides in high doses, cause severe diuresis, can interfere with the production of breast milk. If the drug Sevikar HCT is used during breast-feeding, its dose should be as low as possible.

Fertility.


There have been reported cases when some patients taking calcium channel blockers had reverse biochemical changes in the sperm head. There is insufficient clinical data on the potential effect of amlodipine on fertility. In a study on rats, an undesirable effect on male fertility was found (see the Section "Pharmacological properties").


THE ABILITY TO INFLUENCE THE REACTION SPEED WHEN DRIVING VEHICLES OR OTHER MECHANISMS


No studies have been conducted on the effect on the reaction speed when driving vehicles or other mechanisms. 

However, it should be borne in mind that patients who are undergoing antihypertensive therapy may sometimes have dizziness, headache, nausea or fatigue, which may worsen their reaction. Caution is recommended, especially at the beginning of treatment.

METHOD OF ADMINISTRATION AND DOSAGE


adults


Tablets of the drug Sevikar HCT are taken 1 time a day, regardless of food intake.


The tablet should be washed down with a sufficient amount of liquid (for example, a glass of water). The tablet should not be chewed. The drug should be taken every day at one and the same time.


Additional therapy


The drug Sevicar NST 20 mg / 5 mg / 12.5 mg can be used in patients whose blood pressure is insufficiently controlled when using olmesartan medoxomil 20 mg and amlodipine 5 mg in a two-component combination.


The drug Sevicar NST 40 mg / 5 mg / 12.5 mg can be used in patients whose blood pressure is insufficiently controlled when using olmesartan medoxomil 40 mg and amlodipine 5 mg in a two-component combination, or in patients whose blood pressure is insufficiently controlled when using the drug Sevicar HCT 20 mg / 5 mg / 12.5 mg.


Sevicar HCT 40 mg / 5 mg / 25 mg can be used in patients whose arterial pressure is insufficiently controlled with the drug Sevicar HCT 40 mg / 5 mg / 12.5 mg.


Sevicar NST 40 mg / 10 mg / 12.5 mg can be used in patients whose blood pressure is insufficiently controlled when using olmesartan medoxomil 40 mg and amlodipine 10 mg in a two-component combination when using the drug Sevicar HCT 40 mg / 5 mg / 12.5 mg.


Sevicar HCT 40 mg / 10 mg / 25 mg can be used in patients whose blood pressure is insufficiently controlled when using the drug Sevicar HCT 40 mg / 10 mg / 12.5 mg Sevicar HCT 40 mg / 5 mg / 25 mg.


Before switching to a three-component combination, it is recommended to gradually titrate the dose of individual components. If clinically appropriate, a direct replacement of a two-component combination with a three-component combination can be considered.


substitution therapy


Patients using simultaneously stable doses of olmesartan medoxomil, amlodipine and hydrochlorothiazide as a two-component drug (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component drug (hydrochlorothiazide or amlodipine) can switch to Sevicar HCT containing the same doses of components .


The maximum dose of the drug Sevikar HCT is 40 mg / 10 mg / 25 mg per day.


Elderly patients (over 65 years of age).

Elderly patients are recommended to use the drug with caution, often monitoring blood pressure, especially when taking the maximum dose of Sevicar HCT 40 mg / 10 mg / 25 mg per day.


It is necessary to increase the dose with caution in elderly patients (see the sections "Features of use", "Pharmacological properties").


Information on the use of Sevicaru HCT in patients aged 75 years and older is very limited. Extreme caution is required, including frequent monitoring of blood pressure.


Impaired renal function.


The maximum dose for patients with mild to moderate renal impairment (creatinine clearance 30-60 ml / min) is 20 mg / 5 mg / 12.5 mg per day through limited experience of taking 40 mg of olmesartan medoxomil in patients of this group.


Patients with moderate renal impairment are recommended to monitor the concentration of potassium and creatinine in the serum.


Sevicar HCT is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min) (see the sections "Contraindications", "Features of use", "Pharmacological properties").


Impaired liver function.


Sevicar HCT should be used with caution in patients with mild hepatic impairment (see the sections "Application features", "Pharmacological properties").


For patients with moderate hepatic impairment, the maximum dose should not exceed 20 mg / 5 mg / 12.5 mg one time per day. It is recommended to carefully monitor blood pressure and kidney function in patients with impaired liver function.


As with all calcium antagonists, the half-life of amlodipine is prolonged in patients with liver dysfunction; dosage recommendations have not been established. Therefore, the drug Sevikar HCT should be prescribed with caution to such patients. The pharmacokinetics of amlodipine in patients with severe hepatic impairment has not been studied. Taking amlodipine in patients with severe hepatic impairment should start with a low dose and slowly increase it.

The use of Sevicar HCT is contraindicated in patients with severe hepatic impairment, cholestasis or biliary obstruction (see the section "Contraindications").


children


Sevikar HCT is not recommended for use in children and adolescents (under 18 years of age) due to insufficient data on the safety of use and effectiveness.


OVERDOSE


Symptoms.

The maximum dose of Sevicar HCT is 40 mg / 10 mg / 25 mg one time per day. There is no information about an overdose of Sevicaru HCT in humans. The most likely effect of an overdose is hypotension.

The most likely effect of an overdose of olmesartan medoxomil is hypotension and tachycardia bradycardia can be detected if parasympathetic (vaginal) stimulation occurs.

An overdose of amlodipine can lead to excessive peripheral vasodilation with severe hypotension and, possibly, reflex tachycardia. Severe and potentially prolonged systemic hypotension, including fatal shock, has been reported.

An overdose of hydrochlorothiazide is associated with a violation of the electrolyte balance (hypokalemia, hypochloremia) and dehydration due to excessive diuresis.

The most common symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasm and / or severe cardiac arrhythmia associated with simultaneous administration of glycosides or certain antiarrhythmic medications.

Treatment.

In the case of an overdose of Sevicaru HCT, treatment is symptomatic and supportive and depends on the time elapsed after taking it and the severity of the symptoms.

If the reception occurred recently, gastric lavage may be considered. In healthy volunteers, the administration of activated charcoal immediately or at 2: 00 after taking amlodipine significantly reduces the absorption of amlodipine.

Clinically significant hypotension caused by an overdose of Sevicaru HCT requires active support of the cardiovascular system, in particular, carefully monitoring the functions of the heart and lungs, providing the patient with a horizontal position with raised lower limbs and monitoring the volume of circulating fluid and diuresis. Vasoconstrictor can be useful for restoring vascular tone and blood pressure, provided that there are no contraindications to its use. Intravenous calcium gluconate may be useful in restoring the effect of calcium channel blockade.

Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be in a lying position and receive replacement therapy with saline solutions.

Since amlodipine binds strongly to proteins, dialysis may not be useful. 

The degree of withdrawal of olmesartan and hydrochlorothiazide by hemodialysis has not been established.

Tags: Amlodipine, Hydrochlorothiazide, Olmesartan Medoxomil