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Composition:

active ingredients: Olmesartan Medoxomil; amlodipine besylate;

Attento 20/5:

1 tablet contains Olmesartan Medoxomil 20 mg and amlodipine besylate 6.944 mg (equivalent to amlodipine 5 mg);

Attento 40/5:

1 tablet contains Olmesartan Medoxomil 40 mg and amlodipine besylate 6.944 mg (equivalent to amlodipine 5 mg);

Attento 40/10:

1 tablet contains Olmesartan Medoxomil 40 mg and amlodipine besylate 13,888 mg (equivalent to amlodipine 10 mg);

excipients:

pre-chelated starch (corn), microcrystalline silicified cellulose (contains 98% microcrystalline cellulose (Ph. Eur.) and 2% colloidal anhydrous silicon dioxide (Ph. Eur.)), sodium croscarmellose, magnesium stearate;

film shell:

Attento 20/5:

Opadry II 85f18422 White (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc);

Attento 40/5:

Opadry II 85f22093 yellow (polyvinyl alcohol, titanium dioxide (E 171), iron oxide yellow (E 172), polyethylene glycol, talc);

Attento 40/10:

Opadry II 85f25467 red (polyvinyl alcohol, titanium dioxide (E 171), iron oxide yellow (E 172), Iron Oxide Red (E 172), polyethylene glycol, talc).

Dosage form. Film-coated tablets.

Basic physical and chemical properties.

Attento 20/5:

white round Film-coated tablets embossed with " C73 " on one side;

Attento 40/5:

cream round Film-coated tablets embossed with " C75 " on one side;

Attento 40/10:

brownish-red round Film-coated tablets embossed with "C77" on one side.

Pharmacotherapeutic group. Angiotensin II antagonists and calcium channel blockers.

ATX code C09D B02.
Clinical characteristics.

Indications.

Treatment of essential hypertension.

Attento is indicated for patients in whom monotherapy with Olmesartan Medoxomil or amlodipine does not provide the necessary blood pressure control (see sections "dosage and administration", "pharmacodynamics").

Contraindications.

- Hypersensitivity to active substances, dihydropyridine derivatives or any of the excipients (see the section "composition").

- Pregnancy and pregnancy planning (see the sections "contraindications" and "use during pregnancy or lactation").

- Severe hepatic insufficiency and biliary tract obstruction (see Section "pharmacokinetics").

- The combined use of attento® and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR 2) (see the sections "interactions with other drugs and other types of interactions" and "pharmacodynamics").

Due to the presence of amlodipine in the composition, attento® is also contraindicated in patients who have:

- severe hypotension;

- shock (including cardiogenic shock);

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

- Hemodynamically Unstable heart failure after acute myocardial infarction.

Interactions with other drugs and other types of interactions.

Potential interactions caused by combination with attento®.

Caution should be exercised when using it simultaneously

Other antihypertensive agents

The hypotensive effect of attento®may be enhanced by concomitant use of other antihypertensive drugs (for example, alpha-blockers, diuretics).

Potential interactions associated with the attento® olmesartan component Medoxomil.

Concomitant use is not recommended

ACE inhibitors, angiotensin II or aliskiren receptor blockers.

Data from clinical trials show that double blockade of the renin-angiotensin-aldosterone system (RAAS) associated with the combined use of ACE inhibitors and angiotensin II receptor blockers or aliskiren leads to an increase in the frequency of adverse events, such as hypotension, hyperkalemia and decreased renal function (including acute renal failure), compared with the use of a single agent that acts on RAAS (see Section "contraindications", "application features", "pharmacodynamics").

Medications that affect potassium levels

Concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medications that may increase potassium levels (for example, heparin, ACE inhibitors) may lead to an increase in serum potassium concentrations (see the section "special applications"). When prescribing drugs that affect potassium levels in combination with attento®, monitoring of serum potassium concentration is recommended.

Lithium preparations

When lithium was co-administered with angiotensin-converting enzyme inhibitors and rarely with angiotensin II receptor antagonists, a reversible increase in the serum concentration of lithium and the toxicity of its drugs was observed. In this regard, the combined use of attento® and lithium preparations is not recommended (see the section "application features"). If concomitant use of attento® and lithium preparations is necessary, regular monitoring of serum lithium levels is recommended.

Combined use requires caution

Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (>3 g / day), and non-selective NSAIDs

When angiotensin II antagonists are prescribed together with NSAIDs, the hypotensive effect may be weakened. In addition, concomitant use of angiotensin II antagonists and NSAIDs may increase the risk of impaired renal function and lead to an increase in serum potassium concentrations. Therefore, with such co-therapy, it is initially recommended to regularly evaluate kidney function, as well as monitor the patient's proper hydration.

Colesevelam drug that binds bile acids

The combined use of Colesevelam Hydrochloride, which binds bile acids, reduces the systemic effect and peak concentration of olmesartan in plasma, and also reduces the Half-Life. Taking Olmesartan Medoxomil at least 4 hours before taking Colesevelam Hydrochloride reduced the effect of drug interaction. Consideration should be given to taking Olmesartan Medoxomil at least 4 hours before taking Colesevelam Hydrochloride (see Section "pharmacokinetics").

Additional information

There was a moderate decrease in the bioavailability of Olmesartan Medoxomil after treatment with antacids (magnesium and aluminum hydroxides).

Olmesartan Medoxomil does not significantly affect the pharmacokinetics and pharmacodynamics of warfarin or digoxin pharmacokinetics. The combined use of Olmesartan Medoxomil with pravastatin does not lead to clinically significant changes in the pharmacokinetics of these drugs in healthy volunteers.

There was no clinically significant inhibitory effect of olmesartan on human cytochrome P450 enzymes 1A1/2, 2A6, 2c8/9, 2c19, 2d6, 2e1, and 3A4 in vitro, and minimal or zero inducing effect on rat cytochrome P450 activity was noted. Thus, clinically significant interactions between olmesartan and drugs metabolized by the above-mentioned cytochrome P450 enzymes can not be expected.

Potential interactions associated with the attento® component of amlodipine.

Effect of other drugs on the effect of amlodipine.

CYP3A4 inhibitors

When amlodipine is co-administered with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole fungicides, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem), the effect of amlodipine may be significantly increased, which may also lead to an increased risk of hypotension. The clinical manifestations of these FC variations in elderly patients may be more pronounced. There is an increased risk of hypotension. A thorough examination of patients is recommended. Therefore, clinical monitoring and dose adjustment may be required.

CYP3A4 inducers

When known CYP3A4 inducers are co-administered, the plasma concentration of amlodipine may differ. Therefore, blood pressure should be monitored and the dose adjusted both during and after concomitant therapy, especially with respect to concomitant therapy with strong CYP3A4 inducers (such as rifampicin, St. John's wort).

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

Dantrolene (infusion): in experiments on laboratory animals, ventricular fibrillation and fatal cardiovascular collapse were observed after taking verapamil and intravenous dantrolene due to the development of hyperkalemia. Given the risk of hyperkalemia in patients prone to malignant hyperthermia, as well as during the treatment of malignant hyperthermia, it is recommended to Avoid concomitant use of calcium channel blockers, such as amlodipine.

Effect of amlodipine on the effect of other drugs.

The hypotensive effect of amlodipine is added to the hypotensive effect of other blood pressure-lowering drugs.

In clinical trials of drug interactions, amlodipine does not affect the pharmacokinetics of atorvastatin, digoxin, or warfarin.

Simvastatin. Concomitant use of multiple doses of amlodipine 10 mg and simvastatin

80 mg was shown to increase the effect of simvastatin 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 tacrolimus levels in the blood when used concomitantly with amlodipine. To avoid the effects of Tacrolimus toxicity with concomitant use of amlodipine, regular monitoring of Tacrolimus levels in the blood and, if necessary, dosage adjustment is necessary.

Cyclosporine. During a prospective clinical trial involving kidney transplant patients, the minimum level of cyclosporine increased by an average of 40% when it was co-administered with amlodipine. Concomitant use of attento® with cyclosporine may increase the effect of cyclosporine. When used concomitantly with amlodipine, the need to monitor the minimum level of cyclosporine in the blood should be considered, and if necessary, the dose of cyclosporine should be reduced.

Application features.

Patients with hypovolemia or sodium deficiency.

Patients with hypovolemia and/or hyponatremia that have occurred as a result of intensive diuretic therapy, restriction of salt intake with food, diarrhea or vomiting may experience symptomatic hypotension, especially after taking the first dose. It is recommended to eliminate these conditions before starting treatment with attento® or to establish careful monitoring of the patient at the beginning of treatment.

Other conditions that are accompanied by stimulation of the renin-angiotensin-aldosterone system.

Patients whose vascular tone and renal function are highly dependent on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe congestive heart failure or kidney disease, including renal artery stenosis) may respond to other drugs affecting this system (such as angiotensin II receptor antagonists), acute hypotension, azotemia, oliguria, or rarely acute renal failure.

Renovascular hypertension.

The use of drugs that affect the renin-angiotensin-aldosterone system in patients with bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney is associated with an increased risk of severe hypotension and renal failure.
Dosage and administration.

Adults.

The recommended dose of attento® is 1 tablet per day.

Attento® 20/5 can be prescribed to patients with insufficient body response to monotherapy with Olmesartan Medoxomil at a dose of 20 mg or amlodipine at a dose of 5 mg.

Attento ® 40/5 can be prescribed to patients with insufficient body response to attento®20/5.

Attento ® 40/10 can be prescribed to patients with insufficient body response to attento® 40/5.

Before prescribing a combined drug with fixed doses of active ingredients, a step-by-step selection of doses of these components as monopreparations is recommended. If necessary, direct replacement of monopreparations with a combined drug is possible.

For convenience, patients receiving Olmesartan Medoxomil and amlodipine as separate tablets can be transferred to attento® tablets containing these components in similar doses.

Attento® can be taken regardless of food intake.

Elderly patients (aged 65 years and older).

As a rule, elderly patients do not need to change the recommended dose of the drug, but the dose should be increased with caution (see the sections "application features", "pharmacokinetics").

When increasing the dose of Olmesartan Medoxomil to the maximum (40 mg per day), the patient's blood pressure should be carefully monitored.

Impaired renal function.

The maximum dose of Olmesartan Medoxomil for patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min) is 20 mg once a day, since the experience of using higher doses in this group of patients is limited. Attento® is not recommended for patients with severe renal impairment (creatinine clearance

When using the drug in patients with moderate renal impairment, it is recommended to monitor the concentration of potassium and creatinine.

Impaired liver function.

Attento® is prescribed with caution to patients with mild to moderate hepatic impairment (see the sections "application features", "pharmacokinetics").

With moderate hepatic impairment, Olmesartan Medoxomil is prescribed at an initial dose of 10 mg once a day. The maximum dose for such patients should not exceed 20 mg once a day. With concomitant therapy with diuretics and / or other antihypertensive drugs, careful monitoring of blood pressure and renal function is recommended for patients with impaired liver function. There is no experience of using Olmesartan Medoxomil in patients with severe hepatic impairment.

As with all calcium antagonists, the elimination half-life of amlodipine is prolonged in patients with liver dysfunction; dosage recommendations have not been established. Therefore, such patients should be prescribed attento® with caution. The pharmacokinetics of amlodipine in patients with severe hepatic impairment have not been studied. Patients with severe hepatic impairment should start taking amlodipine with the lowest dose and slowly increase it. Attento® is contraindicated in patients with severe hepatic impairment (see Section "contraindications").

Method of application.

Tablets are swallowed whole, washed down with a sufficient amount of liquid (for example, a glass of water). Tablets should not be chewed. The drug is recommended to be taken daily at the same time.

Children.

The safety and efficacy of attento in children and adolescents (under 18 years of age) have not been studied. No data available.

Overdose.

Symptoms.

No cases of attento® overdose have been reported. The most likely effects of Olmesartan Medoxomil overdose are hypotension and tachycardia; bradycardia is also possible in the case of parasympathetic stimulation (vagus nerve). Overdose of amlodipine can lead to excessive dilation of peripheral blood vessels, accompanied by a pronounced decrease in blood pressure, and possibly to reflex tachycardia. There are reports of prolonged severe generalized hypotension, up to shock with a fatal outcome.

Treatment.

If the drug has been taken recently, gastric lavage is indicated. In healthy volunteers, the use of activated charcoal immediately or within 2 hours after taking amlodipine orally significantly reduces the absorption of this substance.

If clinically significant hypotension occurs due to an overdose of attento®, active support of the cardiovascular system is required, including careful monitoring of heart and lung function, elevated position of the lower extremities, monitoring of circulating blood volume and diuresis. To restore vascular tone and blood pressure, the use of vasoconstrictors may be useful in the absence of contraindications. Intravenous calcium gluconate is recommended to eliminate calcium channel blockage.

Since amlodipine binds significantly to proteins, its elimination by dialysis is unlikely. There is no information about the possibility of removing olmesartan by dialysis.

Tags: Attento