Attento (olmesartan medoxomil) coated tablets 40 mg/10 mg. №28

$79.00

Manufacturer: Germany

Attento is recommended for individuals who do not achieve adequate blood pressure control with olmesartan medoxomil or amlodipine treatment alone.

Category:

Description

Ingredients

active ingredients: olmesartan medoxomil; amlodipine besilate;

Attento®40/10:

1 tablet contains olmesartan medoxomil 40 mg and amlodipine besylate 13.888 mg (equivalent to amlodipine 10 mg);

other components:

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

film sheath:

Attento® 40/10:

Oradry 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®40/10: brownish-red round film-coated tablets, embossed “C77” on one side.

Pharmacotherapeutic group

Angiotensin II antagonists and calcium channel blockers.

ATX code C09D B02.

Pharmacodynamics

Attento is a combination drug containing olmesartan medoxomil, an angiotensin II receptor antagonist, and amlodipine besylate, a calcium channel blocker. The combination of these two active substances has a synergistic effect and contributes to lower blood pressure to a greater extent than either active substance alone.

In an 8-week, double-blind, randomized, placebo-controlled factorial study in 1940 patients (71% Caucasian and 29% non-racial), treatment with Attento was shown to result in a significantly greater reduction in systolic blood pressure. compared with monotherapy with suitable components. The mean decrease in systolic/diastolic pressure was dose dependent: 24/14 mm Hg. Art. (20 mg/5 mg), 25/16 mmHg Art. (40 mg/5 mg) and 30/19 mm Hg. Art. (40 mg/10 mg).

Attento 40/5 reduced systolic/diastolic pressure in the sitting position by an additional 2.5/1.7 mm Hg. Art. compared to Attento 20/5. Similarly, Attento 40/10 reduced systolic/diastolic pressure in the sitting position by an additional 4.7/3.5 mmHg. Art. compared to Attento 40/5.

The proportion of patients who managed to achieve the target blood pressure values ​​(<140/90 mmHg in non-diabetic patients and <130/80 mmHg in diabetics) was 42.5%. , 51.0% and 49.1% for Attento 20/5, Attento 40/5 and Attento 40/10, respectively.

The main hypotensive effect of Attento, as a rule, was achieved within the first 2 weeks of therapy.

A second double-blind, randomized, placebo-controlled study examined the efficacy of adding amlodipine to a treatment regimen in Caucasian patients with poor response to olmesartan medoxomil monotherapy at a dose of 20 mg for 8 weeks.

In patients who continued to receive only olmesartan medoxomil 20 mg, systolic / diastolic pressure decreased by 10.6 / 7.8 mm Hg. Art. over the next 8 weeks. With the addition of 5 mg of amlodipine for 8 weeks, it was possible to achieve a decrease in systolic / diastolic pressure by 16.2 / 10.6 mm Hg. Art. (p=0.0006).

The proportion of patients who achieved target blood pressure values ​​(<140/90 mmHg in non-diabetic patients and <130/80 mmHg in diabetics) was 44.5%. for Attento 20/5 compared to 28.5% for olmesartan medoxomil 20 mg.

In the course of further studies, the effectiveness of adding various doses of olmesartan medoxomil to the treatment regimen of Caucasian patients with insufficient body response to amlodipine monotherapy at a dose of 5 mg for 8 weeks was evaluated.

In patients continuing to receive only 5 mg of amlodipine, systolic / diastolic pressure decreased by 9.9 / 5.7 mm Hg. Art. over the next 8 weeks. The addition of 20 mg of olmesartan medoxomil resulted in a decrease in systolic/diastolic blood pressure by 15.3/9.3 mm Hg. Art., the addition of 40 mg of olmesartan medoxomil – by 16.7 / 9.5 mm Hg. Art. (p<0.0001).

Indications

Treatment of essential hypertension.

Attento is indicated for patients in whom monotherapy with olmesartan medoxomil or amlodipine does not provide the necessary control of blood pressure.

Contraindications

  • Hypersensitivity to the active ingredients, dihydropyridine derivatives or any of the excipients.
  • Pregnancy and pregnancy planning.
  • Severe liver failure and obstruction of the biliary tract.
  • The combined use of Attento and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR <60 ml / min / 1.73 m2).
  • Due to the presence of amlodipine, Attento is also contraindicated in patients who:
    • severe arterial hypotension;
    • shock (including cardiogenic shock);
    • violation of the outflow of blood from the left ventricle (for example, with severe aortic stenosis);
    • hemodynamically unstable heart failure after acute myocardial infarction.

Dosage and administration

adults

The recommended dose of the drug Attento-1 tablet per day.

Attento 20/5 can be administered 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 administered to patients with insufficient body response to Attento® 20/5.

Attento 40/10 can be administered to patients with insufficient body response to Attento 40/5.

Prior to prescribing a combination drug with fixed doses of active ingredients, it is recommended to select these components step by step as monopreparations. If necessary, a direct replacement of monopreparations with a combined preparation is possible.

For convenience, patients receiving olmesartan medoxomil and amlodipine as separate tablets can be switched to Attento tablets containing these components in similar doses.

Attento can be taken with or without food.

Elderly patients (age 65 and older)

As a rule, for elderly patients, a change in the recommended dose of the drug is not required, however, the dose should be increased with caution.

When increasing the dose of olmesartan medoxomil to the maximum (40 mg / day), the patient should carefully monitor blood pressure.

Impaired kidney 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 daily, since experience with higher doses in this group of patients is limited. Attento is not recommended for patients with severe renal impairment (creatinine clearance <20 ml / min).

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

Impaired liver function

Attento is prescribed with caution to patients with mild to moderate hepatic impairment.

With moderate impairment of liver function, olmesartan is prescribed medoxomil at an initial dose of 10 mg once a day. The maximum dose for such patients should not exceed 20 mg 1 time per day. When concomitant therapy with diuretics and (or) other antihypertensive drugs in patients with impaired liver function, careful monitoring of blood pressure and renal function is recommended. There is no experience with olmesartan medoxomil in patients with severe hepatic impairment.

As with all calcium antagonists, the half-life of amlodipine is prolonged in patients with liver dysfunction; dosage recommendations have not been established. Therefore, Attento should be used with caution in such patients. The pharmacokinetics of amlodipine in patients with severe hepatic impairment has not been studied. Amlodipine in patients with severe hepatic impairment should be started at the lowest dose and increased slowly. Attento is contraindicated in patients with severe hepatic impairment.

Mode of application

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