Cardosal (olmesartan medoxomi) coated tablets 20 mg. №28

Description

Cardosal (olmesartan medoxomi) coated tablets 20 mg. №28

Composition

active substance: olmesartan medoxomil;

1 film-coated tablet contains 20 mg of olmesartan medoxomil;

Excipients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, titanium dioxide (E 171), talc, hypromellose.

Dosage form

Film-coated tablets.

Main physical and chemical properties: round tablets, white, film-coated, with a characteristic odor, about 6.5 mm in diameter, embossed with “C13” on one side.

Pharmacotherapeutic group

Angiotensin II receptor blockers. ATX code C09C A08.

Pharmacological properties

Olmesartan medoxomil is a potent orally active selective angiotensin II receptor antagonist (type AT1). It is expected to block all angiotensin II-mediated actions of the AT1 receptor, regardless of the source and route of angiotensin II synthesis. Selective antagonism of angiotensin II receptor AT1 leads to increased plasma renin levels and angiotensin I and II concentrations, as well as some reduction in plasma aldosterone concentrations.

Angiotensin II is the major vasoactive hormone of the renin-angiotensin-aldosterone system and plays an important role in the pathophysiology of hypertension through type 1 (AT1) receptors.

Indication:

• treatment of essential hypertension in adult patients;
• treatment of hypertension in children and adolescents aged 6 to 18 years.

Contraindication:

• hypersensitivity to the active substance or to any of the components of the medicinal product Cardosal coated tablets;
• pregnant or women who are planning to become pregnant;
• obstruction of the biliary tract;
• co-administration of olmesartan medoxomil with aliskiren-containing products is contraindicated in patients with diabetes mellitus and renal insufficiency (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2).

Method of application and dosage

Dosage

Adults

The initial daily dose of Cardosal coated tablets is 10 mg once daily. If the reduction in blood pressure is insufficient, the dose should be increased to 20 mg once daily. If necessary, the dose can be increased to 40 mg 1 time per day (maximum daily dose) or add hydrochlorothiazide to treatment.

The antihypertensive effect of Cardosal coated tablets is usually observed within 2 weeks after starting treatment, and the maximum effect is observed 8 weeks after starting treatment. This should be borne in mind when considering a change in dosing regimen for any patient.

Pediatric population

Children and adolescents aged 6 to 18

The recommended starting dose of Cardosal coated tablets children aged 6 to 18 years is 10 mg once a day. If blood pressure is not reduced sufficiently, the dose can be increased to 20 mg once daily. If a more pronounced reduction in blood pressure is required, the dose of olmesartan medoxomil can be increased to 40 mg per day in children weighing ≥ 35 kg. For children weighing <35 kg, the daily dose should not exceed 20 mg.

Application method

In order to adhere to the dosing regimen, Cardosal coated tablets is recommended to be administered at about the same time each day, with or without food, such as breakfast. The tablets should be washed down with plenty of fluids. The tablet should not be chewed.

Side effects:

• metabolism and digestion: hypertriglyceridemia, hyperuricemia;
• from the nervous system: dizziness, headache;
• respiratory, thoracic and mediastinal disorders: bronchitis, pharyngitis, cough, rhinitis;
• from the gastrointestinal tract: gastroenteritis, diarrhea, abdominal pain, nausea, dyspepsia;
• general disorders: pain, fatigue.

Composition

active substance: olmesartan medoxomil;

1 film-coated tablet contains 10 mg of olmesartan medoxomil;

Excipients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, titanium dioxide (E 171), talc, hypromellose.

Dosage form

Film-coated tablets.

Main physical and chemical properties: round tablets, white, film-coated, with a characteristic odor, about 6.5 mm in diameter, embossed with “C13” on one side.

Pharmacotherapeutic group

Angiotensin II receptor blockers. ATX code C09C A08.

Pharmacological properties

Olmesartan medoxomil is a potent orally active selective angiotensin II receptor antagonist (type AT1). It is expected to block all angiotensin II-mediated actions of the AT1 receptor, regardless of the source and route of angiotensin II synthesis. Selective antagonism of angiotensin II receptor AT1 leads to increased plasma renin levels and angiotensin I and II concentrations, as well as some reduction in plasma aldosterone concentrations.

Angiotensin II is the major vasoactive hormone of the renin-angiotensin-aldosterone system and plays an important role in the pathophysiology of hypertension through type 1 (AT1) receptors.

Indication:

• treatment of essential hypertension in adult patients;
• treatment of hypertension in children and adolescents aged 6 to 18 years.

Contraindication:

• hypersensitivity to the active substance or to any of the components of the medicinal product Cardosal 20;
• pregnant or women who are planning to become pregnant;
• obstruction of the biliary tract;
• co-administration of olmesartan medoxomil with aliskiren-containing products is contraindicated in patients with diabetes mellitus and renal insufficiency (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2).

Method of application and dosage

Dosage

Adults

The initial daily dose of Cardosal 20 is 10 mg once daily. If the reduction in blood pressure is insufficient, the dose should be increased to 20 mg once daily. If necessary, the dose can be increased to 40 mg 1 time per day (maximum daily dose) or add hydrochlorothiazide to treatment.

The antihypertensive effect of Cardosal 20 is usually observed within 2 weeks after starting treatment, and the maximum effect is observed 8 weeks after starting treatment. This should be borne in mind when considering a change in dosing regimen for any patient.

Pediatric population

Children and adolescents aged 6 to 18

The recommended starting dose of Cardosal 20 children aged 6 to 18 years is 10 mg once a day. If blood pressure is not reduced sufficiently, the dose can be increased to 20 mg once daily. If a more pronounced reduction in blood pressure is required, the dose of olmesartan medoxomil can be increased to 40 mg per day in children weighing ≥ 35 kg. For children weighing <35 kg, the daily dose should not exceed 20 mg.

Application method

In order to adhere to the dosing regimen, Cardosal 20 is recommended to be administered at about the same time each day, with or without food, such as breakfast. The tablets should be washed down with plenty of fluids. The tablet should not be chewed.

Side effects:

• metabolism and digestion: hypertriglyceridemia, hyperuricemia;
• from the nervous system: dizziness, headache;
• respiratory, thoracic and mediastinal disorders: bronchitis, pharyngitis, cough, rhinitis;
• from the gastrointestinal tract: gastroenteritis, diarrhea, abdominal pain, nausea, dyspepsia;
• general disorders: pain, fatigue.