Aprovel (Irbesartan) coated tablets 300 mg. №28

$31.80

Manufacturer: France

Irbesartan lowers blood pressure (BP) with minimal change in heart rate. When taken in doses up to 300 mg once a day, the decrease in blood pressure is dose-dependent, however, with a further increase in the dose of irbesartan, the increase in the hypotensive effect is insignificant.

The maximum decrease in blood pressure is achieved 3-6 hours after taking the drug inside, and the hypotensive effect persists for at least 24 hours. 24 hours after taking the recommended doses of irbesartan, the decrease in blood pressure is 60-70% compared with the maximum hypotensive response to the drug from diastolic and systolic blood pressure. When taken once a day at a dose of 150-300 mg, the magnitude of the decrease in blood pressure by the end of the interdose interval (i.e. 24 hours after taking the drug) in the position of the patient lying or sitting on average by 8-13 / 5-8 mm Hg .st. (systolic / diastolic blood pressure) is greater than that when taking placebo.

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Description

Instructions for use

Description

Biconvex oval tablets, white or off-white, engraved with a heart on one side and the number 2772 on the other.

Active ingredients

Irbesartan

Release form

Pills

Ingredients

Active ingredient: irbesartan – 300 mg.

Excipients: lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, poloxamer 188, aqueous colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate.

Pharmacological effect

Angiotensin II receptor antagonist.

Irbesartan is a potent, orally active selective angiotensin II receptor antagonist (ATI type). It blocks all physiologically significant effects of angiotensin II through ATI-type receptors, regardless of the source or route of angiotensin II synthesis. Specific antagonistic action against angiotensin II receptors (ATI) leads to an increase in plasma concentrations of renin and angiotensin II and a decrease in plasma concentrations of aldosterone. When using the recommended doses of the drug, the serum concentration of potassium ions does not change significantly. Irbesartan does not inhibit kininase-P (angiotensin-converting enzyme), which is responsible for the formation of angiotensin II and the destruction of bradykinin to inactive metabolites. For the manifestation of the action of irbesartan, its metabolic activation is not required.

Irbesartan lowers blood pressure (BP) with minimal change in heart rate. When taken in doses up to 300 mg once a day, the decrease in blood pressure is dose-dependent, however, with a further increase in the dose of irbesartan, the increase in the hypotensive effect is insignificant.

The maximum decrease in blood pressure is achieved 3-6 hours after taking the drug inside, and the hypotensive effect persists for at least 24 hours. 24 hours after taking the recommended doses of irbesartan, the decrease in blood pressure is 60-70% compared with the maximum hypotensive response to the drug from diastolic and systolic blood pressure. When taken once a day at a dose of 150-300 mg, the magnitude of the decrease in blood pressure by the end of the interdose interval (i.e. 24 hours after taking the drug) in the position of the patient lying or sitting on average by 8-13 / 5-8 mm Hg .st. (systolic / diastolic blood pressure) is greater than that when taking placebo.

Taking Aprovel (Irbesartan) at a dose of 150 mg once a day causes the same hypotensive response (lowering blood pressure before taking the next dose of the drug and the average decrease in blood pressure over 24 hours) as taking the same dose divided into two doses.

The hypotensive effect of the drug Aprovel develops within 1-2 weeks, and the maximum therapeutic effect is achieved 4-6 weeks after the start of treatment. Hypotensive effect on the background of long-term treatment persists. After discontinuation of treatment, blood pressure gradually returns to its original value. When the drug is discontinued, there is no withdrawal syndrome.

The effectiveness of Aprovel (Irbesartan) does not depend on age and gender. Patients of the Negroid race are less responsive to motor therapy with Aprovel (as well as to all other drugs that affect the renin-angiotensin-aldosterone system).

Irbesartan does not affect the content of uric acid in the blood serum or the excretion of uric acid in the urine.

Indications

  • Essential hypertension
  • Nephropathy in arterial hypertension and type 2 diabetes mellitus (as part of combined antihypertensive therapy).

Contraindications

  • Hypersensitivity to any of the components of the drug.
  • Pregnancy.
  • lactation period.
  • Age up to 18 years (efficacy and safety not established).
  • Hereditary galactose intolerance, lactase deficiency or

malabsorption of glucose and galactose.

Dosage and administration

Inside, the tablet is swallowed whole with water.

Usually taken initially and maintenance dose is 150 mg 1 time per day, regardless of the meal. Aprovel at a dose of 150 mg 1 time per day generally provides better 24-hour blood pressure control than at a dose of 75 mg. However, in some patients, especially in patients on hemodialysis or in patients over 75 years of age, the initial dose should be 75 mg (possible use of the drug Aprovel in tablets of 75 mg).

In patients in whom the therapeutic effect when taking Aprovel at a dose of 150 mg 1 time per day is insufficient, the dose of Aprovel may be increased to 300 mg, or another antihypertensive agent may be prescribed. In particular, it was shown that the appointment of a diuretic, such as hydrochlorothiazide, enhanced the effect of Aprovel.

In patients with arterial hypertension and type 2 diabetes, treatment should begin with a dose of 150 mg! once a day, which should be gradually increased to 300 mg – the dose that is the preferred maintenance dose for the treatment of nephropathy.

Evidence of a beneficial effect of Aprovel on the kidneys in patients with arterial hypertension and type 2 diabetes was obtained in studies in which it was used in combination with other antihypertensive drugs necessary to achieve the target level of blood pressure.

Impaired kidney function. In patients with impaired renal function, correction of the dosing regimen is not required. For patients on hemodialysis, the initial dose should be 75 mg (it is possible to use the drug Aprovel in tablets of 75 mg).

Violation of water and electrolyte balance. Before you start taking Aprovel (Irbesartan), you should restore the volume of circulating blood and / or eliminate hyponatremia.

Impaired liver function. No correction of the dosing regimen of Aprovel is required in patients with mild or moderate hepatic impairment. There is no clinical experience with the drug in patients with severe hepatic impairment.

Elderly patients. Although it is recommended to start the treatment of patients over the age of 75 years with a dose of 75 mg (it is possible to use Aprovel (Irbesartan)l in tablets of 75 mg), usually in elderly patients, adjustment of the dosing regimen is not required.

Use in pediatrics. The safety and efficacy of Aprovel in pediatric and adolescent patients has not been established.