Universal reference book for medicines
Product name: OLIMESTRA (OLIMESTRA)

Active substance: olmesartan medoxomil

Type: Angiotensin II receptor antagonist

Manufacturer: KRKA (Slovenia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Antihypertensive agent, angiotensin II receptor blocker.
It has a high selectivity for angiotensin II receptor type 1 (AT 1 ), with the participation of which the main effects of angiotensin II are realized. Blocking these receptors, olmesartan medoxomil prevents and eliminates the vasoconstrictive effect of angiotensin II, causes a secondary increase in plasma renin activity by eliminating negative feedback during the release of renin and a direct decrease in aldosterone secretion.
In the arterial hypertension of olmesartan, medoxomil causes a dose-dependent, prolonged decrease in blood pressure.

There is no data on the development of arterial hypotension after taking the first dose of olmesartan medoxomil, tachyphylaxis with prolonged treatment and withdrawal syndrome.

With the use of olmesartan, medoxomil 1 times / day provides an effective and gentle decrease in blood pressure for 24 hours. The maximum antihypertensive effect is achieved after 8 weeks.
from the beginning of therapy, although a significant effect of reducing blood pressure is noted after 2 weeks. treatment.
PHARMACOKINETICS
Olmesartan medoxomil is a prodrug.
It quickly turns into a pharmacologically active metabolite of olmesartan under the influence of esterases in the intestinal mucosa and in the blood of the portal vein during absorption from the digestive tract. In the blood plasma or in the secretions, undecomposed olmesartan medoxomil or the unchanged side chain of the medoxomil group was not detected. C max of olmesartan in blood plasma is on average approximately 2 hours after ingestion and increases almost linearly with a dose increase of up to 80 mg. Simultaneous food intake practically does not affect the bioavailability of olmesartan. The binding of olmesartan to plasma proteins is 99.7%, but the potential for a clinically significant shift in the amount of binding to proteins in the interaction of olmesartan with other drugs having a high degree of binding to proteins is low (this is confirmed by the absence of clinically significant interaction between olmesartan and warfarin) .Olmesartan is excreted in the urine (approximately 40%) and bile (approximately 60%), T 1/2 is 10-15 hours. Olmisartan cumulation is not noted.
INDICATIONS
Essential arterial hypertension.

DOSING MODE
Is taken orally, daily.
The initial dose is 10 mg / day. With insufficient effectiveness, the dose is increased to the optimal dose of 20 mg / day. If necessary, the dose can be increased to a maximum of 40 mg / day.
For elderly patients, dose adjustment is not required.
If it is necessary to increase the daily dose to a maximum of 40 mg / day, the increase should be carried out under the close supervision of blood pressure.
For patients with impaired renal function of mild or moderate degree (CK 20-60 ml / min), the maximum daily dose is 20 mg.

SIDE EFFECT
From the cardiovascular system: arterial hypotension, angina.

From the hemopoietic system: thrombocytopenia.

From the side of the central nervous system: vertigo, dizziness, headache, asthenic syndrome (fatigue, drowsiness, general malaise).

On the part of the respiratory system: bronchitis, pharyngitis, rhinitis, cough.

On the part of the digestive system: diarrhea, indigestion, gastroenteritis, abdominal pain, nausea, vomiting, increased activity of liver enzymes.

Dermatological reactions: skin itching, rash, angioedema, allergic dermatitis, face swelling, urticaria.

From the musculoskeletal system: arthritis, back pain, bone pain, muscle cramps, myalgia, increased activity of CK.

From the urinary system: hematuria, urinary tract infection.

On the part of metabolism: hypertriglyceridemia, hyperuricemia, hyperkalemia, increased serum creatinine and urea levels, peripheral edema.

Other: chest pain, flu-like symptoms.

CONTRAINDICATIONS
Obstruction of the biliary tract, pregnancy, the period of breastfeeding, children and adolescents younger than 18 years.

PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER
In view of the lack of sufficient clinical experience, the use of olmesartan medoxomil is not recommended in patients with severe renal insufficiency (CK ≥ 20 mL / min).

Olmesartan medoxomil should be used with caution in patients with kidney disease, with renal artery stenosis of both or single kidneys, since there is a risk of developing acute hypotension, azotemia, oliguria, acute renal failure.

In the treatment of patients with impaired renal function, periodic monitoring of the serum level of potassium and serum creatinine is recommended.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In view of the lack of sufficient clinical experience, the use of olmesartan medoxomil in patients with impaired hepatic function is not recommended.

APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under the age of 18 years.

APPLICATION IN ELDERLY PATIENTS
For elderly patients, dose adjustment is not required.
If it is necessary to increase the daily dose to a maximum of 40 mg / day, the increase should be carried out under the careful control of blood pressure.
SPECIAL INSTRUCTIONS
In view of the lack of sufficient clinical experience, the use of olmesartan medoxomil is not recommended in patients with severe renal insufficiency (CK-20 ml / min), in patients with impaired hepatic function.

Use with caution in patients with stenosis of the aortic or mitral valves or with obstructive hypertrophic cardiomyopathy.

In the case of previous intensive diuretic therapy, compliance with a salt-free diet, with diarrhea and / or vomiting, then after taking the first dose, it is possible to develop arterial hypotension as a result of a decrease in BCC.
Therefore, it is necessary to eliminate the possibility of hypovolemia before starting treatment with olmesartan medoxomil.
Olmesartan medoxomil should be used with caution in patients with heart failure, kidney disease, renal artery stenosis of both or single kidneys, since there is a risk of acute hypotension, azotemia, oliguria, acute renal failure.

In the treatment of patients with impaired renal function, periodic monitoring of the serum level of potassium and serum creatinine is recommended.

It is not recommended to use olmesartan medoxomil in patients with primary hyperaldosteronism.

It should be borne in mind that an excessive decrease in blood pressure in patients with IHD or atherosclerosis of cerebral vessels can lead to the development of myocardial infarction or ischemic stroke.

Impact on the ability to drive vehicles and manage mechanisms

With the use of olmesartan medoxomil, dizziness or fatigue can occur occasionally, which should be taken into account when used in patients who drive vehicles and / or engage in other potentially hazardous activities.

DRUG INTERACTION
With the simultaneous use of olmesartan medoxomil with other antihypertensive agents, the effect may increase the hypotensive effect.

With the simultaneous use of olmesartan medoxomil with NSAIDs, it is possible to reduce the hypotensive effect and increase the risk of acute renal failure.

After therapy with antacids (magnesium aluminum hydroxide), the bioavailability of olmesartan medoxomil decreased.

With the simultaneous use of olmesartan medoxomil with lithium drugs, the toxicity of the latter increases (the combination is not recommended).

The risk of developing hyperkalemia increases with the simultaneous use of olmesartan medoxomil with potassium-sparing diuretics, preparations containing potassium, or with other drugs that can cause an increase in serum potassium levels, for example, with heparin (a combination is not recommended).

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