CARDOSAL PILLS 10 MG

Dosage form

Coated tablets

Composition

In 1 tablet, film coated, contains: Olmesartana Medoxomil - 10,00 mg

Excipients: Microcrystalline cellulose, giproloza (with a low degree of substitution), lactose monohydrate, giproloza (viscosity 6-10 mPa-C), Magnesium stearate

Shell composition: Titanium dioxide (E 171), talc, hypromellose (viscosity 5 mPa-C)

Packing

In the blister 14 tablets. In packing 2 blisters.

Mechanism of action

The active ingredient of the drug Cardosal 10 - Olmesartan medoxomil is a specific antagonist of angiotensin II receptors (type AT 1) for oral administration.

Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of arterial hypertension via the AT 1 receptor. It is assumed that olmesartan blocks all the actions of angiotensin II mediated by AT 1 receptors, regardless of the source and route of synthesis of angiotensin II.

In hypertension, olmesartan causes a dose-dependent, prolonged decrease in blood pressure (BP).

There is no data on the development of arterial hypotension after taking the first dose of the drug and on the development of "withdrawal" syndrome (a sharp increase in blood pressure after drug withdrawal).

Taking olmesartan medoxomil 1 time per day provides an effective and mild decrease in blood pressure for 24 hours, and the effect after a single dose is similar to the effect of taking the drug twice a day in the same daily dose.

The antihypertensive effect of olmesartan develops, as a rule, already after 2 weeks, and the maximum effect develops after about 8 weeks. after initiation of therapy.

Indications and usage

Essential hypertension.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients that make up the drug.
- Obstruction of the biliary tract.
- Renal failure (creatinine clearance (CC) less than 20 ml / min).
- Condition after kidney transplantation (no experience with clinical use).
- Pregnancy.
- Lactation period.
- Age up to 18 years (efficacy and safety have not been established).
- Lactase deficiency, galactosemia or malabsorption syndrome.

With caution:

- Stenosis of the aortic or mitral valves.
- Hypertrophic obstructive cardiomyopathy.
- Primary aldosteronism.
- Hyperkalemia, hyponatremia (risk of dehydration, arterial hypotension, renal failure).
- Renal failure (CC more than 20 ml / min).
- Chronic heart failure.
- Bilateral renal artery stenosis or arterial stenosis of a single kidney.
- Coronary heart disease.
- Cerebrovascular diseases.
- Older age (over 65).
- Impaired liver function.
- Conditions associated with a decrease in circulating blood volume (including diarrhea, vomiting), as well as in patients on a sodium-restricted diet.
- When used simultaneously with diuretics.

Pregnancy and Breastfeeding

Pregnancy Experience with olmesartan medoxomil in pregnant women is absent. However, due to the existing reports of severe teratogenic effects of drugs acting directly on the renin-angiotensin system, like any drug of this class, olmesartan is contraindicated during pregnancy. In the case of pregnancy during treatment with the drug Cardosal 10, the drug must be withdrawn.

- Lactation It is not known whether olmesartan is excreted in breast milk, so if you need to use the drug Cardosal 10 during lactation, breastfeeding for the period of taking the drug should be stopped.

Dosage and administration

It is recommended to take Cardosal 10 inside every day at the same time, regardless of the meal.

Adults: The recommended initial dose of Cardosal 10 for adults is 1 pill (10 mg) 1 time per day.

In case of insufficient reduction of blood pressure while taking the drug at a dose of 10 mg / day, the dose of the drug can be increased to 20 mg / day (use of the drug Cardosal 20 is possible).

If necessary, an additional reduction in blood pressure can be increased to a maximum dose of 40 mg / day (use of the drug Cardosal 40 is possible) or a diuretic (hydrochlorothiazide) may be added.

The maximum daily dose is 40 mg.

Adverse reactions

Possible side effects are listed below in descending frequency of occurrence:

- Very often (> 1/10).
- Often (> 1/100, - Sometimes (> 1/1000, - Rarely (> 1/10000, - Very rarely (

On the part of the circulatory and lymphatic systems: Very rarely - thrombocytopenia.

On the part of the central nervous system: Sometimes - dizziness. Very rarely - a headache.

On the part of the respiratory system: Often - pharyngitis, rhinitis. Very rarely - cough, bronchitis.

On the part of the digestive tract: Often - diarrhea, dyspepsia, gastroenteritis. Very rarely - abdominal pain, nausea, vomiting.

On the part of the skin: Very rarely - itchy skin, rash, angioedema, allergic dermatitis, urticaria.

On the part of the musculoskeletal system: Often - back pain, bone pain, arthralgia, arthritis. Very rarely - muscle cramps, myalgia.

From the urinary system: Often - hematuria, urinary tract infection. Very rarely - acute renal failure.

From the laboratory indicators: Very rarely - an increase in serum creatinine and urea levels, an increase in the activity of liver enzymes.

Cardiovascular: Rarely - excessive decrease in blood pressure. Sometimes: angina, tachycardia.

On the part of metabolism: Often - increased levels of creatine phosphokinase, hypertriglyceridemia, hyperuricemia. Rarely - hyperkalemia.

Other disorders: Often - chest pain, flu-like symptoms, peripheral edema.Very rarely - asthenia, fatigue, malaise, drowsiness.

Special notes

Symptomatic arterial hypotension, especially after taking the first dose of the drug, can occur in patients with reduced blood volume and / or low sodium levels due to intensive diuretic therapy, restriction of salt intake with food in the diet, and also due to diarrhea or vomiting. Relevant factors should be eliminated before using Cardosal 10.

In patients whose vascular tone and renal function depend to a large extent on the activity of the renin-angiotensin-aldosterone system (for example, in patients with severe chronic heart failure or impaired renal function, including renal artery stenosis), treatment with other drugs acting on this system is associated with the possibility of the development of acute arterial hypotension, azotemia, oliguria, or, in rare cases, acute renal failure. The possibility of a similar effect cannot be excluded when using angiotensin II receptor antagonists.

There is an increased risk of developing severe arterial hypotension and renal failure if a patient with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney receives therapy with drugs that affect the renin-angiotensin-aldosterone system.

When using the drug Cardosal 10 in patients with impaired renal function, it is recommended to periodically monitor the level of potassium and creatinine in the blood serum. Experience with the use of the drug Cardosal 10 is absent in patients with recently performed kidney transplantation or in patients with the last stage of impaired renal function (for example, CC less than 12 ml / min).

As in the case of other angiotensin II receptor antagonists and ACE inhibitors, hyperkalemia may develop when treated with Cardosal 10 if the patient has impaired renal function and / or chronic heart failure. In patients of this risk group, it is recommended to monitor the level of potassium in the blood serum.

As in the case of other angiotensin II receptor antagonists, a combination of lithium and cardosal 10 is not recommended.

As in the case of other angiotensin II receptor antagonists, in patients of the Negroid race suffering from arterial hypertension, the effectiveness of treatment with Cardosal 10 is somewhat lower than in patients of other races.

As in the case of any antihypertensive agent, an excessive decrease in blood pressure in patients with ischemic heart disease or cerebrovascular insufficiency can lead to myocardial infarction or stroke.

- The impact on the ability to drive vehicles and mechanisms The effect of the drug Cardosal 10 on the ability to drive vehicles and control mechanisms has not been studied,therefore, during the period of treatment with Cardosal 10, care should be taken when driving vehicles and practicing potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions (dizziness and weakness are possible).

Combined use with potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, or other drugs that can increase the level of potassium in the blood serum (eg, heparin) is not recommended, this may lead to an increase in the level of potassium in the blood serum.

The antihypertensive effect of olmesartan therapy can be enhanced when combined with other antihypertensive drugs.

Non-steroidal anti-inflammatory drugs (NSAIDs), including Acetylsalicylic acid in doses of more than 3 g / day, as well as cyclooxygenase-2 inhibitors (COX-2), and angiotensin II receptor antagonists can act synergistically, reducing glomerular filtration. With simultaneous use of NSAIDs and angiotensin II receptor antagonists, there may be a risk of developing acute renal failure, therefore, monitoring renal function at the beginning of treatment is recommended, as well as regular intake of sufficient amounts of fluid. However, simultaneous treatment can reduce the antihypertensive effect of angiotensin II receptor antagonists,leading to a partial loss of their therapeutic efficacy.

With simultaneous use with antacids (aluminum and magnesium hydroxide), a moderate decrease in the bioavailability of olmesartan is possible.

There are reports of a reversible increase in serum lithium concentration and toxicity during simultaneous use of lithium preparations with angiotensin-converting enzyme inhibitors (ACE) and angiotensin II receptor antagonists, therefore, the use of olmesartan medoxomil in combination with lithium preparations is not recommended (see section Special instructions). If necessary, the use of appropriate combination therapy is recommended to regularly monitor the level of lithium in the serum.

- Symptoms: pronounced decrease in blood pressure.
- Treatment: when there is a pronounced decrease in blood pressure, it is recommended to lay the patient on his back, raising his legs. Recommended gastric lavage and / or reception of Activated carbon, therapy aimed at correcting dehydration and disorders of water-salt metabolism, replenishment of circulating blood volume.

Store at a temperature not higher than 30? С.

3 years.

Cardosal