Ordiss 32mg №30

Composition

1 pill contains:

active substance: Candesartan Cilexetil 8.0 mg / 16.0 mg / 32.0 mg;

Excipients : pregelatinized starch 3.75 mg / 7.5 mg / 15.0 mg; Poloxamer 188 0.5 mg / 1.0 mg / 2.0 mg; Povidone-QZO 4.0 mg / 8.0 mg / 16.0 mg; iron oxide red dye (E172) 0.075 mg / 0.15 mg / 0.3 mg; Calcium carmellose 1.65 mg / 3.3 mg / 6.6 mg; microcrystalline cellulose 17.5 mg / 35.0 mg / 70.0 mg; lactose monohydrate 43.725 mg / 87.45 mg / 174.9 mg; Magnesium stearate 0.8 mg / 1.6 mg / 3.2 mg.

Indications and usage

Arterial hypertension.

Chronic heart failure and violation of the systolic function of the left ventricle (left ventricular ejection fraction (LVEF) is not more than 40%) as an adjunctive therapy with ACE inhibitors or with ACF intolerance inhibitors.

Contraindications

Hypersensitivity to candesartan and other components of the drug; lactose intolerance; lactase deficiency; glucose-galactosia malabsorption syndrome; severe abnormal liver function and / or cholestasis; pregnancy; breastfeeding period; children up to 18 years; simultaneous use with aliskiren in patients with diabetes mellitus and impaired renal function (QA less than 60 ml / min).

Adverse reactions

The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often not less than 1%, but less than 10%; infrequently - not less than 0.1%,but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including single messages.

Blood and lymphatic system : very rarely - leukopenia, neutropenia, thrombocytopenia, agranulocytosis.

The immune system : very rarely - skin rash, pruritus, urticaria, angioedema.

The nervous system : often - dizziness, headache, weakness.

On the part of the respiratory system : often - respiratory infections, pharyngitis, rhinitis.

From the gastrointestinal tract : very rarely - nausea.

Cardiovascular: often - a pronounced decrease in blood pressure.

Liver and biliary tract : very rarely - increased activity of liver transaminases, abnormal liver function, hepatitis.

From the musculoskeletal system and connective tissue : Very rarely - back pain, arthralgia, myalgia.

From the kidneys and urinary tract: often - impaired renal function (see section "Special instructions").

Laboratory values: very rarely - hyperkalemia, hyponatremia, increased creatinine concentration, hyperuricemia, decreased hemoglobin.

Other : very rarely - exacerbation of the flow of gout, "tides" of blood to the face.

Drug interactions

With the simultaneous use of candesartan with hydrochlorothiazide, Warfarin, Digoxin, oral contraceptives (ethinyl estradiol / levonorgesgrel), glibenclamide, Nifedipine and Enalapril, there were no clinically significant drug interactions.

With simultaneous use of candesartan with ACE inhibitors, other angiotensin II receptor antagonists, aliskiren, the risk of hyperkalemia, a sharp decrease in blood pressure, impaired renal function, including acute renal failure, increases, which requires careful monitoring of blood pressure, as well as indicators of kidney function and water electrolyte balance.

Simultaneous use of candesartan with aliskiren in patients with diabetes mellitus and impaired renal function (JUS less than 60 ml / min) is not recommended. Candesartan is metabolized in the liver to a small extent with the participation of the CYP2C9 isoenzyme. The conducted interaction studies did not reveal the effect of candesartan on CYP2C9 and CYP3A4 isoenzymes, the effect on other isoenzymes of the cytochrome P450 system has not been studied.

The simultaneous use of candesartan with other antihypertensive drugs enhances the antihypertensive effect.

Experience with other drugs acting on the RAAS shows that concomitant therapy with potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes, and other means that increase serum potassium (for example, heparin) can lead to the development of hyperkalemia.

With the simultaneous use of lithium and ACE inhibitors, there is a reversible increase in the concentration of lithium in the blood serum and the development of toxic reactions.Such reactions can also occur with the use of angiotensin II receptor antagonists, and therefore it is recommended to control the content of lithium in blood serum.

Simultaneous use with non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2), Acetylsalicylic acid (more than 3 g / day) and non-selective NSAIDs, can reduce the antihypertensive effect of candesartan, and may also lead to an increased risk of dysfunction of function kidneys, including the development of acute renal failure and an increase in the content of potassium in the blood serum. The combination of these drugs should be used with caution, especially in elderly patients.

How to take, the course of administration and dosage

Inside, regardless of the meal, 1 time per day.

Arterial hypertension

The recommended initial dose of Ordiss® is 8 mg 1 time per day. Patients who need a further reduction in blood pressure (BP), it is recommended to increase the dose to 16 mg 1 time per day. The maximum antihypertensive effect is achieved within 4 weeks from the start of treatment. The maximum daily dose of 32 mg / day. If, against the background of treatment with Ordiss ®, adequate blood pressure control is not achieved, it is recommended to add thiazide diuretic to therapy.

In patients of the reduced age There is no need to adjust the initial dose of the drug.

In patients with reduced BCC there is a risk of arterial hypotension, so you should start treatment with the drug with a dose of 4 mg / day (1/2 pill 8 mg).

Have patients with renal failure. When used in patients with mild or moderate renal insufficiency (QA not less than 30 ml / min / 1.73 m2 of body surface area), an initial dose of 4 mg / day (1/2 pill 8 mg).

Clinical experience with the drug in patients with severe renal failure (CC less than 30 ml / min / 1.73 m2 of body surface area) is limited. In these cases, consideration should be given to starting treatment with a dose of 4 mg / day (1/2 pill of 8 mg).

In patients with impaired liver function. When using the drug in patients with mild to moderate hepatic impairment, an initial dose of 2 mg / day (1/4 pill 8 mg) is recommended. If necessary, may increase the dose. Clinical experience with the drug in patients with severe impaired liver function and / or cholestasis is limited (see section "Contraindications").

The drug Ordiss® can be used in conjunction with thiazide diuretics (for example, hydrochlorothiazide), which leads to an increase in the hypotensive effect.

Chronic Heart Failure (CHF)

The recommended initial dose of Ordiss® is 4 mg 1 time per day (1/2 pill 8 mg). Increasing the dose to 32 mg 1 time per day or to the maximum tolerated dose is carried out by doubling it at intervals of at least 2 weeks.

The drug Ordiss® can be used in conjunction with other drugs used in CHF, for example, with ACE inhibitors, beta-blockers, diuretics, and cardiac glycosides.

Special patient groups

Elderly patients, patients with renal insufficiency or abnormal liver function do not need to change the initial dose of the drug.

Overdosage

Symptoms : analysis of the pharmacological properties of the drug suggests that the main manifestation of overdose may be a clinically pronounced decrease in blood pressure, dizziness. Individual cases of drug overdose (up to 672 mg of candesartan), which ended in the recovery of patients without serious consequences, were described.

Treatment : With the development of a clinically pronounced decrease in blood pressure, it is necessary to conduct symptomatic treatment and monitor the patient's condition. Lay the patient on his back and lift his legs. If necessary, increase the bcc, for example, by intravenous injection of 0.9% sodium chloride solution. If necessary, you can apply sympathomimetic means. Removal of candesartan using hemodialysis is ineffective.

Impaired renal function. Against the background of the use of the drug Ordiss®, as with the use of other drugs that suppress the RAAS, in some cases, renal dysfunction may develop.

When using the drug Ordiss® in patients with hypertension and severe renal failure (CC less than 30 ml / min), it is recommended to regularly monitor the content of potassium and the concentration of creatinine in blood serum.Clinical experience with the drug in patients with end-stage renal disease (CC less than 15 ml / min) is limited. When Ordiss® is used in such patients, it is necessary to adjust the dose of Ordiss® under the control of blood pressure.

In patients with chronic kidney disease, it is necessary to periodically monitor renal function, especially in patients over the age of 75 years and patients with impaired renal function. At higher doses, it is also recommended to monitor the content of potassium and the concentration of creatinine in the serum.

There are no data on the use of the drug Ordiss® in CHF with a creatinine concentration of more than 265 μmol / l (more than 3 mg / ml).

Hemodialysis. During hemodialysis, BP may be especially sensitive to blockade of AT1 receptors as a result of a decrease in the BCC and activation of the RAAS. Therefore, patients on hemodialysis, it is necessary to monitor blood pressure and individual selection of the dose of the drug Ordiss® in accordance with the indicators of blood pressure.

Simultaneous use with ACE inhibitors in CHF. With simultaneous use with ACE inhibitors increases the risk of side effects, especially impaired renal function and hyperkalemia. Patients should be monitored for their clinical status and associated laboratory findings.

Renal artery stenosis. Drugs that affect the RAAS (for example, ACE inhibitors) can lead to an increase in serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a single kidney.A similar effect can be expected with the use of angiotensin II receptor antagonists.

Transplantation kidneys. There is no experience with Ordiss® in patients who have recently had a kidney transplant.

Hypotension. Patients with CHF with the use of the drug Ordiss® may develop arterial hypotension. It is also possible the development of arterial hypotension in patients with BCC deficiency, for example, when using large doses of diuretics. In this case, before using the drug Ordiss®, it is necessary to correct the BCC.

General anesthesia and / or surgery. In patients receiving angiotensin II antagonists, during general anesthesia and during surgical procedures, arterial hypotension may develop as a result of blockade of the RAAS. In rare cases, arterial hypotension may be severe, requiring intravenous fluids and / or vasopressors.

Stenosis of the aortic and / or mitral valves, GOKMP. At use of the drug Ordiss® for patients with GOKMP or hemodynamically significant stenosis of the aortic or mitral valves, care should be taken.

Primary hyperaldosteronism. Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect the RAAS, therefore, it is not recommended to use Ordiss® in this group of patients. Hyperkalemia. Simultaneous use of Ordiss® with potassium-sparing diuretics,potassium preparations or salt substitutes containing potassium, or other drugs that can increase the content of potassium in the blood serum (eg, heparin), can lead to the development of hyperkalemia in patients with arterial hypertension.

Hyperkalemia can also develop in patients with CHF who take Ordiss®. During therapy with Ordiss®, patients with CHF should be periodically monitored for serum potassium, especially with simultaneous use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamterene, amiloride).

Are common. Patients whose vascular tone and kidney function are primarily dependent on the activity of the RAAS (for example, patients with severe chronic heart failure, kidney disease, including renal artery stenosis) are particularly sensitive to drugs that act on the RAAS. The use of such drugs is accompanied in these patients by acute arterial hypotension, azotemia, oliguria and, less commonly, acute renal failure. The possibility of the development of these effects is not excluded with the use of angiotensin II receptor antagonists. A sharp decrease in blood pressure in patients with ischemic cardiopathy, cerebrovascular diseases of ischemic genesis in the application of any antihypertensive drugs, may lead to the development of myocardial infarction or stroke.

Use in pediatrics. The safety and efficacy of the use of Ordiss® at the age of 18 years have not been established.

In a dry, dark place at a temperature of no higher than 25 ° C.