Ordiss, tablets 8 mg 30 pcs

Hypertension (high blood pressure), Heart failure

Arterial hypertension.

Chronic heart failure and impaired left ventricular systolic function (left ventricular ejection fraction (LVEF) of 40% or less) as adjunctive therapy with ACE inhibitors or when ACE inhibitors are intolerant.

Active ingredient

Composition

Tablets weighing 8 mg

1 tablet contains:

the active ingredient:

Candesartan cylexetil 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-CZO 4.0 mg/8.0 mg/16.0 mg;

Red iron oxide 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.

How to take, the dosage

Ingestion, regardless of meals. The recommended dose is 1 tablet once daily. It is recommended to titrate the dose of candesartan before transferring patients to therapy with Ordiss N. If necessary, patients are transferred from candesartan ionotherapy to therapy with Ordiss N. The main hypotensive effect is usually achieved in the first 4 weeks after the start of treatment.

In patients with impaired renal function, the use of loop diuretics is preferable to thiazide diuretics. Prior to initiating therapy with Ordiss H in patients with mild to moderate renal impairment (CK greater than 30 mL/min), including patients on hemodialysis, a dose titration of candesartan starting at 4 mg is recommended.

The drug Ordiss N is contraindicated in patients with severe renal impairment (CKD less than 30 mL/min).

For patients at risk of arterial hypotension (e.g., with reduced circulating blood volume (CBV)), titration of the dose of candesartan starting at 4 mg is recommended.

In patients with moderate hepatic impairment prior to initiating therapy with Ordiss II, titration of the dose of candesartan starting at 2 mg is recommended. In patients with severe hepatic impairment, use of Ordiss H is contraindicated.

Dose adjustment is not necessary in elderly patients.

Interaction

No clinically significant drug interactions have been identified with the concomitant use of candesartan with hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinylestradiol/levonorgesgrel), glibenclamide, nifedipine and enalapril.

The concomitant use of candesartan with ACE inhibitors, other angiotensin II receptor antagonists, aliskiren increases the risk of hyperkalemia, rapid decrease of blood pressure, renal impairment, including acute renal failure, which requires close monitoring of blood pressure, renal function and electrolyte balance.

The concomitant use of candesartan with aliskiren in patients with diabetes mellitus and impaired renal function (US less than 60 ml/min) is not recommended. Candesartan is slightly metabolized in the liver with participation of CYP2C9 isoenzyme. Interaction studies have shown no effect of candesartan on CYP2C9 and CYP3A4 isoenzymes, the effect on other cytochrome P450 system isoenzymes has not been studied.

The concomitant use of candesartan with other hypotensive agents increases the antihypertensive effect.

The experience with other drugs acting on the RAAS shows that concomitant therapy with potassium-saving diuretics, potassium preparations, salt substitutes containing potassium, and other agents that increase serum potassium (e.g., heparin) may lead to the development of hyperkalemia.

When lithium preparations and ACE inhibitors are used concomitantly, there is a reversible increase in serum lithium concentration and development of toxic reactions. Similar reactions may also occur with angiotensin II receptor antagonists, and therefore it is recommended that serum lithium levels be monitored.

. Concomitant 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, may reduce the antihypertensive effect of candesartan, and may also lead to increased risk of renal function disorders, including acute renal failure and increased serum potassium levels. The combination of these drugs should be used with caution, especially in elderly patients.

Special Instructions

Renal dysfunction. As with the use of Ordiss® , as with other drugs that inhibit the RAAS, renal dysfunction may develop in some cases.

When using Ordiss® in patients with severe arterial hypertension and renal failure (CKR less than 30 ml/min), it is recommended to monitor regularly potassium and serum creatinine concentration. Clinical experience of using the drug in patients with end-stage renal failure (CKR less than 15 ml/min) is limited. When using Ordiss® in these patients, the dose of Ordiss® should be adjusted under control of BP.

In patients with COPD, renal function should be monitored periodically, especially in patients over 75 years of age and patients with impaired renal function. When increasing the dose, it is also recommended that serum potassium and creatinine concentrations be monitored.

The use of Ordiss® in patients with chronic heart failure with creatinine greater than 265 µmol/L (greater than 3 mg/ml) is not known.

Hemodialysis. During hemodialysis, BP may be particularly sensitive to AT1-receptor blockade as a result of decreased ODC and activation of the RAAS. Therefore, patients on hemodialysis should have their blood pressure monitored and the dose of Ordiss® adjusted individually according to their blood pressure.

Simultaneous use with ACE inhibitors in CHF. Concomitant use with ACE inhibitors increases the risk of adverse effects, especially renal dysfunction and hyperkalemia. The clinical condition of patients and relevant laboratory parameters should be monitored.

Renal artery stenosis. Drugs affecting the RAAS (e.g., ACE inhibitors) may result in increased serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of the sole renal artery. A similar effect can be expected with angiotensin II receptor antagonists.

Transplantation Kidney. There is no experience with the use of Ordiss® in patients who have recently undergone a kidney transplant.

Arterial hypotension. Patients with CHF when using Ordiss® may develop arterial hypotension. Hypotension is also possible in patients with circulatory blood pressure deficiency, e.g., when using high doses of diuretics. In this case, correction of the blood pressure before Ordiss® administration should be performed.

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

Aortic and/or mitral valve stenosis, GOCMP. Caution should be exercised when using Ordiss® in patients with GOCMP or hemodynamically significant aortic or mitral valve stenosis.

Primary hyperaldosteronism. Patients with primary hyperaldosteronism are usually resistant to therapy with hypotensive agents affecting the RAAS, therefore, use of Ordiss® in this group of patients is not recommended. Hyperkalemia: Simultaneous use of Ordiss® with potassium-saving diuretics, potassium preparations or salt substitutes containing potassium, or other drugs that may increase serum potassium (e.g. heparin) may cause hyperkalemia in patients with arterial hypertension.

Hyperkalemia may also occur in patients with CHF taking Ordiss®. During therapy with Ordiss® in patients with CHF, periodic monitoring of serum potassium is recommended, especially if ACE inhibitors and potassium saving diuretics (spironolactone, triamterene, amiloride) are used simultaneously.

General.Patients in whom vascular tone and renal function are predominantly dependent on RAAS activity (e.g., patients with severe chronic heart failure, renal disease, including renal artery stenosis) are particularly sensitive to drugs acting on the RAAS. The use of such drugs in these patients is accompanied by severe arterial hypotension, azotemia, oliguria and, less frequently, acute renal failure. The possibility of these effects is not excluded by the use of angiotensin II receptor antagonists. Sharp decrease of BP in patients with ischemic cardiopathy, cerebrovascular diseases of ischemic genesis while using any hypotensive agents may lead to myocardial infarction or stroke.

Use in pediatrics. The safety and effectiveness of the use of Ordiss® under 18 years of age has not been established.

Contraindications

Hypersensitivity to candesartan and other drug components; lactose intolerance; lactase deficiency; glucose-galactose malabsorption syndrome; severe hepatic impairment and/or cholestasis; pregnancy; breastfeeding period; childhood age below 18 years; simultaneous use with aliskiren in patients with diabetes and impaired renal function (CK less than 60 ml/min).

Side effects

The frequency of side effects is classified according to the recommendations of the World Health Organization: very frequently – at least 10%; frequently – at least 1%, but less than 10%; infrequently – at least 0.1%, but less than 1%; rarely – at least 0.01%, but less than 0.1%; very rarely – less than 0.01%, including single reports.

With the blood and lymphatic system: very rare – leukopenia, neutropenia, thrombocytopenia, agranulocytosis.

In immune system disorders: very rare – skin rash, pruritus, urticaria, angioedema.

Nervous system disorders: often – dizziness, headache, weakness.

Respiratory system: often – respiratory infections, pharyngitis, rhinitis.

Gastrointestinal system disorders: very rare – nausea.

Cardiovascular system disorders:often – marked decrease in BP.

Hepatic and biliary tract: very rare – increased activity of “hepatic” transaminases, impaired liver function, hepatitis.

Sports of the musculoskeletal system and connective tissue: very rare – back pain, arthralgia, myalgia.

Kidney and urinary tract disorders:often – renal dysfunction (see section “Special Precautions”).

Laboratory findings:very rarely – hyperkalemia, hyponatremia, increased concentration of creatinine, hyperuricemia, decreased hemoglobin.

Others: very rare – aggravation of the course of gout, “flushes” of blood to the face.

Overdose

Symptoms: Analysis of the pharmacological properties of the drug suggests that the main manifestation of overdose may be clinically pronounced BP decrease and dizziness. Individual cases of overdose of the drug (up to 672 mg of candesartan) have been described, resulting in recovery of patients without serious consequences.

Treatment: if clinically pronounced BP decrease develops, symptomatic treatment should be administered and the patient’s condition monitored. Place patient on back and elevate legs. If necessary, increase the BOD, e.g., by intravenous injection of 0.9% sodium chloride solution. Sympathomimetic agents may be used if necessary. Excretion of candesartan by hemodialysis is ineffective.

Similarities