Co-renitec® (Co-renitec)

Pharmacodynamics and pharmacokinetics

This drug reduces the level of sodium ions in the vascular wall, blood pressure , arterial vascular tone, peripheral , and also increases diuresis . The hypotensive effect lasts throughout the day.

Thus, the drug is effective in cases of arterial hypertension . The hypotensive effect of the active components of the drug complements each other. Therapy with this drug is more effective in most cases for arterial hypertension than the use of enalapril maleate and hydrochlorothiazide separately.

Enalapril is an ACE inhibitor . Once absorbed it is metabolized to enalaprilat . Its action leads to a decrease in the level of angiotensin II in plasma, which increases the activity renin and decreases the secretion of aldosterone . In addition, enalapril prevents the destruction of bradykinin .

The decrease in blood pressure is accompanied by a decrease in total peripheral vascular resistance and a slight increase in cardiac output. The drug increases renal blood flow . the glomerular filtration rate does not change , unless it was initially reduced in patients.

Hydrochlorothiazide is a diuretic and antihypertensive agent that helps increase renin . Thus, when combined with enalapril , it results in a greater reduction in blood pressure . Discontinuation of the drug does not cause its sharp increase.

The maximum effect, as a rule, appears 2-4 hours after application. The hypotensive effect is noticeable within an hour. The duration of action of the medicine largely depends on the dosage. As a rule, it lasts throughout the day.

Co-renitec® (Co-renitec)

During treatment with Corenitec, as with any antihypertensive therapy, the development of symptomatic hypertension is possible. Patients should be examined to identify clinical signs of fluid and electrolyte imbalance, i.e. dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may occur due to episodes of diarrhea or vomiting. In such patients, during therapy, periodic determination of the electrolyte composition of the blood should be carried out at certain intervals.

The drug should be prescribed with extreme caution to patients with ischemic heart disease or cerebrovascular diseases, because An excessive decrease in blood pressure can lead to the development of myocardial infarction or stroke.

With the development of arterial hypotension, bed rest and, if necessary, intravenous administration of saline are indicated. Transient arterial hypotension when prescribing Korenitek is not a contraindication to its further use. After normalization of blood pressure and blood volume, therapy can be resumed either in slightly reduced doses, or each of the components of the drug can be used separately.

Korenitek should not be prescribed to patients with renal failure (creatinine clearance <80 ml/min) until the selection of individual components of the drug shows that the required doses for a given patient are present in a given dosage form.

In some patients without any evidence of renal disease before treatment, usually slight and transient increases in blood urea and serum creatinine occurred when treated with enalapril in combination with a diuretic. In such cases, treatment with Corenitec should be discontinued. In the future, it is possible to resume therapy in reduced doses or prescribe each of the components of the drug separately.

Like all drugs that have a vasodilating effect, ACE inhibitors should be prescribed with caution to patients who have difficulty with the outflow of blood from the left ventricle of the heart.

In some patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney, increases in blood urea and serum creatinine were observed when treated with ACE inhibitors. These changes were reversible; as a rule, the indicators returned to normal after cessation of treatment.

Thiazide diuretics should be used with caution in patients with impaired liver function or progressive liver disease, since even minor changes in water and electrolyte balance can lead to hepatic coma.

When performing major surgical operations or during general anesthesia with the use of drugs that cause arterial hypotension, enalaprilat blocks the formation of angiotensin II caused by compensatory release of renin. If severe arterial hypotension develops, explained by a similar mechanism, it can be corrected by increasing the volume of blood volume.

Thiazide diuretics may not be effective enough in patients with impaired renal function and are ineffective when CC ≤ 30 ml/min (i.e., with moderate to severe renal failure).

Thiazide diuretics can cause impaired glucose tolerance. Dosage adjustments of hypoglycemic medications, including insulin, may be required.

Thiazide diuretics may decrease urinary calcium excretion and may also cause a slight and transient increase in serum calcium. Severe hypercalcemia may be a sign of hidden hyperparathyroidism. Thiazides should be discontinued before testing parathyroid function.

Increases in cholesterol and TG levels may also be associated with therapy with thiazide diuretics, however, with a dose of hydrochlorothiazide of 12.5 mg contained in 1 Korenitek tablet, such effects were either not observed or were insignificant.

Thiazide therapy may lead to hyperuricemia and/or gout in some patients. However, enalapril may increase uric acid levels in the urine and thereby reduce the hyperuricemic effect of hydrochlorothiazide.

Rare cases of angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been described during treatment with ACE inhibitors, including enalapril maleate. These reactions can occur at any stage of therapy. In such cases, it is necessary to immediately stop taking enalapril maleate and carefully monitor the patient's condition in order to monitor and correct clinical symptoms. Even in cases where there is only swelling of the tongue without swelling of the respiratory organs, patients may require long-term observation as therapy with antihistamines and corticosteroids may not be sufficient.

There have been rare reports of death due to angioedema accompanied by laryngeal edema or tongue edema. Swelling of the tongue, glottis, or larynx can lead to airway obstruction, especially in patients who have undergone respiratory surgery.

In cases where swelling is localized in the area of ​​the tongue, glottis or larynx, which can lead to airway obstruction, 0.3-0.5 ml of a 0.1% solution of epinephrine (adrenaline) should be immediately administered subcutaneously and quickly ensure airway patency.

In black patients taking ACE inhibitors, angioedema was observed more often than in other patients.

If there is a history of angioedema not associated with taking ACE inhibitors, the risk of developing angioedema during therapy with ACE inhibitors increases significantly.

In patients receiving thiazides, allergic reactions may occur regardless of a history of allergic conditions or bronchial asthma. Relapses or worsening severity of SLE have been reported in patients receiving thiazides.

In rare cases, patients receiving ACE inhibitors have developed life-threatening anaphylactoid reactions during hyposensitization with hymenoptera venom allergen. Such reactions can be avoided if you temporarily stop taking the ACE inhibitor before starting hyposensitization.

The use of Korenitek is contraindicated in patients with renal failure undergoing hemodialysis. Anaphylactoid reactions have been observed in patients on dialysis using high-flow membranes (such as AN69) and concomitantly treated with ACE inhibitors. In these patients, it is necessary to use a different type of dialysis membrane or different classes of antihypertensive drugs.

Cases of cough have been reported during ACE therapy. As a rule, the cough is dry, persistent and disappears after the end of therapy. Cough associated with the use of ACE inhibitors should be considered in the differential diagnosis of cough.

The results of clinical studies of the efficacy and tolerability of enalapril maleate and hydrochlorothiazide when administered concomitantly were similar in elderly and younger patients.

Use in pediatrics

The safety and effectiveness of Corenitec in children have not been established, therefore use in pediatrics is not recommended.

Contraindications

Co-Renitec should not be used in case of hypersensitivity to its components, childhood , anuria , history of angioedema , as well as hereditary or idiopathic angioedema .

This drug is prescribed with caution for:

• bilateral renal artery stenosis ;
• coronary heart disease;
• aortic stenosis;
• severe systemic connective tissue diseases;
• diabetes mellitus;
• condition after kidney transplantation;
• a diet with limited sodium content;
• old age;
• cerebrovascular diseases;
• chronic heart failure ;
• renal failure;
• inhibition of bone marrow hematopoiesis;
• conditions accompanied by a decrease in circulating blood volume;
• liver failure;
• hyperkalemia;
• stenosis of the artery of a single kidney.

Instructions for use CO-RENITEC® (CO-RENITEC)

Hypotension and electrolyte/water imbalance

As with other antihypertensive drugs, some patients may develop symptomatic hypotension. Patients should be monitored for clinical signs of fluid or electrolyte imbalance, such as dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia, which may occur as a result of diarrhea or vomiting. Serum electrolyte levels should be checked periodically in such patients. A particularly careful approach should be taken to the treatment of patients with coronary heart disease or cerebrovascular diseases, since excessive lowering of blood pressure can lead to myocardial infarction or stroke. If arterial hypotension develops, the patient should be placed on his back and, if necessary, saline sodium chloride solution should be administered intravenously. Temporary hypotension is not a contraindication to the use of subsequent doses of the drug. After normalization of circulating blood volume and blood pressure, therapy can be resumed in reduced doses or using each component of the drug separately.

Aortic stenosis/hypertrophic cardiomyopathy

Like all other vasodilators, ACE inhibitors should be administered with caution to patients with left ventricular outflow tract obstruction.

Renal dysfunction

Thiazides may be inappropriate for use in patients with renal impairment and may not be effective when creatinine clearance is 30 mL/min or lower (i.e., moderate to severe renal impairment). Korenitec should not be administered to patients with impaired renal function (creatinine clearance <80 ml/min) until the dose titration of each component of the drug reaches the dose of this combination drug.

In some patients with arterial hypertension without evidence of existing kidney disease, concomitant use of enalapril and a diuretic usually results in a slight and temporary increase in blood urea and serum creatinine levels. If this phenomenon occurs during use of the drug Korenitek, this combination drug should be discontinued. Treatment with the drug can be resumed in reduced doses or using each of the components of the drug separately.

In some patients with bilateral renal artery stenosis or solitary renal artery stenosis, increases in blood urea and serum creatinine have been observed when using ACE inhibitors, which are usually reversible when the drug is discontinued.

Liver diseases

Thiazides should be used with caution in patients with impaired liver function or progressive liver disease, since minimal changes in fluid or electrolyte balance may lead to the development of hepatic coma.

Surgery/anesthesia

In patients undergoing major surgery or anesthesia using agents that cause hypotension, enalapril may block the formation of angiotensin II as a result of compensatory release of renin. If arterial hypotension occurs, which is explained by a similar mechanism, it can be corrected by increasing the volume of circulating blood.

Metabolic and endocrine effects

Thiazide therapy may lead to deterioration of glucose tolerance. Dosage adjustments of antidiabetic agents, including insulin, may be necessary. Thiazides may reduce urinary calcium excretion and may also cause intermittent and slight increases in serum calcium levels. Severe hypercalcemia may indicate latent hyperparathyroidism. The use of thiazides should be discontinued before testing the function of the parathyroid glands.

Elevations in cholesterol and triglyceride levels may be associated with treatment with thiazide diuretics; however, minimal or no effects were reported with the 12.5 mg dose of Corenitec. Thiazide therapy may lead to the development of hyperuricemia and/or gout in certain patients. However, enalapril may increase urinary excretion of uric acid and thus reduce the hyperuricemic effect of hydrochlorothiazide.

Hypersensitivity/angioedema

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has rarely been reported in patients receiving ACE inhibitors, including enalapril maleate. These reactions may occur at any time during treatment. In such cases, enalapril maleate should be discontinued immediately and the patient should be monitored appropriately to ensure complete resolution of symptoms before the patient is discharged. Even in cases where there is only swelling of the tongue without respiratory distress, long-term monitoring of the patient's condition is necessary, since treatment with antihistamines and corticosteroids may not be sufficient. Very rarely, fatal cases have been reported due to angioedema, which was accompanied by swelling of the larynx or tongue. Patients with swelling of the tongue, glottis, or larynx are more likely to develop airway obstruction, especially in patients with a history of airway surgery. In cases where swelling of the tongue, glottis or larynx may lead to airway obstruction, appropriate therapy should be administered immediately, which may include subcutaneous administration of epinephrine solution 1:

• 1000 (0.3-0.5 ml) and/or measures to maintain airway patency.

The development of angioedema was more often reported in patients of the Black race than in patients of other races.

Patients with a history of angioedema that is not associated with the use of an ACE inhibitor may be at higher risk of developing angioedema while using an ACE inhibitor.

In patients using thiazides, sensitivity reactions may occur regardless of a history of allergies or bronchial asthma. Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.

Anaphylactoid reactions during desensitization with hymenoptera venom

Life-threatening anaphylactoid reactions have rarely occurred in patients who used ACE inhibitors during hymenoptera venom desensitization. The occurrence of such reactions can be avoided by temporarily stopping the use of the ACE inhibitor before starting desensitization.

Anaphylactoid reactions during LDL apheresis

Life-threatening anaphylactoid reactions have rarely occurred in patients who used ACE inhibitors during LDL apheresis using dextran sulfate. The occurrence of such reactions can be avoided by temporarily stopping the use of the ACE inhibitor before each apheresis.

Patients undergoing hemodialysis

The use of Korenitek is contraindicated in patients who require hemodialysis for renal failure. Anaphylactic reactions have been reported in patients undergoing dialysis using high-permeability membranes (eg, AN 69®) and concomitant treatment with an ACE inhibitor. In such patients, consideration should be given to the use of a different type of dialysis membrane or a different class of antihypertensive drug.

Cough

Cough has been reported with the use of ACE inhibitors. As a rule, the cough is nonproductive, persistent and disappears after cessation of therapy. Cough that occurs as a result of the use of ACE inhibitors should be considered in the differential diagnosis of cough.

Hyperkalemia

Risk factors for the development of hyperkalemia include renal impairment, diabetes mellitus, and concomitant use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or salt substitutes containing potassium.

The use of potassium supplements, potassium-sparing drugs, or salt substitutes containing potassium, especially in patients with impaired renal function, may result in marked increases in serum potassium levels. Hyperkalemia can cause serious, sometimes fatal, arrhythmias.

If concomitant use of Corenitec and the above agents is considered necessary, they should be used with caution and frequent monitoring of serum potassium levels.

Lactose

Ko-Renitek contains less than 200 mg of lactose per tablet. Patients with rare hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.

Kidney transplant

There is no experience with the use of enalapril in patients with recent kidney transplantation. Therefore, treatment with enalapril is not recommended.

Use in elderly patients

In clinical studies, the efficacy and tolerability of enalapril maleate and hydrochlorothiazide administered concomitantly were similar in elderly patients and in younger patients with hypertension.

Use in children

The safety and effectiveness of the drug in children have not been established.

Impact on the ability to drive vehicles and other mechanisms

When operating vehicles and machinery, it should be taken into account that dizziness or fatigue may occasionally occur.

Side effects

Negative side effects, according to research, are usually moderate in nature. They usually do not require discontinuation of therapy. Side effects may be as follows:

• respiratory system – shortness of breath, cough;
• CVS - palpitations, orthostatic effects, fainting, arterial hypotension , chest pain, tachycardia ;
• musculoskeletal system - the appearance of muscle cramps, pain in the joints;
• kidneys – development of renal failure , problems with kidney function;
• laboratory indicators – hyperglycemia , hyperkalemia , hypokalemia , hyperuricemia , decreased hematocrit and hemoglobin ;
• CNS – dizziness , increased excitability, asthenia , paresthesia , increased fatigue, drowsiness , headache , sleep disturbances ;
• digestive system - dyspepsia , diarrhea , nausea, flatulence , dry mouth, vomiting, abdominal pain, constipation , pancreatitis ;
• allergies – itching , rash;
• reproductive system – development of impotence , decreased libido;
• others – tinnitus, gout .

In addition, in rare cases, when taking the medicine, undesirable manifestations such as angioedema of the glottis, limbs, tongue, face, larynx, lips, Stevens-Johnson syndrome , intestinal Quincke's edema , hyperhidrosis .

Side effects of the drug Ko-renitek

Co-Renitec is generally well tolerated. The most common side effects were dizziness and fatigue, which usually resolved with dose reduction and rarely required discontinuation of therapy. Other side effects (1–2%) were: muscle cramps, nausea, asthenia, orthostatic effects including hypotension, headache, cough, impotence. The following side effects were rarely noted: from the cardiovascular system - fainting, non-orthostatic hypotension, palpitations, tachycardia, chest pain; from the gastrointestinal tract - pancreatitis, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, constipation; from the nervous system and psyche - insomnia, drowsiness, paresthesia, dizziness, increased excitability; from the respiratory system - shortness of breath; on the part of the skin - Stevens-Johnson syndrome, rash, itching, increased sweating; others - impaired renal function, renal failure, decreased libido, dry mouth, tinnitus, gout, arthralgia. A constellation of symptoms has been noted that may include fever, serositis, vasculitis, myalgia and myositis, arthralgia and arthritis, positive antinuclear antibody (ANA) testing, accelerated ESR, eosinophilia and leukocytosis. May detect rash, photosensitivity and other dermatological manifestations. Hypersensitivity and angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely (see SPECIAL INSTRUCTIONS). From the side of laboratory parameters When prescribing Ko-Renitek, clinically significant changes in laboratory parameters were rarely detected. In rare cases, hyperglycemia, hyperuricemia and hypokalemia, increased blood urea levels, serum creatinine, increased liver enzyme activity and/or increased serum bilirubin levels have been observed. After cessation of Corenitec therapy, these indicators usually returned to normal. Hyperkalemia, decreased hemoglobin levels, and decreased hematocrit levels have also been reported.

Instructions for use Co-Renitek (Method and dosage)

This medication is taken orally , one tablet once a day. If necessary, the dosage can be increased to two tablets per day.

Instructions for use Co-Renitek recommends monitoring water and electrolyte balance data. If the patient has previously taken diuretics , you must wait 2-3 days before using Co-Renitec tablets. In cases where there is an increase in urea and creatinine in the blood, the use of the drug should be discontinued.

Use of the drug Ko-Renitek

AH (arterial hypertension) Adults are usually prescribed 1 tablet once a day. If necessary, the dose can be increased to 2 tablets per day for 1 dose. Previous diuretic therapy At the beginning of treatment with Corenitec, symptomatic arterial hypotension may be noted; it is more often detected in patients in whom previous diuretic therapy has led to an imbalance of water and electrolyte balance. Diuretic therapy should be discontinued 2–3 days before starting Corenitec therapy. Dosing in Renal Impairment Thiazide diuretics may not be effective in patients with impaired renal function and may not be effective in patients with creatinine clearance of 30 mL/min or less (i.e., moderate to severe renal impairment). In patients with creatinine clearance in the range of 30–80 ml/min, Corenitec can be used only after preliminary selection of doses of each component. The recommended starting dose of enalapril maleate taken alone for moderate renal impairment is 5 to 10 mg.

Interaction

Co-Renitec can be used with other antihypertensive drugs. Then the summation of the action is observed. In combination with potassium supplements, potassium-containing salts and potassium-sparing diuretics hyperkalemia is likely .

When interacting with lithium drugs, lithium excretion through the kidneys is reduced. lithium intoxication increases .

NSAIDs reduce the effect of the drug. And if they are taken by patients with kidney function problems, this combination can lead to a deterioration in kidney function. But these changes are reversible.

The hypotensive effect of the drug is reduced by estrogens and ethanol . Immunosuppressants , cytostatics and Allopurinol increase the likelihood of hematotoxicity .

Analogues of Ko-Renitek

Level 4 ATX code matches:
Akkuzid

Enap-N

Iruzid

Co-Diroton

Enalozide

Enap NL

Enapril-N

Capozide

Tritace Plus

Enzix

Liprazid

Hartil N

Hartil D

Noliprel

Ko-Perineva

Kaptopres

The following analogues of Co-Renitek are sold in pharmacies:

• Enalapril-HL-Health;
• Berlipril Plus;
• Ena Sandoz Compositum;
• Enalapril-H-Health;
• Enalozide;
• Enalozid Forte;
• Enap-N;
• Enap-HL;
• Enapril-N.

Co-Renitek price, where to buy

The price of Co-Renitek, which contains 28 tablets per package, is on average about 340 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• KO-Renitek tablets 20mg+12.5mg 28 pcs.Merck Sharp & Dohme BV
  RUB 494 order

Pharmacy Dialogue

• Co-Renitek (tab. 20/12.5 mg No. 28) Merck Sharp

  RUR 538 order

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Pharmacy24

• Tablets Co-Renitek 20/12.5 mg No. 28 Merck Sharp i Dome B.V./Merck Sharp i Dome Limited, Netherlands/Great Britain
  189 UAH order