Ko renitek instructions for use reviews. Indications and contraindications. Similar drugs

Manufacturer: Merck Sharp & Dohme Corp. (Merck Sharp and Dome Corp.) USA

ATC code: C09BA02

Farm group:

Release form: Solid dosage forms. Tablets.

General characteristics. Compound:

Active ingredients: enalapril maleate 20 mg, hydrochlorothiazide 12.5 mg.

Excipients: sodium bicarbonate, lactose monohydrate (hydrous lactose), corn starch, pregelatinized corn starch, iron dye yellow oxide, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Combined antihypertensive drug, which includes an ACE inhibitor (enalapril maleate) and a thiazide diuretic (hydrochlorothiazide). It has antihypertensive and diuretic effects.

Enalapril is an ACE inhibitor that catalyzes the conversion of angiotensin I to the pressor substance angiotensin II. After absorption, enalapril is converted by hydrolysis into enalaprilat, which inhibits ACE. Inhibition of ACE leads to a decrease in the concentration of angiotensin II in blood plasma, which entails an increase in plasma renin activity (due to the elimination of the reverse negative reaction to changes in renin production) and a decrease in aldosterone secretion.

ACE is identical to the enzyme kininase II, so enalapril can also block the destruction of bradykinin, a vasodilatory peptide. The significance of this mechanism in the therapeutic action of enalapril requires clarification. Despite the fact that enalapril reduces blood pressure by suppressing the renin-angiotensin-aldosterone system, which plays an important role in the regulation of blood pressure, the drug reduces blood pressure even in hypertensive patients with low renin content.

A decrease in blood pressure is accompanied by a decrease in TPVR, a slight increase in cardiac output, and no or slight changes in heart rate. As a result of taking enalapril, renal blood flow increases, the glomerular filtration rate remains unchanged. However, in patients with initially reduced glomerular filtration rate, its rate usually increases.

Antihypertensive therapy with enalapril leads to significant regression and preservation of left ventricular systolic function.

Therapy with enalapril is accompanied by a favorable effect on the ratio of lipoprotein fractions and no effect or a favorable effect on the content of total cholesterol.

The intake of enalapril by patients with arterial hypertension leads to a decrease in blood pressure both in the standing position and in the supine position without a significant increase in heart rate.

Symptomatic postural hypotension is rare. In some patients, achieving optimal blood pressure reduction may require several weeks of therapy. Interruption of enalapril therapy does not cause a sharp rise in blood pressure.

Effective inhibition of ACE activity usually develops 2-4 hours after a single oral dose of enalapril. The onset of antihypertensive action occurs within 1 hour, the maximum decrease in blood pressure is observed 4-6 hours after taking the drug. The duration of action depends on the dose. However, when used at recommended doses, the antihypertensive effect and hemodynamic effects persist for 24 hours.

Hydrochlorothiazide has a diuretic and antihypertensive effect, increases renin activity. Although enalapril itself exhibits an antihypertensive effect even in patients with arterial hypertension against the background of low renin concentration, the concomitant use of hydrochlorothiazide in such patients leads to a more pronounced decrease in blood pressure.

Enalapril reduces the loss of potassium ions caused by the use of hydrochlorothiazide. Enalapril and hydrochlorothiazide have a similar dosing regimen. Therefore, Co-renitec is a convenient dosage form for the co-administration of enalapril and hydrochlorothiazide.

The use of a combination of enalapril and hydrochlorothiazide leads to a more pronounced decrease in blood pressure compared with monotherapy with each drug separately and allows you to maintain the antihypertensive effect of the drug Corenitec for at least 24 hours.

Pharmacokinetics. Enalapril. Suction. After oral administration, enalapril maleate is rapidly absorbed. Cmax of enalapril in serum is observed within 1 hour after administration. After oral administration, absorption is approximately 60%.

Eating does not affect the absorption of enalapril. The duration of absorption and hydrolysis of enalapril is similar for various recommended therapeutic doses.

After absorption, enalapril is rapidly hydrolyzed to form the active substance enalaprilat, a potent ACE inhibitor. Cmax of enalaprilat in serum is observed 3-4 hours after taking a dose of enalapril inside.

Withdrawal. Enalapril is excreted mainly by the kidneys. The main metabolites detected in urine are enalaprilat, accounting for approximately 40% of the dose, and unchanged enalapril. Data on other significant pathways of metabolism of enalapril, with the exception of hydrolysis to enalaprilat, are not available. The enalaprilat plasma concentration curve has a long final phase, apparently due to its binding to ACE. In persons with normal renal function, a stable concentration of enalaprilat is reached on the 4th day from the start of enalapril. T1 / 2 of enalaprilat with the course use of the drug inside is 11 hours.

Hydrochlorothiazide.Metabolism and distribution.Does not undergo metabolism. Hydrochlorothiazide crosses the placental barrier, but does not cross the BBB.

Withdrawal. T1 / 2 hydrochlorothiazide from 5.6 to 14.8 hours. Rapidly excreted by the kidneys. At least 61% of an oral dose is excreted unchanged within 24 hours.

Combination of enalaprilat maleate and hydrochlorothiazide.Regular intake of a combination of enalapril and hydrochlorothiazide does not affect or slightly affects the bioavailability of each component of the drug. The use of a combination tablet of Co-renitec is bioequivalent to the simultaneous administration of its ingredients in separate dosage forms.

Indications for use:

- treatment in patients for whom combination therapy is indicated.

Dosage and administration:

The drug is administered orally, regardless of the meal.

With arterial hypertension, the initial dose is 1 tab. 1 time / day If necessary, the dose can be increased to 2 tab. 1 time / day

At the beginning of therapy with Corenitec, symptomatic arterial hypotension may develop, more often in patients with impaired water and electrolyte balance due to previous treatment with diuretics. Therapy with diuretics should be discontinued 2-3 days before the start of the use of Co-Renitec.

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

In mild renal failure, the recommended dose of enalapril maleate taken alone is 5 mg to 10 mg.

Application Features:

Use during pregnancy and lactation.The use of Co-Renitec during pregnancy is not recommended. When pregnancy is established, the drug should be stopped immediately.

The appointment of ACE inhibitors in the II and III trimesters of pregnancy can cause disease or death of the fetus or newborn. The negative effect of ACE inhibitors on the fetus and newborn is manifested by arterial hypotension, renal failure, hyperkalemia and / or skull hypoplasia. Perhaps the development of oligohydramnios, apparently due to impaired renal function of the fetus. This complication can lead to contracture of the limbs, deformation of the skull, including its frontal part, to pulmonary hypoplasia.

The use of diuretics in women during pregnancy is not recommended, as there is a risk of jaundice in the fetus and newborn, and possibly other side effects observed in adult patients.

If Co-Renitec is prescribed during pregnancy, the patient should be warned of the potential risk to the fetus. In those rare cases when the appointment of the drug during pregnancy is considered necessary, periodic ultrasound examinations should be performed to assess the condition of the fetus, as well as the intra-amniotic space.

Newborns whose mothers took Ko-renitek should be carefully monitored for the development of arterial hypotension, oliguria and. Enalapril, which crosses the placental barrier, has been removed from the neonatal circulation with some beneficial clinical effect, theoretically it can be removed by exchange.

Enalapril and thiazides, incl. hydrochlorothiazide are excreted in breast milk. If necessary, the use of the drug during lactation, breastfeeding should be discontinued.

Application for violations of liver function.With caution, the drug should be prescribed for.

Application for violations of kidney function.In patients with impaired renal function, thiazides may not be effective enough, and with CC less than or equal to 30 ml / min (i.e., with severe) they are ineffective.

With a CC of 80-30 ml / min, Co-renitek should be used only after a preliminary selection of doses of each of the components.

In moderate renal failure, the recommended dose of enalapril maleate taken alone is 5 mg to 10 mg.

Special instructions.During treatment with Corenitec, as with any antihypertensive therapy, symptomatic hypertension may develop. Patients should be examined for clinical signs of fluid and electrolyte imbalance, i.e. organism, hypochloremic, or, which may occur due to episodes of or. In such patients, during therapy, periodic determination of the electrolyte composition of the blood should be carried out at regular intervals.

With extreme caution, the drug should be prescribed to patients with coronary artery disease or cerebrovascular diseases, because. an excessive decrease in blood pressure can lead to the development of myocardial infarction or.

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

Corenitec should not be given to patients with renal insufficiency (QC<80 мл/мин) до тех пор, пока подбор отдельных компонентов препарата не покажет, что необходимые дозы для данного пациента присутствуют в данной лекарственной форме.

In some patients without any symptoms prior to treatment with enalapril in combination with a diuretic, there was usually a slight and transient increase in blood urea and serum creatinine. In such cases, treatment with Co-renitec should be discontinued. In the future, it is possible to resume therapy in reduced doses or to prescribe each of the components of the drug separately.

As with all drugs that have a vasodilatory effect, ACE inhibitors should be used with caution in patients who have difficulty in outflow of blood from the left ventricle of the heart.

In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, an increase in blood urea and serum creatinine was observed during treatment with ACE inhibitors. These changes were reversible, as a rule, the indicators returned to normal after the treatment was stopped.

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

When carrying out major surgical operations or during general use of drugs that cause arterial hypotension, enalaprilat blocks the formation of angiotensin II, caused by the compensatory release of renin. If, at the same time, severe arterial hypotension develops, explained by a similar mechanism, it can be corrected by an increase in BCC.

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. Doses of hypoglycemic drugs, including insulin, may need to be adjusted.

Thiazide diuretics may decrease urinary calcium excretion and cause slight and transient increases in serum calcium. Expressed may be a sign of hidden. Thiazides should be discontinued before conducting a study of the function of the parathyroid glands.

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

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

In the treatment of ACE inhibitors, including enalapril maleate, rare cases of angioedema of the face, extremities, lips, tongue, glottis and / or larynx have been described. These reactions can occur at any stage of therapy. In such cases, it is necessary to immediately stop taking enalapril maleate and establish careful monitoring of the patient's condition in order to control 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, since therapy with antihistamines and corticosteroids may not be enough.

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

In cases where edema 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 injected subcutaneously and the airway should be quickly secured.

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

With indications in the history of angioedema, not associated with the use of 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. Recurrence or worsening of SLE severity has been reported in patients treated with thiazides.

In rare cases, patients receiving ACE inhibitors have developed life-threatening anaphylactoid reactions during hyposensitization with an allergen from hymenoptera venom. Such reactions can be avoided if the ACE inhibitor is temporarily stopped before the start of hyposensitization.

The appointment of Ko-renitek is contraindicated in patients with renal insufficiency who are on hemodialysis. Anaphylactoid reactions have been observed in patients on dialysis using high-capacity membranes (such as AN69) and receiving concomitant treatment with ACE inhibitors. In these patients, a different type of dialysis membrane or other classes of antihypertensive drugs should be used.

During ACE therapy, cases of coughing were noted. As a rule, the cough is dry, has a permanent character and disappears after the end of therapy. 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 with simultaneous administration were similar in elderly and younger patients.

Use in pediatrics.The safety and efficacy of Co-Renitec in children have not been established, therefore pediatric use is not recommended.

Side effects:

In clinical studies, side effects were usually mild, transient and in most cases did not require interruption of treatment.

From the side of the cardiovascular system: 1-2% - orthostatic effects, including arterial hypotension; rarely - fainting, arterial hypotension regardless of body position, palpitations, chest pain.

From the side of the central nervous system and peripheral nervous system: often - increased fatigue (usually resolved with a decrease in dose and rarely required discontinuation of the drug); 1-2% - asthenia, headaches; rarely - insomnia, drowsiness, systemic dizziness, irritability.

From the respiratory system: 1-2% - cough; rarely - .

From the digestive system: 1-2% -; rarely - diarrhea, vomiting, abdominal pain, dry mouth.

From the musculoskeletal system: 1-2% - muscle; rarely - .

Allergic reactions: rarely - angioedema of the face, limbs, lips, tongue, glottis and / or larynx. There are rare reports of the development of angioedema of the intestine in connection with the use of ACE inhibitors, including enalapril.

Dermatological reactions: rarely - Stevens-Johnson syndrome, hyperhidrosis, itching.

From the urinary system: rarely - impaired renal function, renal failure.

From the reproductive system: 1-2% - impotence; rarely - decreased libido.

On the part of laboratory parameters: hyperuricemia, hypo- or hyperkalemia, an increase in the concentration of urea in the blood, serum creatinine, an increase in the activity of liver enzymes and / or an increase in serum bilirubin are possible (these indicators usually returned to normal after discontinuation of Corenitek therapy); in some cases - a decrease in hemoglobin and hematocrit.

Others: rarely -,

The use of potassium supplements, potassium-sparing diuretics or potassium-containing salts, especially in patients with renal insufficiency, can lead to a significant increase in serum potassium.

Diuretics and ACE inhibitors reduce the excretion of lithium by the kidneys and increase the risk of lithium toxicity. Lithium preparations, as a rule, are not prescribed simultaneously with diuretics or ACE inhibitors.

NSAIDs, including selective COX-2 inhibitors, may reduce the effectiveness of diuretics and other antihypertensive drugs. Therefore, it is possible to reduce the hypotensive effect of ACE inhibitors when administered simultaneously with NSAIDs, including selective COX-2 inhibitors.

In patients with impaired renal function receiving NSAIDs, including selective COX-2 inhibitors, concomitant use of ACE inhibitors may further worsen renal function. These changes are usually reversible.

Thiazide diuretics may enhance the effect of tubocurarine.

The hypotensive effect of the drug is reduced by NSAIDs, estrogens, ethanol.

Immunosuppressants, allopurinol, cytostatics increase the risk of developing hematotoxicity.

Contraindications:

- angioedema in history associated with the appointment of earlier ACE inhibitors, as well as hereditary or idiopathic angioedema;

- hypersensitivity to the components of the drug;

- Hypersensitivity to other sulfonamide derivatives.

With caution, the drug should be prescribed for aortic stenosis, cerebrovascular diseases (including cerebrovascular insufficiency), coronary heart disease, chronic, severe autoimmune systemic diseases of the connective tissue (including,), oppression of bone marrow hematopoiesis, diabetes mellitus, hyperkalemia, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney, condition after kidney transplantation, renal and / or liver failure, against the background of a diet with sodium restriction, in conditions accompanied by a decrease in BCC (including diarrhea, vomiting), elderly patients.

Overdose:

Symptoms: severe arterial hypotension, starting approximately 6 hours after taking the drug, and stupor. After taking enalapril maleate at doses of 330 mg and 440 mg, plasma concentrations of enalaprilat exceeded, respectively, 100 and 200 times its concentration at therapeutic doses.

With an overdose of hydrochlorothiazide, the most commonly observed symptoms are hypokalemia, hypochloremia, hyponatremia and dehydration due to excessive diuresis. If previously treated with digitalis preparations, the course may be aggravated due to hypokalemia.

Treatment: Ko-renitek should be canceled; close medical supervision is required. Recommended if the drug has been taken recently; conducting symptomatic and supportive therapy in order to correct water and electrolyte imbalance and arterial hypotension. Data on specific overdose therapy are not available.

In case of an overdose of enalapril maleate, an intravenous infusion of saline is recommended, the administration of angiotensin II is effective. Enalaprilat can be removed from the systemic circulation with the help of.

Storage conditions:

The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Shelf life for tablets in blister packs is 3 years, for tablets in high-density vials - 2 years.

Leave conditions:

On prescription

Package:

7 pcs. - blisters (2) - packs of cardboard.
7 pcs. - blisters (4) - packs of cardboard.
56 pcs. - polyethylene bottles (1) - cardboard packs.

Co-Renitec is a drug from the group of antihypertensive drugs.

What is the composition and form of release of Co-Renitek?

The drug is supplied to the pharmaceutical market in yellow, round tablets with a corrugated edge, you can see the engraving "MSD 718" on one side, and there will be a mark on the other. Active compounds: enalapril maleate and hydrochlorothiazide.

The excipients of Co-Renitec are as follows: sodium bicarbonate, magnesium stearate, aqueous lactose, corn starch and pregelatinized are added, there is a yellow iron oxide dye, magnesium stearate.

The drug is supplied for sale in blisters placed in cardboard packaging, and the tablets are also sealed in small polyethylene bottles. You can see the expiration date on the medicine box. Co-Renitek is sold by prescription.

What is the effect of Co-Renitec?

The combined drug Co-Renitec has an antihypertensive effect due to the presence of a thiazide diuretic and an ACE inhibitor, which is represented by enalapril. The decrease in pressure is accompanied by a slight increase in cardiac output, in addition, the use of the drug can lead to a slowdown in the hypertrophic process in the left ventricle.

Hydrochlorothiazide has a diuretic effect and antihypertensive effect, it is not metabolized, it is excreted in the urine. The use of Co-Renitec leads to a long-term antihypertensive effect, at least, it lasts one day. Enalapril is excreted by the kidneys.

What are the indications for the use of Co-Renitec?

Co-Renitec is prescribed for arterial hypertension in patients who need combined treatment.

What are the contraindications for Co-Renitec?

I will list the cases when the drug Co-Renitec instruction for use prohibits the use of:

With anuria;
With increased sensitivity to the components of the drug;
In the presence of angioedema.

With caution, the agent is used in the following situations: aortic stenosis, diabetes mellitus, cerebrovascular diseases, coronary artery disease, autoimmune systemic connective tissue diseases, hyperkalemia, renal artery stenosis, condition after kidney transplantation, and so on.

What are the uses and dosages of Co-Renitec?

The doctor prescribes the drug Co-Renitec to the patient after a preliminary examination of the patient. Usually, treatment begins with one tablet per day, it is recommended to swallow it whole with water. If necessary, the dose of the drug is increased.

Overdose from Co-Renitec

In case of an overdose, excessive arterial hypotension will develop. In this situation, the patient is prescribed symptomatic treatment.

What are the side effects of Co-Renitec?

The Co-Renitek medication provokes the development of some side effects that should be familiarized with: orthostatic effects are characteristic, arterial hypotension joins, fainting occurs, tachycardia, chest pains are noted, cough and shortness of breath, nausea and vomiting, loose stools, possible pancreatitis, constipation in addition, bloating, muscle cramps, dry mouth, and arthralgia.

In addition, when using this medicine, some changes in the nervous system are not excluded in the patient: dizziness, irritability, fatigue is added, headache is possible, drowsiness or insomnia is noted, dizziness is characteristic, as well as paresthesia.

Among other negative reactions of the body to the drug Co-Renitec, the following symptoms can be noted: allergic reactions in the form of angioedema, localized on the face, limbs, dermatological reactions in the form of itching and rashes on the skin are added, increased sweating is characteristic, Stevens-Johnson syndrome is sometimes possible.

Among other side effects, it can be noted: disruption of the kidneys, which can lead to the development of renal failure, in addition, libido decreases, impotence is noted, tinnitus, vasculitis may occur, gout, fever, photosensitivity is characteristic.

There are changes in laboratory parameters, which will be expressed in the form of the following manifestations: hyperglycemia is possible, hyperuricemia joins, hypokalemia or hyperkalemia occurs, an increase in urea in the blood is characteristic, as well as liver enzymes, serum creatinine, bilirubin, in addition, hemoglobin sometimes decreases.

If any side effects appear, the patient should consult a doctor in a timely manner and consult a doctor about the further use of the drug.

special instructions

During therapy with Co-Renitec, impaired glucose tolerance may occur.

How to replace Co-Renitek, what analogs to use?

The drug Enam N, Enap-NL, Renipril GT, in addition, the drug Enalapril-Akri N, Berlipril plus, Enap-NL 20, Enap-N, Enapharm-N, Enalapril-Akri NL, Enalapril N, as well as Prilenap, Enalapril NL can be attributed to analogues.

Conclusion

Treatment of high blood pressure should be carried out under the guidance of a treating specialist. At the same time, one should adhere to both the drug therapy prescribed by the doctor and observe general measures: a balanced diet, giving up bad habits, in addition, performing dosed physical activity, and so on.

The patient should independently study the instructions for the use of the prescribed drug. Be healthy!

MERCK SHARP & DOHME B.V. Merck Sharp and Dome B.V. Merck Sharp & Dome Ltd/ Merck Sharp & Dome B.V.

Country of origin

UK/Netherlands Netherlands Netherlands/UK Puerto Rico/Netherlands United Kingdom

Product group

Cardiovascular drugs

Antihypertensive drug

Release form

7 - blisters (2) - packs of cardboard. 7 - blisters (4) - packs of cardboard. 7 - blisters (2) - packs of cardboard. 7 - blisters (4) - packs of cardboard. 56 - polyethylene bottles (1) - cardboard packs 7 - blisters (2) - cardboard packs. 7 - blisters (4) - packs of cardboard. 56 - polyethylene bottles (1) - cardboard packs. pack 14 tabs pack 28 tabs

Description of the dosage form

Tablets Tablets are yellow, round, biconvex, with a corrugated edge, engraved "MSD 718" on one side, and a line on the other. Tablets are yellow, round, biconvex, with a corrugated edge, engraved "MSD 718" on one side and a line on the other. Tablets are yellow, round, biconvex, with a corrugated edge, engraved "MSD 718" on one side and a line on the other.

pharmachologic effect

Antihypertensive drug. It is a combination of an ACE inhibitor (enalapril maleate) and a thiazide diuretic (hydrochlorothiazide). A more pronounced clinical efficacy of Corenitec was shown in a larger number of patients than when each of the components of the drug was administered separately. Enalapril is an ACE inhibitor that catalyzes the conversion of angiotensin I to the pressor substance angiotensin II. After absorption, enalapril is converted by hydrolysis into enalaprilat, which inhibits ACE. Inhibition of ACE leads to a decrease in the concentration of angiotensin II in blood plasma, which entails an increase in plasma renin activity (due to the elimination of the reverse negative reaction to changes in renin production) and a decrease in aldosterone secretion. ACE is identical to the enzyme kininase II, so enalapril can also block the destruction of bradykinin, a vasodilatory peptide. The significance of this effect in the therapeutic action of enalapril requires clarification. Currently, it is believed that the mechanism by which enalapril reduces blood pressure is the suppression of the renin-angiotensin-aldosterone system, which plays an important role in the regulation of blood pressure. Enalapril exhibits an antihypertensive effect even in patients with reduced renin levels. The decrease in blood pressure is accompanied by a decrease in total peripheral vascular resistance, a slight increase in cardiac output, and no or little change in heart rate. As a result of taking enalapril, renal blood flow increases, but the level of glomerular filtration remains unchanged. However, in patients with initially reduced glomerular filtration, its level usually increases. Antihypertensive therapy with enalapril leads to a significant regression of left ventricular hypertrophy and a slowdown in the progression of left ventricular dysfunction due to a decrease in pre- and post-load on the myocardium. Therapy with enalapril is accompanied by a favorable effect on the ratio of lipoprotein fractions and no effect or a favorable effect on the concentration of total cholesterol. The intake of enalapril by patients with arterial hypertension leads to a decrease in blood pressure both in an upright position and at rest without a significant increase in heart rate. Symptomatic postural hypotension is rare. In some patients, achieving optimal blood pressure reduction may require several weeks of therapy. Interruption of enalapril therapy does not cause a sharp rise in blood pressure. Effective inhibition of ACE activity usually develops 2-4 hours after a single oral dose of enalapril. The onset of antihypertensive action occurs within 1 hour, the maximum decrease in blood pressure is observed 4-6 hours after taking the drug. The duration of action depends on the dose. However, when using the recommended doses, the antihypertensive effect and hemodynamic effects are maintained for 24 hours. Hydrochlorothiazide has a diuretic and antihypertensive effect, increases renin activity. Although enalapril itself exhibits an antihypertensive effect even in patients with arterial hypertension against the background of low renin concentration, the concomitant use of hydrochlorothiazide in such patients leads to a more pronounced decrease in blood pressure. Enalapril reduces the loss of potassium ions caused by the use of hydrochlorothiazide. Enalapril and hydrochlorothiazide have a similar dosing regimen. Therefore, Co-renitec is a convenient dosage form for the co-administration of enalapril and hydrochlorothiazide. The use of a combination of enalapril and hydrochlorothiazide leads to an increase in the effect of lowering blood pressure compared to treatment regimens when each of these drugs is administered separately, and allows you to maintain the antihypertensive effect of the drug Corenitec for at least 24 hours.

Pharmacokinetics

Reduces the content of sodium ions in the vascular wall, reduces the tone of arterial vessels, blood pressure, peripheral vascular resistance, increases diuresis. The hypotensive effect persists for 24 hours.

Special conditions

In the course of treatment, patients should be examined to identify clinical signs of impaired water and electrolyte balance, i.e. dehydration of the body, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may occur due to episodes of diarrhea or vomiting. In such patients, periodic determination of the electrolyte composition of the blood should be carried out at appropriate intervals. With extreme caution, the drug should be prescribed to patients with coronary artery 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 is indicated and, if necessary, intravenous administration of saline. Transient arterial hypotension when prescribing Co-renitec is not a contraindication to its further use. After normalization of blood pressure and BCC, therapy can be resumed either in slightly reduced doses, or each of the components of the drug can be used separately. Corenitec should not be given to patients with renal insufficiency (QC

Compound

1 tab. enalapril maleate 20 mg hydrochlorothiazide 12.5 mg Excipients: sodium bicarbonate, aqueous lactose, corn starch, pregelatinized corn starch, iron dye yellow oxide, magnesium stearate. 1 tab. enalapril maleate 20 mg hydrochlorothiazide 12.5 mg Excipients: sodium bicarbonate, aqueous lactose, corn starch, pregelatinized corn starch, iron dye yellow oxide, magnesium stearate. enalapril maleate 20 mg hydrochlorothiazide 12.5 mg Excipients: sodium bicarbonate, aqueous lactose, corn starch, pregelatinized corn starch, iron dye yellow oxide, magnesium stearate. enalapril maleate 20 mg hydrochlorothiazide 12.5 mg Excipients: sodium bicarbonate, aqueous lactose, corn starch, pregelatinized corn starch, iron dye yellow oxide, magnesium stearate. enalapril maleate 20 mg hydrochlorothiazide 12.5 mg Excipients: sodium bicarbonate, aqueous lactose, corn starch, pregelatinized corn starch, iron dye yellow oxide, magnesium stearate.

Ko-renitek indications for use

treatment of arterial hypertension in patients who are more effective combination therapy

Ko-renitek contraindications

- anuria; - hemodialysis in patients with renal insufficiency; - age up to 18 years (efficacy and safety have not been established); - angioedema in history associated with the appointment of earlier ACE inhibitors, as well as hereditary or idiopathic angioedema; - hypersensitivity to the components of the drug; - Hypersensitivity to other sulfonamide derivatives. With caution, the drug should be prescribed for aortic stenosis, cerebrovascular diseases (including cerebrovascular insufficiency), coronary heart disease, chronic heart failure, severe autoimmune systemic diseases of the connective tissue (including systemic lupus erythematosus, scleroderma), oppression bone marrow hematopoiesis, diabetes mellitus, hyperkalemia, bilateral renal artery stenosis, arterial stenosis of a single kidney, condition after kidney transplantation, renal and/or liver failure

Co-renitec dosage

12.5 mg + 20 mg 12.5 mg + 20 mg 20 mg + 12.5 mg

Co-renitec side effects

In clinical studies, side effects were usually mild, transient and in most cases did not require interruption of treatment. From the side of the cardiovascular system: 1-2% - orthostatic effects, including arterial hypotension; less often - fainting, arterial hypotension, palpitations, tachycardia, chest pain. From the side of the central nervous system and peripheral nervous system: often - dizziness, increased fatigue (usually passed with a decrease in dose and rarely required discontinuation of the drug); 1-2% - asthenia, headaches; less often - insomnia, drowsiness, paresthesia, increased nervous excitability. From the respiratory system: 1-2% - cough; less often shortness of breath. From the digestive system: 1-2% - nausea; less often - diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, constipation, dry mouth, pancreatitis. From the musculoskeletal system: 1-2% - muscle cramps; less often arthralgia. Allergic reactions: less often - skin rash, itching; rarely - angioedema of the face, limbs, lips, tongue, glottis and / or larynx. There are rare reports of the development of intestinal angioedema associated with the use of ACE inhibitors, including enalapril. Dermatological reactions: less often - Stevens-Johnson syndrome, hyperhidrosis, skin rash, itching. From the urinary system: less often - impaired renal function, renal failure. From the reproductive system: 1-2% - impotence; less often - decreased libido.

drug interaction

When prescribing enalapril in combination with other antihypertensive drugs, the summation of the effect is possible. Potassium loss caused by thiazide diuretics is usually reduced by enalaprilat. Serum potassium concentration usually remains within the normal range. The use of potassium supplements, potassium-sparing diuretics or potassium-containing salts, especially in patients with renal insufficiency, can lead to a significant increase in serum potassium. Diuretics and ACE inhibitors reduce the excretion of lithium by the kidneys and increase the risk of lithium toxicity. Lithium preparations, as a rule, are not prescribed simultaneously with diuretics or ACE inhibitors. In patients with impaired renal function receiving NSAIDs, in some cases, the use of ACE inhibitors may further worsen renal function. These changes are usually reversible. Thiazide diuretics may increase sensitivity to tubocurarine. The hypotensive effect of the drug is reduced by NSAIDs

Storage conditions

store at room temperature 15-25 degrees
keep away from children

Information provided

Instructions for use
Ko-renitek tab. 20mg + 12.5mg №28

Dosage forms
tablets 12.5mg+20mg

Synonyms
Berlipril plus
Renipril GT
Enalapril N

Enap-NL
Enap-NL 20

Group
Combination of angiotensin-converting enzyme inhibitors and diuretics

International non-proprietary name
Hydrochlorothiazide + Enalapril

Compound
Active ingredients: enalapril maleate and hydrochlorothiazide.

Manufacturers
Merck Sharp & Dome (Netherlands), Merck Sharp & Dome, packaged by Merck Sharp & Dome B.V. (Great Britain)

pharmachologic effect
Antihypertensive drug. It is a combination of an ACE inhibitor (enalapril maleate) and a thiazide diuretic (hydrochlorothiazide). The mechanism of the antihypertensive action of enalapril maleate is associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin I to angiotensin II (which has a pronounced vasoconstrictor effect and stimulates the secretion of aldosterone in the adrenal cortex). Due to its vasodilating action, enalapril maleate reduces total peripheral vascular resistance (afterload), pulmonary capillary wedge pressure (preload), and pulmonary vascular resistance; increases cardiac output and exercise tolerance. Hydrochlorothiazide disrupts the reabsorption of sodium, chloride and water ions in the distal tubules of the nephron. Helps reduce high blood pressure. Increases the excretion of potassium, magnesium, bicarbonate ions; retains calcium ions in the body.

Side effect
From the side of the cardiovascular system: orthostatic effects, including arterial hypotension; possible fainting, arterial hypotension, not associated with the position of the body, palpitations, tachycardia, chest pain. From the side of the central nervous system: often - dizziness, increased fatigue (usually passed with a decrease in dose and rarely required discontinuation of the drug); asthenia, headaches; possible insomnia, drowsiness, paresthesia, increased nervous excitability and irritability. From the respiratory system: cough; possible difficulty breathing. From the digestive system: nausea; possible diarrhea, vomiting, indigestion, abdominal pain, flatulence, constipation, dry mouth, pancreatitis. From the musculoskeletal system: muscle cramps; possible arthralgia. Allergic reactions: possible skin rash, itching; rarely - angioedema of the face, limbs, lips, tongue, glottis and / or larynx. Dermatological reactions: possible Stevens-Johnson syndrome, profuse sweating, skin rash. From the urinary system: possible violations of kidney function, renal failure. From the reproductive system: impotence; possibly decreased libido. On the part of laboratory parameters: rarely - hyperglycemia, hyperuricemia, hypokalemia, increased levels of urea in the blood, serum creatinine, increased activity of liver enzymes and / or increased serum bilirubin, hyperkalemia; in some cases - a decrease in hemoglobin and hematocrit. Other: possible tinnitus, gout.

Indications for use
Arterial hypertension in patients who are more effective combination therapy.

Contraindications
anuria; hypersensitivity to the components of the drug; a history of angioedema associated with the use of ACE inhibitors; hypersensitivity to other sulfonamide derivatives. The use of the drug during pregnancy is not recommended. When pregnancy is established, the drug should be stopped immediately, except in cases of vital need for therapy for the mother.

Method of application and dosage
With arterial hypertension, 1 tablet is prescribed 1 time / day. If necessary, the dose can be increased to 2 tablets 1 time / day. In patients with impaired renal function, Corenitec should be used only after prior selection of doses of each of the components. In moderate renal failure, the recommended dose of enalapril maleate taken alone is 5 mg to 10 mg.

Overdose
Symptoms: The most pronounced symptoms of an overdose of enalapril are severe arterial hypotension, starting approximately 6 hours after taking the drug, and stupor. With an overdose of hydrochlorothiazide, the most commonly observed symptoms are hypokalemia, hypochloremia, hyponatremia and dehydration due to excessive diuresis. If previously treated with digitalis preparations, arrhythmias may increase due to hypokalemia. Treatment: the drug should be discontinued; gastric lavage is recommended if the drug has been taken recently; conducting symptomatic and supportive therapy in order to correct water and electrolyte imbalance and arterial hypotension. In case of an overdose of enalapril maleate, intravenous infusion of saline is recommended; in the presence of angiotensin II, its administration may be useful. Enalaprilat can be removed from the systemic circulation by hemodialysis.

Interaction
When prescribing enalapril maleate in combination with other antihypertensive drugs, the summation of the effect is possible. Potassium loss caused by thiazide diuretics is usually reduced by enalaprilat. The content of potassium in serum usually remains within the normal range. The use of potassium supplements, potassium-sparing diuretics or potassium-containing salts, especially in patients with renal insufficiency, can lead to a significant increase in serum potassium. Diuretics and ACE inhibitors reduce the excretion of lithium by the kidneys, and increase the risk of developing lithium intoxication. Lithium preparations, as a rule, are not prescribed simultaneously with diuretics or ACE inhibitors. In patients with impaired renal function receiving NSAIDs, in some cases, the use of ACE inhibitors may further worsen renal function. Thiazides may increase sensitivity to tubocurarine.

special instructions
At the beginning of therapy, symptomatic arterial hypotension may develop, more often in patients with impaired water and electrolyte balance due to previous treatment with diuretics. Therapy with diuretics should be discontinued 2-3 days before the start of the drug. In the course of treatment, patients should be examined to identify clinical signs of impaired water and electrolyte balance, i.e. dehydration of the body, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may occur due to episodes of diarrhea or vomiting. In such patients, periodic determination of the electrolyte composition of the blood should be carried out at appropriate intervals. With extreme caution, the drug should be prescribed to patients with coronary artery disease or cerebrovascular diseases, because. an excessive decrease in blood pressure can lead to the development of myocardial infarction or stroke. For more information, see the instructions for use of the drug.

Storage conditions
List B. The drug should be stored at a temperature not exceeding 30°C.

Name:

Co-Renitec

Pharmachologic effect:

Co-Renitec is a combined drug with a pronounced antihypertensive and diuretic effect. The composition of the drug includes two active ingredients - enalapril maleate and hydrochlorothiazide. The mechanism of action and therapeutic effects of the drug are based on the pharmacological properties of the active components that make up its composition.

Enalapril maleate is an angiotensin-converting enzyme inhibitor. Enalapril maleate after oral administration is metabolized in the body with the formation of a pharmacologically active form of enalaprilat, which has an inhibitory effect on the angiotensin-converting enzyme. As a result of this action, there is a decrease in the formation of angiotensin II from angiotensin I, an increase in plasma renin activity and a decrease in aldosterone secretion. In addition, enalaprilat reduces the breakdown of bradykinin. Thus, the drug helps to reduce systemic blood pressure, preload on the heart and total peripheral vascular resistance, increases renal blood flow. Enalaprilat has practically no effect on heart rate and minute blood volume. The drug also contributes to a significant regression of left ventricular hypertrophy, while maintaining its systolic function.

Hydrochlorothiazide is a medicinal substance with a diuretic and antihypertensive effect. Hydrochlorothiazide reduces the reabsorption of sodium, chloride, other electrolytes and water ions in the renal tubules. The drug enhances diuresis, and also slightly increases the activity of plasma renin. Hydrochlorothiazide enhances the antihypertensive effect of enalapril.

The therapeutic effect of the drug develops within 1 hour after oral administration and lasts for a day.

After oral administration, the active components of the drug are well absorbed in the gastrointestinal tract. Eating does not affect the absorption of the active components of the drug. After taking enalapril, maleate is metabolized to form a pharmacologically active metabolite, enalaprilat. The maximum plasma concentration of enalaprilat is observed 3-4 hours after oral administration of Co-Renitec. Some of the hydrochlorothiazide is metabolized in the body. Hydrochlorothiazide crosses the hematoplacental barrier and is excreted in breast milk.

The active components of the drug are excreted mainly by the kidneys, both unchanged and in the form of metabolites. The half-life of enalaprilat is about - 11 hours, hydrochlorothiazide - from 5.6 to 14.8 hours.

In patients with normal renal function, steady state concentrations of enalaprilat are reached on day 4 of drug therapy.

Indications for use:

The drug is used to treat patients suffering from arterial hypertension, which requires combination therapy.

Application method:

The drug is intended for oral use. The tablet is recommended to be swallowed whole, without chewing or crushing, with a sufficient amount of liquid. If necessary, the tablet can be divided. The drug is taken regardless of the meal, to achieve the maximum therapeutic effect, the drug is recommended to be taken at one time of the day. If the patient received diuretic therapy, they should be discontinued 2-3 days before the start of Co-Renitec. The duration of the course of treatment and the dose of the drug is determined by the attending physician individually for each patient.

Patients with arterial hypertension are usually prescribed 1 tablet of the drug 1 time per day. If necessary, the dose of the drug is increased to 2 tablets of the drug 1 time per day.

For patients with renal dysfunction and creatinine clearance from 80 to 30 ml / min, the dose of the drug is selected individually, while the dose of enalapril is usually 5-10 mg.

Patients with renal dysfunction and creatinine clearance less than 30 ml / min, the drug is not prescribed.

Undesirable phenomena:

The drug is usually well tolerated by patients, in some cases, patients have experienced the following side effects:

From the gastrointestinal tract: nausea, vomiting, stool disorders, pain in the epigastric region, flatulence, indigestion, pancreatitis, dryness of the oral mucosa.

From the side of the cardiovascular system: arterial hypotension, including orthostatic hypotension, palpitations, chest pain, heart rhythm disturbance.

From the side of the central and peripheral nervous system: headache, dizziness, fatigue, tinnitus, asthenia, disturbed sleep and wakefulness, paresthesia, convulsions.

From the urinary system: impaired renal function, acute renal failure.

On the part of laboratory parameters: an increase in the level of urea, creatinine, bilirubin and glucose in the blood plasma, a decrease in the level of potassium in the blood plasma.

Allergic reactions: skin rash, itching, urticaria, Stevens-Johnson syndrome, photosensitivity, angioedema.

Others: dry cough, shortness of breath, impotence, increased sweating, decreased libido, joint pain.

With prolonged use of the drug, patients may develop gout.

With the development of side effects, you should stop taking the drug and consult your doctor.

Contraindications:

Increased individual sensitivity to the components of the drug, as well as other medicinal substances of the group of angiotensin-converting enzyme inhibitors and sulfonamide derivatives.

The drug is not prescribed for patients with lactase deficiency, galactosemia and malabsorption of glucose-galactose.

The drug is contraindicated in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, impaired renal function with creatinine clearance less than 30 ml / min, as well as in patients who are on hemodialysis using high-capacity membranes.

The drug is not used for the treatment of women during pregnancy and lactation, as well as for the treatment of children under the age of 18 years.

The drug is prescribed with caution to patients suffering from impaired water and electrolyte balance, including those caused by diarrhea and vomiting.

Caution should be observed when prescribing the drug to patients with coronary heart disease, impaired cerebral circulation, hypertrophic cardiopathy, aortic stenosis and renal artery stenosis, impaired renal and / or liver function.

The drug should be used with caution in patients who are scheduled for surgery, as well as in patients with diabetes mellitus.

The drug should be used with caution in patients whose work is associated with the management of potentially dangerous mechanisms and driving a car, since the use of the drug may cause dizziness.

During pregnancy:

The drug is not prescribed to women during pregnancy and lactation. Short-term use of the drug during pregnancy is allowed for health reasons and under the supervision of the attending physician. Before prescribing the drug to women of childbearing age, pregnancy should be excluded. During the period of drug therapy, women of childbearing age should use reliable contraception. If during the period of drug therapy pregnancy occurs, you should stop taking the drug, when planning pregnancy, you should stop taking the drug a few weeks before the expected onset of pregnancy.

When using the drug in the second and third trimester of pregnancy, it is possible to reduce the function of the kidneys in the fetus, the death of the fetus, as well as the appearance of other malformations. In newborns whose mothers received drug therapy, renal failure, pulmonary hypoplasia and skull deformity may develop.

If it is necessary to use the drug during lactation, you should consult with your doctor and decide on the abolition of breastfeeding.

Interaction with other drugs:

Antihypertensive drugs with combined use enhance the therapeutic effect of the drug Co-Renitec.

With the combined use of the drug with potassium preparations and potassium-sparing diuretics, the risk of developing hyperkalemia increases.

The drug enhances the toxicity of lithium preparations with simultaneous use.

With the combined use of the drug with non-narcotic painkillers, the risk of developing a nephrotoxic effect increases.

The drug with simultaneous use enhances sensitivity to tubocurarine.

Overdose:

When using excessive doses of the drug in patients, the development of nausea, vomiting, lowering blood pressure, dizziness, and disturbances in water and electrolyte balance was noted.

In case of an overdose, gastric lavage and the intake of enterosorbents are indicated (if no more than 2 hours have passed after taking the drug). With the development of arterial hypotension, infusion administration of 0.9% sodium chloride solution is indicated. In severe arterial hypotension, the introduction of angiotensin II is indicated. The level of enalaprilat in the blood plasma is significantly reduced during hemodialysis.

Release form of the drug:

Tablets of 7 pieces in blisters, 2 or 4 blisters in a carton box.

Tablets of 56 pieces in vials, 1 vial in a carton.

Storage conditions:

The shelf life of the drug in the form of tablets in blisters is 3 years.

The shelf life of the drug in the form of tablets in vials is 2 years.

Synonyms:

Enalozide, Enap-N.

Compound:

1 tablet contains:

Enalapril maleate - 20 mg,

Hydrochlorothiazide - 12.5 mg,

Excipients, including lactose.

Similar drugs:

Liprilum Enam Candesar H Candesar Fosicard H

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