Co-Renitec tabs 20mg + 12.5mg #28

Co-Renitec user manual

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Co-Renitec is a drug with hypotensive and diuretic effects.

Release form and composition

Co-Renitec is produced in the form of tablets: yellow, biconvex, round, with a corrugated edge, on one side - engraving "MSD 718", on the other - risk (in blisters of 7 or 14 pcs., 1, 2 or 4 blisters per cardboard box; in polyethylene bottles, 56 pcs., 1 bottle in a cardboard box).
The composition of 1 tablet includes:
    Enalapril maleate - 20 mg;
    Hydrochlorothiazide - 12.5 mg
Auxiliary components: iron dye yellow oxide, sodium bicarbonate, aqueous lactose (lactose monohydrate), pregelatinized corn starch, corn starch, magnesium stearate.

Pharmacodynamics

Co-Renitec is a combination of a diuretic (hydrochlorothiazide) and an ACE inhibitor (enalapril). It has a diuretic and antihypertensive effect. Hydrochlorothiazide and enalapril can be used alone or in combination with other drugs for the treatment of hypertension. The antihypertensive effect of the active components of the drug complements each other, and the therapeutic effect is prolonged and lasts for 24 hours.
When taking enalapril in patients with arterial hypertension, blood pressure decreases both in the "lying" position and in the "standing" position without a clinically significant increase in heart rate. During therapy, cases of symptomatic postural hypotension are rare. In some patients, it is possible to achieve an optimal reduction in blood pressure only after a few weeks of therapy. Interruption of treatment with enalapril does not lead to a sharp increase in blood pressure.
Effective inhibition of ACE activity is traditionally observed 2-4 hours after a single oral dose of the drug. The antihypertensive effect develops within 1 hour, and the maximum decrease in blood pressure is noted 4-6 hours after taking the drug. The duration of action of enalapril is directly proportional to the dose taken. However, when taking therapeutic doses, the antihypertensive effect and hemodynamic effects are recorded within 24 hours after administration.
Clinical studies of hemodynamics in patients with essential hypertension have shown that a decrease in blood pressure in them is combined with a decrease in total peripheral vascular resistance, a slight increase in cardiac output and small changes (or their absence) in heart rate. After taking enalapril, there was an intensification of renal blood flow, but the glomerular filtration rate remained unchanged. But in patients diagnosed with decreased glomerular filtration, its rate predominantly increased.
Treatment with enalapril for antihypertensive purposes causes a significant regression of left ventricular hypertrophy and maintenance of its systolic function. Therapy with the drug has a beneficial effect on the ratio of lipoprotein fractions in the blood plasma and is characterized by no effect or a beneficial effect on the total cholesterol content.
The mechanism of the antihypertensive action of thiazides has not been studied. Usually these compounds do not affect normal blood pressure readings. Hydrochlorothiazide is a diuretic and antihypertensive drug. It changes the mechanism of electrolyte reabsorption in the distal convoluted renal tubules. This substance enhances the excretion of chloride and sodium in approximately equivalent amounts. Natriuresis is sometimes accompanied by a certain loss of bicarbonate and potassium ions. After oral administration, the onset of diuresis is recorded after 2 hours, reaches a peak within approximately 4 hours and lasts approximately 6-12 hours.
Clinical studies have confirmed that the use of a combination of hydrochlorothiazide and enalapril causes a more pronounced decrease in blood pressure compared to monotherapy with each of the drugs separately and allows you to extend the antihypertensive effect of Co-Renitec for at least 24 hours from the moment of administration. Enalapril reduces the loss of potassium ions caused by the use of hydrochlorothiazide. Both active components of Co-Renitec have a similar dosage regimen - 1 time per day, so the drug is a convenient dosage form for combined administration of hydrochlorothiazide and enalapril.

Pharmacokinetics

After oral administration, enalapril is rapidly absorbed in the gastrointestinal tract. Its maximum serum level is reached within 1 hour after ingestion. When taken orally, the absorption rate is approximately 60%.
After absorption, enalapril is hydrolyzed relatively quickly, forming the active metabolite enalaprilat, which is considered a potent ACE inhibitor. The maximum content of enalaprilat in the blood serum is observed 3-4 hours after oral administration.
Enalapril is excreted mainly through the kidneys. The main metabolites that are found in urine are enalapril, which has not entered into any reactions in the body, and enalaprilat, which is approximately 40% of the dose taken. Information on other significant pathways of metabolism of enalapril, except for hydrolysis with the formation of enalaprilat, is absent. The curve of the content of enalaprilat in blood plasma is characterized by a long final phase, probably due to its binding to ACE.
In healthy volunteers with normally functioning kidneys, the equilibrium concentration of enalaprilat is established by the 4th day after the start of treatment. The half-life of this substance during the course of treatment with Co-Renitec, taken orally, is 11 hours. Food intake does not directly affect the absorption of enalapril. The duration of hydrolysis of enalapril and its absorption does not differ much when the recommended therapeutic doses are varied.
Hydrochlorothiazide is not metabolized, but excreted in the urine rather quickly. Monitoring the content of the substance in the blood plasma showed that for at least 24 hours the half-life is 5.6-14.8 hours. At least 61% of the oral dose taken is excreted unchanged within 24 hours. Hydrochlorothiazide crosses the placental barrier, but the blood-brain barrier is inaccessible to it.
Regular intake of hydrochlorothiazide and enalapril in combination with each other has little or no effect on the bioavailability of each of the active ingredients of the drug. Co-Renitec is bioequivalent to the combination of hydrochlorothiazide and enalapril.

Indications for use

Co-Renitec is prescribed for arterial hypertension in the presence of indications for combination therapy.

Contraindications

    Anuria;
    Angioneurotic edema (idiopathic, hereditary, or the presence of indications in the history of its development with the previous use of angiotensin-converting enzyme inhibitors);
    Hypersensitivity to the components of the drug, as well as to other sulfonamide derivatives.
The efficacy and safety of Co-Renitec in children have not been established, and therefore the use of the drug in pediatrics is not recommended.
Co-Renitec is not prescribed for patients with renal failure who are on hemodialysis.
The use of Co-Renitec by pregnant women is not recommended; during lactation, when prescribing the drug, breastfeeding should be interrupted.
According to the instructions, Co-Renitec should be used with caution in elderly patients, in conditions after kidney transplantation, on a sodium-restricted diet, in conditions accompanied by a decrease in circulating blood volume (including diarrhea and vomiting), as well as in patients with aortic stenosis, cerebrovascular diseases (including cerebral circulation insufficiency), ischemic heart disease, chronic heart failure, severe autoimmune systemic diseases of connective tissue (including systemic lupus erythematosus and scleroderma), inhibition of bone marrow hematopoiesis, diabetes mellitus, hyperkalemia, bilateral artery stenosis, renal artery stenosis renal and / or hepatic impairment.

Instructions for use of Co-Renitec: method and dosage

Co-Renitec is taken orally, regardless of food intake.
The initial daily dose for arterial hypertension is 1 tablet, in the future, if necessary, it can be increased by 2 times (in 1 dose).
At the beginning of therapy, symptomatic arterial hypotension may occur, mainly with violations of the water-electrolyte balance due to previous treatment with diuretics (2-3 days before the start of taking Co-Renitec, diuretic therapy should be discontinued).
With functional impairment of the kidneys, thiazides may not be effective enough, and with creatinine clearance ≤30 ml per minute (i.e., with severe and moderate renal failure), they are ineffective.
With creatinine clearance of 30-80 ml per minute, Co-Renitec can be taken only after individual selection of the dose of each of the components. For mild renal impairment, the recommended dose of enalapril maleate taken alone is 5-10 mg.

Side effects

In clinical trials, side effects were usually mild, transient and in most cases did not require interruption of therapy. During the use of Co-Renitec, the following disorders may occur (> 1-2% - often; 1-2% - infrequently; <1-2% - rarely):
    Central and peripheral nervous system: often - increased fatigue (usually disappears with dose reduction, rarely requires discontinuation of the drug), dizziness; infrequently - headaches, asthenia; rarely - drowsiness, insomnia, paresthesia, systemic dizziness, increased excitability;
    Cardiovascular system: infrequently - orthostatic effects, including arterial hypotension; rarely - tachycardia, fainting, arterial hypotension, regardless of body position, chest pain, palpitations;
    Digestive system: infrequently - nausea; rarely - diarrhea, pancreatitis, dyspepsia, vomiting, abdominal pain, constipation, flatulence, dry mouth;
    Reproductive system: infrequently - impotence; rarely - decreased libido;
    Urinary system: rarely - functional disorders of the kidneys, renal failure;
    Respiratory system: infrequently - cough; rarely - shortness of breath;
    Musculoskeletal system: infrequently - muscle cramps; rarely - arthralgia;
    Laboratory indicators: hyperglycemia, hyperuricemia, hyper- or hypokalemia, an increase in the concentration of serum creatinine and urea in the blood, an increase in serum bilirubin and / or the activity of hepatic enzymes (these indicators usually return to normal after discontinuation of the drug); in some cases - a decrease in hematocrit and hemoglobin;
    Dermatological reactions: rarely - hyperhidrosis, Stevens-Johnson syndrome, itching, skin rash;
    Allergic reactions: rarely - angioedema of the extremities, face, tongue, lips, larynx and / or glottis. There are rare reports of the occurrence of angioedema of the intestine due to the use of angiotensin-converting enzyme inhibitors, including enalapril;
    Others: rarely - gout, tinnitus. A symptom complex is described, the possible manifestations of which are arthritis / arthralgia, fever, vasculitis, serositis, myositis, myalgia, a positive test for antinuclear antibodies, accelerated erythrocyte sedimentation rate, leukocytosis, eosinophilia; development of photosensitization is possible.

Overdose

An overdose can be determined by severe arterial hypotension, starting approximately 6 hours after taking Co-Renitec, and stupor. When enalapril maleate is taken in doses of 330 and 440 mg, the content of enalaprilat in the blood plasma is 100 and 200 times higher, respectively, when using therapeutic doses.
An overdose of hydrochlorothiazide leads to the onset of symptoms due to hypokalemia, hyponatremia, hypochloremia and dehydration due to excessive diuresis. If the patient was previously treated with digitalis drugs, it is likely that the course of arrhythmia is aggravated due to hypokalemia.
In case of an overdose, Co-Renitec should be canceled immediately and the patient should be left under the close supervision of a specialist. If the drug has been taken recently, gastric lavage is prescribed, as well as supportive and symptomatic therapy to correct arterial hypotension and disturbances in water and electrolyte balance. There is no information on the specific treatment of overdose.
In case of an overdose of enalapril maleate, physiological saline should be injected intravenously, the administration of angiotensin II is also shown. Enalaprilat can be removed from the systemic circulation through hemodialysis.

Special instructions

During the use of Co-Renitec, symptomatic hypertension may occur. It is necessary to monitor the clinical signs of violations of water and electrolyte balance, including dehydration of the body, hypochloremic alkalosis, hyponatremia, hypomagnesemia or hypokalemia, which may occur due to episodes of vomiting or diarrhea. In such patients, during therapy, periodically at regular intervals, it is necessary to determine the electrolyte composition of the blood.
With extreme caution, Co-Renitec is prescribed for ischemic heart disease or cerebrovascular diseases, since an excessive decrease in blood pressure can lead to the development of a stroke or myocardial infarction.
In cases of arterial hypotension, adherence to bed rest and, if necessary, intravenous administration of saline is indicated. When the drug is prescribed, transient arterial hypotension is not a contraindication to its further use. After normalization of blood pressure and circulating blood volume, treatment can be resumed either in slightly reduced doses, or by taking each of the components of the drug separately.
In renal failure (creatinine clearance <80 ml per minute), Co-Renitec should not be prescribed until the selection of its individual components shows that the necessary doses are present for this patient in this dosage form.
In some patients without any signs of kidney disease before starting therapy, when using enalapril in combination with a diuretic, a slight and transient increase in serum creatinine and blood urea may occur. In such cases, therapy is discontinued. Resumption of treatment in the future is possible either in slightly reduced doses, or by taking each of the components of the drug separately.
Like other drugs with a vasodilating effect, Co-Renitec should be taken with caution by patients in whom the outflow of blood from the left ventricle of the heart is difficult.
Sometimes, with bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney, when using the drug, an increase in serum creatinine and blood urea is observed. As a rule, these changes are reversible, and after stopping treatment, the indicators return to normal.
Thiazide diuretics should be used with caution in patients with progressive liver disease or impaired liver function, since even minor changes in water and electrolyte balance can lead to the development of hepatic coma.
During major surgical operations or during general anesthesia using drugs that cause arterial hypotension, enalaprilat can block the formation of angiotensin II, which is caused by compensatory release of renin. If severe arterial hypotension occurs, which can be caused by a similar mechanism, it can be corrected by increasing the volume of circulating blood.
The drug can lead to the development of impaired glucose tolerance. In this case, the dosage of hypoglycemic drugs, including insulin, is usually adjusted.
Co-Renitec can reduce urinary calcium excretion and slightly and transiently increase serum calcium. Severe hypercalcemia may be a symptom of latent hyperparathyroidism. Before conducting a study of the function of the parathyroid glands, the intake of thiazides should be interrupted.
Increases in cholesterol and triglyceride levels can also be associated with the use of thiazide diuretics, however, with a dose of hydrochlorothiazide of 12.5 mg, such effects are usually either not observed or are insignificant.
In some patients, the use of thiazides can lead to the development of hyperuricemia and / or gout. However, enalapril can increase the content of uric acid in the urine and thereby weaken the hyperuricemic effect of hydrochlorothiazide.
When using enalapril maleate, rare cases of angioedema of the extremities, face, tongue, lips, larynx and / or glottis have been described. These disorders can develop at any stage of therapy. In such cases, it is necessary to immediately interrupt the reception of Co-Renitec and carefully monitor the patient's condition to monitor and correct clinical signs. Even if there is only swelling of the tongue without edema of the respiratory organs, patients may need to be monitored for a long time, since the use of antihistamines and corticosteroids may not be enough.
In cases where edema is localized in the region of the tongue, larynx or glottis, which can cause airway obstruction, it is necessary to inject 0.3-0.5 ml of 0.1% adrenaline (epinephrine) solution subcutaneously in a short time and ensure airway patency ...
In patients of the Negroid race, taking angiotensin-converting enzyme inhibitors, angioedema was observed more often than in other patients.
If there is a history of indications of angioedema, which is not associated with the use of angiotensin-converting enzyme inhibitors, the risk of developing angioedema significantly increases during therapy.
In patients receiving thiazides, allergic reactions can develop regardless of a history of bronchial asthma or allergic conditions. There are reports of an aggravation of the severity of the course or recurrence of systemic lupus erythematosus in patients treated with thiazides.
In rare cases, patients receiving angiotensin-converting enzyme inhibitors have developed life-threatening anaphylactoid reactions during hyposensitization with an allergen from hymenoptera venom. Such violations can be avoided if, temporarily, before the start of hyposensitization, the reception of Co-Renitec is interrupted.
Coughs have been reported with the use of angiotensin-converting enzyme inhibitors. Usually the cough is dry, persistent and disappears after the end of therapy (it must be taken into account when conducting differential diagnostics).

Influence on the ability to drive vehicles and complex mechanisms

When taking Co-Renitec, patients who drive vehicles or work with complex mechanisms should take into account the risk of developing weakness or dizziness.

Application during pregnancy and lactation

It is not recommended to prescribe Co-Renitec during pregnancy. If pregnancy is established, taking the drug must be stopped immediately.
Taking ACE inhibitors in the II or III trimesters of pregnancy significantly increases the risk of illness or death of the fetus or newborn. The negative effect of these substances on the fetus or child is expressed in the form of hypoplasia of the skull and / or hyperkalemia, renal failure, arterial hypotension. In some cases, oligohydramnios develops, probably due to fetal renal dysfunction. This complication can lead to hypoplasia of the lungs, deformation of the skull, including its facial part, contracture of the extremities.
The use of diuretics in pregnant women is not recommended due to the high risk of thrombocytopenia, jaundice in the fetus and newborn and other possible side effects observed in adult patients.
When prescribing Co-Renitec during pregnancy, a woman should be warned of the potential risks to the fetus. In those few cases when it is not possible to avoid taking it, it is necessary to regularly conduct ultrasound examinations to monitor the condition of the fetus, as well as the intra-amniotic space.
Newborns whose mothers took the drug should be carefully monitored for the development of hyperkalemia, oliguria, and arterial hypotension. Enalapril, which crosses the placental barrier, is removed from the child's circulatory system through peritoneal dialysis. In this case, a favorable clinical effect is observed. In theory, the substance can also be removed by exchange transfusion.
Enalapril and hydrochlorothiazide pass into breast milk. Therefore, if it is necessary to use the drug during lactation, breastfeeding is canceled.

Drug interactions

With the simultaneous use of Co-Renitec with certain drugs, the following undesirable effects may occur:
    Other antihypertensive drugs: summation of the effect;
    Potassium supplements, potassium-sparing diuretics, or potassium-containing salts (especially in patients with renal failure): significant increase in serum potassium;
    Lithium preparations: reducing the excretion of lithium by the kidneys and increasing the risk of developing lithium intoxication;
    Non-steroidal anti-inflammatory drugs, including selective inhibitors of COX-2, ethanol, estrogens: reducing the hypotensive effect of Co-Renitec;
    Allopurinol, immunosuppressants, cytostatics: increased risk of hematotoxicity;
    Thiazide diuretics: enhancing the effect of tubocurarine.

Terms and conditions of storage

Keep out of reach of children at temperatures up to 30 ° C.
Shelf life - 2 years (for tablets in high density vials) or 3 years (for tablets in blisters).

Reviews about Co-Renitec

Numerous reviews of Co-Renitec confirm its effectiveness. Reported serious adverse reactions are rare. Patients usually note that they go away on their own and do not require discontinuation of the drug.

Terms of sell

A prescription is not required to buy Co-Renitec.