Co-Renitec Tablets 20mg 12.5mg N28
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Active ingredients
Hydrochlorothiazide + Enalapril
Release form
Pills
Composition
Active ingredient: Hydrochlorothiazide + Enalapril (Hydrochlorothiazide + Enalapril) Concentration of the active substance (mg): Enalapril maleate 20 mg, hydrochlorothiazide 12. 5 mg
Pharmacological effect
Combined antihypertensive drug, which consists of an ACE inhibitor (enalapril maleate) and thiazide diuretic (hydrochlorothiazide). It has an antihypertensive and diuretic effect. 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 to enalaprilat, which inhibits ACE. Inhibition of ACE leads to a decrease in plasma angiotensin II concentration, which leads to 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. The ACF is identical to the enzyme kininase II, therefore enalapril can also block the destruction of bradykinin , peptide with vasodilating action. 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 regulating blood pressure, the drug lowers blood pressure even in patients with arterial hypertension with a low renin content. A decrease in blood pressure is accompanied by a decrease in CRPS, a slight increase in cardiac output and no changes or minor changes in heart rate. As a result of enalapril, the renal blood flow increases, the glomerular filtration rate remains unchanged. However, in patients with initially reduced glomerular filtration, its speed usually increases. Enalapril antihypertensive therapy leads to significant regression of left ventricular hypertrophy and preservation of left ventricular systolic function. Enalapril therapy is accompanied by a favorable effect on the ratio of lipoproteins and the absence of influence or favorable effect on total cholesterol. Taking enalapril in patients with hypertension leads to a decrease in blood pressure in both standing and supine position without a significant increase ChSS.Simptomaticheskaya postural hypotension is rare. In some patients, achieving an optimal reduction in blood pressure may require several weeks of therapy.Interruption of therapy with enalapril does not cause a sharp rise in blood pressure. Effective inhibition of ACE activity usually develops 2-4 hours after a single dose of enalapril orally. The onset of the antihypertensive effect begins 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 in 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 a background of low renin concentrations, the concomitant use of hydrochlorothiazide in these 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 co-administration of enalapril and hydrochlorothiazide. Using the combination of enalapril and hydrochlorothiazide results in a more pronounced decrease in blood pressure compared to monotherapy with each drug separately and allows you to maintain the antihypertensive effect of Co-drug at least for 24 h
Pharmacokinetics
Enalapril Absorption After enalapril intake, the maleate is rapidly absorbed. C max enalapril in serum is observed within 1 h after administration. After oral administration, absorption is approximately 60%. Food intake does not affect the absorption of enalapril. The duration of absorption and hydrolysis of enalapril is similar for the various recommended therapeutic doses. After absorption, enalapril is rapidly hydrolyzed to form the active substance enalaprilat, a powerful ACE inhibitor. Cmax enalaprilat in serum is observed after 3-4 hours after taking a dose of enalapril inside. ExcretionEnalapril is excreted mainly by the kidneys. The main metabolites detected in urine are enalaprilat, which constitutes approximately 40% of the dose, and unchanged enalapril. Data on other significant pathways of enalapril metabolism, with the exception of enalaprilat hydrolysis, is not available.The concentration curve of enalaprilat in the blood plasma has a long end 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 enalaprilat with the course of oral administration of the drug is 11 hours. Hydrochlorothiazide Metabolism and distribution is not metabolized. Hydrochlorothiazide penetrates the placental barrier, but does not penetrate the BBB. The release of T1 / 2 hydrochlorothiazide from 5.6 to 14.8 h. It is rapidly excreted by the kidneys. Not less than 61% of the dose taken orally is excreted unchanged within 24 hours. Combination of enalaprilat maleate and hydrochlorothiazide Regular intake of the combination of enalapril and hydrochlorothiazide does not affect or slightly affect the bioavailability of each component of the preparation. The use of the combined tablet of the drug Co-Renitec is bioequivalent to simultaneously taking its ingredients in separate dosage forms.
Indications
Treatment of hypertension in patients for whom combination therapy is indicated.
Contraindications
Anuria: Increased sensitivity to any of the components of the drug. Increased sensitivity to sulfonamide derivatives. A history of angioedema associated with the prescription of ACE inhibitors, as well as hereditary or idiopathic angioedema.
Precautionary measures
Do not exceed the recommended dose. With caution, you should prescribe the drug for aortic stenosis, cerebrovascular diseases (including cerebrovascular insufficiency), ischemic heart disease, chronic heart failure, severe autoimmune systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma ), inhibition 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 second and / or liver failure, against diet sodium restriction, for conditions involving reduction bcc (including diarrhea, vomiting), elderly patients.
Use during pregnancy and lactation
It is not recommended to use the drug Co-renitec during pregnancy.With an established pregnancy, taking the drug should be immediately stopped. The appointment of ACE inhibitors in the second and third trimesters of pregnancy can cause illness 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 cranial hypoplasia. Perhaps the development of oligohydramnios, apparently due to impaired renal function of the fetus. This complication can lead to contracture of the extremities, skull deformity, including its facial part, to lung hypoplasia. The use of diuretics in women during pregnancy is not recommended, since there is a risk of jaundice in the fetus and newborn, thrombocytopenia, and possibly other side effects, observed in adult patients. If the Co-doctor is prescribed during pregnancy, the patient should be warned of the potential risk to the fetus. In those rare cases where the prescription of a drug during pregnancy is considered necessary, periodic ultrasound examinations should be carried out to assess the condition of the fetus, as well as the intraamniotic space. Newborns whose mothers have taken Ro-rogenc should be carefully monitored for the development of arterial hypotension, oliguria and hyperkalemia. Enalapril, which penetrates the placental barrier, was removed from the blood circulation of the newborn by peritoneal dialysis with some favorable clinical effect, it can theoretically be removed by exchange transfusion. Enalapril and thiazides, including hydrochlorothiazide, are excreted in breast milk. If necessary, the use of the drug during lactation breastfeeding should be discontinued.
Dosage and administration
Hypertension: Initial dose of 1 tablet 1 time per day. If necessary, the dose can be increased to 2 pills 1 time per day. Inside, regardless of the meal
Side effects
Since the cardiovascular system: 1-2% - orthostatic effects, including hypotension; rarely - fainting, hypotension, regardless of the position of the body, heartbeat, tachycardia, chest pain. From the side of the central nervous system and the peripheral nervous system: often - dizziness,fatigue (usually took place at a lower dose and rarely required discontinuation of the drug); 1-2% - asthenia, headaches; rarely - insomnia, drowsiness, systemic dizziness, paresthesias, irritability. For the respiratory system: 1-2% - cough; rarely - shortness of breath. From the digestive system: 1-2% - nausea; rarely - pancreatitis, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence, constipation, dry mouth. From the musculoskeletal system: 1-2% - muscle cramps; rarely - arthralgia. Allergic reactions: rarely - angioedema of the face, extremities, lips, tongue, glottis and / or larynx. There are rare reports of the development of angioedema of the intestine in connection with taking ACE inhibitors, including enalapril. Dermatological reactions: rarely - Stevens-Johnson syndrome, hyperhidrosis, skin rash, itching. Urinary system: rarely - renal failure, renal insufficiency. side of the reproductive system: 1-2% - impotence; rarely, decreased libido. From laboratory indicators: hyperglycemia, hyperuricemia, hypo or hyperkalemia, increased blood levels of urea, serum creatinine, increased liver enzymes and / or elevated serum bilirubin are possible (these indicators usually returned to normal after discontinuation of Co-radiotherapy ); in some cases - decrease in hemoglobin and hematocrit. Others: rarely - tinnitus, gout. Symptom complex is described, the possible manifestations of which are fever, serositis, vasculitis, myalgia, myositis, arthralgia / arthritis, a positive test for antinuclear antibodies, accelerated ESR, eosinophilia and leukocytosis; possible development of photosensitivity.
Overdose
Symptoms: severe hypotension, starting approximately 6 hours after taking the drug, and stupor. After taking enalapril maleate in doses of 330 mg and 440 mg, plasma concentrations of enalaprilat were 100 and 200 times higher, respectively, at therapeutic doses. Symptoms caused by hypokalemia, hypochloremia, hyponatremia and dehydration due to excessive diuresis are most often observed in hydrochlorothiazide overdose. If therapy with digitalis has been previously administered, the arrhythmia may be aggravated as a result of hypokalemia. Treatment: Co-rnitec should be canceled; requires close medical supervision.A gastric lavage is recommended if the drug has been recently taken; conducting symptomatic and maintenance therapy in order to correct disorders of water and electrolyte balance and arterial hypotension. Data on the specific therapy of overdose is not available. In case of an overdose of enalapril maleate, intravenous saline injection is recommended, and the administration of angiotensin II is effective. Enalaprilat can be removed from the systemic circulation by hemodialysis.
Interaction with other drugs
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. 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. lithium. Lithium preparations, as a rule, are not prescribed simultaneously with diuretics or ACE inhibitors. NSA, including selective COX-2 inhibitors, may decrease the effectiveness of diuretics and other antihypertensive drugs. Therefore, it is possible to reduce the hypotensive effect of ACE inhibitors, while simultaneously prescribing with NSAIDs, including selective COX-2 inhibitors. These changes are usually reversible. Thiazide diuretics can enhance the effect of tubocurarine. The antihypertensive effect of the drug reduces NSAIDs, estrogens, ethanol. Immunosuppressants, allopurinol, and cytostatics increase the risk of hematotoxicity.
special instructions
During treatment with Co-renitis, as with any antihypertensive therapy, symptomatic hypertension may develop. Patients should be examined to identify the clinical signs of impaired water and electrolyte balance, i.e.dehydration of the body, hyponatremia, hypochloraemic alkalosis, hypomagnesemia, or hypokalemia, which may occur as a result of episodes of diarrhea or vomiting. In such patients during therapy, the 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, since excessive decrease in blood pressure can lead to the development of myocardial infarction or stroke. In the development of arterial hypotension, bed rest is indicated and, if necessary, IV saline is introduced. Transient hypotension in the appointment of the Co-remission 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. Patients with renal insufficiency (CC <80 ml / min) should not be prescribed until the selection of individual components of the drug will not show that the required dose for this patient is present in this dosage form. Some patients without any signs of kidney disease before treatment with enalapril in combination with a diuretic occurred usually minor and transient increases in blood urea and serum creatinine. In such cases, treatment with Co-pitcite should be discontinued. In the future, it is possible to resume therapy in reduced doses or to assign each of the components of the drug separately. As with all drugs that have a vasodilating effect, ACE inhibitors should be used with caution in patients who have difficulty with blood outflow from the left ventricle of the heart. In some patients with bilateral stenosis renal arteries or stenosis of the artery of a single kidney in the treatment of ACE inhibitors, an increase in blood urea and serum creatinine was observed. 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 with progressive liver disease,since even small changes in water-electrolyte balance can lead to a hepatic coma. When performing major surgeries or during general anesthesia with the use of agents that cause arterial hypotension, enalaprilat blocks the formation of angiotensin II caused by compensatory renin release. If this develops severe arterial hypotension, which is explained by a similar mechanism, it can be corrected by increasing the BCC. Thiazide diuretics may not be effective enough in patients with impaired renal function and are ineffective with CC ≤ 30 ml / min (i.e., in case of moderate to severe renal failure degree). Thiazide diuretics can cause impaired glucose tolerance. Correction of doses of hypoglycemic drugs, including insulin, may be required. Thiazide diuretics may reduce urinary calcium excretion, as well as cause a slight and transient increase in serum calcium. Severe hypercalcemia can be a sign of latent hyperparathyroidism. Thiazide intake should be discontinued before the study of the function of the parathyroid glands. Increased cholesterol and TG levels may also be associated with therapy with thiazide diuretics, however, at a dose of 12.5 mg hydrochlorothiazide contained in 1 Co-phenetic tablet, these effects were either not observed or were insignificant. Thiazide therapy can lead to hyperuricemia 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 treatment with 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 to establish careful monitoring of the patient's condition in order to control and correct the clinical symptoms. Even in cases where there is only swelling of the tongue without swelling of the respiratory organs, patients may need long-term follow-up, because therapy with antihistamines and corticosteroids may not be enough. There are rare reports of death due to angioedema of the larynx or swelling of the tongue.Swelling of the tongue, glottis or larynx can lead to airway obstruction, especially in patients who have undergone respiratory surgery. In cases where the swelling is localized in the tongue, glottis or larynx, which can lead to airway obstruction, Immediately inject 0.3-0.5 ml of a 0.1% solution of epinephrine (adrenaline) and quickly ensure airway patency. In patients of the Negroid race who used ACE inhibitors, angioedema was more often observed than in the rest of the pas If you have a history of angioedema that is not associated with the use of ACE inhibitors, the risk of developing angioedema significantly increases during therapy with ACE inhibitors. Patients receiving thiazides may experience allergic reactions regardless of the presence of allergic conditions or bronchial asthma. . Reported or exacerbated severity of SLE in patients treated with thiazides was reported. In rare cases, patients receiving ACE inhibitors developed life-threatening anaphylactoid reactions during an allergen hyposensitization from hymenoptera. Such reactions can be avoided if you temporarily stop taking an ACE inhibitor prior to the start of desensitization. Purpose This is contraindicated in patients with renal insufficiency who are on hemodialysis. Anaphylactoid reactions were observed in patients on dialysis using high-capacity membranes (such as AN69) and simultaneously treated with ACE inhibitors. In these patients, it is necessary to use dialysis membranes of another type or antihypertensive drugs of other classes. Coughing cases have been noted against the background of ACE therapy. As a rule, the cough is dry, permanent 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 effectiveness and tolerability of enalapril maleate and hydrochlorothiazide with simultaneous appointment were similar in elderly and younger patients. Pediatric useSafety and efficacy of Co-use in children have not been established therefore, pediatric use is not recommended.