Renitec pills 20 mg 14 pcs
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Active ingredients
Enalapril
Release form
Pills
Composition
Active ingredient: Enalapril maleate Concentration of active ingredient (mg): 20
Pharmacological effect
ACE inhibitor. It is a prodrug from which the active metabolite enalaprilat is formed in the body. The mechanism of antihypertensive action is believed to be associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of angiotensin I conversion to angiotensin II (which has a pronounced vasoconstrictor effect and stimulates the secretion of aldosterone in the adrenal cortex). plasma by eliminating negative feedback during renin release and a direct decrease in aldosterone secretion. In addition, enalaprilat appears to have an effect on the kinin-kallikrein system, preventing the breakdown of bradykinin. Due to its vasodilator action, it reduces the congestion resistance (afterload), the jamming pressure in the pulmonary capillaries (preload) and the resistance in the pulmonary vessels; increases cardiac output and exercise tolerance. In patients with chronic heart failure, long-term use of enalapril increases exercise tolerance and reduces the severity of heart failure (assessed by NYHA criteria). Enalapril in patients with mild to moderate heart failure slows its progression and also slows the development of left ventricular dilatation. When left ventricular dysfunction enalapril reduces the risk of major ischemic outcomes (including the incidence of myocardial infarction and the number of hospitalizations for unstable angina).
Pharmacokinetics
When ingested, about 60% is absorbed from the gastrointestinal tract. Simultaneous food intake does not affect absorption. Metabolized in the liver by hydrolysis with the formation of enalaprilat, due to the pharmacological activity of which hypotensive action is realized. The binding of enalaprilat to plasma proteins is 50-60% .T1 / 2 enalaprilat is 11 h and increases in renal failure.After ingestion, 60% of the dose is eliminated by the kidneys (20% as enalapril, 40% as enalaprilat), 33% is excreted through the intestine (6% as enalapril, 27% as enalaprilat). After the on / in the introduction of enalaprilat 100% excreted by the kidneys in unchanged form.
Indications
Essential arterial hypertension (mild, moderate and severe); Renovascular hypertension; Chronic heart failure of all functional classes. In patients with clinical manifestations of heart failure, Renitec has been shown to improve patient survival rates, slow the progression of heart failure, reduce hospitalization rates. failure, reduce the frequency of hospitalizations. In patients with dysfunction iey left ventricular Renitec is indicated for the prevention of coronary ischemia, reducing the incidence of myocardial infarction, reduce the frequency of hospitalizations for unstable angina.
Contraindications
Angioedema associated with taking ACE inhibitors in history; Hypersensitivity to enalapril; Pregnancy and lactation.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Contraindicated for use in pregnancy. When pregnancy begins, enalapril should be stopped immediately. Enalapril is excreted in breast milk. If necessary, its use during lactation should decide on the termination of breastfeeding.
Dosage and administration
Renitec can be used as monotherapy at the beginning of treatment or as part of a combination therapy with other antihypertensive drugs, especially diuretics. The drug can be taken regardless of the meal. With hypertension, depending on its degree, the initial dose is 10-20 mg 1 time / day. With mild hypertension, the recommended initial dose is 10 mg / day, with moderate and severe - 20 mg / day. Maintenance dose - 20 mg 1 time / day. The dose should be selected individually for each patient.The maximum daily dose is 40 mg. Patients with renovascular hypertension may be particularly sensitive to the action of ACE inhibitors, so therapy should be started with a low initial dose, for example, with 5 mg or less. Then the dose is selected in accordance with the needs of the patient. In most patients, the effect is manifested when taking 20 mg of the drug daily. The maximum daily dose is 40 mg. Care should be taken when prescribing Renetec patients who receive diuretic therapy, because in such patients, in the presence of a lack of liquid or sodium, after the first dose of Renitec, hypotension may develop. Treatment with diuretic should be stopped 2-3 days before the start of the use of Renitec. If this is not possible, then Renitec therapy begins with a dose of 5 mg in order to determine the primary effect of the drug on the level of blood pressure. Next, the dose of the drug is set in accordance with the needs of the patient. In case of chronic heart failure or asymptomatic dysfunction of the left ventricle, the initial dose of the drug is 2.5 mg. Renitec should be prescribed under close medical supervision in order to establish the primary effect of the drug on blood pressure. If there is no effect or after appropriate correction of symptomatic hypotension resulting from treatment with Renitec, the dose should be gradually increased to an average maintenance dose of 20 mg / day, which is prescribed in 1 or 2 doses, depending on what the patient tolerates. Selection of the dose can be carried out within 2-4 weeks or in a shorter time if there are residual signs and symptoms of heart failure. In patients with impaired renal function, the interval between doses of the drug should be increased or the dose should be reduced. Dosing regimen corrected depending on the values of creatinine clearance. When QC 80-30 ml / min, the dose of the drug is 5-10 mg / day; 30-10 ml / min - 2.5-5 mg / day; less than 10 ml / min - 2.5 mg on dialysis days. Correction of the dosing regimen in the days when dialysis is not performed should be carried out depending on the level of blood pressure.
Side effects
Since the cardiovascular system: less than 2% of patients - arterial hypotension, orthostatic hypotension, syncope; in very rare cases - pain in the chest, palpitations, heart rhythm disturbances, angina.Perhaps the development of acute myocardial infarction or stroke in patients belonging to the risk group. From the CNS and peripheral nervous system: most often - dizziness, headache; in 2-3% of cases - increased fatigue, asthenia; in very rare cases - depression, confusion, sleep disturbances, paresthesia, tinnitus, blurred vision. On the part of the digestive system: in less than 2% of patients - nausea, diarrhea; in very rare cases - intestinal obstruction, pancreatitis, liver failure, hepatitis, jaundice, abdominal pain, vomiting, dyspepsia, constipation, anorexia, stomatitis, increased activity of hepatic transaminases and plasma bilirubin concentration (these changes are usually reversible and normalized after stopping reception of Renitec). From the side of the respiratory system: in less than 2% of patients - cough; in very rare cases - pulmonary infiltrates, bronchospasm, shortness of breath, rhinorrhea, pharyngitis, dysphonia (hoarseness). On the urinary system: in rare cases - renal dysfunction, renal failure, oliguria; an increase in the level of urea, creatinine (these changes are usually reversible and normalize after stopping Reinek). Allergic reactions: in less than 2% of patients - a skin rash; rarely, angioedema of the face, extremities, lips, tongue, glottis and / or larynx; in very rare cases, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria. It was reported about the development of a complex symptom complex that included fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, a positive test for antinuclear antibodies, increased ESR, eosinophilia, and leukocytosis. reactions: itching, alopecia, flushing of the skin of the face. From the laboratory parameters: the development of hyperkalemia and hyponatremia is possible; decrease in hemoglobin and hematocrit levels. Other: increased sweating, seizures, impotence, glossitis, changes in taste, tinnitus.
Overdose
Overdose of the drug is not described.
Interaction with other drugs
With simultaneous use with immunosuppressants, cytostatics, the risk of developing leukopenia increases. With simultaneous use of potassium-saving diuretics (including spironolactone, triamterene, amiloride), potassium preparations, salt substitutes and dietary supplements containing potassium, hyperkalemia may develop (especially with impaired renal function), because ACE inhibitors reduce aldosterone levels, which leads to a delay of potassium in the body against the background of limiting the excretion of potassium or its supplemental intake in the body. When opioid analgesics and anesthetics are used simultaneously, the antihypertensive effect of enalapril is enhanced. . There is a risk of hypokalemia. Increased risk of renal dysfunction reduce the antihypertensive effect of enalapril. It is not fully established whether acetylsalicylic acid reduces therapeutic efficacy ngibitorov ACE in patients with coronary artery disease and heart failure. The nature of this interaction depends on the course of the disease. Acetylsalicylic acid, inhibiting COX and prostaglandin synthesis, can cause vasoconstriction, which reduces cardiac output and worsens the condition of heart failure patients receiving ACE inhibitors. When beta-blockers, methyldopes, nitrates are used simultaneously, calcium channel blockers, hydralazine, prazosin may increase antihypertensive action. When used simultaneously with NSAIDs (including with indomethacin), reduce tsya antihypertensive effect of enalapril, apparently by inhibiting NSAIDs influenced prostaglandin synthesis (which is believed to play a role in the development of hypotensive effect of ACE inhibitors).The risk of developing impaired renal function increases; hyperkalemia is rarely observed. If insulin is used at the same time, hypoglycemic agents of sulfonylurea derivatives may develop hypoglycemia. When ACP inhibitors and interleukin-3 are used simultaneously, there is a risk of arterial hypotension. increased action of clomipramine and the development of toxic effects. When used simultaneously with co-trimoxazole, cases of in case of simultaneous use of lithium carbonate with lithium carbonate, the concentration of lithium in serum increases, which is accompanied by symptoms of lithium intoxication. When used with orlistat, the antihypertensive effect of enalapril decreases, which can lead to a significant increase in blood pressure and hypertensive crisis. use with procainamide may increase the risk of developing leukopenia. When used simultaneously with enalapril, the effect of the drug decreases of those containing theophylline. There are reports of the development of acute renal failure in patients after kidney transplantation with simultaneous use with cyclosporine. With simultaneous use with cimetidine, T1 / 2 enalapril increases and its concentration in the blood plasma increases. concurrent administration with erythropoietin. Concurrent administration with ethanol increases the risk of arterial hypotension.
special instructions
It is used with extreme caution in patients with autoimmune diseases, diabetes mellitus, abnormal liver function, severe aortic stenosis, subaortic muscular stenosis of unknown origin, hypertrophic cardiomyopathy, with loss of fluids and salts. In the case of previous treatment with saluretics, in particular in patients with chronic heart failure, the risk of orthostatic hypotension increases, therefore, before starting treatment with enalapril, it is necessary to compensate for the loss of fluid and salt.Sudden discontinuation of enalapril does not cause a sharp increase in blood pressure. During surgical interventions during the period of treatment with enalapril, hypotension may develop, which should be corrected by administering a sufficient amount of fluid. driving or doing other work that requires increased attention, because dizziness may occur, especially after taking the initial dose of enalapril.