Enalapril tablets 5mg №10×6

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Enalapril tab. 5 mg in a cell. pack No. 10×3
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Tablets are round, yellowish-pink in color, with a risk on one side and with a fault line on the other side, blotches are possible. The main active ingredient Enalapril Release form Tablets Dosage 5 mg Pharmacological action ACE inhibitor is an antihypertensive agent. Suppresses the formation of angiotensin II from angiotensin I and eliminates its vasoconstrictor effect. The drug gradually reduces blood pressure without causing changes in heart rate and minute blood volume. Reduces total peripheral vascular resistance, reduces afterload. It also reduces preload, reduces pressure in the right atrium and pulmonary circulation. The drug reduces left ventricular hypertrophy. The drug reduces the tone of the glomeruli that carry out arterioles of the kidneys, thereby improving intraglomerular hemodynamics, and prevents the development of diabetic nephropathy. The time of onset of the hypotensive effect when taken orally is 1 hour, it reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, therapy for several weeks is necessary to achieve the optimal level of blood pressure. In chronic heart failure, a noticeable clinical effect is observed with long-term treatment – 6 months or more. Pharmacokinetics After oral administration, approximately 60% of enalapril is absorbed from the gastrointestinal tract. It is metabolized in the liver to form an active metabolite, enalaprilat. The maximum concentration of enalaprilat in the blood serum is reached 3-4 hours after administration. Communication with plasma proteins of enalaprilat is 50-60%. The maximum plasma concentration of enalapril is achieved after 1 hour, enalaprilat – 3-4 hours. Enalaprilat easily passes through histohematic barriers, excluding the BBB, a small amount passes through the placenta and into breast milk. The half-life of enalaprilat is 11 hours. It is excreted mainly by the kidneys – 60% (20% – in the form of enalapril and 40% – in the form of enalaprilat), through the intestines – 33% (6% – in the form of enalapril and 27% – in the form of enalaprilat). It is removed during hemodialysis (speed 62 ml / min) and peritoneal dialysis. 4 days after the start of taking the drug, the half-life of enalaprilat stabilizes and is 11 hours. Excreted by the kidneys. Indications for use Treatment of arterial hypertension; Treatment of clinically significant heart failure; Prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction? 35%). food) with a small amount of liquid. The dosage regimen is set individually depending on the patient’s condition. In the treatment of arterial hypertension, the drug is prescribed at an initial dose of 5 mg / day (in this case, it is recommended to use the Enalapril dosage form – 5 mg tablets). After taking the initial dose, patients should be under medical supervision for 2 hours and an additional 1 hour until blood pressure stabilizes. Dose adjustment is carried out depending on the achieved clinical effect. Usually the maintenance daily dose is from 10-20 mg, in exceptional cases – up to 40 mg in 1 or 2 doses. If prescribed to patients simultaneously receiving diuretics, diuretic treatment should be discontinued 2 to 3 days before the appointment of enalapril. The initial dose for patients who received diuretics is 2.5 mg 1 time / day. When the initial dose of the drug is 2.5 mg, it is recommended to use the Enalapril dosage form – 2.5 mg tablets. With asymptomatic left ventricular dysfunction, the recommended initial dose of the drug is 2.5 mg 2 times / day, in this case it is recommended to use the Enalapril dosage form – 2.5 mg tablets. Dose adjustment is possible depending on the patient’s condition. The average maintenance dose is 10 mg 2 times / day. In chronic heart failure, the recommended initial dose of the drug is 2.5 mg 1 time / day, in this case it is recommended to use the Enalapril dosage form – 2.5 mg tablets. The dose of the drug should be increased gradually until the maximum clinical effect is achieved; on average, it takes 2 to 4 weeks to select the optimal dose. The average maintenance dose is 2.5-10 mg 1 time / day, the maximum daily maintenance dose is 40 mg (divided into 2 doses). In the treatment of arterial hypertension in kidney diseases, the dosing regimen is set depending on the severity of renal dysfunction or on the values of creatinine clearance. The initial dose of the drug should be gradually increased until a satisfactory clinical effect is achieved. With a creatinine clearance of 80-30 ml / min, the dose is usually 5-10 mg / day, creatinine clearance of 30-10 ml / min – 2.5 – 5 mg / day (in the case of 2.5 mg, it is recommended to use the Enalapril dosage form – tablets 2.5 mg). The duration of treatment depends on the effectiveness of therapy. With a too pronounced decrease in blood pressure, the dose of the drug is gradually reduced. Patients with impaired renal function Dosage in renal insufficiency The interval between doses of enalapril should be increased and / or the dose reduced. Enalapril is removed during dialysis. Dosage on days without dialysis should be adjusted according to blood pressure. If it is necessary to take the drug at a dose of 2.5 mg or 5 mg, it is recommended to use the dosage form of Enalapril – tablets of 2.5 mg or 5 mg. Elderly patients The dose should be adjusted according to the patient’s renal function. Children with arterial hypertension over the age of 6 years Experience with the clinical use of enalapril in children with arterial hypertension is limited. For children who can swallow tablets, the dose should be administered individually, according to the patient’s condition, response to treatment and the patient’s body weight. The recommended starting dose is 2.5 mg for patients weighing 20 to 50 kg (it is recommended to use Enalapril 2.5 mg tablets) and 5 mg for patients weighing ? 50 kg (it is recommended to use Enalapril dosage form – 5 mg tablets). Enalapril is taken once a day. The dosage should be adjusted according to needs up to a maximum of 20 mg per day for patients weighing 20 to 50 kg and 40 mg for patients weighing ? 50 kg. Use during pregnancy and lactation Pregnancy The use of ACE inhibitors is not recommended in the first trimester of pregnancy. Unless it is not possible to replace an ACE inhibitor with another alternative therapy, patients planning pregnancy should be switched to antihypertensive therapy with drugs whose safety profile for pregnant women is well established. If pregnancy occurs, the ACE inhibitor should be discontinued immediately and, if necessary, other antihypertensive therapy should be prescribed. The use of ACE inhibitors is contraindicated in the second and third trimesters of pregnancy. When using ACE inhibitors in the second and third trimesters of pregnancy, a manifestation of a fetotoxic effect (impaired kidney function, oligohydramniosis, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia) was established. In the event that an ACE inhibitor was taken from the second trimester of pregnancy, ultrasound of the function of the kidneys and bones of the skull is recommended. In newborns whose mothers have taken ACE inhibitors, blood pressure should be carefully monitored to prevent the possible development of hypotension. Lactation At the time of treatment should stop breastfeeding. Enalapril passes into breast milk in very low concentrations. Although the concentrations generated can be considered clinically insignificant, the use of this drug during breastfeeding is not recommended in case of birth of premature infants, as well as in the first few weeks after birth due to the perceived risk of adverse effects on the cardiovascular system and kidneys, as well as insufficient clinical experience. When feeding an older child, the use of these drugs is possible if therapy is considered necessary for the mother and the child’s condition is monitored in terms of the possible development of any adverse reactions. Precautions Enalapril should be used with caution in patients with obstruction of the outflow of blood from the left ventricle of the heart, coronary artery disease, cerebrovascular disease. During treatment with enalapril, systematic monitoring of blood pressure and renal function is necessary in patients with heart failure. In patients receiving diuretics, the dose of diuretics, if possible, should be reduced before starting treatment with enalapril. During the period of treatment, the content of potassium in the blood serum should also be monitored. Arterial hypotension often develops against the background of hypovolemia, salt restriction, during hemodialysis, against the background of diarrhea or vomiting, during surgery or anesthesia using compounds that cause arterial hypotension. In cases where hypotension becomes persistent, dose reduction and/or discontinuation of diuretic and/or enalapril treatment should be considered. In patients with bilateral stenosis of the arteries of the kidneys or stenosis of the artery of a single kidney, arterial hypotension that develops after the start of treatment with enalapril can lead to a deterioration in kidney function, an increase in serum urea and creatinine. When prescribing enalapril, rare cases of angioedema have been described (more often in patients of the Negroid race). In such cases, you should immediately stop treatment and establish constant monitoring of the patient until the symptoms disappear completely. Antihistamines in this case have a positive effect. With the development of suffocation against the background of edema, a solution of epinephrine (adrenaline) 0.1% (0.3-0.5 ml) should be injected subcutaneously and / or measures should be taken to ensure airway patency. In rare cases, the use of ACE inhibitors against the background of hyposensitization with hymenoptera allergens or dialysis using high-capacity membranes (for example, AN69) causes severe anaphylactoid reactions. In such patients, the use of another class of antihypertensive agents is recommended. There are reports of reversible non-productive cough during treatment with ACE inhibitors. In patients treated with enalapril for 48 weeks, there is an increase in serum potassium levels of 0.02 mEq / L. When treating with enalapril, the content of potassium in the blood serum should be monitored. Interaction with other drugs When administered simultaneously with potassium-sparing diuretics or potassium preparations, hyperkalemia may develop. With simultaneous use with diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin, an increase in the hypotensive effect is possible. With simultaneous use with NSAIDs (including acetylsalicylic acid), it is possible to reduce the effect of enalapril and increase the risk of developing impaired renal function. With simultaneous use with ethanol, as well as agents for general anesthesia, the risk of arterial hypotension increases. Enalapril weakens the effect of drugs containing theophylline. With simultaneous use with lithium preparations, the excretion of lithium is slowed down and its effect is enhanced. With simultaneous use with cimetidine, the half-life of enalapril is prolonged. Dual blockade of the renin-angiotensin-aldosterone system Based on available data, dual blockade of the RAAS with an ACE inhibitor, ARB II, or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR<60 ml/min/1.73 m2), the concomitant use of Aliskiren with an ACE inhibitor or ARB II is contraindicated. In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Gold preparations There have been isolated reports of nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) in patients receiving injectable gold preparations (sodium aurothiomalate) and ACE inhibitors, including enalapril. Antidiabetic drugs Epidemiological studies suggest that the concomitant use of ACE inhibitors and antidiabetic drugs (insulin, oral antidiabetic drugs) can lead to a marked decrease in blood sugar levels with a risk of hypoglycemia. This phenomenon is most likely to occur in patients with kidney damage during the first weeks of combined treatment. Tricyclic antidepressants / neuroleptics / anesthetics / narcotics The simultaneous use of some anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to an additional decrease in blood pressure. Sympathomimetics Sympathomimetics may reduce the antihypertensive effect. Acetylsalicylic acid, thrombolytics and β-blockers Enalapril can be safely administered simultaneously with acetylsalicylic acid (at a kadiologic dosage), thrombolytics and β-blockers. Contraindications Hypersensitivity to enalapril and other ACE inhibitors, a history of angioedema, pregnancy (especially the second and third trimesters of pregnancy), lactation, children under 18 years of age (safety and efficacy have not been determined). Renal failure: creatinine clearance less than 10 ml / min (for this dosage form). The simultaneous use of angiotensin-converting enzyme inhibitors or ATP receptor blockers with Aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2) is contraindicated. With caution: reduced function of the kidneys, liver, simultaneously with immunosuppressants, with bilateral stenosis of the renal arteries. Composition Each tablet contains: active substance enalapril maleate - 10.0 mg; auxiliary components: collidone 25 (povidone), lactose, corn starch, aerosil 200 (colloidal silicon dioxide), magnesium stearate, crimson 4 R (E-124), orange yellow (E-110). Overdose Data on overdose in humans are limited. The most characteristic features of an overdose recorded to date are severe arterial hypotension, which begins approximately 6 hours after taking the pill, simultaneously with the blockade of the renin-angiotensin system, stupor. Symptoms associated with an overdose of ACE inhibitors may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, restlessness, and cough. The recommended treatment for overdose is an intravenous infusion of saline. If hypotension occurs, the patient is placed horizontally with raised legs. Infusion of angiotensin II and/or catecholamines intravenously should be considered. If the drug has been taken recently, measures should be taken to remove enalapril maleate (for example, vomiting, gastric lavage, the introduction of sorbents and sodium sulfate). Enalapril can be removed from the general circulation by hemodialysis. With therapy-resistant bradycardia, the use of pacemakers is indicated. It is necessary to constantly monitor the basic vital functions, the concentration of electrolytes and creatinine in the blood serum. Side effects The side effects indicated below are presented in accordance with the following gradations of the frequency of their occurrence: very often (> 1/10); often (>1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (>1/10000, <1/1000); very rarely (<1/10000) (including isolated messages), unknown frequency (it is not possible to determine the frequency of occurrence from the available data). On the part of the blood: rarely - anemia (including aplastic and hemolytic), neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia, lymphadenopathy, autoimmune diseases. From the endocrine system: unknown - syndrome of impaired secretion of ADH. Metabolic disorders: infrequently - hypoglycemia. From the nervous system and psyche: often - depression, headache; rarely - confusion, drowsiness, insomnia, nervousness, paresthesia, vertigo, sleep disorders, abnormal dreams. On the part of the organs of vision: very often - blurred vision. From the side of the cardiovascular system: very often - dizziness; often - hypotension (including orthostatic hypotension), syncope, chest pain, rhythm disturbances, angina pectoris, tachycardia; rarely - orthostatic hypotension, tachycardia, myocardial infarction or stroke (possibly as a result of excessive pressure reduction in high-risk patients), Raynaud's phenomenon. From the respiratory system: very often - cough; often - shortness of breath; rarely - rhinorrhea, sore throat and hoarseness, bronchospasm / asthma, pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia. From the digestive tract: very often - nausea; often - diarrhea, abdominal pain, change in taste; rarely - intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, stomach irritation, dry mouth, peptic ulcers, stomatitis / aphthous ulcers, glossitis; very rarely - angioedema of the intestine. On the part of the digestive system: rarely - liver failure, hepatocellular or cholestatic hepatitis, hepatitis, including necrosis, cholestasis (including jaundice). From the skin and subcutaneous tissues: often - rash, hypersensitivity / angioedema of the face, limbs, lips, tongue, glottis and / or larynx; infrequently - increased sweating, itching, urticaria, alopecia; rarely - multiple erythema, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma. A complex symptom complex has been reported that includes some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity and other skin reactions can occur as side effects. From the urinary system: infrequently - impaired renal function, renal failure, proteinuria; rarely - oliguria. From the reproductive system: infrequently - impotence; rarely - gynecomastia. General disorders: very often - asthenia; often - fatigue; infrequently - muscle cramps, hot flashes, ringing in the ears, discomfort, fever. Changes in laboratory parameters: often - hyperkalemia, increased serum creatinine; rarely - an increase in the level of urea in the blood, hyponatremia, an increase in liver enzymes, bilirubin in the blood serum. Storage conditions In a place protected from moisture at a temperature not exceeding 25? Keep out of reach of children. Buy Enalapril tablets 5mg No. 10x6 Price for Enalapril tablets 5 mg No. 10x6