Name Enalapril Pharmland tabl. The main active ingredient is enalapril maleate Release form Tablets Dosage 10 mg Special instructions Like all vasodilators, ACE inhibitors should be used with caution in patients who have difficulty in outflow of blood from the left ventricle of the heart. Both before and after treatment with enalapril, systematic monitoring of blood pressure and renal function is necessary in patients with heart failure, since there have been reports of the development of arterial hypotension and (much less often) renal failure, as a result of taking the drug. In patients receiving diuretics, the dose of diuretics, if possible, should be reduced before starting treatment with enalapril. The development of arterial hypotension after taking the first dose of enalapril does not mean that arterial hypotension will persist during long-term treatment and does not indicate the need to stop taking the drug. During the period of treatment, the content of potassium in the blood serum should also be monitored. Clinically significant hypotension is rarely seen in patients with uncomplicated hypertension. In patients with arterial hypertension receiving enalapril, arterial hypotension develops more often against the background of hypovolemia, which occurs, for example, as a result of diuretic therapy, salt restriction; in patients on hemodialysis, as well as on the background of diarrhea or vomiting. Clinically pronounced arterial hypotension was also observed in patients with heart failure, accompanied or not accompanied by renal failure. Arterial hypotension is observed more often in patients with more severe forms of heart failure when using “loop” diuretics in high doses, in patients with hyponatremia or impaired renal function. In such patients, treatment with enalapril should be started under medical supervision, which should be especially careful when changing the dose of enalapril and / or diuretic. Similarly, patients with coronary artery disease, as well as those with cerebrovascular disease, in whom a sharp decrease in blood pressure can lead to a heart attack or stroke, should be monitored. With the development of arterial hypotension, the patient should be given a horizontal position and, if necessary, inject intravenous saline. Transient arterial hypotension when taking Enalapril is not a contraindication to treatment with the drug, which can be continued after replenishment of fluid volume and normalization of blood pressure. In some patients with heart failure and normal or reduced blood pressure, enalapril may cause an additional decrease in blood pressure. Such a reaction to taking the drug can be expected and should not be regarded as a reason to stop treatment. In cases where hypotension becomes persistent, the dose should be reduced and/or treatment with the diuretic and/or enalapril should be discontinued. In some patients, arterial hypotension that develops after the start of treatment with Enalapril may lead to deterioration in renal function. In some cases, the development of acute renal failure, usually reversible, has been reported. In some patients with bilateral stenosis of the arteries of the kidneys or stenosis of the artery of a single kidney, an increase in the content of urea in the blood and serum creatinine was observed. The changes were reversible, and the parameters returned to normal after treatment was stopped. This pattern of changes is most likely in patients with renal insufficiency. In some patients who did not show kidney disease prior to treatment, enalapril in combination with diuretics caused a slight increase in blood urea and serum creatinine. In such cases, it may be necessary to reduce the dose or cancel the diuretic and / or Enalapril. In patients with heart failure, treatment is carried out under close medical supervision. Both before and after the start of treatment with enalapril, careful monitoring of blood pressure and kidney function in patients with heart failure should be carried out, since there are reports of the development of arterial hypotension as a result of taking the drug, followed by (which is much less common) the development of renal failure. ACE, including Enalapril, described rare cases of angioedema of the face, extremities, lips, tongue, glottis and / or larynx that occurred at different periods of treatment.In such cases, you should immediately stop treatment with Enalapril and establish constant monitoring of the patient until the symptoms disappear completely. Only then can the observation be stopped.If the edema is limited to the face and lips, usually no special treatment is required, although antihistamines have a positive effect, improving the patient’s condition.Angioedema of the larynx can be fatal.In cases where the edema is localized in area of the tongue, glottis, or larynx and may cause airway obstruction, appropriate treatment should be initiated promptly, including s.c. In patients with a history of angioedema, not associated with the use of ACE inhibitors, there is an increased risk of its occurrence in the treatment of enalapril. In patients of the Black race who took ACE inhibitors, angioedema was observed more often than in representatives of other races. In rare cases, patients receiving ACE inhibitors have developed severe, life-threatening anaphylactoid reactions during hyposensitization with an allergen from hymenoptera venom. Such reactions can be avoided if you temporarily stop taking Enalapril before the onset of hyposensitization. In patients on dialysis using high-capacity membranes (eg, AN69) and concomitantly treated with an ACE inhibitor, in some cases, the use of a different type of dialysis membrane or a different class of antihypertensive drug is recommended. There are reports of coughing during treatment with ACE inhibitors. Usually the cough is unproductive, persistent and stops after the drug is discontinued. Cough associated with the use of ACE inhibitors should be considered in the differential diagnosis of cough. During major surgery or during anesthesia using compounds that cause arterial hypotension, enalapril blocks the formation of angiotensin II secondary to compensatory renin release. If at the same time severe arterial hypotension develops, which can be explained by this mechanism, then it should be corrected by increasing the volume of fluid administered. Serum potassium concentration usually remains within the normal range. In patients with arterial hypertension treated with enalapril for up to 48 weeks, there is an increase in serum potassium concentration up to 0.2 mEq / l. In the treatment of Enalapril, the content of potassium in the blood serum should be monitored. Enalapril is characterized by similar efficacy and tolerability in elderly and younger patients. Use in Pediatrics Data on the use of enalapril in children are limited. Pharmacological action Enalapril is an antihypertensive drug, the mechanism of action of which is associated with inhibition of the activity of angiotensin-converting enzyme, leading to a decrease in the formation of angiotensin-II. Enalapril refers to “prodrugs”: after its hydrolysis in the body, enalaprilat is formed, which inhibits the specified enzyme. Enalapril also has some diuretic effect. Along with a decrease in blood pressure, the drug reduces pre- and afterload on the myocardium in heart failure, improves blood circulation in the pulmonary circulation and respiratory function, lowers resistance in the kidney vessels, which contributes to the normalization of blood circulation in them. Pharmacokinetics After oral administration, Enalapril is rapidly and fairly completely absorbed from the gastrointestinal tract. The bioavailability of the drug is 53-74%, binding to plasma proteins – 50%. Cmax in the blood is achieved 3-4 hours after taking the drug inside. The duration of action is 1224 hours. The drug is metabolized in the liver, part of it is hydrolyzed into enalaprilat, therefore, in patients with impaired liver function, the time of maximum action may increase. The drug is excreted by the kidneys. T1 / 2 is about 11 hours. Indications for use – arterial hypertension of various forms and severity (including renovascular hypertension); – heart failure stage I-III as part of complex therapy, including asymptomatic left ventricular dysfunction (to slow the progression of heart failure, reduce the frequency of hospitalizations); – prevention of coronary ischemia in patients with left ventricular dysfunction (reduction in the incidence of myocardial infarction, reduction in the frequency of hospitalizations for unstable angina pectoris). Dosage and administration Inside, regardless of the time of the meal. Arterial hypertension The initial dose for mild hypertension is 5 mg and is prescribed 1 time / day. For other degrees of hypertension, the initial dose is 10 mg 1 time / day. If there is no effect, the dosage of the drug is increased by 5 mg with an interval of 1 week. Maintenance dose – 20 mg 1 time / day. The dosage is selected individually for each patient, but the dose should not exceed 40 mg / day. Renovascular hypertension Since blood pressure and renal function may be particularly sensitive to ACE inhibition in this group of patients, therapy is started with a lower initial dose of 2.5 mg. The dose is then adjusted according to the needs of the patient. The maximum daily dose is 40 mg of enalapril with daily intake. Concomitant treatment of arterial hypertension with diuretics After the first dose of Enalapril, arterial hypotension may develop. This effect is most likely in patients treated with diuretics. The drug is recommended to be administered with caution, as these patients may experience fluid or sodium deficiency. Treatment with diuretics should be discontinued 2-3 days before the start of treatment with enalapril. If this is not possible, then the initial dose of Enalapril should be reduced (to 5 mg or less) to determine the initial effect of the drug. Further, the dosage should be selected taking into account the patient’s condition. Dosage in renal insufficiency The interval between doses of Enalapril should be increased and / or the dose reduced. Heart failure / asymptomatic left ventricular dysfunction The initial dose of Enalapril in patients with chronic heart failure is 2.5 mg / day, while the drug should be prescribed under close medical supervision to establish the initial effect of the drug. Enalapril may be used to treat symptomatic heart failure, usually in conjunction with diuretics and, when appropriate, cardiac glycosides. In the absence of symptomatic hypotension, or after its appropriate correction at the beginning of treatment with enalapril, the dose should be increased at intervals of 1 week by 5 mg to the usual maintenance daily dose of 20 mg, which is administered once or divided into two doses, depending on the tolerability of the drug. patient. Dose adjustments may be made over 2-4 weeks, or shorter if there are residual signs and symptoms of heart failure. Recommended dosage titration of enalapril in patients with heart failure or asymptomatic left ventricular dysfunction. The development of arterial hypotension after taking the first dose of Enalapril does not mean that arterial hypotension will persist during long-term treatment, and does not indicate the need to stop taking the drug. Use in Elderly Patients The dose should be appropriate for the renal function of the elderly patient. Use during pregnancy and lactation Use during pregnancy and lactation The use of enalapril during pregnancy is not recommended. If pregnancy occurs, Enalapril should be discontinued immediately. ACE inhibitors can cause disease or death of the fetus or newborn when administered in the II and III trimesters of pregnancy. The use of ACE inhibitors during this period was accompanied by negative effects on the fetus and newborn, including arterial hypotension, renal failure, hyperkalemia and / or hypoplasia of the skull in the newborn. Perhaps the development of oligohydramnios, apparently due to a decrease in fetal kidney function. This complication can lead to contracture of the limbs, deformities of the facial bones of the skull, and hypoplasia of the lungs. When appointing Enalapril, it is necessary to inform the patient about the potential risk to the fetus. Such a complication, as a rule, did not occur in the first trimester of pregnancy due to the limited effect of ACE inhibitors on the fetus during this period. In those rare cases when the use of the drug during pregnancy is considered necessary, periodic ultrasound examinations should be performed to assess the intra-amniotic space. If oligohydramnios is detected, Enalapril should be discontinued unless its appointment is considered vital for the mother. However, both physicians and patients should be aware that oligohydramnios can develop after the fetus has suffered irreversible damage. Newborns whose mothers took Enalapril should be carefully examined to detect arterial hypotension, oliguria and hyperkalemia. Enalapril, which crosses the placental barrier, can be partially removed from the neonate by peritoneal dialysis; theoretically, it can be removed by exchange transfusion. Enalapril and enalaprilat are excreted in breast milk in trace concentrations. If necessary, the use of the drug during lactation, breastfeeding should be discontinued. Interaction with other drugs With the simultaneous appointment of enalapril with non-steroidal anti-inflammatory drugs (NSAIDs), it is possible to reduce the hypotensive effect of enalapril; with potassium-sparing diuretics (spironolactone, triamterene, amiloride) – hyperkalemia may develop; with lithium salts – slowing down the excretion of lithium (control of the concentration of lithium in the blood plasma is shown). During the period of treatment, it is forbidden to drink alcoholic beverages, since alcohol enhances the hypotensive effect of the drug. Simultaneous use of enalapril with antipyretic and analgesic drugs may reduce the effectiveness of enalapril. Enalapril weakens the effect of drugs containing theophylline. Cimetidine prolongs the action of enalapril. Simultaneous use with diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin enhances the hypotensive effect of enalapril. Contraindications – hypersensitivity to enalapril and other angiotensin-converting enzyme inhibitors; – a history of angioedema associated with treatment with ACE inhibitors; – aortic stenosis, mitral stenosis; – pregnancy, lactation; – childhood. Composition of enalapril maleate 10 mg Excipients: magnesium stearate, corn starch, gelatin, methyl parahydroxybenzoate, calcium phosphate, purified talc, E 122 carmoisine, dihydrate dihydrate. Overdose Symptoms: arterial hypotension. Treatment: put the patient on his back and raise his legs. In mild cases of overdose, a saline solution is administered orally to the patient. In more serious cases, in a hospital setting, measures are taken to stabilize blood pressure: intravenous administration of saline or plasma substitutes. Perhaps the use of hemodialysis. Side effects Enalapril is generally well tolerated and in most cases does not cause adverse reactions requiring discontinuation of the drug. From the side of the cardiovascular system: less than 2% – arterial hypotension, orthostatic hypotension, fainting; in some cases – myocardial infarction, stroke, possibly secondary to severe arterial hypotension in patients at high risk, chest pain, palpitations, cardiac arrhythmias, angina pectoris, Raynaud’s syndrome. From the side of the central nervous system and peripheral nervous system: most often – dizziness, headache; in 2-3% of cases – increased fatigue, asthenia; in some cases – depression, confusion, drowsiness, insomnia, irritability, sleep disturbances, paresthesia, tinnitus, blurred vision. From the digestive system: less than 2% – nausea, diarrhea; in some cases – intestinal obstruction, pancreatitis, liver failure, hepatitis (hepatocellular or cholestatic), jaundice, abdominal pain, vomiting, dyspepsia, constipation, anorexia, stomatitis, taste disturbance, glossitis, increased activity of hepatic transaminases and plasma bilirubin concentration (These changes are usually reversible and normalize after discontinuation of enalapril). From the respiratory system: less than 2% – cough; in some cases – pulmonary infiltrates, bronchospasm, bronchial asthma, shortness of breath, rhinorrhea, sore throat, hoarseness. From the urinary system: rarely – impaired renal function, renal failure, oliguria, increased urea, creatinine (these changes are usually reversible and normalize after stopping enalapril). Allergic reactions: less than 2% – skin rash; rarely – angioedema of the face, limbs, lips, tongue, glottis and / or larynx; in some cases – erythema multiforme, exfoliative dermatitis, Steven-Johnson syndrome, toxic epidermal necrolysis, urticaria. A complex symptom complex has been reported, which may include all or some of the following symptoms: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, elevated ESR, eosinophilia, and leukocytosis. On the part of the hematopoietic system: a decrease in hemoglobin and hematocrit levels is possible; in some cases – neutropenia, thrombocytopenia, agranulocytosis. Dermatological reactions: in some cases – increased sweating, pemphigus, itching, rash, alopecia, photosensitivity, redness of the skin of the face. On the part of laboratory parameters: the development of hyperkalemia and hyponatremia is possible. Others: less than 2% – muscle cramps; in some cases – impotence. In general, enalapril is well tolerated. The overall frequency of side effects when using Enalapril does not exceed that when prescribing placebo. In most cases, side effects are minor, are temporary and do not require discontinuation of therapy. Storage conditions Keep the drug out of the reach of children, in a place protected from moisture and light at a temperature not exceeding 25 ° C. Buy Enalapril Pharmland tablets 10mg No. 10×3 Price for Enalapril Pharmland tablets 10mg No. 10×3
INN | ENALAPRIL |
---|---|
The code | 3 901 |
Barcode | 4 810 368 009 715 |
Dosage | 10mg |
Active substance | Enalapril |
Manufacturer | Pharmland SP LLC, Belarus |
Indications Applications | arterial hypertension of various forms and severity (including renovascular hypertension); – heart failure stage I-III as part of complex therapy, including asymptomatic left ventricular dysfunction (to slow the progression of heart failure, reduce the frequency of hospitalizations); – prevention of coronary ischemia in patients with left ventricular dysfunction (reduction in the incidence of myocardial infarction, reduction in the frequency of hospitalizations for unstable angina pectoris). |
Contraindications | hypersensitivity to enalapril and other angiotensin-converting enzyme inhibitors; – a history of angioedema associated with treatment with ACE inhibitors; – aortic stenosis, mitral stenosis; – pregnancy, lactation; – childhood. |
Side effects | Enalapril is generally well tolerated and in most cases does not cause adverse reactions requiring discontinuation of the drug. From the side of the cardiovascular system: less than 2% – arterial hypotension, orthostatic hypotension, fainting; in some cases – myocardial infarction, stroke, possibly secondary to severe arterial hypotension in patients at high risk, chest pain, palpitations, cardiac arrhythmias, angina pectoris, Raynaud's syndrome. From the side of the central nervous system and peripheral nervous system: most often – dizziness, headache; in 2-3% of cases – increased fatigue, asthenia; in some cases – depression, confusion, drowsiness, insomnia, irritability, sleep disturbances, paresthesia, tinnitus, blurred vision. From the digestive system: less than 2% – nausea, diarrhea; in some cases – intestinal obstruction, pancreatitis, liver failure, hepatitis (hepatocellular or cholestatic), jaundice, abdominal pain, vomiting, dyspepsia, constipation, anorexia, stomatitis, taste disturbance, glossitis, increased activity of hepatic transaminases and plasma bilirubin concentration (These changes are usually reversible and normalize after discontinuation of enalapril). From the respiratory system: less than 2% – cough; in some cases – pulmonary infiltrates, bronchospasm, bronchial asthma, shortness of breath, rhinorrhea, sore throat, hoarseness. From the urinary system: rarely – impaired renal function, renal failure, oliguria, increased urea, creatinine (these changes are usually reversible and normalize after stopping enalapril). Allergic reactions: less than 2% – skin rash; rarely – angioedema of the face, limbs, lips, tongue, glottis and / or larynx; in some cases – erythema multiforme, exfoliative dermatitis, Steven-Johnson syndrome, toxic epidermal necrolysis, urticaria. A complex symptom complex has been reported, which may include all or some of the following symptoms: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, elevated ESR, eosinophilia, and leukocytosis. On the part of the hematopoietic system: a decrease in hemoglobin and hematocrit levels is possible; in some cases – neutropenia, thrombocytopenia, agranulocytosis. Dermatological reactions: in some cases – increased sweating, pemphigus, itching, rash, alopecia, photosensitivity, redness of the skin of the face. On the part of laboratory parameters: the development of hyperkalemia and hyponatremia is possible. Others: less than 2% – muscle cramps; in some cases – impotence. In general, enalapril is well tolerated. The overall frequency of side effects when using Enalapril does not exceed that when prescribing placebo. In most cases, side effects are minor, temporary and do not require discontinuation of therapy. |
Use during pregnancy and lactation | Forbidden to use |
Application Gender | Any |
Release Form | tablets |
Main Active Substances | enalapril maleate |
Composition Means | enalapril maleate 10 mg Excipients: magnesium stearate, corn starch, gelatin, methyl parahydroxybenzoate, calcium phosphate, purified talc, carmoisine E 122, disubstituted dihydrate. |
Reviews
There are no reviews yet.