Indapamide, Enalapril
Hemofarm
1096 Items
2019-09-19
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Clinical Pharmacology
Enzix DUO FORTE contains two separate medicines in one package: angiotensin-converting enzyme (APF) inhibitor ENALAPRIL and diuretic Indapamide.
Enalapril
Antihypertensive drug, its mechanism of action is associated with a decrease in the formation of angiotensin I angiotensin II, a decrease in the content of which leads to a direct decrease in the release of aldosterone. At the same time, the total peripheral vascular resistance, systolic and diastolic blood pressure (BP), post- and preload on the myocardium decrease. Expands the arteries to a greater extent than the veins, while a reflex increase in heart rate is not observed. Reduces the degradation of bradykinin, increases prostaglandin synthesis.
The hypotensive effect is more pronounced with a high level of plasma renin than with its normal or reduced level.
Reducing blood pressure in therapeutic limits does not affect the cerebral circulation, the blood flow in the brain vessels is maintained at a sufficient level and against the background of low blood pressure. Enhances coronary and renal blood flow. With prolonged use, the left ventricular hypertrophy of the myocardium and myocytes of the walls of resistant-type arteries is reduced, it prevents the progression of heart failure and slows down the development of left ventricular dilatation. Improves blood supply to ischemic myocardium.
Reduces platelet aggregation. It has some diuretic effect. Enalapril is a “prodrug”: as a result of its hydrolysis, enalaprilat is formed, which inhibits the angiotensin-converting enzyme (ACE).
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.
Indapamide
Antihypertensive, thiazide-like diuretic with moderate strength and long-lasting action, derived benzamidov. Reduces the tone of the smooth muscles of the arteries, reduces the total peripheral vascular resistance. It has moderate saluretic and diuretic effects, which are associated with the blockade of reabsorption of sodium ions, chlorine, hydrogen, and to a lesser extent potassium ions in the proximal tubule and the cortical segment of the distal nephron tubule. Vasodilator effects and a decrease in the total peripheral vascular resistance are based on the following mechanisms: a decrease in the reactivity of the vascular wall to norepinephrine and angiotensin II; an increase in the synthesis of prostaglandins with vasodilating activity; inhibition of calcium current in vascular smooth muscle cells. Helps to reduce left ventricular hypertrophy. In therapeutic doses, it does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).
The antihypertensive effect develops at the end of the first / beginning of the second week with constant use of the drug and persists for 24 hours against the background of a single dose.
The simultaneous use of enapril and indapamide leads to increased antihypertensive effect of enalapril.
Pharmacokinetics
Enalapril
After ingestion, about 60% is absorbed from the gastrointestinal tract. A simultaneous meal does not affect the absorption of enalapril. The link to plasma proteins for enalaprilat is 50-60%. Enalapril is rapidly and completely hydrolyzed in the liver to form an active metabolite, enalaprilat, which is a more active ACE inhibitor than enalapril. Bioavailability of the drug 40%.
The maximum concentration of enalapril in blood plasma is reached in 1-2 hours, enalaprilat - in 3-4 hours. Enalaprilat easily passes through histohematic barriers, excluding the blood-brain, a small amount penetrates the placenta and into breast milk.
The half-life of enalaprilat is about 11 hours. Enalapril is eliminated mainly through 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.
Indapamide
After ingestion is rapidly and completely absorbed from the gastrointestinal tract; bioavailability is high (93%). Meal somewhat slows down the rate of absorption, but does not affect the completeness of absorption. The maximum concentration in blood plasma is reached within 1-2 hours after ingestion. Equilibrium concentration is established after 7 days of regular intake. The average elimination half-life averages 14-18 h, the bond with plasma proteins is 79%. Also associated with elastin smooth muscle of the vascular wall. It has a high volume of distribution, passes through histohematogenous barriers (including placental), penetrates into breast milk.
Metabolized in the liver. 60 - 80% are excreted by the kidneys as metabolites (about 5% are excreted unchanged), through the intestine - 20%. In patients with renal insufficiency, pharmacokinetics do not change. Not cumulated.
Indications
Arterial hypertension.
Composition
1 tablet of enalapril contains: active ingredient - enalapril maleate - 20,000 mg;
excipients: lactose monohydrate - 116.400 mg, magnesium carbonate — 120,000 mg, gelatin — 10.700 mg, crospovidone — 10.700 mg, magnesium stearate — 2.200 mg.
1 tablet of indapamide contains: active ingredient - indapamide 2,5000 mg; excipients: lactose monohydrate - 76.9600 mg, povidone-K30 - 2.8200 mg, crospovidone - 0.8800 mg, magnesium stearate - 0.8800 mg, sodium lauryl sulfate - 0.4400 mg, talc - 3.5200 mg;
shell composition: hypromellose - 1.7222 mg, marogrogol 6000 - 0.3445 mg, talc - 1.9030 mg, titanium dioxide E 171 - 0.4303 mg.
Indapamide, Enalapril is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Enzix Duo Forte | Hemofarm | Serbia | pills |
| Enzix duo | Hemofarm | Serbia | pills |
| Enzix | Hemofarm | Serbia | pills |
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Dosage and Administration
Enzix DUO FORTE: 1 tablet Enalapril (20 mg) and 1 tablet film coated Indapamide (2.5 mg) are taken orally, in the morning at the same time. Depending on the dynamics of blood pressure indicators, the dose of Enalapril can be increased to twice the dose per day.
The maximum daily dose of enalapril is 40 mg, and indapamide is 2.5 mg.
In chronic renal failure, cumulation of Enalapril
occurs when filtration decreases below 10 ml / min. With creatinine clearance 80-30 ml / min. Enalapril dose should be 5-10 mg / day.
Adverse reactions
Enalapril
From the side of the central nervous system: headache, dizziness, weakness, insomnia, anxiety, confusion, fatigue, drowsiness (2-3%), very rarely with the use of high doses of nervousness, depression, paresthesia.
On the part of the respiratory system: non-productive dry cough, interstitial pneumonitis, bronchospasm / bronchial asthma, shortness of breath, rhinorrhea, pharyngitis.
On the part of the senses: disorders of the vestibular apparatus, impairment of hearing and vision, tinnitus.
On the part of the digestive tract: dry mouth, anorexia, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, abdominal pain), intestinal obstruction, pancreatitis, abnormal liver function and biliary excretion, hepatitis (hepatocellular or cholestatic), jaundice, stomatitis.
From the side of the cardiovascular system: excessive decrease in blood pressure, orthostatic collapse, rarely - chest pain, angina pectoris, myocardial infarction (usually associated with a pronounced decrease in blood pressure), arrhythmias (atrial brady or tachycardia, atrial fibrillation), heartbeat, thromboembolism vetmia , pain in the heart, fainting.
On the part of laboratory parameters: hypercreatininemia, an increase in the content of urea, an increase in the activity of “liver” enzymes, hyperbilirubinemia, hyperkalemia, hyponatremia. In rare cases, there is a decrease in hematocrit and hemoglobin concentration, increased ESR, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia. Hypoglycemia (in patients with diabetes).
Allergic reactions: skin rash, angioneurotic edema of face and extremities, lips, tongue, glottis and / or throat, dysphonia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, rash, photosensitivity, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis, intestinal angioedema (very rare).
On the part of the urinary system: renal dysfunction, proteinuria.
Other: alopecia, decreased libido, hot flashes, decreased potency.
Indapamide
On the part of the gastrointestinal tract: nausea / anorexia, dry mouth, gastralgia, vomiting, diarrhea, constipation, and discomfort in the abdomen are possible.
From the side of the central nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression; rarely - increased fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety.
From the senses: conjunctivitis, blurred vision.
On the part of the respiratory system: cough, pharyngitis, sinusitis, rarely - rhinitis.
Since the cardiovascular system: orthostatic hypotension, changes in the electrocardiogram, characteristic of hypokalemia, arrhythmias, palpitations.
On the part of the urinary system: an increase in the incidence of infections, nocturia, polyuria.
Allergic reactions: skin rash, urticaria, pruritus, hemorrhagic vasculitis.
Laboratory indicators: hypokalemia, hyponatremia, hypochloraemic alkalosis, increased urea nitrogen in blood plasma, hypercreatininemia, glycosuria, hypercalcemia.
Others - flu-like syndrome, chest pain, back pain, infections, decreased potency, decreased libido, rhinorrhea, sweating, weight loss, paresthesia, pancreatitis, exacerbation of systemic lupus erythematosus.
Enalapril
Hypersensitivity to enalapril and other ACE inhibitors, history of angioneurotic edema associated with treatment with ACE inhibitors, hereditary or idiopathic angioedema, simultaneous application of aliskiren and / or aliskirensoderzhaschimi drugs in patients with diabetes and / or moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m²), pregnancy, breastfeeding period, age up to 18 years (efficacy and safety is not tired) are updated).
Use with caution in primary hyperaldosteronism, bilateral renal artery stenosis, conditions accompanied by a decrease in circulating blood volume (BCC) (including vomiting, diarrhea), single kidney artery stenosis, hyperkalemia, condition after kidney transplantation; aortic stenosis, mitral stenosis (with impaired hemodynamic parameters), hypertrophic obstructive cardiomyopathy, renovascular hypertension, systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, etc.), ischemic heart disease, cerebrovascular diseases, diabetes mellitus, cerebrovascular disease, scleroderma, etc., ischemic heart disease, cerebrovascular diseases, diabetes mellitus, cerebrovascular disease, etc. g / day), liver failure, aggravated allergic history or angioedema in patients with a history of patients with restricted diet I eat salt or in hemodialysis; when taken concurrently with immunosuppressants, saluretics, potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes and lithium preparations, during the procedure for low-density lipoprotein apheresis (LDL-apheresis) using dextran sulfate, during the desensitization with the use of dextran, you can use dextran sulfate during the procedure for desensitization with the use of sulphate during the procedure for desensitization with IOM, using dextran sulphate, and in the case of a low density lipoprotein in patients of the Negroid race; in patients after major surgery or during general anesthesia; in patients on dialysis using high-flow membranes (such as AN 69®); in elderly patients (over 65 years).
Indapamide
Hypersensitivity to the drug, other sulfonamide derivatives or other components of the drug, anuria, refractory hypokalemia, severe liver failure (including with encephalopathy) and / or severe renal insufficiency (creatinine clearance less than 30 ml / min), pregnancy, thoracic period feeding, age up to 18 years (efficacy and safety have not been established).
With caution prescribed for diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), impaired liver and kidney function, disorders of water and electrolyte balance, hyperparathyroidism; in debilitated patients or in patients receiving a combination therapy with other antiarrhythmic drugs, while taking medications that prolong the QT interval.
Drug interactions
Enalapril
With the simultaneous appointment of enalapril with nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), it is possible to reduce the antihypertensive effect of enalapril; with potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride) can lead to hyperkalemia; with lithium salts - to slow the removal of lithium (the risk of lithium intoxication), shown to control the concentration of lithium in blood plasma.
In some patients with impaired renal function, and receiving NSAIDs, including inhibitors of COX-2, the concomitant use of ACE inhibitors can lead to a further deterioration in renal function. These changes are reversible.
Enalapril reduces the effect of drugs containing theophylline.
The antihypertensive effect of enalapril is enhanced by diuretics, beta-blockers, methyldopa, nitrates, blockers of “slow” calcium channels of the dihydropyridine series, hydralazine, prazosin.
Immunosuppressants, allopurinol, cytostatics increase hematotoxicity. Drugs that cause bone marrow depression increase the risk of developing neutropenia and / or agranulocytosis.
Combined use of ACE inhibitors and hypoglycemic agents (insulin, hypoglycemic agents for oral administration) can enhance the hypoglycemic effect of the latter with the risk of hypoglycemia. This is most often observed during the first weeks of joint use, as well as in patients with renal insufficiency. In patients with diabetes mellitus, receiving hypoglycemic agents for oral administration and insulin, it is necessary to control the concentration of blood glucose, especially during the first month of joint use with ACE inhibitors.
Symptom complex, including facial flushing, nausea, vomiting and hypotension, has been described in rare cases with the joint use of gold preparations for parenteral use (sodium aurothiomalate) and ACE inhibitors (enalapril).
When used simultaneously with aliskiren and / or aliskiren-containing drugs, the risk of a double blockade of the renin-angiotensin-aldosterone system (RAAS) increases. The combined use of enalapril and aliskiren or aliskiren-containing drugs in patients with diabetes and / or with impaired renal function (GFR less than 60 ml / min / 1.73 m2) is contraindicated.
Ethanol enhances the antihypertensive effect of ACE inhibitors.
Enalapril can be used simultaneously with acetylsalicylic acid (as an antiplatelet agent), thrombolytic agents and beta-blockers.
There was no clinically significant pharmacokinetic interaction between enalapril and hydrochlorothiazide, furosemide, digoxin, timolol, methyldopa, warfarin, indomethacin, sulindac and cimetidine. With the simultaneous use of enalapril and propranolol, the concentration of enalaprilat in the blood serum decreases, but this effect is not clinically significant.
Indapamide
UNDESIRABLE COMBINATIONS OF DRUGS
- Lithium preparations:
with simultaneous use of indapamide and lithium preparations, an increase in plasma lithium concentration may be observed due to a decrease in its excretion, accompanied by the appearance of signs of lithium overdose. If necessary, diuretic drugs can be used in combination with lithium preparations, and you should carefully select the dose of drugs, regularly monitoring the concentration of lithium in the blood plasma.
COMBINATION OF MEDICINES, REQUIRING SPECIAL ATTENTION
Drugs that can cause arrhythmia type "pirouette":
IA class antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide);
Class III antiarrhythmic drugs (amiodarone, dofetilide, ibutilide) and sotalol;
Some neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoroperazine), benzamides (amisulpride, sulpiride, sultopyrid, tiaprid), butyrophenones (droperidol, haloperidol)
others: bepridil, cisapride, difemanil, erythromycin (i.v.), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, astemizol, vincamine (i.v.).
Increased risk of ventricular arrhythmias, especially arrhythmias of the ʻ ʻpiruetʼʼ type (risk factor - hypokalemia).
It is necessary to determine the content of potassium in the blood plasma and, if necessary, correct it before the start of combination therapy with indapamide with the above preparations. It is necessary to control the clinical condition of the patient, control the electrolyte content of blood plasma, ECG parameters.
In patients with hypokalemia, it is necessary to use drugs that do not cause a pirouette-type arrhythmia.
- NSAIDs (for systemic use), including selective cyclooxygenase-2 inhibitors (COX-2), high doses of salicylates (≥ 3 g / day):
may decrease the antihypertensive action of indapamide.
With significant fluid loss, acute renal failure may develop (due to a decrease in GFR). Patients need to compensate for fluid loss and regularly monitor kidney function, both at the beginning of treatment and during treatment.
- ACE inhibitors:
Appointment of ACE inhibitors to patients with hyponatremia (especially patients with renal artery stenosis) is accompanied by the risk of developing sudden arterial hypotension and / or acute renal failure.
Patients with arterial hypertension and possibly reduced, due to the intake of diuretics, sodium plasma levels should:
3 days before the start of treatment with an ACE inhibitor, stop taking diuretics. In the future, if necessary, diuretic administration can be resumed;
or initiate an ACE inhibitor therapy with low doses, followed by a gradual increase in dose if necessary.
In chronic heart failure, treatment with ACE inhibitors should be initiated with low doses with a possible preliminary reduction in diuretic doses.
In all cases, in the first week of taking ACE inhibitors in patients, it is necessary to monitor renal function (plasma creatinine concentration).
- Other drugs that can cause hypokalemia: amphotericin B (IV), gluco-and mineralocorticosteroids (for systemic use), tetracosactide, laxatives that stimulate intestinal motility:
increased risk of hypokalemia (additive effect).
Requires regular monitoring of potassium in the blood plasma, if necessary, its correction. Particular attention should be paid to patients simultaneously receiving cardiac glycosides. It is recommended to use laxatives that do not stimulate intestinal motility.
- Baclofen:
may increase antihypertensive action.
Patients need to compensate for fluid loss and at the beginning of treatment carefully monitor kidney function.
- Cardiac glycosides:
hypokalemia enhances the toxic effect of cardiac glycosides.
With simultaneous use of indapamide and cardiac glycosides should be monitored for the content of potassium in the blood plasma, ECG indicators, and, if necessary, adjust therapy.
COMBINATION OF PREPARATIONS ATTENTION
- Potassium-sparing diuretics (amiloride, spironolactone, triamterene, eplerenone):
co-administration of indapamide with potassium-sparing diuretics is advisable in some patients, however, this does not exclude the possibility of the development of hypokalemia (especially in patients with diabetes and renal failure) or hyperkalemia.
It is necessary to monitor the content of potassium in the blood plasma, ECG indicators and, if necessary, adjust therapy.
- Metformin:
functional renal failure, which may occur in the presence of diuretics, especially “loop”, while the appointment of metformin increases the risk of developing lactic acidosis.
Metformin should not be used if the concentration of creatinine exceeds 15 mg / l (135 μmol / l) in men and 12 mg / l (110 μmol / l) in women.
- Iodine-containing contrast agents:
Dehydration while taking diuretic drugs increases the risk of developing acute renal failure, especially when using high doses of iodine-containing contrast agents.
Patients need to compensate for fluid loss before using iodine-containing contrast agents.
- Tricyclic antidepressants, antipsychotics (antipsychotics):
drugs of these classes enhance the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect).
- Calcium salts:
with simultaneous appointment may develop hypercalcemia due to a decrease in the excretion of calcium ions by the kidneys.
- Cyclosporin, tacrolimus:
It is possible to increase the concentration of creatinine in the blood plasma without changing the concentration of the circulating cyclosporine, even with a normal content of fluid and sodium ions.
- Corticosteroids (mineral and glucocorticosteroids), tetrakozaktid (for systemic use):
reduced antihypertensive effect (fluid retention and sodium ions as a result of corticosteroids).
Pregnancy and Lactation
The drug is contraindicated for use during pregnancy and lactation. If necessary, the use of the drug Enzix during lactation breastfeeding should be stopped.
Newborns and infants who have been exposed to intrauterine effects of ACE inhibitors are recommended to be closely monitored to detect a pronounced decrease in blood pressure, oliguria, hyperkalemia and neurological disorders, which may develop as a result of a decrease in renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors. When oliguria, it is necessary to maintain blood pressure and renal perfusion by injecting appropriate fluids and vasoconstrictor agents.
Special instructions
The simultaneous use of enalapril and indapamide leads to increased antihypertensive effect of enalapril.
Enalapril
Symptomatic arterial hypotension
Symptomatic arterial hypotension is rarely observed in patients with uncomplicated arterial hypertension. In patients with arterial hypertension who take enalapril, arterial hypotension develops more frequently on the background of dehydration resulting, for example, from diuretic therapy, restriction of salt intake, in patients on dialysis, as well as in patients with diarrhea or vomiting (see sections "Side effects"; "Interaction with other drugs"). Symptomatic arterial hypotension was also observed in patients with heart failure with or without renal failure. Hypotension occurs more frequently in patients with severe chronic heart failure with hyponatremia or impaired renal function, who use higher doses of "loop" diuretics. In these patients, treatment with enalapril should be initiated under medical supervision, which should be especially careful when changing the dose of enalapril and / or diuretic. Similarly, patients with coronary heart disease or with cerebrovascular diseases should be monitored for whom an excessive decrease in blood pressure can lead to the development of myocardial infarction or stroke.
With the development of arterial hypotension, the patient should be laid down and, if necessary, 0.9% sodium chloride solution should be introduced. Transient arterial hypotension when taking enalapril is not a contraindication to further use and increasing the dose of the drug, which can be continued after replenishing the fluid volume and normalizing blood pressure.
In some patients with heart failure and with normal or decreased blood pressure, enalapril may cause an additional decrease in blood pressure. This reaction to taking the drug is expected and is not a reason to stop treatment. In cases where arterial hypotension is stable, the dose should be reduced and / or discontinued diuretic and / or enalapril treatment.
Renovascular hypertension
The use of ACE inhibitors has a beneficial effect in patients with renovascular hypertension, both awaiting surgery, and when it is impossible to perform the operation. Treatment should begin with low doses of the drug, in a hospital, evaluating both the functional activity of the kidneys and the content of potassium in the blood plasma. Some patients may develop functional kidney failure, which quickly disappears after drug withdrawal.
Aortic or mitral stenosis / hypertrophic obstructive cardiomyopathy
As with all drugs that have a vasodilating effect, ACE inhibitors should be used with caution in patients with obstruction of the outflow path from the left ventricle.
Renal dysfunction
In some patients, arterial hypotension, which develops after the start of treatment with ACE inhibitors, may lead to a further deterioration in renal function. In some cases, the development of acute renal failure has been reported, usually of a reversible nature.
In patients with renal insufficiency, a reduction in the dose and / or frequency of drug administration may be required. In some patients with bilateral renal artery stenosis or arterial stenosis of a single kidney, an increase in blood urea and serum creatinine was observed. Changes were usually reversible. This pattern of change is most likely in patients with impaired renal function.
In some patients who did not have kidney disease before treatment, enalapril in combination with diuretics usually caused a slight and transient increase in the concentration of urea in the blood and serum creatinine. In such cases, it may be necessary to reduce the dose and / or cancel diuretic and / or enalapril.
Kidney transplantation
There is no experience of using the drug in patients after kidney transplantation; therefore, treatment with enalapril is not recommended in patients after kidney transplantation.
Liver failure
The use of ACE inhibitors has rarely been associated with the development of a syndrome beginning with cholestatic jaundice or hepatitis and progressive to fulminant liver necrosis, sometimes with a fatal outcome. With the appearance of jaundice or a significant increase in the activity of "liver" transaminases against the background of the use of ACE inhibitors, the drug should be discontinued and the appropriate supportive therapy prescribed, the patient should be under appropriate supervision.
Neutropenia / Agranulocytosis
Neutropenia / agranulocytosis, thrombocytopenia and anemia were observed in patients taking ACE inhibitors. Neutropenia occurs rarely in patients with normal renal function and without other complicating factors. Enalapril should be used with extreme caution in patients with systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, etc.) taking immunosuppressive therapy, allopurinol or procainamide, or a combination of these complicating factors, especially if there are impaired renal function. Some of these patients developed serious infectious diseases, which in some cases did not respond to intensive antibiotic therapy. If enalapril is used in these patients, it is recommended that regular monitoring of the number of white blood cells and lymphocytes in the blood is recommended, and patients should be warned to report any signs of an infectious disease.
Hypersensitivity Reactions / Angioedema
When using ACE inhibitors, including enalapril, there were rare cases of angioedema of the face, extremities, lips, tongue, vocal folds and / or larynx that occurred during different periods of treatment. In very rare cases, intestinal edema has been reported.In such cases, you should immediately stop taking enalapril and carefully monitor 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 the development of respiratory distress syndrome, patients may need long-term follow-up, since therapy with antihistamines and corticosteroids may not be sufficient.
Fatalities due to angioedema associated with laryngeal edema or tongue edema have been reported very rarely. Swelling of the tongue, vocal folds, or larynx can lead to airway obstruction, especially in patients who have had respiratory surgery. In cases where edema is localized in the area of the tongue, vocal folds or larynx and can cause obstruction of the respiratory tract, appropriate treatment should be immediately prescribed, which may include subcutaneous administration of a 0.1% solution of epinephrine (epinephrine) (0.3-0.5 ml) and / or to ensure airway patency.
In patients of the Negroid race who took ACE inhibitors, angioedema was observed more often than in patients of other races.
Patients with a history of angioedema, not associated with taking ACE inhibitors, may be at greater risk of developing angioedema during therapy with ACE inhibitors (see the section "Contraindications").
Anaphylactoid reactions during desensitization with hymenoptera venom
In rare cases, patients taking ACE inhibitors developed life-threatening anaphylactoid reactions during desensitization therapy with hymenoptera venom (bees, wasps). Undesirable reactions can be avoided if prior to the start of desensitization, temporarily stop taking an ACE inhibitor.
Anaphylactoid reactions during LDL apheresis
Patients taking ACE inhibitors during LDL apheresis using dextran sulfate, rarely observed life-threatening anaphylactoid reactions. The development of these reactions can be avoided if you temporarily cancel the ACE inhibitor before the start of each LDL-apheresis procedure.
Hemodialysis patients
Anaphylactoid reactions were observed in patients undergoing dialysis using high-flow membranes (such as AN69®) and simultaneously receiving therapy with ACE inhibitors. In such patients, it is necessary to use dialysis membranes of another type or antihypertensive drugs of other classes.
Cough
There have been cases of cough during therapy with ACE inhibitors. As a rule, the cough is unproductive, permanent and stops after discontinuation of therapy. Cough associated with the use of ACE inhibitors should be considered in the differential diagnosis of cough.
Surgical interventions / general anesthesia
During large surgical interventions or general anesthesia using agents that cause an antihypertensive effect, enalaprilat blocks the formation of angiotensin II, caused by a compensatory release of renin. If this develops
a pronounced decrease in blood pressure, explained by a similar mechanism, it can be adjusted by increasing the volume of circulating blood.
Hyperkalemia (see section "Interaction with other drugs")
The risk of developing hyperkalemia is observed in old age, with renal failure, diabetes, some related conditions (heart failure in the decompensation stage, metabolic acidosis), as well as the simultaneous use of potassium-sparing diuretics (for example, spironolactone, eplerenone, triamterene or amyloride), potassium supplements or potassium salts.
The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salts, especially in patients with impaired renal function, can lead to a significant increase in serum potassium. Hyperkalemia can lead to serious, sometimes fatal, arrhythmias.
If necessary, the simultaneous use of enalapril and the above medicines should be careful and regularly monitor the content of potassium in the blood serum.
Hypoglycemia
Patients with diabetes who take hypoglycemic agents for oral administration or insulin should be informed about the need to regularly monitor the concentration of glucose in the blood, especially during the first month of simultaneous use of these drugs (see section "Interaction with other drugs means ").
Lithium preparations
The simultaneous use of lithium and enalapril preparations is not recommended (see the section "Interaction with Other Medicines").
Double blockade of RAAS
It was reported about the development of arterial hypotension, fainting, stroke, hyperkalemia and impaired renal function (including acute renal failure) in susceptible patients, especially if combined therapy with drugs affecting the RAAS is used (see section "Interaction with other drugs") . It is not recommended to conduct a double blockade of RAAS by the combined use of ACE inhibitors with antagonists of angiotensin II or aliskiren receptors. Concurrent use of enalapril with aliskiren or aliskiren-containing drugs in patients with diabetes and / or with impaired renal function (GFR less than 60 ml / min / 1.73 m2) is contraindicated (see section "Contraindications").
The simultaneous use of an ACE inhibitor with angiotensin II receptor antagonists in patients with diabetic nephropathy is not recommended.
Use in elderly patients
In elderly patients, before taking the drug, the kidney function and the potassium content in the body should be evaluated.
Ethnic differences
As with the use of other ACE inhibitors, enalapril seems to be less effective in lowering blood pressure in patients of the Negroid race than in patients of other races, which may be explained by a higher prevalence of conditions with low plasma renin activity in the population of Negroid patients with AH.
Indapamide
In the appointment of thiazide and thiazide-like diuretics in patients with impaired liver function, hepatic encephalopathy may develop, especially in the case of an imbalance of water and electrolyte. In this case, diuretic should be stopped immediately.
Photosensitivity
While receiving thiazide and thiazide-like diuretics, photosensitivity reactions have been reported (see the “Side Effects” section). In the case of the development of photosensitivity reactions on the background of taking the drug should stop treatment. If necessary, continue diuretic therapy is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.
Water and electrolyte balance
The content of sodium ions in the blood plasma
Prior to treatment, it is necessary to determine the sodium content in the blood plasma. While taking the drug, this indicator should be regularly monitored. All diuretic drugs can cause hyponatremia, sometimes leading to extremely serious consequences. Regular monitoring of the sodium content is necessary, as initially the reduction of sodium in the blood plasma may not be accompanied by the appearance of pathological symptoms. The most careful control of the sodium content is necessary for patients with cirrhosis of the liver and elderly patients.
Content of potassium ions in blood plasma
In the treatment of thiazide and thiazide-like diuretics, the main risk lies in a sharp decrease in the content of potassium in the blood plasma and the development of hypokalemia. It is necessary to avoid the risk of hypokalemia (potassium content less than 3.4 mmol / l) in the following groups of patients: elderly patients, debilitated patients or patients receiving combined drug therapy with other antiarrhythmic drugs and drugs that can increase the QT interval, patients with cirrhosis liver, peripheral edema or ascites, coronary heart disease, heart failure. Hypokalemia in patients of these groups increases the toxic effect of cardiac glycosides and increases the risk of developing arrhythmias.
In addition, high-risk patients are patients with an extended QT interval, and it does not matter if this increase is caused by congenital causes or effects of drugs.
Hypokalemia, as well as bradycardia, is a condition that contributes to the development of severe arrhythmias and, especially, pirouette-type arrhythmias, which can be fatal. In all the cases described above, it is necessary to regularly monitor the content of potassium in the blood plasma. The first measurement of the potassium content in the blood must be carried out within the first week of starting treatment. When hypokus appears
- Brand name: Enzix Duo Forte
- Active ingredient: Indapamide, Enalapril
- Dosage form: Enzix DUO FORTE, pills set: indapamide, pills, film-coated 2.5 mg + enalapril, pills 20 mg.
On 10 pills of enalapril and on 5 pills of Indapamide in the Al / Al blister laminated by PVC and a polyamide film. On 3 blisters with the application instruction in a pack cardboard.
- Manufacturer: Hemofarm
- Country of Origin: Serbia
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