Noliprel® A B-forte
Lithium preparations
Simultaneous use of a combination of perindopril and indapamide with lithium preparations is not recommended (see section "Interaction with other drugs").
Impaired renal function
Therapy with Noliprel ® A B-forte is contraindicated in patients with moderate and severe renal insufficiency (CC less than 60 ml / min.). In some patients with AH, without previous obvious impairment of kidney function on the background of therapy, there may be laboratory signs of functional renal failure. In this case, treatment with Noliprel® A B-forte should be discontinued. In the future, you can resume combination therapy using low doses of a combination of perindopril and indapamide, or use drugs in monotherapy.
Such patients need regular monitoring of the content of potassium and creatinine ions in the blood serum - 2 weeks after the start of therapy and then every 2 months. Renal failure often occurs in patients with severe chronic heart failure or an initial impairment of kidney function, including with renal artery stenosis.
Noliprel® A B-forte is not recommended for patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single functioning kidney.
Arterial hypotension and disturbance of water-electrolyte balance
Hyponatremia is associated with a risk of sudden development of arterial hypotension (especially in patients with renal artery stenosis, including bilateral). Therefore, when monitoring patients, attention should be paid to possible symptoms of dehydration and a decrease in the electrolyte content in the blood plasma, for example, after diarrhea or vomiting. Such patients need regular monitoring of the content of plasma electrolytes.
With severe arterial hypotension, intravenous administration of 0.9% sodium chloride solution may be required.
Transient arterial hypotension is not a contraindication for the continuation of therapy. After the recovery of bcc and blood pressure, one can resume therapy using low doses of a combination of perindopril and indapamide, or use drugs in monotherapy.
The content of potassium
The combined use of perindopril and indapamide does not prevent the development of hypokalemia, especially in patients with diabetes mellitus or renal insufficiency. As with other antihypertensive agents in combination with a diuretic, regular monitoring of the potassium ion content in the blood plasma is necessary.
Excipients
It should be borne in mind that the composition of excipients of the drug includes lactose monohydrate. Do not prescribe Noliprel® fort for patients with hereditary intolerance to galactose, lactase deficiency and glucose-galactose malabsorption.
Perindopril
Neutropenia / agranulocytosis
The risk of developing neutropenia against the background of the administration of ACE inhibitors is dose-dependent and depends on the drug taken and the presence of concomitant diseases.Neutropenia rarely occurs in patients without concomitant diseases, but the risk increases in patients with impaired renal function, especially against the background of systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma).
After the withdrawal of ACE inhibitors, the clinical signs of neutropenia pass independently.
With extreme caution should be applied perindopril in patients with systemic connective tissue diseases, with the use of immunosuppressive agents, allopurinol or procainamide and when they are used together, especially in patients with initial renal impairment. Some patients experienced severe infectious diseases, in some cases, resistant to intensive antibiotic therapy. When prescribing perindopril to such patients it is recommended to periodically monitor the number of white blood cells in the blood. Patients should inform the doctor of any signs of infectious diseases (eg, angina, fever).
Hypersensitivity / angioedema (angioedema)
When taking ACE inhibitors, including perindopril, in rare cases, development of angioedema of the face, limbs, lips, tongue, glottis and / or larynx can be observed.If symptoms appear, taking Nolipret A B-forte should be stopped immediately and the patient should be observed until the signs of edema disappear completely. If the edema affects only the face and lips, then its manifestations usually pass independently, although antihistamines can be used to treat its symptoms. Angioedema, accompanied by swelling of the larynx, can lead to death. Swelling of the tongue, glottis or larynx can lead to airway obstruction. When such symptoms occur, immediately enter subcutaneously epinephrine (epinephrine) in a dilution of 1: 1000 (0.3 or 0.5 ml) and / or provide airway patency.
Patients with a history of Quincke edema who are not associated with the administration of ACE inhibitors may be at increased risk of developing it with the use of this group of drugs (see section "Contraindications").
In rare cases, against the background of therapy with ACE inhibitors, angioedema develops in the intestine. In this case, patients have abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without a prior angioedema and with normal activity of the C1-esterase enzyme.The diagnosis is established using computed tomography of the abdominal region, ultrasound or at the time of surgery. Symptoms disappear after stopping the intake of ACE inhibitors. In patients with abdominal pain receiving ACE inhibitors, the differential diagnosis should take into account the possibility of developing angioedema edema of the intestine.
Anaphylactoid reactions during desensitization
There are separate reports on the development of long-term, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with the poison of Hymenoptera insects (bees, wasps). ACE inhibitors should be used with caution in patients with a history of allergic anamnesis or susceptibility to allergic reactions following desensitization procedures. The use of an ACE inhibitor should be avoided in patients receiving immunotherapy with venom of Hymenoptera. However, the anaphylactoid reaction can be avoided by the temporary withdrawal of the ACE inhibitor at least 24 hours before the desensitization procedure begins.
Anaphylactoid reactions during apheresis of LDL
In rare cases, patients receiving ACE inhibitors may develop life-threatening anaphylactoid reactions during LDL-apheresis with dextran sulfate. To prevent anaphylactoid reaction, therapy with an ACE inhibitor should be temporarily discontinued before each apheresis procedure.
Hemodialysis
In patients receiving ACE inhibitors, anaphylactoid reactions were noted in hemodialysis using high-flow membranes (eg AN69®). Therefore, it is desirable to use a membrane of a different type or to use an antihypertensive agent of another pharmacotherapeutic group.
Potassium-sparing diuretics and potassium preparations
As a rule, the combined use of perindopril and potassium-sparing diuretics, as well as potassium and potassium-containing substitutes for edible salt is not recommended (see section "Interaction with other drugs").
Cough
Against the background of therapy with an ACE inhibitor, dry cough may occur. Cough persists for a long time against the background of taking this group's drugs and disappears after their withdrawal.When a patient has a dry cough, remember the possible connection of this symptom with the use of an ACE inhibitor. If the doctor believes that ACE inhibitor therapy is necessary for the patient, the drug may be continued.
Children and teens
Noliprel® A B-Fort should not be given to children and adolescents under the age of 18 due to a lack of data on the efficacy and safety of monopreparations or combination therapy in patients of this age group.
The risk of arterial hypotension and / or renal failure (in patients with chronic heart failure, water-electrolyte balance disorders, etc.)
In some pathological states, a significant activation of RAAS can occur, especially in severe hypovolemia and a decrease in the content of plasma electrolytes (against a background of a salt-free diet or long-term diuretics), in patients with initially low blood pressure, renal artery stenosis (including bilateral), chronic heart failure or cirrhosis of the liver with edema and ascites.
The use of ACE inhibitors causes blockade of the RAAS and therefore may be accompanied by a sharp decrease in blood pressure and / or an increasethe concentration of creatinine in the blood plasma, indicating the development of functional renal failure. These phenomena are more often observed with the first dose of the drug or during the first two weeks of therapy. Sometimes these conditions develop sharply. In such cases, when restarting therapy, it is recommended that a combination of perindopril and indapamide be used at a lower dose and then gradually increased the dose.
Elderly patients
Before starting the drug Noliprel® A B-forte it is necessary to evaluate the functional activity of the kidneys and the content of potassium ions in the blood plasma. At the beginning of therapy, the dose of the drug is selected, taking into account the degree of BP reduction, especially in case of a decrease in bcc and loss of electrolytes. Such measures allow to avoid a sharp decrease in blood pressure.
Atherosclerosis
The risk of hypotension exists in all patients but particular care should be taken using the drug in patients with ischemic heart disease and cerebrovascular insufficiency. In such patients, treatment should begin with low doses of a combination of perindopril arginine and indapamide.
Patients with Renovascular Hypertension
The method of treating reninvascular hypertension is revascularization. Nevertheless, the use of ACE inhibitors has a beneficial effect in patients, both awaiting surgery, and in the case when surgical intervention can not be performed.
In patients with diagnosed or suspected renal artery stenosis, treatment should begin with lower doses of a combination of perindopril and inadampamide. Some patients may develop functional renal failure, which disappears when the drug Noliprel® A B-forte is discontinued.
Other risk groups
In patients with chronic heart failure (NYHA functional class IV) and patients with type 1 diabetes (risk of spontaneous increase in potassium ions) treatment should begin with lower doses of the combination of perindopril and indapamide. and under constant medical supervision.
Patients with arterial hypertension and coronary heart disease should not stop taking beta-blockers: a combination of perindopril and indapamide should be used in conjunction with beta-blockers.
Patients with diabetes mellitus
When Noliprel® A B-forte is prescribed, patients with diabetes mellitus who receive hypoglycemic agents for ingestion or insulin during the first month of therapy need regular monitoring of the glucose concentration in the blood plasma.
Ethnic differences
Perindopril, like other ACE inhibitors, obviously has a less pronounced hypotensive effect in patients of the Negroid race compared with representatives of other races. Perhaps this difference is due to the fact that patients with arterial hypertension of the Negroid race are more likely to have low renin activity.
Surgery / General Anesthesia
The use of ACE inhibitors in patients undergoing surgery with general anesthesia can lead to a marked decrease in blood pressure, especially when using means for general anesthesia that have an antihypertensive effect.
It is recommended to stop the use of long-acting ACE inhibitors, including perindopril, 12 hours before surgery.
Aortic stenosis / mitral stenosis / Hypertrophic cardiomyopathy
ACE inhibitors should be administered with caution to patients with left ventricular outflow obstruction and mitral stenosis.
Liver failure
In rare cases, when taking ACE inhibitors, cholestatic jaundice occurs. With the progression of this syndrome, fulminant liver necrosis develops, sometimes with a fatal outcome. The mechanism of development of this syndrome is unclear. When jaundice appears on the background of taking ACE inhibitors, the patient should consult a doctor. With a significant increase in the activity of "liver" enzymes against the background of taking ACE inhibitors, stop taking Nolipret A B-forte (see "Side effect").
Anemia
Anemia can develop in patients after kidney transplantation or in patients on hemodialysis. In this case, the decrease in hemoglobin is greater, the higher was its initial value. This effect, apparently, is not dose-dependent, but may be related to the mechanism of action of ACE inhibitors.
Hyperkalemia
Hyperkalemia can develop during treatment with ACE inhibitors, including perindopril.Risk factors for hyperkalemia include renal failure, impaired renal function, advanced age, diabetes mellitus, certain concomitant conditions (dehydration, acute decompensation of chronic heart failure, metabolic acidosis), concurrent administration of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as preparations of potassium or potassium-containing substitutes for edible salt, as well as the use of other agents that increase the content of potassium ions in the blood plasma (eg, heparin) (especially in patients with reduced renal function). Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If combined use of the aforementioned agents is required, treatment should be conducted with caution, against a background of regular monitoring of potassium ions in the blood serum (see section "Interaction with other drugs").
Indapamide
In the presence of violations of the liver, the use of thiazide and thiazide-like diuretics can lead to the development of hepatic encephalopathy.In this case, stop taking Nolipret A B-forte immediately.
Photosensitivity
In patients receiving thiazide and thiazide diuretics reported cases of photosensitivity reactions (see. Section "Side effects"). In the case of developing photosensitivity reaction against the background of taking the drug should stop treatment. If it is necessary to continue therapy with diuretics, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.
Water-electrolyte balance
Content of sodium ions in blood plasma
Before the start of treatment it is necessary to determine the content of sodium ions in the blood plasma. Against the background of taking the drug should regularly monitor this figure. All diuretics can cause hyponatraemia, which sometimes leads to serious complications. Hyponatremia at the initial stage may not be accompanied by clinical symptoms, so regular laboratory monitoring is necessary. More frequent monitoring of the content of sodium ions is shown elderly patients (see. The sections "Side effect" and "Overdose").
The content of potassium ions in the blood plasma
Therapy with thiazide and thiazide-like diuretics is associated with a risk of hypokalemia. It is necessary to avoid hypokalemia (less than 3.4 mmol / L) in the following categories of patients at high risk: elderly patients, depleted patients or receiving concomitant medication, patients with cirrhosis, peripheral edema or ascites, coronary heart disease, chronic heart failure . Hypokalemia in these patients increases the toxic effect of cardiac glycosides and increases the risk of arrhythmia.
Patients with an increased QT interval also belong to the high-risk group, but it does not matter whether this increase is due to congenital causes or effects of drugs.
Hypokalemia, like bradycardia, contributes to the development of severe cardiac arrhythmias, especially arrhythmias such as pirouettes, which can be fatal. In all cases described above, regular monitoring of the potassium ion content in the blood plasma is necessary. The first measurement of the content of potassium ions should be carried out during the first week after the start of therapy.
If hypokalemia is detected, appropriate treatment should be prescribed.
The content of calcium ions in the blood plasma
Thiazide and thiazide-like diuretics reduce the excretion of calcium ions by the kidneys, leading to a slight and temporary increase in the content of calcium ions in the blood plasma. Expressed hypercalcemia may be a consequence of previously not diagnosed hyperparathyroidism. Before examining the function of parathyroid glands, you should cancel the use of diuretics.
The concentration of glucose in the blood plasma
It is necessary to monitor the concentration of glucose in the blood in patients with diabetes mellitus, especially in the presence of hypokalemia.
Uric acid
In patients with elevated uric acid concentration in blood plasma, the frequency of gout attacks may increase with therapy.
Diuretics and kidney function
Thiazide and thiazide-like diuretics are effective only in patients with normal or slightly impaired renal function (creatinine plasma concentration in adult patients is below 25 mg / L or 220 μmol / L). In elderly patients, CC is calculated taking into account age, body weight and sex.
At the beginning of treatment with diuretics in patients due to hypovolemia and hyponatremia, there may be a temporary decrease in the glomerular filtration rate and an increase in the concentration of urea and creatinine in the blood plasma. This transient functional renal failure is not dangerous for patients with unchanged kidney function, however, in patients with renal insufficiency, its severity can increase.
Athletes
Indapamide can give a positive reaction during doping control.