Noliprel
Noliprel: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Drug interactions
- 11. Analogs
- 12. Terms and conditions of storage
- 13. Terms of dispensing from pharmacies
- 14. Reviews
- 15. Price in pharmacies
Latin name: Noliprel
ATX code: C09BA04
Active ingredient: Indapamide + Perindopril (Indapamide + Perindopril)
Producer: Les Laboratoires Servier Industrie (France)
Description and photo update: 2019-12-08
Prices in pharmacies: from 510 rubles.
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Noliprel is a combined antihypertensive agent.
Release form and composition
Dosage form - tablets: oblong, white, with a dividing line on both sides (14 or 30 pcs. In blisters, packed in sachets, in a cardboard box, 1 sachet).
Content of active ingredients in 1 tablet:
- Perindopril erbumine (perindopril tert-butylamine) - 2 mg, equivalent to 1.669 mg perindopril base;
- Indapamide - 0.625 mg.
Auxiliary components: microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate.
Pharmacological properties
Noliprel is a combination drug that includes indapamide (a diuretic belonging to the group of sulfonamide derivatives) and perindopril (an angiotensin-converting enzyme inhibitor). Its pharmacological properties are a combination of the individual properties of each of the components. The combination of indapamide and perindopril enhances the action of each.
Pharmacodynamics
Noliprel has a dose-dependent hypotensive effect, affecting both systolic and diastolic blood pressure in the supine or standing position. The antihypertensive effect of the drug is prolonged and lasts for 1 day. The therapeutic effect is observed less than 1 month after the start of treatment and is not accompanied by tachycardia. Cancellation of Noliprel does not provoke the development of withdrawal syndrome. Indapamide and perindopril are characterized by a synergistic antihypertensive effect compared to monotherapy with these drugs.
The drug reduces the degree of left ventricular hypertrophy, increases the elasticity of the arteries, helps to reduce the total peripheral vascular resistance and does not affect the metabolism of lipids (low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol, total cholesterol, triglycerides).
The effect of Noliprel on rates of cardiovascular morbidity and mortality is not well understood.
Perindopril
Perindopril is an inhibitor of the enzyme responsible for the conversion of angiotensin I to angiotensin II (ACE inhibitor). Kinase (angiotensin-converting enzyme) is an exopeptidase that carries out both the transition of angiotensin I into the vasoconstrictor compound angiotensin II and the destruction of bradykinin, which is characterized by a vasodilating effect, with the formation of an inactive heptapeptide.
As a result, perindopril reduces the production of aldosterone, in accordance with the principle of negative feedback, increases the activity of renin in the blood plasma and, with prolonged therapy, lowers the total peripheral vascular resistance, which is mainly caused by the effect on the vessels localized in the kidneys and muscles.
These effects are not accompanied by the occurrence of reflex tachycardia or salt and fluid retention.
Perindopril normalizes myocardial function by reducing preload and afterload.
Studies of hemodynamic parameters in patients with chronic heart failure have revealed that this substance increases muscle peripheral blood flow, increases cardiac output and increases cardiac index, decreases filling pressure in both ventricles of the heart, and decreases total peripheral vascular resistance.
Perindopril is effective in the treatment of hypertension of varying severity. The antihypertensive effect of the drug reaches its peak 4-6 hours after a single dose and lasts 24 hours. One day after the application of Noliprel, there is a pronounced (about 80%) inhibition of residual ACE.
Perindopril has an antihypertensive effect in patients with both reduced and normal renin activity in blood plasma. The compound is characterized by a vasodilator effect, provides the regeneration of the structure of the vascular wall of small arteries and restoration of the elasticity of large arteries, and also minimizes left ventricular hypertrophy.
The combination of Noliprel with thiazide diuretics makes the antihypertensive effect more pronounced. Also, the simultaneous administration of a thiazide diuretic and an ACE inhibitor reduces the risk of hypokalemia during the appointment of diuretics.
Indapamide
Indapamide is part of the sulfonamide group and is similar in pharmacological characteristics to thiazide diuretics. The substance slows down the reabsorption of sodium ions in the cortical element of the loop of Henle, which causes a more intensive excretion through the kidneys of chlorine, sodium ions and, to a lesser extent, magnesium and potassium ions. This helps to increase urine output and lower blood pressure.
Indapamide as a monotherapy drug has an antihypertensive effect lasting 24 hours. It becomes noticeable when the drug is taken in doses that have a minimal diuretic effect. The compound improves the elastic properties of large arteries, reduces the total peripheral vascular resistance and reduces left ventricular hypertrophy.
At a certain dose of indapamide, thiazide and thiazide-like diuretics reach a plateau of therapeutic effect, while the frequency of side effects continues to increase with a further increase in the dose of the drug. Therefore, an increase in the dose of indapamide is not justified if there is no therapeutic effect when taking the recommended dose.
Indapamide does not alter the concentration of lipids (triglycerides, LDL, HDL, cholesterol) and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).
Pharmacokinetics
With the combined use of indapamide and perindopril, their pharmacokinetic parameters do not change compared with the separate administration of these drugs.
Perindopril
When taken orally, perindopril is absorbed at a significant rate. Its maximum content in blood plasma is recorded 1 hour after administration. The half-life of a substance from blood plasma is 1 hour. Pharmacological activity is not characteristic of perindopril. Approximately 27% of the dose taken orally enters the bloodstream after conversion to the active metabolite perindoprilat. In addition to perindoprilat, 5 more metabolites are formed that do not exhibit pharmacological activity. The maximum content of perindoprilat in blood plasma is observed 3-4 hours after oral administration. Food intake inhibits the transition of perindopril to perindoprilat, affecting its bioavailability. Therefore, the drug should be taken once a day, in the morning and on an empty stomach.
A linear dependence of the content of perindopril in the blood plasma on its dose was revealed. The volume of distribution of unbound perindoprilat is about 0.2 l / kg. Perindoprilat binds to blood plasma proteins, mainly to ACE, and the degree of binding is determined by the level of perindopril in the blood and is approximately 20%.
Perindoprilat is excreted in the urine. The effective half-life is approximately 17 hours, so equilibrium concentrations are reached within 4 days.
Excretion of perindoprilat is slowed down in elderly patients, as well as in patients with renal and heart failure. The dialysis clearance of perindoprilat is 70 ml / min. The pharmacokinetics of perindopril changes in patients with liver cirrhosis: the hepatic clearance of the compound is reduced by 2 times. However, the amount of perindoprilat formed does not show a tendency to decrease, so there is no need for dose adjustment.
Indapamide
Indapamide is rapidly absorbed and completely absorbed from the gastrointestinal tract. The maximum level of the compound in the blood plasma is recorded 1 hour after oral administration.
Indapamide binds to plasma proteins by 79%. The half-life is 14-24 hours (mean -18 hours). Repeated administration of the drug does not cause its accumulation in the tissues of the body. Indapamide is excreted mainly through the kidneys (70% of the dose taken) and through the intestines (22% of the dose taken) as inactive metabolites. Renal failure does not affect the pharmacokinetics of the compound.
Indications for use
The use of Noliprel is indicated for the treatment of essential arterial hypertension.
Contraindications
- Chronic heart failure in the stage of decompensation in untreated patients;
- Hypokalemia;
- Elevated plasma potassium;
- A history of angioedema (Quincke's edema);
- Idiopathic or hereditary angioedema;
- Severe renal (creatinine clearance (CC) less than 30 ml / min) and / or hepatic (including encephalopathy) failure;
- Glucose-galactose malabsorption syndrome, lactase deficiency, galactosemia;
- Simultaneous use of potassium-sparing diuretics, potassium and lithium preparations, antiarrhythmic drugs (risk of developing arrhythmias of the "pirouette" type), drugs that lengthen the QT interval;
- The period of pregnancy and breastfeeding;
- Age under 18;
- Hypersensitivity to angiotensin-converting enzyme (ACE) inhibitors and sulfonamides;
- Hypersensitivity to drug components.
Also, Noliprel is contraindicated in patients on hemodialysis.
Care should be taken to prescribe the drug for systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), inhibition of bone marrow hematopoiesis, treatment with immunosuppressants (due to the risk of agranulocytosis, neutropenia), reduced circulating blood volume (while taking diuretics, salt-free diet, vomiting, diarrhea), cerebrovascular diseases, renovascular hypertension, diabetes mellitus, angina pectoris, stenosis of the aortic valve, hypertrophic cardiomyopathy, chronic heart failure of functional class IV (NYHA classification), hyperuricemia (especially accompanied by urate nephrolithiasis and gout), hemodialysis, lability of blood pressure (BP); during the period after kidney transplantation; elderly patients.
Instructions for the use of Noliprel: method and dosage
Noliprel is taken orally, preferably before breakfast.
Recommended dosage: 1 tablet 1 time per day. In the absence of a hypotensive effect after 1 month of therapy, the daily dose can be doubled.
Prescribing the drug to elderly patients should be based on data on the level of potassium concentration in blood plasma and functional activity of the kidneys. Treatment should begin with an individual dose selection taking into account the degree of blood pressure reduction, especially in patients with dehydration and electrolyte loss. Treatment should be started with 1 tablet 1 time per day.
In patients with moderate renal failure (CC 30-60 ml / min), the daily dose should not exceed 1 tablet, with CC 60 ml / min and higher, dose adjustment is not required. Treatment must be accompanied by monitoring the level of potassium and creatinine in the blood plasma (after two weeks of therapy and then once every 2 months).
If laboratory signs of functional renal failure appear against the background of Noliprel's use, the drug should be canceled. The combination treatment should be resumed only with the use of low doses of the drug or in the monotherapy regimen. Patients with underlying renal dysfunction, including renal artery stenosis and severe heart failure, are at risk of developing renal failure.
No dose adjustment is required in patients with moderate hepatic impairment.
Side effects
- General disorders: often - asthenia; infrequently - sweating;
- Cardiovascular system: infrequently - a strong decrease in blood pressure, including orthostatic hypotension; very rarely - bradycardia, atrial fibrillation, ventricular tachycardia, angina pectoris, myocardial infarction and other cardiac arrhythmias;
- Lymphatic and circulatory systems: very rarely - leukopenia or neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia; in patients after kidney transplantation who are on hemodialysis, anemia may develop;
- Digestive system: often - dry mouth, constipation, diarrhea, nausea, abdominal pain, vomiting, epigastric pain, loss of appetite, impaired taste, dyspepsia; rarely - cholestatic jaundice, angioedema of the intestine; very rarely - pancreatitis; possibly - hepatic encephalopathy (in patients with liver failure);
- Organ of vision: often - visual impairment;
- Hearing organ: often - tinnitus;
- Nervous system: often - headache, paresthesia, asthenia, dizziness; infrequently - mood lability, sleep disturbance; very rarely - confusion of consciousness;
- Respiratory system: often - transient dry cough, shortness of breath; infrequently - bronchospasm; very rarely - rhinitis, eosinophilic pneumonia;
- Musculoskeletal system and connective tissues: often - muscle spasms;
- Reproductive system: infrequently - impotence;
- Urinary system: infrequently - renal failure; very rarely - acute renal failure;
- Dermatological and allergic reactions: often - skin rash, itching, maculopapular rash; infrequently - urticaria, angioedema of the larynx and / or glottis, mucous membranes of the tongue, lips, face, extremities, hypersensitivity reactions (more often skin, in predisposed patients), hemorrhagic vasculitis; exacerbation of disseminated lupus erythematosus; very rarely - toxic epidermal necrolysis, erythema multiforme, Stephen-Jones syndrome, photosensitivity reactions;
- Laboratory indicators: hypovolemia and hyponatremia, hypokalemia, a transient increase in the level of glucose and uric acid in the blood, transient hyperkalemia, a slight increase in the level of creatinine and urea in the blood plasma (more often with renal artery stenosis, renal failure, during therapy of arterial hypertension with diuretics); rarely, hypercalcemia.
Overdose
When taking high doses of Noliprel, the most common symptom of an overdose is a pronounced decrease in blood pressure, sometimes combined with drowsiness, dizziness, blurred consciousness, convulsions, nausea, vomiting and oliguria, which can turn into anuria (due to hypovolemia). Also, electrolyte disturbances often develop: hypokalemia or hyponatremia.
Emergency care consists in removing Noliprel from the body by washing the stomach and / or prescribing activated charcoal, followed by the subsequent normalization of the water-electrolyte balance. With a significant decrease in blood pressure, the patient is placed in a supine position with his legs raised. If necessary, hypovolemia is corrected (for example, by intravenous infusion of 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, is effectively removed from the body by dialysis.
special instructions
At the beginning of therapy, careful monitoring of patients who have not previously taken two antihypertensive drugs (perindopril, indapamide) at the same time is required, since the risk of idiosyncrasy increases.
Simultaneous administration with lithium preparations is not recommended.
The drug is not recommended for patients with stenosis of two renal arteries or a single functioning kidney.
Since hyponatremia can cause the sudden development of arterial hypotension, regular monitoring of the level of electrolyte concentration in blood plasma is required, especially in patients with renal artery stenosis after vomiting or diarrhea. To restore the water-electrolyte balance, intravenous administration of 0.9% sodium chloride solution is recommended. Therapy can be continued after normalization of blood pressure and blood volume, using a low dose of the drug or switching to monotherapy.
Treatment should be accompanied by regular monitoring of plasma potassium levels.
The risk of developing neutropenia while using the drug increases in patients with functional kidney disorders, more often with scleroderma, systemic lupus erythematosus. Symptoms of neutropenia are dose-dependent.
With concomitant therapy with immunosuppressive drugs in patients with diffuse connective tissue pathologies, the level of leukocytes in the blood should be monitored. If symptoms of sore throat, fever and other infectious diseases appear, you should consult a doctor.
If signs of hypersensitivity to the drug appear in the form of angioedema, the drug should be immediately canceled and the patient should be prescribed appropriate therapy. For swelling of the tongue, larynx, or glottis, airway management and immediate subcutaneous administration of epinephrine (adrenaline) are recommended.
When carrying out a differential diagnosis in patients with pain in the abdominal region, the possibility of developing angioedema of the intestine should be considered.
Simultaneous administration with immunotherapy with hymenoptera poison is not recommended (in order to prevent the development of anaphylactoid reaction, Noliprel should be temporarily discontinued 24 hours before the start of the desensitization procedure).
There is a risk of anaphylactoid reactions during low-density lipoprotein (LDL) apheresis with dextran sulfate, and the drug should be discontinued before each apheresis procedure.
Taking pills can cause a dry cough in the patient.
To avoid a sharp drop in blood pressure, treatment should be started with low doses of the drug and then gradually increased, taking into account the tolerance and laboratory parameters of the creatinine level in the blood plasma.
Treatment of patients with coronary heart disease and cerebrovascular insufficiency should be started with low doses.
With renovascular hypertension, the use of the drug should be started only in a hospital setting with low doses with regular monitoring of renal function and potassium content in blood plasma.
With arterial hypertension and coronary heart disease, the drug should be used together with beta-blockers.
Treatment of patients with diabetes mellitus, who are on insulin or hypoglycemic agents for oral administration, during the first month, should be accompanied by regular monitoring of blood glucose levels, especially with hypokalemia.
With planned surgery, the drug is stopped 12 hours before the start of general anesthesia.
In the case of a significant increase in the activity of liver enzymes or the appearance of jaundice, the use of Noliprel should be canceled.
Anemia may develop in patients on hemodialysis or after kidney transplantation.
With the development of hepatic encephalopathy, the use of diuretics should be discontinued.
Avoid exposure to direct sunlight and ultraviolet radiation. If photosensitivity reactions develop against the background of drug treatment, it should be discontinued.
Before starting the use of the drug and during the treatment period, it is necessary to regularly determine the concentration of sodium ions in the blood plasma, especially in elderly patients and patients with liver cirrhosis.
Elderly patients, malnourished patients on concomitant medication, patients with cirrhosis of the liver, peripheral edema or ascites, with an increased QT interval, heart failure, and ischemic heart disease are most at risk of developing hypokalemia while using Noliprel. In this category of patients, hypokalemia contributes to the appearance of severe cardiac arrhythmias, so they need to ensure regular monitoring of the level of potassium ions in the blood plasma from the first week of treatment.
An increase in plasma uric acid levels increases the risk of gout attacks.
Before conducting a study of the function of the parathyroid gland, it is necessary to stop taking diuretics.
During doping control, Noliprel may give a positive reaction.
During the period of use of the drug, patients should be careful when driving vehicles and mechanisms.
Application during pregnancy and lactation
According to the instructions, Noliprel is not recommended to be prescribed during pregnancy. His admission in the first trimester is strictly prohibited. Planning for pregnancy or its occurrence against the background of drug therapy is a direct indication for discontinuation of the drug and the selection of another scheme of antihypertensive therapy. Appropriate controlled studies of ACE inhibitors in pregnant women have not been conducted. There are limited data on the effects of Noliprel in the first trimester of pregnancy, indicating that treatment with it did not increase the risk of malformations caused by fetotoxicity.
The effect of the drug on the fetus over a long period of time in the II and III trimesters of pregnancy can cause disturbances in its development (delayed ossification of the skull bones, oligohydramnios, decreased renal function) and provoke complications in the newborn (hyperkalemia, arterial hypotension, renal failure).
Prolonged use of thiazide diuretics in the third trimester of pregnancy can cause hypovolemia in the mother, as well as deterioration of uteroplacental blood flow, which causes placental ischemia and fetal growth retardation. Occasionally, against the background of treatment with diuretics shortly before the onset of labor, thrombocytopenia and hypoglycemia occur in newborns.
If a woman took Noliprel during the II or III trimester of pregnancy, an ultrasound examination of the fetus should be performed to assess kidney function and the condition of the skull bones.
The lactation period is a contraindication to the administration of the drug. Information about the possible penetration of perindopril into breast milk is not considered reliable. Indapamide passes into breast milk. Taking thiazide diuretics can lead to suppression of lactation or a decrease in breast milk production. At the same time, the child sometimes develops an increased sensitivity to sulfonamide derivatives, kernicterus and hypokalemia.
Since the appointment of Noliprel during lactation can cause severe complications in an infant, it is recommended to carefully weigh the significance of therapy for the mother and decide whether to stop breastfeeding or discontinue the drug.
Drug interactions
The safety of the simultaneous administration of Noliprel with other drugs can only be determined by the attending physician, taking into account the patient's condition and concomitant pathologies.
Analogs
Noliprel's analogs are: Ko-prenesa, Prestarium, Ko-perineva, Perindopril-Indapamid Richter, Noliprel A Bi-forte.
Terms and conditions of storage
Keep out of reach of children at room temperature.
Shelf life - 3 years, after opening the sachet - 2 months.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Noliprele
According to reviews, Noliprel is very effective in lowering blood pressure, normalizing its values and reducing the risk of developing myocardial infarction and strokes. Many patients claim that the use of the drug has allowed to achieve good results in cases where other drugs did not help. Sometimes patients describe some side effects, such as headache or dry cough, but their manifestations are not too intense.
Doctors talk about the positive effects of Noliprel on the body, but insist that it should be used strictly in accordance with the instructions and under the close supervision of a specialist. In addition, the drug must be taken regularly, and not only with a sharp increase in blood pressure.
The price of Noliprel in pharmacies
The price of Noliprel remains unknown, since the drug is not on sale and at the moment only its analogues can be purchased.
Noliprel: prices in online pharmacies
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Drug name Price Pharmacy |
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Noliprel A 2.5 mg + 0.625 mg film-coated tablets 30 pcs. RUB 510 Buy |
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Noliprel A tablets p.p. 2.5mg + 0.625mg 30 pcs. RUB 512 Buy |
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Noliprel A Forte tablets p.o. 5mg + 1.25mg 30 pcs. 595 RUB Buy |
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Noliprel A forte 1.25 mg + 5 mg film-coated tablets 30 pcs. 595 RUB Buy |
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Noliprel A Bi-forte 10 mg + 2.5 mg film-coated tablets 30 pcs. RUB 681 Buy |
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Noliprel A Bi-Forte tablets p.o. 10mg + 2.5mg 30 pcs. 689 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
