Description
Release form
Tablets.
Packing
30 pcs.
Pharmacological action
Noliprel A forte is a combined antihypertensive drug containing perindopril (an ACE inhibitor) and indapamide (a diuretic from the sulfonamide derivative group). The pharmacological effect of Noliprel is due to a combination of the individual properties of each of the components. The combination of perindopril and indapamide enhances the action of each of them.
Noliprel A has a pronounced dose-dependent hypotensive effect on both systolic, and on diastolic blood pressure in the supine and standing position. The effect of the drug lasts 24 hours. A persistent clinical effect occurs less than 1 month after the start of therapy and is not accompanied by tachycardia. Discontinuation of treatment is not accompanied by the development of withdrawal syndrome.
Noliprel reduces the degree of left ventricular hypertrophy, improves arterial elasticity, reduces OPSS, does not affect lipid metabolism (total cholesterol, HDL, LDL, triglycerides) and does not affect carbohydrate metabolism (including in patients with diabetes mellitus).
Indications
Essential arterial hypertension.
Contraindications
Hypersensitivity to perindopril and other ACE inhibitors
Hypersensitivity to indapamide and sulfonamides
Angioedema in the anamnesis (including those treated with ACE inhibitors) mildcrimp )
Severe liver failure (including with encephalopathy)
Concomitant use of drugs prolonging the QT interval
Pregnancy, lactation (breastfeeding).
With caution, the drug should be used with bilateral renal artery stenosis or artery stenosis of the only functioning kidney, with renal failure, systemic diseases of the connective tissue (SLE, scleroderma), during therapy with immunosuppressants (risk of neutropenia, agranulocytosis), inhibition of bone marrow hematopoiesis, decreased BCC (taking diuretics, salt-free diet, vomiting, diarrhea, hemodialysis), in cerebrovascular diseases, renovascular hypertension, diabetes mellitus, severe heart failure (stage IV), with hyperuricemia and with concurrent hypoglycemia nephrolithiasis), while taking potassium-sparing diuretics, potassium and lithium preparations, with blood pressure lability, during hemodialysis using high-flow membranes, during desensitization and, after kidney transplantation, with aortic valve stenosis / hypertrophic cardiomyopathy, with lactose deficiency, galactosemia or glucose / galactose malabsorption syndrome, in elderly patients, in patients under the age of 18 (efficacy and safety have not been established).
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and should be discontinued immediately when pregnancy is established.
Toxic and fatal effects on the fetus and newborn
Amlodipine
drugs that directly affect RAAS can cause damage and death to the fetus and newborn when prescribed to pregnant women. Isolated cases of the use of ACE inhibitors during pregnancy are described.
The use of drugs directly affecting RAAS in the second and third trimesters of pregnancy is associated with damage to the fetus and newborn, such as arterial hypotension, neonatal hypoplasia of the cranial bones, anuria, reversible and irreversible renal failure, and death. There have also been cases of oligohydramnios, presumably developed as a result of decreased kidney function in the fetus. In these cases, oligohydramnios was associated with limb contractures, craniofacial deformities, and fetal lung hypoplasia. In addition, there were cases of premature birth, intrauterine growth retardation and non-closure of the ductus arteriosus, however, no connection with the effect of the drug was found in these cases. The listed side effects, apparently, are not a consequence of the use of the drug in the first trimester of pregnancy. Nevertheless, pregnant women taking ARA drugs in the first trimester must be informed about the consequences of taking these drugs in the second third trimesters.
Depending on the gestational age, you can apply a stress test for uterine contractions, a stress-free test or an assessment of the biophysical profile of the fetus.
When planning a pregnancy or when it occurs while taking Noliprel ® A forte, you should immediately stop taking the drug and prescribe another antihypertensive therapy.
Noliprel ® A forte should not be used in the first trimester of pregnancy.
Appropriate controlled trials of the use of ACE inhibitors in pregnant women have not been conducted. Limited data on the effects of ACE inhibitors in the first trimester of pregnancy indicate that taking ACE inhibitors did not lead to fetal malformations associated with fetotoxicity, but the fetotoxic effect of the drug cannot be completely ruled out.
Noliprel ® A Forte is contraindicated in the second and third trimesters of pregnancy. Known that prolonged exposure of ACE inhibitors to the fetus in the second and third trimesters of pregnancy can lead to impaired development (decreased renal function, oligohydramnios, slowed ossification of the skull bones) and the development of complications in the newborn (renal failure, hypotension, hyperkalemia). Long-term use of thiazide diuretics in the III trimester of pregnancy can cause maternal hypovolemia and a decrease in uteroplacental blood flow, which leads to fetoplacental ischemia and fetal growth retardation. In rare cases, while taking diuretics shortly before birth, newborns develop hypoglycemia and thrombocytopenia. If the patient received Noliprel ® A forte during the second or third trimester of pregnancy, it is necessary to evaluate the significance of therapy for the mother and decide on the termination of breastfeeding or on the termination of the drug.
Special instructions
The use of Noliprel may cause a sharp decrease in blood pressure, especially when taking the drug for the first time and during the first 2 weeks of therapy.
Composition
Arginine 5 mg,
indapamide 1.25 mg.
Excipients:
sodium carboxymethyl starch (type A),
silicon dioxide colloidal anhydrous,
lactose monohydrate,
magnesium stearate,
maltodextrin.
14 and 30 pcs per pack.
Dosage and administration of
Adults, including elderly patients, are prescribed 1 tablet per day, preferably in the morning.
Side effects of
Perindopril has an inhibitory effect on the renin-angiotensin-aldosterone (RAAS) system and reduces the excretion of potassium ions by the kidneys while taking indapamide. In 4% of patients with the use of Noliprel ® A forte, hypokalemia develops (potassium level less than 3.4 mmol / l).
The frequency of adverse reactions that may occur during therapy, shown as the following gradation: very often (> 1/10) often (> 1/100, 1/1000, 1/10000, from the circulatory and lymphatic systems
Very rarely: thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia.
Anemia: in certain clinical situations (patients after kidney transplantation, patients undergoing hemodialysis) ACE inhibitors can cause anemia (see section Special instructions ).
From the central nervous system
Often: paresthesia, headache , dizziness, asthenia, vert yoke Infrequently: sleep disturbance, lability of mood Very rarely: confusion Unspecified frequency: fainting
From the organ of vision
Often: impaired by the organ of
Often from the organ of hearing
Often: tinnitus.
From the cardiovascular system
Often: marked decrease in blood pressure, including orthostatic hypotension. Very rarely: cardiac arrhythmias, including bradycardia, ventricular tachycardia, atrial fibrillation, as well as angina pectoris and myocardial infarction, possibly due to an excessive decrease in blood pressure in patients at high risk (see section “Special Instructions”). Unspecified frequency: pirouette type arrhythmias (possibly fatal) (see section Interaction with other drugs ).
On the part of the respiratory system, chest organs and mediastinum
Often: with the use of ACE inhibitors, a dry cough may occur, which persists for a long time while taking this group of drugs and disappears after they are canceled. Dyspnea. Infrequently: bronchospasm. Very rarely: eosinophilic pneumonia, rhinitis.
From the digestive system
Often: dry oral mucosa, nausea, vomiting, abdominal pain, epigastric pain, impaired taste, loss of appetite, dyspepsia, constipation, diarrhea. Very rarely: angioedema of the intestine, cholestatic jaundice, pancreatitis. Unspecified frequency: hepatic encephalopathy in patients with liver failure (see sections “Contraindications” and “Special Instructions”), hepatitis.
From the skin and subcutaneous fat.
Often: skin rash, itching, maculopapular rash. Infrequently: angioedema of the face, lips, limbs, mucous membrane of the tongue, vocal folds and / or larynx, urticaria (see section “Special Instructions”), hypersensitivity reactions in patients, predisposed to bronchial obstructive and allergic reactions of purpura. In patients with acute systemic lupus erythematosus, the course of the disease may worsen. Very rarely: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome. Cases of photosensitivity reaction have been noted (see the section “Special Instructions”).
From the musculoskeletal system and connective tissue
Often: muscle cramps.
Urinary system
Infrequently: renal failure. Very rare: acute renal failure.
From the reproductive system
Infrequently: impotence.
General disorders and symptoms of
Often: asthenia. Infrequently: increased sweating.
Laboratory findings
– Hyperkalemia, more often transient.
– A slight increase in the concentration of creatinine in the urine and in the blood plasma that occurs after discontinuation of therapy, more often in patients with renal artery stenosis, in the treatment of hypertension with diuretics and in case of renal failure.
Rarely: hypercalcemia.
Unspecified frequency: – An increase in the QT interval on the ECG (see “Special Instructions”).
– Increased levels of uric acid and blood glucose.
– Increased activity of “liver” enzymes.
– Hypokalemia, especially significant for patients at risk (see section “Special instructions”).
– Hyponatremia and hypovolemia, leading to dehydration and orthostatic hypotension. Simultaneous hypochloremia can lead to metabolic alkalosis of the compensatory nature of
(the probability and severity of this effect is low).
Adverse events reported during clinical trials
Adverse events reported during the ADVANCE study are consistent with the previously established safety profile for the combination of perindopril and indapamide.
Serious adverse events were noted in some patients in the study groups: hyperkalemia (0.1%), acute renal failure (0.1%), arterial hypotension (0.1%) and cough (0.1%).
Three patients in the perindopril / indapamide group had angioedema (versus 2 in the placebo group).
Overdose
Symptoms
The most likely symptom of overdose is a pronounced decrease in blood pressure, sometimes in combination with nausea, vomiting, convulsions, dizziness, drowsiness, confusion and oliguria, and oliguria. Electrolyte disorders (hyponatremia, hypokalaemia).
Treatment
Emergency measures are reduced to removing the drug from the body: washing the stomach and / or the appointment of activated carbon with the subsequent restoration of the water-electrolyte balance.
With a significant decrease in blood pressure, the patient should be placed in a “lying” position with his legs elevated. If necessary, correct hypovolemia (eg, intravenous infusion of 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, can be removed by dialysis.
Storage Conditions
In a dark place at a temperature not exceeding 30 ° C.
Shelf life
3 years.
Active ingredient
Indapamide, Perindopril
Terms and conditions
prescription
tablet dosage form of tablets
Possible product names
Noliprel A 5mg / 1.25mg No. 30
NOLIPREL A FORT 0,005 + 0,00125 N30 TABLE P / O
NOLIPREL A FORT 0,005 + 0,00125 N90 TABL A pt Om 5 s mg Tab. p / pl / rev X30
Noliprel A Fort 5mg + 1.25mg Tab. p / pl / rev X90
Servye, France
