Buy Uperio tablets 50 mg 28 pcs
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Uperio pills 50 mg 28 pcs

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Description

Tablets "Yuperio" 50 mg - oval biconvex pills, film-coated white with a violet tint with a chamfer, without risks. “LZ” engraved on one side and “NVR” on the other. In cross section, the core is white or almost white. Mechanism of action. The action of the drug Yuperio is mediated by a new mechanism, namely, the simultaneous suppression of the activity of neprilysin (neutral endopeptidase (neutral endopeptidase, NEP)) with LBQ657 (the active metabolite of sacubitrile) and blockade of receptors for angiotensin II type 1 (AT1) valsartan and that is a virus that is an antiviral receptor that is an antiviral receptor blockade of type 1 angiotensin II (AT1), which is an antiviral receptor that is an anubitine inhibitor. II (ARA II). The mutually complementary beneficial effects of sacubitrile and valsartan on the cardiovascular system and kidneys in patients with heart failure are due to an increase in the number of peptides cleaved by neprilisin (such as natriuretic peptides (NP)), which is mediated by LBQ657, while the negative effects of angiotensin are suppressed by valsartan Ii. NPs activate membrane-bound receptors coupled with guanylyl cyclase, which leads to an increase in the concentration of cyclic guanosine monophosphate (cGMP), which causes symptoms of vasodilation, an increase in natriuresis and diuresis, an increase in glomerular filtration rate and renal blood flow, suppression of renin and aldosterone, and suppression of the renal and aldosterone, and a reduction of the symptomatology of the renal and aldosterone; and antifibrotic action. Valsartan, selectively blocking the AT1 receptor, suppresses the negative effects of angiotensin II on the cardiovascular system and kidneys, and also blocks angiotensin II-dependent release of aldosterone. This prevents the persistent activation of the renin-angiotensin-aldosterone system (RAAS), which causes vasoconstriction, sodium and water retention by the kidneys, growth activation and cell proliferation, as well as the subsequent rearrangement of the cardiovascular system, which aggravates impairments in its functioning.

Active ingredients

Valsartan + Sakubitril

Release form

Pills

Composition

Active ingredient: sacubitrile and valsartan hydrate complex of sodium salts. Auxiliary substances: microcrystalline cellulose, hyprolosis, crospovidone, magnesium stearate, talc,colloidal silicon dioxide. Shell: shell premix white (hypromellose, titanium dioxide, macrogol 4000, talc), red shell premix (hypromellose, iron dye red oxide, macrogol 4000, talc), black shell premix (hypromellose, iron dye black oxide, macrogol 4000, talc).

Indications

Chronic heart failure (NYHA Class II-IV) in patients with systolic dysfunction to reduce the risk of cardiovascular mortality and hospitalization for heart failure.

Precautionary measures

Before use, it is recommended to consult a doctor. It is released on prescription.

Use during pregnancy and lactation

Patients with preserved reproductive potential should be informed about the possible consequences of using the drug during pregnancy, as well as the need to use reliable methods of contraception during drug treatment and within a week after its last administration. Like other drugs directly acting on the RAAS, Juperio does not should be used during pregnancy. The action of the drug Yuprio is mediated by blockade of angiotensin II receptors, so the risk to the fetus cannot be excluded. In pregnant women who took valsartan, there have been cases of spontaneous abortion, low flow and impaired renal function in the newborn. If pregnancy occurs during drug treatment, the patient should stop taking the drug and inform your doctor. Since preclinical studies have noted the release of sacubitrile and valsartan with the milk of lactating animals, it is not recommended to use the drug Uperio during breastfeeding. The decision to refuse breastfeeding or to discontinue the drug Yuperio and the continuation of breastfeeding should be made taking into account the importance of its use for the mother.

Dosage and administration

The time of taking the drug Juperio does not depend on the time of eating. The target (maximum daily) dose of the drug Juperio is 200 mg (102.8 mg + 97.2 mg) 2 times a day. The recommended initial dose of Yuperio is 100 mg (51.4 mg + 48.6 mg) 2 times a day. In patients who have not previously received ACE or APA II inhibitors, or who received these drugs in low doses, they should begin therapy with Uperio. at a dose of 50 mg (25.7 mg + 24.3 mg) 2 times a day with a slow increase in dose (doubling the daily dose 1 time in 3-4 weeks).Depending on the tolerability, the dose of the drug Intresto should be doubled every 2-4 weeks until the target (maximum daily) dose of 200 mg (102.8 mg + 97.2 mg) is reached 2 times a day. Use of the drug Juperi is possible no earlier than 36 hours after discontinuation of the ACE inhibitor, as in the case of simultaneous use may develop angioedema. Since ARPA II valsartan is part of the drug, it should not be used concurrently with another drug, which includes ARA II. temporary dose reduction or dose adjustment of simultaneously used drugs. Patients of special categories. Patients with impaired renal function. In patients with impaired renal mild (eGFR 60–90 ml / min / 1.73 m2) or moderate severity (eGFR 30–60 ml / min / 1.73 m2), dose adjustment is not required. In patients with severe impaired renal function (eGFR <30 ml / min / 1.73 m2), the recommended initial dose of the drug is 50 mg twice a day. When using the drug Uperiou patients in this category, it is recommended to be careful due to the limited relevant data. Patients with impaired liver function. Patients with impaired mild liver function (Child-Pugh class A) do not require dose adjustment of Juperio. In patients with impaired moderate liver function (Child-Pugh class B), the recommended initial dose of the drug is 50 mg twice a day. Yuperio is not recommended for use in patients with severely impaired liver function (Child-Pugh class C). Use in children and adolescents under 18 years of age. There are no data on the safety and efficacy of the use of the drug Yuperio in children and adolescents. The use in patients over 65 years of age. In patients older than 65 years, dose adjustment is not required.

Side effects

Identified adverse events (AEs) corresponded to the pharmacological characteristics of the drug Juperio and associated diseases that are present in patients. The most common AEs were a pronounced decrease in blood pressure, hyperkalemia, and impaired renal function, caused by dose adjustment of the drug Uperio or discontinuation of therapy. The frequency of AE was not dependent on the gender, age, or race of the patients.AEs are listed in accordance with the system-organ class of the medical dictionary for the regulatory activities of MedDRA. Within each system-organ class, the AEs are distributed by frequency of occurrence in order of decreasing importance. For evaluation of frequency, the following criteria are used: very often (> 1/10), often (from> 1/100 to <1/10), infrequently ( from> 1 / 1.000 to <1/100), rarely (from> 1/10000 to <1/1000), very rarely (<1/10000), including individual messages. Metabolism and nutrition disorders: very often - hyperkalemia, often - hypokalemia. Violations of the nervous system: often - dizziness, headache, infrequently - orthostatic dizziness. Violations by the org ana of hearing and labyrinth disorders: often - vertigo. Vascular disorders: very often - marked decrease in blood pressure: often - fainting, orthostatic hypotension. Violations of the respiratory system, chest organs and mediastinum: often - cough. Gastrointestinal disorders intestinal tract: often - diarrhea, nausea. Violations of the rut and subcutaneous tissues: infrequently - angioedema. Violations of the kidneys and urinary tract: very often - renal dysfunction, often - renal failure (including acute renal failure). General disorders and disorders at the injection site: often - fatigue, asthenia. If any of the side effects indicated in the instructions are exacerbated, or you notice any other side effects that are not listed in the instructions, tell your doctor.

Overdose

There is not enough data on overdose with Juperio in humans. A single use of the drug at a dose of 1200 mg and repeated at a dose of 900 mg in healthy volunteers was accompanied by good tolerance. The most likely symptom of overdose is a pronounced decrease in blood pressure due to the antihypertensive effect of the active substances. In this case, symptomatic treatment is recommended. In case of an accidental overdose, it is necessary to induce vomiting (if the drug has been taken recently) or to have a gastric lavage. If a pronounced decrease in blood pressure occurs as a therapy, intravenous administration of 0.9% sodium chloride solution is necessary, the patient should be laid, raising his legs for a period of time necessary for therapy, to take active measures to maintain the cardiovascular system, including regular monitoring of the heart and respiratory system, circulating blood volume (BCC) and the amount of urine released.Removal of active substances during hemodialysis is unlikely, since a significant part of them binds to plasma proteins.

Interaction with other drugs

Contraindicated drug interactions ACE inhibitors The drug Yuperio is contraindicated for use simultaneously with ACE inhibitors, since the suppression of neprilysin simultaneously with the use of an ACE inhibitor may increase the risk of developing angioedema. The use of the drug Yuperio can be possible not earlier than 36 hours after discontinuation of the ACE inhibitor. The use of an ACE inhibitor is possible no earlier than 36 hours after the last dose of the drug, Juperio. Aliskiren. In patients with diabetes mellitus and in patients with impaired renal function (eGFR <60 ml / min / 1.73 m2 of body surface area), Uperio should not be used concurrently with aliskiren. Not recommended drug interactions Angiotensin receptor antagonists. Since one of the active ingredients of the drug is an antagonist of angiotensin II receptors, simultaneous use with another drug containing APA II is not recommended. Drug interactions that need to be considered are HMG-CoA reductase inhibitors (statins). Research data show that sacubitrile inhibits the activity of the OATR1B1 and OATR1BZ carriers. The drug Yuperio can increase the systemic exposure of such substrates OATR1B1 and OATR1VZ, as statins. In patients who received the drug Yuperio simultaneously with atorvastatin, the maximum plasma concentration (Cmax) of atorvastatin and its metabolites increased up to 2 times, and AUC - up to 1.3 times. For this reason, the drug Uperio simultaneously with statins should be used with caution.Sildenafil. In patients with a pronounced increase in blood pressure, receiving the drug Yuperio (before reaching the equilibrium concentration), a single use of sildenafil increased the antihypertensive effect compared with the use of the drug Yuperio in monotherapy. For this reason, in patients receiving Yuperio, use of sildenafil or another type 5 phosphodiesterase inhibitor should be taken with caution. Estimated drug interactions that should be considered Kaliya.Simultaneous use of potassium-sparing diuretics (for example, triamterene and amiloride), antagonists of mineralocorticoids (for example, spironolactone and eplerenone), potassium preparations or potassium-containing salt substitutes can cause an increase in the content of potassium and serum creatinine concentration. In patients receiving the drug Yuperio simultaneously with these drugs, it is recommended to regularly monitor the content of potassium in the blood serum. Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). The use of drug Yuperio simultaneously with NSAIDs in patients over the age of 65 years, in patients with hypovolemia (including patients receiving diuretics) and in patients with impaired renal function may increase the risk of impaired renal function. In patients receiving the drug Yuperio simultaneously with NSAIDs, when prescribing such a treatment regimen and in case of its change, it is recommended to monitor the function of the kidneys. Preparations of lithium. The possibility of drug interactions between the drug and preparations of lupium luperium not studied. With the simultaneous use of lithium preparations with ACE and APA II inhibitors, there was a reversible increase in the concentration of lithium in the blood serum and an increase, in this connection, toxic manifestations. In patients receiving the drug Yuperio with lithium preparations, it is recommended to carefully monitor the lithium content in the serum. In the case of an additional use of a diuretic drug, the risk of the toxic effect of lithium may increase. Protein carriers. The active metabolite of sacubitrile (LBQ657) and valsartan are substrates of carrier proteins 0ATP1B1, 0ATP1BZ and OATZ, valsartan is also a substrate of carrier protein MRP2. In patients receiving Yuperio simultaneously with inhibitors OATP1B1, OATP1VZ, OATZ (for example, rifampicin and cyclosporine) or MRP2 (for example, ritonavir), systemic exposure to LBQ657 or valsartan, respectively, may increase. At the beginning and at the time of the completion of the joint use of the drug by Yuperio and this group of drugs, care must be taken. The absence of significant drug interactions. In case of using the drug Yuperio in combination with furosemide, digoxin, warfarin,hydrochlorothiazide, amlodipine, metformin, omeprazole, carvedilol, nitroglycerin intravenously (iv) or the combined drug levonorgestrel and ethinylestradiol showed no clinically significant interactions. . Interactions with cytochrome P450 isoenzymes. Existing studies demonstrate that the probability of drug interactions mediated by cytochrome CYP450 isoenzymes is low, since the complex of active substances to a small extent is metabolized with the participation of CYP450 isoenzymes. The complex of active ingredients of the drug Yuperio is not an inhibitor or inducer of CYP450 isoenzymes.

special instructions

Contraindications: hypersensitivity to sacubitril or to valsartan, as well as to other auxiliary components of the drug. Simultaneous use with inhibitors of an angiotensin-converting enzyme (ACE), and also the period of 36 hours after cancellation of ACE inhibitors. The presence of angioedema in history against the background of previous therapy with ACE or APA II inhibitors. Simultaneous use with aliskiren in patients with diabetes mellitus or in patients with moderate or severe renal impairment (eGFR <60 ml / min / 1.73 m of body surface area). Severe liver function impairment (Child Pugh class C), biliary cirrhosis and cholestasis. The drug Intresto is not recommended for use in children under the age of 18 years due to the lack of data on efficacy and safety. Pregnancy, pregnancy planning and breastfeeding period. Simultaneous use with other drugs containing ARA II, because The drug contains valsartan. With caution: care should be taken when using the drug Uperio in patients with severely impaired renal function (eGFR <30 ml / min / 1.73 m2 of body surface area), incl. in patients on hemodialysis or undergoing hemodialysis (eGFR <15 ml / min / 1.73 m body surface area) due to the lack of safety data in patients of this category, patients with bilateral renal artery stenosis,which can be caused by diuretic therapy, a low-salt diet, diarrhea or vomiting, as well as in patients taking drugs that can increase serum potassium (for example, potassium-saving diuretics, potassium drugs). Care should be taken while using the drug with statins, inhibitors phosphodiesterase type 5. Care should be taken when using the drug in patients with angioedema in the history of the lack of data on the use of the drug in patients s in this category. Patients of the Negroid race may be more at risk for angioedema. A marked decrease in blood pressure. In patients who received the drug Uperio, there were cases of clinically severe arterial hypotension. If a pronounced decrease in blood pressure occurs, the question of dose adjustment of diuretics, concomitant antihypertensive drugs should be considered, as well as the elimination of the causes of the pronounced decrease in blood pressure (for example, hypovolemia). If, despite these measures, a pronounced decrease in blood pressure is maintained, the dose of the drug Juperio should be reduced or the drug should be temporarily canceled. Final drug withdrawal is usually not required. The probability of a pronounced decrease in blood pressure is usually higher in patients with hypovolemia, which can be caused by diuretic therapy, a low-salt diet, diarrhea, or vomiting. Before starting the use of the drug Yuperio, a correction should be made to the sodium content in the body and / or replenish the BCC. Renal impairment. Like any other drug that is acting on the RAAS, Juperio can cause kidney function deterioration. In a comparative study of the safety and efficacy of 14/17 (compared with enalapril), clinically significant impairment of renal function was rarely observed, and Juperio was canceled less frequently (0.65%) than enalapril (1.28%). In the case of clinically significant impairment of renal function, consideration should be given to reducing the dose of the drug Juperio. Caution should be exercised when using Yuperio in patients with severely impaired renal function. Hyperkalemia. Like any other drug that acts on the RAAS, Juperio may increase the risk of developing hyperkalemia.In a comparative study of safety and efficacy (compared with enalapril), clinically significant hyperkalemia was rarely observed, Juperio was canceled due to hyperkalemia in 0.26% of patients, and enalapril in 0.35% of patients. Drugs that can increase the content of potassium in the blood serum (for example, potassium-saving diuretics, potassium preparations) should be used with caution at the same time as the drug Uperio. In the case of clinically significant hyperkalemia, measures such as reducing food intake of potassium or adjusting the dose of related drugs should be considered. It is recommended to regularly monitor the content of potassium in the blood serum, especially in patients with such risk factors as severe renal dysfunction, diabetes mellitus, hypoaldosteronism, or a diet high in potassium. Angioedema. Against the background of the use of the drug Yuperio, cases of angioedema were noted. In the event of angioedema, drug Yuperio should be immediately canceled and appropriate treatment and monitoring of the patient should be prescribed until all the symptoms have been resolved. Re-prescribe drug should not. In cases of confirmed angioedema, in which the edema spreads only to the face and lips, this condition was usually resolved without intervention, although the use of antihistamines helped alleviate the symptoms. Angioedema, accompanied by swelling of the larynx, can be fatal. In cases where edema spreads to the tongue, vocal folds or larynx, which can lead to obstruction of the airways, proper treatment should immediately begin, for example, subcutaneous administration of epinephrine (epinephrine) solution 1: 1000 (0.3-0.5 ml) and / or take appropriate measures to ensure airway obstruction. Patients with a history of angioedema caused by the use of an ACE inhibitor or ARA II should not be used. Patients of the Negroid race may be more at risk for angionovrotic edema. Patients with renal artery stenosis.Like other drugs acting on the RAAS, Yuperio may cause an increase in serum urea and creatinine concentrations in patients with unilateral or bilateral stenosis of the renal arteries. In patients with renal artery stenosis, the drug should be used with caution, regularly monitoring kidney function. Effect on ability to drive vehicles and / or mechanisms. There are no data on the effect of the drug on the ability to drive vehicles and / or mechanisms. In connection with the possible occurrence of dizziness or increased fatigue, caution should be exercised when driving vehicles or working with mechanisms.

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