Sartval tablets p/o 160mg №14×2

Name:
Sartval (Valsartan Sandoz) tablets 160 mg No. 28 Main active ingredient Valsartan Tablet release form Composition 1 tablet contains 80 mg or 160 mg of valsartan; excipients: Valsartan Sandoz 80 mg: microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 8000, iron oxide red (E172), iron oxide yellow (E172). Valsartan Sandoz 160 mg: microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
Description:
Valsartan Sandoz 80mg: Pale red, round, film-coated tablets with beveled edges, scored on one side of the tablet; with the inscriptions “D” on one side of the risks and “V” – on the other; and the inscription “NVR” on the back of the tablet. Valsartan Sandoz 160 mg: gray-orange oval coated tablets, slightly convex, scored on one side of the tablet; with the inscriptions “DX” on one side of the risks and “DX” on the other, and with the inscription “NVR” on the reverse side of the tablet. Pharmacological action Valsartan is an active specific angiotensin II receptor antagonist intended for oral administration. It acts selectively on receptors of the AT subtype), which are responsible for the action of angiotensin II. Elevated plasma levels of angiotensin II due to blockade of ATi receptors by valsartan can stimulate unblocked ATg receptors, which counterbalance the effect of AT receptors. Valsartan does not exhibit any AT receptor agonist activity, but has a much greater (about 20,000 times) affinity for the AT receptor than for the AT receptor. Valsartan does not inhibit the angiotensin-converting enzyme (ACE), also known as kininase II, which converts angiotensin I to angiotensin II and affects the bradykinin system. In clinical trials comparing valsartan with an ACE inhibitor, the incidence of dry cough was significantly lower (p<0.05) in patients treated with valsartan than in patients treated with an ACE inhibitor (2.6% vs. 7.9%, respectively). ). The use of the drug in patients with arterial hypertension ultimately leads to a decrease in blood pressure without affecting the pulse rate. The onset of hypotensive action is noted within 2 hours, maximum - within 4-6 hours after ingestion; duration of action - over 24 hours. The maximum therapeutic effect develops after 2-4 weeks from the start of treatment and persists with long-term therapy. When used with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved. Sudden withdrawal of the drug is not accompanied by the development of a withdrawal syndrome. The use of the drug leads to a decrease in hospitalizations for heart failure, a slowdown in the progression of heart failure, an improvement in NYHA functional class, an increase in ejection fraction, as well as a decrease in signs and symptoms of heart failure and an improvement in quality of life compared with placebo. Pharmacokinetics After taking the drug inside on an empty stomach, the maximum concentration of valsartan in plasma is reached after 2-4 hours. The average bioavailability of the drug is 23%. When prescribing valsartan with food, the area under the concentration-time curve (AUC) decreases by 48%, although, starting from about 8 hours after taking the drug, plasma concentrations are the same when taken on an empty stomach and when taken with food. . A decrease in the area under the AUC curve, however, is not accompanied by a significant decrease in the therapeutic effect. A significant part of valsartan is not biotransformed, only about 20% of the dose is excreted as metabolites. The hydroxymetabolite is found in plasma at low concentrations (less than 10% of the AUC of valsartan). This metabolite is pharmacologically inactive. The kinetics of elimination of valsartan has a multiexponential character (tl/2a < 1 h and tl/2|3 about 9 h). When taking the drug once a day, the cumulation is negligible. Plasma concentrations of the drug in women and men were the same. Valsartan is largely associated with plasma proteins (94-97%), mainly with albumin. The volume of distribution during the equilibrium state is low (about 17 liters). After intravenous administration, the plasma clearance of valsartan is about 2 l / h and its renal clearance is 0.62 l / h (about 30% of the total clearance). The half-life is 6 hours. The amount of valsartan excreted in the feces is 83% (of the dose taken orally), approximately 13% is excreted in the urine, mostly unchanged. The mean time to peak concentration and half-life of valsartan in patients with heart failure and healthy volunteers are the same. The area under the concentration-time curve and the maximum concentration of valsartan increase linearly and almost in proportion to the dose increase within the dose range of 40-160 mg twice a day. The cumulation coefficient is on average 1.7. The clearance of valsartan after oral administration is approximately 4.5 l / h. Age does not affect the clearance of the drug in patients with heart failure. Pharmacokinetics in selected groups of patients. Elderly patients. In some elderly patients, the systemic exposure to valsartan was slightly more pronounced than in young patients; however, this has not been shown to be of any clinical relevance. Patients with impaired renal function. For compounds with renal clearance less than 30% of total plasma clearance, there is no correlation between renal function and systemic exposure. Therefore, in patients with impaired renal function (creatinine clearance> 10 ml / min), dose adjustment of the drug is not required. Currently, there is no experience on the safe use of valsartan in patients with creatinine clearance <10 ml / min and in patients on hemodialysis. However, valsartan has a high degree of binding to plasma proteins, so its removal during hemodialysis is unlikely. Patients with impaired liver function. About 70% of the absorbed dose of the drug is excreted in the bile, mostly unchanged. In patients with mild to moderate hepatic insufficiency, there is a two-fold increase in AUC compared with healthy people. However, no correlation was found between plasma concentrations of valsartan and the degree of liver dysfunction. The use of valsartan has not been studied in patients with severe hepatic impairment (see sections "Contraindications", "Method of administration and dosage", "Peculiarities of use"). Indications for use Arterial hypertension. Heart failure (treatment of symptomatic heart failure in patients not receiving angiotensin-converting enzyme (ACE) inhibitors, or as add-on therapy to ACE inhibitors in patients not receiving beta-blockers). Recent myocardial infarction (in clinically stable patients with clinical manifestations of heart failure or asymptomatic left ventricular systolic dysfunction after a previous (12 hours - 10 days) myocardial infarction). Contraindications Hypersensitivity to valsartan or to any of the components of the drug. Pregnancy, breastfeeding. Childhood. Severe liver failure, biliary cirrhosis and cholestasis. Simultaneous use of angiotensin receptor antagonists, including valsartan, or angiotensin-converting enzyme (ACE) inhibitors with aliskiren in patients with type 2 diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2). Use during pregnancy and lactation Angiotensin II receptor antagonists are not recommended during the first trimester of pregnancy. Angiotensin II receptor antagonists are contraindicated in the second and third trimesters of pregnancy. Epidemiological data have shown an increased risk of teratogenic effects with the use of ACE inhibitors in the first trimester of pregnancy. A similar risk may also exist when taking angiotensin II receptor antagonists. In patients planning a pregnancy, if necessary, an alternative antihypertensive treatment that has an established safety profile for use during pregnancy should be prescribed. When pregnancy is detected, treatment with angiotensin II receptor antagonists should be stopped immediately and, if necessary, alternative treatment should be initiated. It is known that the use of angiotensin II receptor antagonists in the second and third trimesters of pregnancy causes fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of the skull) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If a woman took angiotensin II receptor antagonists in the second trimester of pregnancy, ultrasound monitoring of kidney and fetal skull function is necessary. Newborns whose mothers have taken angiotensin II receptor antagonists should be closely monitored because of possible hypotension. It is not recommended to use Valsartan Sandoz during lactation, as there is no information on the use of valsartan during breastfeeding. It is preferable to use alternative therapies with an established safety profile, especially if the baby is newborn or premature. Children. The safety and efficacy of Valsartan Sandoz in children under 18 years of age have not been established. Dosage and administration Arterial hypertension. The recommended starting dose of Valsartan Sandoz for adults is 80 mg or 160 mg once daily. The antihypertensive effect is achieved within two weeks, and the maximum effect occurs after four weeks. For patients who fail to achieve an adequate reduction in blood pressure, the daily dose can be increased to 320 mg; additional appointment of diuretics is possible. Valsartan Sandoz can also be administered in conjunction with other antihypertensive agents. Heart failure. The recommended starting dose of Valsartan Sandoz is 40 mg twice daily. Increasing the dose to 80 mg and 160 mg twice a day should be carried out at intervals of at least 2 weeks, taking into account the tolerability of the drug by the patient. The maximum daily dose used in clinical studies was 320 mg divided into several doses. With concomitant treatment with a diuretic, consideration should be given to reducing the dose of the latter. Valsartan may be used in conjunction with other medicines used to treat heart failure. The simultaneous use of a triple combination of ACE inhibitors, beta-blockers and valsartan is not recommended. Evaluation of patients with heart failure should always include monitoring of renal function. postinfarction condition. In clinically stable patients, treatment can be started as early as 12 hours after myocardial infarction. After an initial dose of 20 mg twice daily, the dose of valsartan should be increased to 40 mg, 80 mg and 160 mg twice daily over the next few weeks. The maximum dose is 160 mg twice a day. In general, it is recommended that the dose of 80 mg twice daily be reached within two weeks of starting treatment and the target maximum dose within three months, based on patient tolerance of valsartan during the dose titration period. If symptomatic hypotension or renal dysfunction occurs, dose reduction should be considered. Valsartan can be administered to patients who have been treated with other drugs recommended after myocardial infarction (for example, thrombolytics, acetylsalicylic acid, P-blockers and statins). The simultaneous use of a triple combination of ACE inhibitors, beta-blockers and valsartan is not recommended. Evaluation of patients after myocardial infarction should always include monitoring of renal function. Valsartan Sandoz can be used to treat hypertension in patients with impaired glucose tolerance and risk of cardiovascular insufficiency. For dosing recommendations, see the Hypertension section. The drug can be taken with or without food, with a small amount of water. Dosing in special groups of patients. Elderly patients. There is no need for dose adjustment in elderly patients. Patients with impaired renal function. There is no need for dose adjustment in patients with creatinine clearance greater than 10 ml/min. Patients with impaired liver function. Valsartan is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis. In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. Particular caution should be observed when prescribing valsartan to patients with biliary tract obstruction. Side effects The frequency of occurrence of adverse reactions is estimated as follows: very often -> 1/10, often – from > 1/100, <1/10, infrequently - from > 1/1000, < 1/100, rarely - from > 1/10000 , <1/1000, very rarely - <1/100000. From the blood and lymphatic system: the frequency is unknown - * decrease in hemoglobin, * decrease in hematocrit, * neutropenia, * # thrombocytopenia. From the immune system: the frequency is unknown - * # hypersensitivity reactions, including serum sickness. Metabolic disorders: frequency unknown - *#increase in serum potassium, *#hyponatremia; infrequently - #hyperkalemia. Nervous system disorders: often - dizziness, postural dizziness; infrequently - #fainting, #headache. On the part of the hearing organs: infrequently - * # vertigo. From the side of the cardiovascular system: the frequency is unknown - * # vasculitis, often - # orthostatic hypotension, # hypotension; infrequently - #heart failure. From the respiratory system: infrequently - * # cough. From the digestive system: infrequently - *abdominal pain, #diarrhea, #nausea. From the hepatobiliary system: the frequency is unknown - ^ increased levels of liver enzymes, * increased levels of liver enzymes, including an increase in the level of bilirubin in the blood serum. From the side of the skin and subcutaneous fat: the frequency is unknown * angioedema, * # bullous dermatitis, * # rash, * # itching; infrequently - angioedema. From the musculoskeletal system: the frequency is unknown - * # myalgia. From the genitourinary system: the frequency is unknown - * impaired renal function, * renal failure, * increased serum creatinine, increased blood urea; often - Impaired kidney function, #renal failure, infrequently - #acute renal failure, Increased serum creatinine levels. General violations: infrequently - * # weakness; #asthenia. The following side effects have been observed in clinical trials, regardless of their causal relationship to the study drug: *#arthralgia, Abdominal pain, *asthenia, *#back pain, *diarrhea, *dizziness, *headache, pain, *insomnia , * decreased libido, neutropenia, * nausea, * edema, * pharyngitis, * # rhinitis, * # sinusitis, * # upper respiratory tract infections, * # viral infections. NOTE Reported in: *hypertension; #heart failure and / or post-infarction condition. Overdose Due to an overdose of Valsartan Sandoz, severe arterial hypotension may develop, which can lead to depression of consciousness, collapse and / or shock. If the drug has been taken recently, induce vomiting. In arterial hypotension, the usual method of therapy is intravenous administration of saline. Removal of valsartan from the body by hemodialysis is unlikely. Interactions with other drugs In clinical studies, no interactions of clinical significance were found between valsartan and the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide. Lithium. With the simultaneous use of ACE inhibitors or angiotensin II receptor antagonists with lithium preparations, a reversible increase in the concentration of lithium in the blood serum and the appearance of toxic effects were observed. If there is a need for co-administration of these drugs, careful monitoring of serum lithium concentrations is necessary. If a diuretic is also used, an increased risk of lithium toxicity may be expected with Valsartan Sandoz. Drugs affecting CYP 450. Since Valsartan Sandoz is not metabolized significantly, no clinically significant interactions with other drugs in the form of metabolic induction or inhibition of the cytochrome P450 system were observed when used together with valsartan. Despite the fact that valsartan has a high degree of binding to plasma proteins, in vitro studies have not shown any interaction at this level with a number of molecules that also have a high degree of protein binding, namely diclofenac, furosemide and warfarin. Potassium-sparing diuretics, potassium preparations, preparations containing potassium in the form of salts, and other preparations that can increase potassium levels. Concomitant use with potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium preparations, or preparations containing potassium in the form of salts may lead to an increase in serum potassium levels. Potassium levels should be monitored if co-administration of these drugs is necessary. Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (> 3 g / day) and non-selective NSAIDs. The simultaneous use of NSAIDs and angiotensin II receptor antagonists can lead to a weakening of the antihypertensive effect. In addition, the concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening renal function and an increase in serum potassium levels. In this regard, Transporters. Simultaneous administration of transfer inhibitors (rifampin, cyclosporine) or efflux transporters (ritonavir) may enhance the effect of valsartan. Double blockade of the renin-angiotensin system (RAS) with angiotensin receptor antagonists, ACE inhibitors or aliskiren. The simultaneous use of angiotensin receptor antagonists, including valsartan, with other substances acting on the RAS is associated with an increase in the incidence of hypotension, hyperkalemia, and changes in renal function compared with monotherapy. It is recommended to monitor blood pressure, renal function and electrolyte levels in patients using Valsartan Sandoz and other substances that affect the RAS. Based on the available data, dual blockade of the RAAS with ACE inhibitors, angiotensin receptor antagonists, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. The simultaneous use of angiotensin receptor antagonists, including valsartan or ACE inhibitors with aliskiren, is contraindicated in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2). Precautions Patients with a deficiency in the body of sodium and / or volume of circulating blood (CBV). In patients with severe sodium and / or BCC deficiency, for example, those receiving high doses of diuretics, in some cases, symptomatic hypotension may occur after the initiation of therapy with Valsartan Sandoz. Before starting treatment, it is necessary to correct the content of sodium and / or BCC in the body, for example, by reducing the dose of the diuretic. If hypotensive, the patient should be laid down and, if necessary, given an intravenous infusion of saline. Treatment can be continued immediately after stabilization of blood pressure. Hyperkalemia. Caution should be exercised when Valsartan Sandoz is co-administered with potassium preparations, potassium-sparing diuretics, preparations containing potassium in the form of salts, or other drugs that can increase potassium levels (heparin, etc.). It is recommended to control the content of potassium in the blood. Stenosis of the renal artery. Short-term use of Valsartan Sandoz in 12 patients with vasorenal hypertension secondary to unilateral renal artery stenosis did not cause any significant changes in hemodynamic parameters of the kidneys, serum creatinine or blood urea nitrogen. Because other drugs that affect the renin-angiotensin-aldosterone system (RAAS) may increase blood urea and serum creatinine in patients with unilateral or bilateral renal artery stenosis, monitoring of these parameters is recommended as a safety measure. Impaired kidney function. In patients with impaired renal function, dose adjustment is not required. However, in severe cases (creatinine clearance < 10 ml / min), caution should be exercised, since there is no experience with the drug in these cases. Use with caution in patients on hemodialysis. Currently, there is no experience on the safe use of valsartan in patients on hemodialysis. However, valsartan has a high degree of binding to plasma proteins, so its excretion during hemodialysis is unlikely. There is no experience with the use of Valsartan Sandoz in patients with kidney transplantation. The concomitant use of angiotensin receptor antagonists, including valsartan, or ACE inhibitors with aliskiren should be avoided in patients with severe renal insufficiency (creatinine clearance < 30 ml/min). Impaired liver function. In patients with mild to moderate hepatic impairment without cholestasis, Valsartan Sandoz should be used with caution (see sections "Contraindications" and "Pharmacokinetics"). Heart failure / Post-infarction condition. Patients with heart failure or a post-infarction condition taking Valsartan Sandoz at usual doses experience a slight decrease in blood pressure, but discontinuation of therapy due to prolonged symptomatic hypotension is usually not required if the dosage instructions for the drug are followed. Caution should be exercised in patients with heart failure or in a post-infarction state starting therapy. As a consequence of the inhibition of the renin-angiotensin-aldosterone system (RAAS), impaired renal function may be observed in hypersensitive individuals. In patients with severe heart failure, in whom renal function depends on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors or angiotensin receptor antagonists could cause oliguria and / or progressive azotemia, acute renal failure (rarely) and / or death. Evaluation of patients with heart failure or in the post-MI state should always include monitoring of renal function. It is not recommended to simultaneously take a triple combination of ACE inhibitors (3-blockers and valsartan. Stenosis of the aortic and mitral valves, hypertrophic cardiomyopathy. As with other vasodilators, special care should be taken when prescribing the drug to patients with aortic or mitral stenosis, as well as hypertrophic cardiomyopathy. Angioedema: Cases of angioedema, including swelling of the larynx and vocal cords, leading to airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue have been reported in patients treated with valsartan, some of these patients previously developed angioedema when taking other drugs, including ACE inhibitors.Valsartan Sandoz should be immediately discontinued in patients who develop angioedema, and the drug should not be administered again.Primary hyperaldosteronism.Valsartan Sandoz is not recommended for patients with primary hyper aldosteronism. Dual blockade of the renin-angiotensin system (RAS) Co-administration of angiotensin receptor antagonists, including valsartan, with ACE inhibitors or aliskiren should be avoided, especially in patients with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and angiotensin receptor antagonists is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This applies to the appointment of valsartan as an additional therapy to ACE inhibitors in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. Storage conditionsStore at a temperature not exceeding 30°C, protect from moisture. Keep out of the reach of children. Buy Sartval tablets p/o 160mg No. 14x2