Valsartan-LF tablets p/o 160mg №10×3

Name:
Valsartan-LF tablets, p / o coating, 160 mg in a cont cell pack No. 10×3
Description:
Round tablets, white, biconvex, film-coated. The main active ingredient Valsartan Release form Film-coated tablets. Dosage 160 mg Indications for use Arterial hypertension in adults and children from 6 to 18 years. Heart failure: treatment of heart failure with clinical symptoms in adult patients with intolerance to angiotensin-converting enzyme inhibitors (ACE inhibitors), or as an additional therapy to ACE inhibitors in patients intolerant to ?- blockers, if mineralocorticoid receptor antagonists cannot be used (see sections “Method of application and doses”, “Precautions”, “Interaction with other drugs”, “Pharmacodynamics”). Recent myocardial infarction (in clinically stable adult patients with clinical manifestations heart failure or asymptomatic left ventricular systolic dysfunction after a previous (12 hours – 10 days) myocardial infarction) (see sections “Pharmacodynamics”, “Precautions”). If you have any doubts or questions, consult your doctor. Dosing and Administration Tablets are taken orally, regardless of the meal, with a small amount of water. Arterial hypertension The recommended starting dose of Valsartan-LF is 80 mg or 160 mg once a day. The antihypertensive effect is achieved within two weeks, and the maximum effect occurs after four weeks. In patients who fail to achieve an adequate reduction in blood pressure, the daily dose can be increased to 160 mg, or, as a maximum, up to 320 mg; additional appointment of diuretics is possible. Valsartan-LF can also be administered in conjunction with other antihypertensive drugs (see section “Interaction with other drugs”). Heart failure Selected groups of patients Arterial hypertension in children and adolescents Children from 6 to 18 years old For children weighing less than 35 kg, the initial dose is 40 mg once a day. For children weighing 35 kg or more, the initial dose is 80 mg once a day. The dose should be adjusted depending on the effect on blood pressure. The maximum doses studied in clinical trials are shown in the table below. Doses higher than those indicated have not been studied and are therefore not recommended. Body weight > 18 kg … < 35 kg Maximum doses studied in clinical trials 80 mg Body weight > 35 kg … < 80 kg Maximum doses studied in clinical trials 160 mg Body weight > 80 kg … < 160 kg Maximum doses studied in clinical trials 320 mg Children under 6 years The safety and efficacy of valsartan in children under 6 years of age has not been established. Heart failure and recent myocardial infarction in children and adolescents Valsartan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents under 18 years of age due to a lack of safety and efficacy data. Elderly patients There is no need for dose adjustment in elderly patients. Patients with impaired renal function Children 6 to 18 years of age The use in children with creatinine clearance <30 ml / min or on dialysis has not been studied, therefore, valsartan is not recommended for such patients. Dose adjustment is not required in children with creatinine clearance greater than 30 ml/min. Kidney function and serum potassium levels should be closely monitored. Adults There is no need to adjust the dose in adult patients with creatinine clearance greater than 10 ml/min. Patients with impaired liver function Valsartan is contraindicated in patients with severe hepatic insufficiency, biliary cirrhosis or biliary tract obstruction. In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. If you forget to take Valsartan-LF If you forget to take a medicine, take it as soon as you remember. However, if this time is close to the time of the next dose, you should skip the forgotten dose of the drug. Do not take a double dose to make up for a missed one! If you stop taking Valsartan-LF Stopping treatment with valsartan may make your condition worse. You should not stop treatment without consulting your doctor. If you have any doubts or questions, please consult your doctor. The recommended starting dose of Valsartan-LF 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 valsartan by the patient. The maximum daily dose used in clinical studies was 320 mg in two divided doses. With concomitant treatment with a diuretic, consideration should be given to reducing the dose of the latter. Valsartan-LF may be given with other medicines used to treat heart failure. The concomitant use of a triple combination of an ACE inhibitor, valsartan and a ?-blocker or a potassium-sparing diuretic is not recommended. Evaluation of patients with heart failure should always include monitoring of renal function. Postinfarction In clinically stable patients, treatment can begin 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. This dosage form cannot provide a dosage of 20 mg. If it is necessary to prescribe valsartan at a dose of 20 mg, it is necessary to use a drug that provides the required single dose. The maximum dose is 160 mg twice a day. In general, it is recommended that the 80 mg twice daily dose 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 may be given to patients who have been treated with other medicinal products recommended after myocardial infarction (eg, thrombolytics, acetylsalicylic acid, ?-blockers, and statins). The simultaneous use of a triple combination of ACE inhibitors, ?-blockers and valsartan is not recommended. Evaluation of patients after myocardial infarction should always include monitoring of renal function. Valsartan-LF can be used to treat arterial hypertension in patients with impaired glucose tolerance and risk of cardiovascular insufficiency. Use during pregnancy and lactation Pregnancy The use of angiotensin II antagonists is not recommended in the first trimester of pregnancy. The use of angiotensin II antagonists is contraindicated in the second and third trimesters of pregnancy (see section "Contraindications"). Patients planning a pregnancy should, if necessary, be given an alternative antihypertensive treatment that has an established safety profile for use during pregnancy. When pregnancy is detected, treatment with angiotensin II receptor antagonists (ARAs) should be stopped immediately and, if necessary, alternative treatment should be initiated. 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 ARAs. It is known that taking ARA in the second and third trimesters of pregnancy causes fetotoxicity (decreased kidney function, oligohydramnios, delayed skull ossification) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If a woman took ARA in the second trimester of pregnancy, ultrasound monitoring of the function of the kidneys and the skull of the fetus is necessary. Newborns whose mothers have taken ARA should be closely monitored due to possible arterial hypotension. Lactation period It is not recommended to use the drug Valsartan-LF during breastfeeding, as there is no information on the use of valsartan during breastfeeding. Patients should be switched to alternative therapy with drugs with a well-established safety profile when breastfeeding, especially if the baby is a newborn or born prematurely. Influence on the ability to drive vehicles or potentially dangerous mechanisms No studies have been conducted to evaluate the effect of valsartan on the ability to drive a car and work with mechanisms. When driving vehicles or working with mechanisms, the possibility of dizziness or weakness should be considered. During the period of treatment, patients must be careful when driving vehicles and engaging in other potentially hazardous activities that require concentration and psychomotor speed. Precautions Hyperkalemia Caution should be exercised when using valsartan with potassium preparations, salt substitutes containing potassium, potassium-sparing diuretics or other drugs that can increase the concentration of potassium in the blood serum (heparin, etc.). It is recommended to control the concentration of potassium in the blood serum. Impaired renal 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 valsartan 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. Kidney transplantation Currently, there are no data on the safety of the use of valsartan in patients who have recently undergone kidney transplantation. Renal artery stenosis Short-term use of valsartan in 12 patients with vasorenal hypertension secondary to unilateral renal artery stenosis did not cause any significant changes in renal hemodynamic parameters, changes in serum creatinine concentration, or an increase in blood urea nitrogen concentration. However, other drugs that affect the RAAS may increase blood urea concentration and serum creatinine concentration in patients with unilateral renal artery stenosis. Based on this, when prescribing valsartan to patients in this group, careful monitoring of renal function is required. Impaired liver function In patients with hepatic insufficiency (mild to moderate severity) without cholestasis, the drug Valsartan-LF should be used with caution (see sections "Contraindications" and "Pharmacokinetics"). Patients with sodium deficiency and/or reduced circulating blood volume (CBV) In patients with severe sodium deficiency and/or reduced circulating blood volume (CBV), for example, those receiving high doses of diuretics, in rare cases after the beginning of treatment with valsartan, symptomatic arterial hypotension may occur. 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. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Dual blockade of the RAAS is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy. Dual blockade of the RAAS with ACE inhibitors, ARAs, or drugs containing aliskiren cannot be recommended for any patient, especially patients with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and ARA is absolutely indicated, careful supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. Conducting a double blockade of the RAAS under the close supervision of a specialist with mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be given valsartan because their renin-angiotensin system is inactive. Stenosis of the aortic or mitral valves, obstructive hypertrophic cardiomyopathy As with other vasodilators, when prescribing valsartan to patients with stenosis of the aortic or mitral valves or hypertrophic obstructive cardiomyopathy, special care should be taken. Heart failure/Post-MI Caution should be exercised when prescribing valsartan to patients in the early post-MI period and patients with chronic heart failure starting therapy. As a consequence of the inhibition of the RAAS, there may be impaired renal function. In those individuals whose renal function may depend on the activity of the RAAS (including patients with severe heart failure), cases of oliguria and / or progressive azotemia, acute renal failure (rarely ) and/or death. Since valsartan is an ARA II, the possibility of developing renal dysfunction in patients cannot be excluded. Evaluation of the condition of patients with heart failure or in the post-infarction state should always include regular monitoring of kidney function. The appointment of valsartan to patients in the period after myocardial infarction and patients with chronic heart failure leads to an insignificant decrease in blood pressure, however, discontinuation of therapy due to symptomatic hypotension is usually not required if the dosage instructions for the drug are followed (see section "Method of application and dose "). In patients with chronic heart failure, therapy with a triple combination of an ACE inhibitor, a β-blocker and valsartan is not recommended, since in the absence of additional clinical benefits, this combination increases the risk of adverse reactions. Angioedema Cases of angioedema have been reported, including laryngeal and glottic edema leading to airway obstruction, and/or swelling of the face, lips, pharynx and/or tongue in patients treated with valsartan. Some of these patients had a history of developing angioedema after taking other drugs, including ACE inhibitors. In the event of the development of angioedema in patients, Valsartan-LF should be discontinued, its re-appointment is not allowed. Pediatric age Use in children with impaired renal function The use in children with creatinine clearance <30 ml / min and in children on dialysis has not been studied, therefore, valsartan is not recommended for such patients. Dose adjustment is not required in children with creatinine clearance >30 ml/min. Kidney function and serum potassium should be closely monitored. This is especially true when valsartan is used in the presence of other conditions (eg, fever, dehydration) that can cause impaired renal function. The simultaneous use of angiotensin II receptor antagonists (including valsartan) or ACE inhibitors with aliskiren-containing drugs is contraindicated in patients with moderate / severe renal insufficiency (GFR <60 ml / min / 1.73 m2). Use in children with impaired liver function As in adults, valsartan is contraindicated in children with severe liver failure, biliary cirrhosis and cholestasis. There is limited clinical experience with valsartan in children with mild to moderate hepatic impairment. In such patients, the dose of valsartan should not exceed 80 mg. Excipients The drug contains sodium in an amount of less than 1 mmol (23 mg) per dose, i.e. practically "sodium-free". Interactions with other drugsAlways tell your doctor what medicines you are taking or have recently taken, even if they are over-the-counter medicines. In clinical studies, there were no clinically significant interactions of valsartan with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide. Co-administration is not recommended Lithium With the simultaneous use of ACE inhibitors or ARAs with lithium preparations, a reversible increase in the concentration of lithium in the blood serum and the appearance of toxic effects were observed. If the simultaneous administration of these drugs is necessary, careful monitoring of the concentration of lithium in the blood serum is recommended. If a diuretic is also used, an increased risk of lithium toxicity may be expected with valsartan. Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other drugs that can increase potassium levels: Co-administration with potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements, potassium-containing salt substitutes, or other drugs , which can increase potassium levels (eg, heparin), may lead to an increase in serum potassium levels, and in patients with heart failure, may increase serum creatinine levels. Potassium levels should be monitored if co-administration of these medicinal products is necessary. Caution should be exercised when used together Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2), acetylsalicylic acid (more than 3 g / day) and other non-selective NSAIDs: With simultaneous administration, a weakening of the antihypertensive effect is possible, and also increase the risk of worsening kidney function and increasing the concentration of potassium in the blood serum. If it is necessary to use such a combination, adequate hydration of patients and monitoring of renal function should be ensured from the start of treatment. Transporters: In vitro studies have demonstrated that valsartan is a substrate for the transport proteins OATP1B1/OATP1B3 and MRP2 in the liver. The clinical significance of this study has not been determined. However, concomitant use of transfer inhibitors (eg, rifampicin, cyclosporine) or efflux transporters (eg, ritonavir) may increase the systemic effects of valsartan. Caution should be exercised when starting and stopping therapy with these medicinal products. Dual blockade of the renin-angiotensin-aldosterone system (RAAS): Based on available data, dual blockade of the RAAS with ACE inhibitors, ARBs, or drugs containing aliskiren cannot be recommended for any patient, especially patients with diabetic nephropathy. In patients with diabetes mellitus or moderate / severe renal insufficiency (GFR <60 ml / min / 1.73 m2), the simultaneous use of aliskiren-containing drugs with ACE inhibitors or ARAs is contraindicated. In some cases, when the combined use of ACE inhibitors and ARA is absolutely indicated, careful supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Drugs affecting CYP 450: Since valsartan is not significantly metabolized, 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. Use in children and adolescents 6 to 18 years of age In children and adolescents, arterial hypertension may be associated with impaired renal function. In this case, valsartan should be used with caution simultaneously with other drugs that affect the RAAS, as this can lead to an increase in the content of potassium in the blood plasma. It is recommended to conduct regular monitoring of kidney function and serum potassium in patients of this group. Contraindications Hypersensitivity to valsartan or to any of the components of the drug. Pregnancy. Severe liver failure, biliary cirrhosis and obstruction of the biliary tract. Simultaneous use of ACE inhibitors or angiotensin II receptor antagonists (ARA) with drugs containing aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2). Composition One tablet contains: Active substance: valsartan - 160 mg. Excipients: sodium starch glycolate (type A), sodium stearyl fumarate, crospovidone (type B), anhydrous colloidal silicon dioxide, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, Opadary II white (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc). Overdose Symptoms: an overdose of valsartan may be accompanied by severe arterial hypotension, which can lead to depression of consciousness, collapse and / or shock. Treatment: the totality of therapeutic measures depends on the time of taking an excess dose of valsartan and the severity of the observed symptoms, the most important measure is the stabilization of the cardiovascular system. If the drug has been taken recently, then vomiting should be induced. With the development of arterial hypotension, it is necessary to give the patient a supine position and take measures to adjust the volume of circulating blood. The usual method of therapy is intravenous administration of saline. Removal of valsartan by hemodialysis is unlikely. 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 - <1/10000. Note: Further in the text of the section, the following conventions are used: * - side effects reported in the treatment of hypertension; # - side effects reported in the treatment of heart failure and / or post-infarction condition. Blood and lymphatic system disorders: frequency unknown - *decreased hemoglobin, *decreased hematocrit, *neutropenia, *#thrombocytopenia. Immune system disorders: frequency unknown - *#hypersensitivity reactions, including serum sickness. Metabolic and nutritional disorders: frequency unknown - * # increase in the content of potassium in the blood, * # hyponatremia; infrequently - #hyperkalemia. Nervous system disorders: often - #dizziness, #postural dizziness; infrequently - #fainting, #headache. Hearing disorders and labyrinth disorders: infrequently - * # vertigo. Heart disorders: infrequently - #heart failure. Vascular disorders: frequency unknown - * # vasculitis, often - # orthostatic hypotension, # hypotension. Respiratory, thoracic and mediastinal disorders: infrequently - *#cough. Gastrointestinal disorders: infrequently - *abdominal pain, #diarrhea, #nausea. Liver and biliary tract disorders: frequency unknown - #increased levels of liver enzymes, *increased levels of liver enzymes, including an increase in the level of bilirubin in the blood. Skin and subcutaneous tissue disorders: frequency unknown - * angioedema, * # bullous dermatitis, * # rash, * # itching; infrequently - angioedema. Musculoskeletal and connective tissue disorders: frequency unknown - * # myalgia. Renal and urinary tract disorders: frequency unknown - *impaired kidney function, *renal failure, *increased serum creatinine, #increased blood urea; often - #impaired kidney function, #renal failure, infrequently - #acute renal failure, #increased blood creatinine. General disorders and disorders at the injection site: infrequently - * # weakness; #asthenia. The following side effects were observed in clinical studies, regardless of their causal relationship with the study drug: *#arthralgia, #abdominal pain, *asthenia, *#back pain, *diarrhea, *dizziness, *headache, *#insomnia, * #decreased libido, #neutropenia, *nausea, *#edema, *#pharyngitis, *#rhinitis, *#sinusitis, *#upper respiratory infections, *#viral infections. Pediatric patients (hypertension) The antihypertensive effect of valsartan was evaluated in two randomized, double-blind clinical trials in 561 children aged 6 to 18 years. There were no significant differences in the type, frequency and severity of side effects between the safety profile for children aged 6 to 18 years and the previously known safety profile in adult patients. Assessment of neurocognitive function and development in children aged 6 to 16 years did not reveal a clinically significant adverse effect after treatment with valsartan for up to one year. In a double-blind, randomized trial in 90 children aged 1 to 6 years, followed by an open extension for one year, two people died and isolated cases of marked elevations in liver transaminases were observed. In the second study, which randomized 75 children aged 1 to 6 years, there were no deaths and one case of marked elevation of liver transaminases during an open extension of one year. These cases occurred in a population of patients with significant comorbidities. A causal relationship with valsartan has not been established. Hyperkalemia has been observed in children aged 6 to 18 years with chronic kidney disease. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Storage conditions In the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Valsartan-LF tablets p/o 160mg No. 10x3