Valsacor coated pills 160mg N30
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Active ingredients
Valsartan
Release form
Pills
Composition
Valsartan 160 mg adjuvants: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, silicon dioxide, anhydrous colloid, magnesium stearate. macrogol 4000.
Indications
- arterial hypertension; - chronic heart failure (NYHA classification II-IV functional class) in patients receiving standard therapy with one or several drugs from the following groups: diuretics, cardiac glycosides, as well as ACE inhibitors or beta-adrenergic blockers (use of each of these drugs is not mandatory); - increased survival of patients with acute myocardial infarction (12 h-10 days), complicated by left ventricular failure and / or systolic dysfunction of the left ventricle, p With stable hemodynamic parameters.
Contraindications
- hypersensitivity to valsartan or to other components of the drug; - liver dysfunction, biliary cirrhosis and cholestasis; - dysfunction of the liver of mild and moderate severity (for a dose of 320 mg); - simultaneous use with aliskiren in patients with diabetes mellitus or dysfunction kidney (CC less than 60 ml / min); - lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome; - pregnancy; - lactation period (breastfeeding); - children and adolescents under 18 years old (effective and safe the use of valsartan in children has not been proven). With caution: severe renal dysfunction (CC less than 10 ml / min); stenosis of the aortic and / or mitral valve; hypertrophic obstructive cardiomyopathy (GOKMP); chronic heart failure (NYHA class III-IV functional class); condition after kidney transplantation; hemodialysis; hyponatremia; diet restriction of salt intake; bilateral renal artery stenosis or arterial stenosis of a single kidney; hyperkalemia; primary hyper aldosteronism; conditions accompanied by a decrease in bcc (including diarrhea, vomiting); hereditary angioedema, or edema in the background of previous therapy with angiotensin II receptor antagonists or ACE inhibitors.
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Dosage and administration
The drug is administered orally, regardless of the meal, the frequency of intake is 1-2 times / day. Arterial hypertension The recommended initial dose is 80 mg 1 time / day, regardless of race, age and sex of the patient. The antihypertensive effect develops within 2 weeks and reaches its maximum after 4 weeks. Patients who fail to achieve optimal control of blood pressure, the daily dose of the drug Valsacor can be gradually increased to a maximum daily dose of 320 mg. The simultaneous use of diuretics, such as hydrochlorothiazide, allows you to achieve a significant additional reduction in blood pressure. Chronic heart failure (NYHA Class II-IV functional class) The recommended initial dose is 40 mg 2 times / day. A gradual (up to at least 2 weeks) increase in dose up to 80 mg 2 times / day is possible, with good tolerance up to 160 mg 2 times / day. The maximum daily dose is 320 mg divided into 2 doses. It is recommended to reduce the dose while taking diuretics. May be used simultaneously with other drugs intended for the treatment of CHF. However, the combination of an ACE inhibitor, beta-blocker and valsartan is not recommended. In patients with heart failure, renal function should always be evaluated. Improving the survival of patients with acute myocardial infarction In patients with stable hemodynamics, treatment should begin as early as 12 hours after the development of myocardial infarction.After the initial dose of 20 mg is prescribed 2 times / day, the dose of the drug Valsacor should be increased by the method of titration to 40 mg, 80 mg 2 times / day for several weeks until the target dose of 160 mg is reached 2 times / day. The maximum daily dose is 320 mg 2 times / day. As a rule, given the tolerance of therapy, it is recommended to increase the dose to 80 mg 2 times / day by the end of the 2nd week of treatment and up to the maximum target dose of 160 mg 2 times / day - by the end 3 month of therapy. In the case of symptomatic arterial hypotension or renal dysfunction, it is advisable to consider reducing the dose. The drug Valsacor can be used in patients after myocardial infarction during therapy with other drugs, including thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers, HMG-CoA inhibitors -reductases (statins) and diuretics. It is not recommended to use Valsacor at the same time as ACE inhibitors. In patients with myocardial infarction, renal function should always be evaluated. For elderly patients (over 65), dose adjustment is not required. Patients with impaired renal function do not need dose adjustment. impaired liver function of mild and moderate severity of nonbiliary genesis without cholestasis; the maximum daily dose should not exceed 80 mg.
Side effects
The incidence of adverse events is comparable to placebo. No data are available on the dependence of the incidence of adverse events on the dose or duration of treatment, as well as on the age, gender or race of the patients. Classification of the incidence of side effects. , infrequently from (more than 1/1000 to less than 1/100), rarely (from more than 1/10 000 to less than 1/1000), very rarely (from less than 1/10 000), the frequency is unknown (cannot be estimated based on the available data) .All adverse effects in the use of valsartan, identified in clinical practice the analysis of laboratory parameters, which can not be attributed to any frequency of occurrence, are assigned to the frequency band neizvestna.Arterialnaya gipertenziyaSo hemopoiesis system: the frequency is unknown - decrease in hemoglobin, hematocrit, neutropenia,thrombocytopenia. On the immune system: frequency unknown - hypersensitivity reactions, including serum sickness. On the part of metabolism: frequency unknown - increased potassium content in the blood serum, hyponatremia. On the part of the sense organs: infrequently - vertigo. On the side of the cardiovascular system : frequency not known - vasculitis. On the part of the respiratory system: infrequently - cough. On the part of the digestive system: not often - abdominal pain; frequency is unknown - impaired liver function, including an increase in plasma bilirubin concentration. From the skin of the subcutaneous tissues: very rarely - angioedema, skin rash, pruritus. From the musculoskeletal system: frequency unknown - myalgia. From the urinary system: the frequency is unknown - impaired renal function, an increase in serum creatinine concentration. Others: infrequently - increased fatigue. Also in clinical studies in patients with arterial hypertension were observed following No undesirable effects (causal relationship with taking the drug has not been established): arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory infections, viral infections In adult patients with myocardial infarction and / or heart failure, the safety profile in clinical studies is somewhat different from that in patients with arterial hypertension. This may be due to the disease itself. Chronic heart failure (NYHA classification II-IV) and increased survival of patients with acute myocardial infarction. From the hematopoietic system: frequency unknown - thrombocytopenia. From the immune system: frequency unknown - hypersensitivity reactions, including serum sickness. From the side of metabolism: infrequently - hyperkalemia; frequency is unknown - an increase in the content of potassium in the blood serum, hyponatremia. From the nervous system: often - dizziness, orthostatic (postural) dizziness; infrequently - fainting, headache. From the side of the sense organs: infrequently - vertigo. From the side of the cardiovascular system: often - pronounced decrease in blood pressure,orthostatic hypotension; infrequently - increased symptoms of heart failure; frequency is unknown - vasculitis. On the part of the respiratory system: infrequently - cough. On the part of the digestive system: rarely - nausea, diarrhea; frequency is unknown - impaired liver function. On the side of the skin and subcutaneous tissues: very rarely - angioedema; frequency is unknown - skin rash, pruritus. From the musculoskeletal system: very rarely - rhabdomyolysis; frequency is unknown - myalgia. From the urinary system: often - impaired renal function; infrequently - acute renal failure, increased serum creatinine concentration; frequency is unknown - an increase in the concentration of residual nitrogen of urea in the blood serum. Other: infrequently - asthenia, increased fatigue.