Index of drugs

Treatment of essential hypertension. Treatment of patients in a clinically stable condition with symptomatic heart failure or asymptomatic left ventricular systolic failure after a recent (12 hours to 10 days) myocardial infarction. Treatment of symptomatic heart failure if ACE inhibitors can not be used or as a combination therapy with ACE inhibitors if beta blockers can not be used.

1 tabl powl. contains 80 mg valsartan.

Valsartan is an active, potent and specific angiotensin II receptor antagonist. It acts selectively on the AT receptor subtype₁by blocking the effects of angiotensin II. It has no agonist activity towards the AT receptor₁, is also not an inhibitor of angiotensin convertase (kininase II) - an enzyme that converts angiotensin I into angiotensin II and breaks down bradykinin. Therefore, unlike ACE inhibitors, the likelihood of coughing is low. Valsartan does not bind or block other hormone receptors or ion channels that play a role in the regulation of cardiovascular function. In patients with hypertension, it causes a reduction in blood pressure without affecting the pulse rate. The onset of action occurs within 2 hrs, maximum pressure reduction is achieved within 4-6 h and persists for 24 h. During repeated administration, the maximum reduction in blood pressure is usually achieved within 4 weeks and persists during long-term treatment. In patients with hypertension, type 2 diabetes and microalbuminuria, urinary albumin excretion is reduced. Valsartan is absorbed quickly after oral administration, bioavailability is 23%. It is strongly bound to plasma proteins (94-97%), mainly with albumin. It is excreted mainly in unchanged form with bile (83%) and urine (13%), to a small extent it is metabolized to pharmacologically inactive hydroxymetabolite. T_0,5 is 6 hours.

Hypersensitivity to the components of the preparation. Severe hepatic dysfunction, liver biliary cirrhosis and cholestasis. II and III trimester of pregnancy.

In rare cases, symptomatic hypotension may occur at the beginning of treatment in patients with hyponatremia and / or in dehydration, eg due to high doses of diuretics. Sodium deficiency and / or circulating blood volume should be corrected before starting treatment, eg by reducing the dose of diuretic. In patients with bilateral renal artery stenosis or artery stenosis of the sole active kidney, the safety of the preparation has not been established. There is no experience regarding the safety of the preparation in patients who have recently had a kidney transplant. It should not be used in patients with primary hyperaldosteronism due to inhibition of the renin-angiotensin system in these patients. Particularly cautiously use in patients with aortic or mitral valve stenosis or hypertrophic cardiomyopathy with narrowing of the left ventricle outflow pathway. Due to lack of experience in the safe use of the drug in patients with creatinine clearance <10 ml / min and patients on dialysis - cautiously use in these groups of patients. Use with caution in patients with mild to moderate hepatic dysfunction without cholestasis. In patients after recent myocardial infarction, the concomitant use of valsartan and an ACE inhibitor is not recommended - combined use increases the risk of side effects compared with monotherapy. Caution should be exercised at the beginning of treatment in patients after myocardial infarction. Use of the preparation in patients after myocardial infarction usually results in lowering of blood pressure, but discontinuation of the product due to persistent symptomatic hypotension is not usually necessary, provided that the patient adheres to the dosing recommendations.In patients with heart failure, combination therapy with three drugs (ACE inhibitor, β-blocker and valsartan) increases the risk of side effects and for this reason combination therapy is not recommended. Caution should be exercised at the beginning of treatment in patients with heart failure. Use of the preparation in patients with heart failure commonly results in lowering of blood pressure, but discontinuation of the preparation due to persistent symptomatic hypotension is not usually necessary, provided that the patient adheres to the dosage recommendations. Due to the lactose content, patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug. The product contains lecithin - if you are hypersensitive to peanut or soya, do not take the medicine. Due to the lack of data on the safety and efficacy of the drug in children under 18 years of age, the use is not recommended in this age group.

It is not recommended during the first trimester of pregnancy. In the second and third trimester, the use of the preparation is contraindicated. Administration of the preparation during the second and third trimester of pregnancy results in toxic effects on the fetus (deterioration of fetal renal function, oligohydramnios, delayed ossification of the skull) and the newborn (renal failure, hypotension, hyperkalemia). If the exposure to valsartan occurred from the second trimester of pregnancy, ultrasound examination of the kidneys and skull is recommended. Newborns whose mothers used valsartan should be observed for hypotension. It is not recommended to use the product during breastfeeding. During breastfeeding, in particular newborns and children born prematurely, it is recommended to use other preparations with a better safety profile.

Common (≥1 / 100, <1/10): dizziness, hypotension, orthostatic hypotension, insufficiency and renal dysfunction. Uncommon (≥1 / 1000, <1/100): cough, abdominal pain, fatigue, hyperkalemia, fainting, headache, heart failure, nausea, diarrhea, angioneurotic edema, acute renal failure, increased creatinine in the blood, weakness. In addition, there may be: reduced hemoglobin, decreased hematocrit, neutropenia, thrombocytopenia, hyperuric reactions, hyperkalemia, vasculitis, increased liver enzymes, increased bilirubin in the blood, angioneurotic edema, rash, pruritus, muscle pain , increase in blood urea nitrogen.

Orally.Hypertension. The recommended starting dose is 80 mg once a day. The antihypertensive effect is noticeable within 2 weeks, the maximum level is reached within 4 weeks. For some patients who do not have adequate blood pressure control, the dose can be increased to 160 mg, up to a maximum of 320 mg. The drug can be used simultaneously with other antihypertensive drugs.Condition after a recent myocardial infarction. In stable clinical patients, treatment can be started 12 hours after the diagnosis of myocardial infarction. After an initial dose of 20 mg twice daily, the dose of valsartan should be gradually increased to 40 mg, 80 mg and 160 mg twice daily for the Next few weeks. The initial dose is provided by a divisible 40 mg tablet. The maximum target dose is 160 mg twice daily. It is usually recommended that patients should receive a dose of 80 mg twice daily for the first 2 weeks after initiation of treatment, and the maximum target dose of 160 mg twice daily should be administered within 3 months. If symptomatic hypotension or renal impairment occurs, a dose reduction should be considered. Valsartan can be used in patients who are taking other medicines for the treatment of myocardial infarction, such as thrombolytics, Acetylsalicylic acid, β-blockers, statins and diuretics. Co-administration with ACE inhibitors is not recommended.Heart failure. The recommended starting dose is 40 mg 2 times a day. Increasing the dose to 80 mg and 160 mg twice daily should be carried out at intervals of at least two weeks to achieve the highest dose tolerated by the patient. If you are taking a diuretic at the same time, you should consider reducing the dose.The maximum daily dose used in clinical trials was 320 mg valsartan in divided doses. Valsartan may be used in patients who are taking other medicines for the treatment of heart failure. However, concomitant combination therapy with three drugs (valsartan with ACE inhibitors and β-blockers) is not recommended.
No dose adjustment is required in patients with creatinine clearance> 10 ml / min. In patients with mild to moderate hepatic impairment without cholestasis, doses above 80 mg daily should not be used.
The tablets can be taken regardless of meals; should be served with water.