Index of drugs

Treatment of spontaneous hypertension in adults. The fixed-dose drug is indicated for use in patients whose blood pressure is not adequately controlled with monotherapy with valsartan or hydrochlorothiazide.

1 tabl contains 160 mg valsartan and 12.5 mg hydrochlorothiazide or 160 mg valsartan and 25 mg hydrochlorothiazide. The preparation contains lactose and sorbitol.

A hypotensive preparation containing an angiotensin II receptor antagonist (valsartan) and a thiazide diuretic (hydrochlorothiazide). Valsartan is a 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 receptor₁it does not bind or block other hormone receptors or ion channels important for regulation in the circulatory system. It is not an ACE inhibitor (kinase II), so it does not increase the effects of bradykinin-dependent effects. In patients with hypertension, it causes a reduction in blood pressure without affecting the pulse rate. The onset of action occurs within 2 h, the maximum reduction of pressure is achieved within 4-6 h and persists for 24 h. In patients with hypertension, type 2 diabetes and microalbuminuria, the elimination of albumin in the urine. The bioavailability of valsartan after oral administration is approximately 23%. Achieve_max 2-4 h after administration. In 94-97% it is bound to plasma proteins. It is metabolized to a small extent to pharmacologically inactive hydroxymetabolite. It is excreted with faeces (83%) and urine (13%), mainly unchanged. T_0,5 in the elimination phase is 6 hours. Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chlorides. The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, increases urinary potassium loss. When co-administered with valsartan and hydrochlorothiazide, the reduction in potassium in the blood is less pronounced than with hydrochlorothiazide alone. The bioavailability of hydrochlorothiazide after oral administration is 60-80%. Achieve_max 2 h after administration. It binds to plasma proteins at 40-70%. Over 95% of the absorbed dose is excreted unchanged in the urine. T_0,5 in the elimination phase is 6-15 hours.

Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide derivatives or other ingredients of the preparation. Severe liver dysfunction, liver biliary cirrhosis, cholestasis. Severe renal impairment (creatinine clearance <30 ml / min), anuria. Resistance-resistant hypokalemia, hyponatremia, hypercalcemia and symptomatic hyperuricemia. Co-administration with aliskiren in patients with diabetes or renal impairment (GFR <60 ml / min / 1.73 m²). II and III trimester of pregnancy.

Do not use the preparation in patients with severe chronic heart failure or other conditions associated with stimulation of the renin-angiotensin-aldosterone system (RAA); with unilateral or bilateral stenosis of the renal artery or stenosis of the artery supplying the only kidney; with primary hyperaldosteronism. Due to the risk of hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure), dual RAA blocking is not recommended (eg, by the combined use of an angiotensin II receptor antagonist with an ACE inhibitor or aliskiren); if the use of the RAA double block is absolutely necessary, it should only be carried out under the supervision of a specialist. At the same time, angiotensin II receptor antagonists and ACE inhibitors should not be used in patients with diabetic nephropathy. Particularly cautiously use in patients with aortic or mitral valve stenosis or hypertrophic cardiomyopathy with narrowing of the left ventricle outflow pathway.Caution use in patients with sodium deficiency or dehydrated (before beginning the treatment should be compensated hyponatraemia and / or volume of circulating blood); with impaired renal function (control of potassium, creatinine and uric acid levels in the blood); with mild to moderate hepatic dysfunction without cholestasis (dosage adjustment needed); with diabetes (you may need to adjust your insulin dose or oral antidiabetic medicines). There are no data on the use of the product in kidney transplant patients. Caution should be exercised in patients who have previously experienced hypersensitivity reactions to other angiotensin II receptor antagonists; the occurrence of hypersensitivity reactions to hydrochlorothiazide is more likely in patients with allergy and asthma. Hydrochlorothiazide may cause slight and transient hypercalcaemia; significant hypercalcemia may indicate an unrecognized hyperparathyroidism - in this case the treatment should be stopped and parathyroid function tests should be performed. In case of hypersensitivity reactions to light, it is recommended to discontinue the drug; if it is necessary to restart the diuretic therapy, it is recommended to protect the body against sunlight or artificial UV radiation. There have been reports of worsening or active systemic lupus erythematosus under the influence of thiazide diuretics. There are no data on the safety and efficacy of the preparation in children <18 years - use in this age group is not recommended. Due to the lactose content, do not use in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; due to the sorbitol content, do not use in patients with fructose intolerance.

The use of the preparation in the first trimester of pregnancy is not recommended. Use in the second and third trimester of pregnancy is contraindicated. Valsartan used in the second and third trimester of pregnancy is toxic to fetal development (deterioration of renal function, oligohydramnios, delayed ossification of the skull) and newborn (renal failure, hypotension, hyperkalemia) - when exposure to valsartan occurred since the second trimester of pregnancy, it is recommended an ultrasound examination of the fetus skull and kidneys; children whose mothers took the drug during pregnancy should be closely monitored for hypotension. Hydrochlorothiazide crosses the placental barrier and may cause effects in the fetus and newborn, such as electrolyte disturbances, jaundice, and thrombocytopenia. It is not recommended to adjust the preparation during breastfeeding.

Uncommon: dehydration, paresthesia, blurred vision, tinnitus, hypotension, coughing, muscle aches, fatigue. Very rare: dizziness, diarrhea, arthralgia. In addition, fainting, non-cardiac pulmonary edema, renal dysfunction, increased uric acid, bilirubin and creatinine in the blood, hypokalaemia, hyponatremia, increased blood urea nitrogen, and neutropenia were observed. Undesirable effects on individual components may be a potential adverse event when using the product, even if not observed in clinical trials. Valsartan - uncommon: dizziness, abdominal pain; of unknown frequency: decrease in hemoglobin, decrease in hematocrit value, thrombocytopenia, hypersensitivity reactions (including serum sickness), hyperkalemia, vasculitis, increased liver enzymes, angioneurotic edema, rash, pruritus, renal failure. Hydrochlorothiazide - often: orthostatic hypotension, loss of appetite, nausea, vomiting, urticaria and other forms of rash, impotence; rarely: thrombocytopenia (sometimes with purpura), depression, sleep disturbances, headache, arrhythmia, constipation, discomfort in the digestive tract, intrahepatic cholestasis or jaundice, hypersensitivity reactions to light; very rare: agranulocytosis, leukopenia, hemolytic anemia, bone marrow suppression, hypersensitivity reactions, respiratory failure with pulmonary inflammation and edema, pancreatitis, necrotizing vasculitis and toxic epidermal necrolysis, cutaneous lupus-like reactions, activation of dermal lupus erythematosus.

Orally. Adults: 1 tabl. once a day.Individual doses of individual components of the preparation are recommended. If your blood pressure fails to control, the dose can be increased by increasing the dose of each component to a maximum of 320 mg / 25 mg. In the majority of patients, the maximum effect is observed within 4 weeks, in some patients within 4-8 weeks. No dosage adjustment is necessary in patients with creatinine clearance ≥30 ml / min and in the elderly. In patients with mild or moderate hepatic impairment without cholestasis, the maximum daily dose of valsartan is 80 mg.
The tablets can be taken with or without water.