Valsacor n160 pills 160 + 12.5mg №30

Indications

- arterial hypertension (in patients for whom combination therapy is indicated).

Dosage and administration

The drug is taken orally, regardless of the meal, the multiplicity of reception - 1 time / day.

Valsacor^® H160 can be combined with other antihypertensive drugs. Treatment must begin with minimal doses of the drug.

For patients who have not reached the target level of blood pressure on the background of monotherapy (valsartan at a dose of 160 mg or hydrochlorothiazide at a dose of 12.5 mg), a fixed combination of doses is recommended - Valsacor ^® H160 (160 / 12.5 mg) 1 time / day.

Maximum antihypertensive effect of the drug Valsacor^® H160 (160 / 12.5 mg) develops within 2-4 weeks. If necessary (the level of diastolic blood pressure above 100 mm Hg against the background of monotherapy with valsartan), to achieve a more pronounced effect, an increase (not earlier than in 4-8 weeks) of the drug dose to 160/25 mg is possible (use of the drug Valsacor^® ND160) 1 time / day.

Patients with impaired renal function (CC more than 30 ml / min (0.5 ml / sec)) no need to change doses of the drug.

Valsacor^® H160 is not recommended patients with impaired liver function. The maximum recommended daily dose of valsartan is patients with mild or moderate hepatic impairment of nonbiliary origin - 80 mg (1 tab. / Day of the drug Valsacor^® H80).

Elderly patients dose adjustment is not required.

Adverse effects

Classification of the incidence of side effects of WHO:

The adverse events were generally mild and transient in nature.

From the side of the central nervous system and peripheral nervous system: often - general weakness; sometimes - increased fatigue, asthenia, dizziness, incl. postural, vertigo, insomnia; rarely - headache, depression, paresthesia, neuralgia; very rarely - fainting (when used after myocardial infarction).

On the part of the respiratory system: often - nasopharyngitis; sometimes - infections of the upper respiratory tract, rhinitis, sinusitis, cough; very rarely - respiratory distress syndrome with pneumonitis and pulmonary edema.

Since the cardiovascular system: sometimes chest pain; often - marked reduction in blood pressure and orthostatic hypotension; very rarely, arrhythmias; potentially possible - peripheral edema.

From the digestive system: often - diarrhea; sometimes nausea, dyspepsia, abdominal pain; rarely - gastroenteritis, loss of appetite, constipation, hyperbilirubinemia, increased activity of hepatic transaminases; very rarely - pancreatitis, intrahepatic cholestasis, jaundice.

From the skin: rarely - skin rash, photosensitivity; very rarely - alopecia.

With sides of the musculoskeletal system: sometimes - pain in the back, limbs, sprain and tears of ligaments and muscles or muscle tendons, arthritis, arthralgia; rarely - myalgia, muscle weakness, muscle cramps.

From the genitourinary system: sometimes - decreased libido, impotence (less than 1%), urinary tract infection, viral infections, increased frequency of urination; rarely, hypercreatininemia, an increase in the concentration of serum urea nitrogen; very rarely - impaired renal function.

With sides of the senses: sometimes - blurred vision; rarely - tinnitus, conjunctivitis.

Allergic reactions: very rarely - angioedema, urticaria, skin rash, itching, hypersensitivity reactions, including serum sickness and necrotizing vasculitis, toxic epidermal necrolysis (Lyell's syndrome), lupus-like reactions, exacerbation of the course of SLE.

Hemic and lymphatic: rarely - anemia, incl. hemolytic, leukopenia, agranulocytosis, bone marrow suppression, decrease in hemoglobin and hematocrit, neutropenia, thrombocytopenia (sometimes with purpura).

From the laboratory indicators: often - hyperkalemia, hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia.

Other: rarely, increased sweating; very rarely - nosebleeds.

Contraindications

- severe liver dysfunction;

- biliary cirrhosis and obstruction of the biliary tract (cholestasis);

- mild and moderate violations of the liver of non-biliary origin (for a given dose of the drug);

- anuria, pronounced renal dysfunction (CC less than 30 ml / min (0.5 ml / sec));

- hemodialysis;

- hypokalemia, hyponatremia, hypercalcemia or hyperuricemia with clinical manifestations, refractory to adequate therapy;

- intolerance to galactose, lactase deficiency lapp or glucose impaired glucose / galactose syndrome;

- age up to 18 years (efficacy and safety of valsartan in children not installed);

- pregnancy;

- lactation period;

- hypersensitivity to valsartan, hydrochlorothiazide, sulfonamide derivatives and other components of the drug.

WITH caution the drug should be used while taking potassium preparations, potassium-sparing diuretics, potassium-containing food salt substitutes and other drugs that can increase the level of potassium in the blood (eg heparin), chronic heart failure IV functional class according to the NYHA classification, renal failure (CC more than 30 ml / min (0.5 ml / sec)), moderate liver dysfunction, bilateral or unilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, condition after kidney transplantation, and, accompanied by a decrease in bcc and / or sodium ions (including diarrhea, vomiting), primary hyperaldosteronism, stenosis of aortic and mitral valves, hypertrophic obstructive cardiomyopathy (GOKMP), systemic lupus erythematosus, hypersensitivity to other antagonists of receptor antagonists, as well as receptor antagonists; allergic reactions and bronchial asthma.

Use during pregnancy and lactation

The use of angiotensin II receptor antagonists is not recommended in the first trimester of pregnancy. The drug is contraindicated in the II and III trimesters of pregnancy, because the use in the II and III trimesters of pregnancy can cause fetotoksicheskie effects (reduced renal function, oligohydramnios, delayed ossification of the fetal skull bones) and neonatal toxic effects (renal failure, hypotension, hyperkalemia). If, nevertheless, the drug was used in the II and III trimesters of pregnancy, then an ultrasound of the kidneys and bones of the fetal skull must be performed.

When planning pregnancy, it is recommended to transfer the patient to alternative antihypertensive therapy with regard to the safety profile.

When confirming pregnancy drug Valsacor^® H160 must be canceled as soon as possible.

No data on the allocation of valsartan with breast milk. However, it is known that valsartan penetrates the milk of lactating rats. Hydrochlorothiazide is excreted in breast milk. Therefore, if necessary, drug therapy Valsacor^® H160 during lactation should be canceled breastfeeding.

Application for violations of the liver

Valsacor^® H160 is not recommended for patients with impaired liver function. The maximum recommended daily dose of valsartan in patients with mild or moderate hepatic impairment of non-biliary origin - 80 mg (1 tab. / Day of the drug Valsacor^® H80).

Application for violations of kidney function

Patients with impaired renal function (CC more than 30 ml / min (0.5 ml / sec)) no need to change doses of the drug. Carefully the drug should be used in case of renal failure (CC <10 ml / min), incl. in patients on hemodialysis, with bilateral renal artery stenosis or single kidney artery stenosis.

Use in children

Contraindicated: age up to 18 years (efficacy and safety of valsartan use in children has not been proven).

Use in elderly patients

Elderly patients dose adjustment is not required.

special instructions

Patients with severe chronic heart failure in the stage of decompensation or other conditions, accompanied by stimulation of the RAAS

Use of the drug Valsacor^® H160 in this group of patients is usually accompanied by a more pronounced decrease in blood pressure, however, subject to the recommendations on the selection of doses, treatment rarely requires cancellation due to arterial hypotension. Therapy with Valsacor^® H160 should be carried out with caution. Due to the suppression of the RAAS activity in some patients, the development of a renal dysfunction may develop. In severe chronic heart failure, oliguria and / or progressive azotemia may develop, up to (in rare cases) acute renal failure and / or death (in rare cases).

In patients with chronic heart failure, regular monitoring of renal function is necessary, while simultaneously prescribing a combination of three classes of drugs - ACE inhibitors, beta-blockers and angiotensin II receptor antagonists (AT₁).May be prescribed in combination with other drugs prescribed after myocardial infarction: thrombolytics, Acetylsalicylic acid, beta-blockers and statins.

Patients with hyponatremia and / or reduced BCC

In patients with severe hyponatremia and / or reduced BCC, for example, due to the administration of large doses of diuretics, in rare cases at the beginning of therapy with Valsacor^® H160 may develop severe hypotension. Before starting treatment, it is recommended to correct violations of water and electrolyte balance, in particular, by reducing the dose of diuretics. With the development of arterial hypotension with clinical manifestations, it is necessary to give the patient a horizontal position with the legs elevated, fill the BCC and correct the disturbances of water and electrolyte balance. Therapy with Valsacor^® H160 can be continued only after stabilization of blood pressure indicators.

Renal artery stenosis

The safety of the drug Valsacor^® H160 in patients with bilateral or unilateral stenosis of the renal arteries, as well as stenosis of the artery of a single kidney, has not been established (elevated serum concentrations of urea and creatinine are possible).

Renal dysfunction

Patients with impaired renal function (CC more than 30 ml / min (more than 0.5 ml / sec)) do not require changes in the dose of the drug. It is recommended to periodically monitor the content of potassium ions, the concentration of creatinine and uric acid in the serum. Experience of using the drug Valsacor^® H160 is absent in patients with recent kidney transplantation.

Liver dysfunction

Patients with impaired liver function is recommended to take no more than 80 mg of valsartan per day.

Primary hyperaldosteronism

Valsacor^® H160 is not recommended for patients with primary hyper aldosteronism.

Hard currency

There are reports of exacerbation of the course of SLE when using thiazide diuretics.

Other metabolic disorders

Thiazide diuretics can alter glucose tolerance and increase serum concentrations of cholesterol, triglycerides, and uric acid.

Valsacor^® H160 contains lactose, so the drug should not be prescribed to patients with hereditary intolerance to galactose, lactase-deficient lapp or impaired glucose-galactose absorption syndrome.

Influence on ability to drive motor transport and control mechanisms

Patients need to be careful when driving and working with other complex mechanisms that require increased attention, because may develop dizziness or weakness on the background of arterial hypotension.

Overdose

Valsartan

Symptoms: pronounced decrease in blood pressure, which can lead to dizziness, collapse and / or fatal shock.

Treatment: symptomatic, it is recommended to induce vomiting and flush the stomach, the appointment of Activated carbon . With the development of arterial hypotension, it is necessary to give the patient a horizontal position with raised legs, fill the BCC and correct the impaired water-electrolyte balance. Hemodialysis is ineffective.

Hydrochlorothiazide

Symptoms: the most frequent symptoms are due to electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis (nausea, drowsiness, arrhythmia, muscle spasm). With simultaneous intake of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias.

Treatment: symptomatic.

Drug interaction

Valsartan

Clinically significant pharmacokinetic drug interactions cimetidine, Warfarin, Digoxin, Atenolol, Indomethacin, hydrochlorothiazide, Amlodipine and glibenclamide not noted.

Since valsartan does not undergo significant metabolism, significant drug interactions associated with the induction or inhibition of the cytochrome P450 system should not be expected.

Simultaneous reception potassium-saving diuretics (spironolactone, triamterene, amiloride), potassium-containing food additives, drugs that increase the level of potassium in the blood serum (ACE inhibitors, Heparin, cyclosporine), can lead to hyperkalemia, and therefore caution is required.

Simultaneous reception with others antihypertensives, including diuretics, leads to increased hypotensive effect.

With simultaneous reception lithium preparations and angiotensin II receptor antagonists have reported cases of a reversible increase in the content of lithium ions in serum and an increase in its toxicity. Regular content monitoring is recommended. lithium ions in the blood.

Hydrochlorothiazide

With thiazide diuretics, drugs such as ethanol, barbiturates and opioid analgesics, may potentiate the risk of orthostatic hypotension.

Hypoglycemic agents (for ingestion and insulin): You may need a dose adjustment of hypoglycemic agents.

Other antihypertensive drugs: additive effect.

Cholinolytics (for example, atropine, biperiden) increase the bioavailability of thiazide diuretics.

Kolestiramin and Kolestipol: in the presence of anionic exchange resins, the absorption of hydrochlorothiazide decreases.

GCS, ACTH, laxatives, amphotericin B, carbenoxolone, benzathine benzylpenicillin, salicylic acid and salicylates: possible reduction of electrolytes, in particular hypokalemia, it is recommended to regularly monitor the content of potassium ions in the blood.

Antiarrhythmic drugs class IA, droperidol), other drugs (bepridil, cisapride, diphemanil, Erythromycin IV, halofantrine, ketanserin, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine IV): risk of developing arrhythmias such as "pirouette" on the background of possible hypokalemia and hypomagnesemia.Recommended to control the content of potassium ions in the blood.

Cardiac glycosides: risk of arrhythmias on the background of hypokalemia and hypomagnesemia.

Beta blockers and diazo oxide: increased hypoglycemic effect of these funds.

Uricosuric drugs (probenecid, sulfinpirazon, allopurinol): may increase the concentration of uric acid in the blood, as well as an increase in the frequency of hypersensitivity reactions to Allopurinol ; if necessary, dose adjustment of uricosuric drugs.

Pressor amines (for example, epinephrine, norepinephrine): It is possible to reduce the effect of pressor amines.

Amantadine: the risk of side effects of amantadine increases.

Cytotoxic agents (for example, cyclophosphamide, methotrexate): excretion of cytotoxic agents and potentiation of myelosuppressive action is reduced.

Muscle relaxants of non-depolarizing type of action (for example, tubocurarine): increased effect of muscle relaxants.

Cyclosporine: the risk of hyperuricemia and gouty-like complications increases.

Tetracyclines (except doxycycline): risk of increasing serum urea concentration.

Methyldopa: described cases of hemolytic anemia.

Lithium: diuretics reduce renal clearance of lithium and increase the risk of the development of the toxic effect of lithium; It is recommended to control the content of lithium in the blood.

NSAIDs (including COX-2 inhibitors; for example, salicylic acid, indole acetic acid derivatives): diuretic, natriuretic, and hypotensive effects of diuretics may decrease, and acute renal failure may develop.

Simultaneous reception with calcium supplements, vitamin D can lead to an increase in the content of Calcium ions in the blood, which can distort the results of the study of the function of the parathyroid glands.

Terms and conditions of storage

List B. The drug should be kept out of the reach of children, dry, protected from light, at a temperature not exceeding 30 ° C.