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Valsakor H 160: instructions for use

ATX-C09DA03 code

Pharmacotherapeutic group : drugs that affect the system of renin-angiotensin. Combined antihypertensive. Angelotenzin II receptor antagonist + diuretic.

Dosage form : tablets.

Form of issue : biconvex tablets of pink oval form, covered with a film membrane.

Pharmacological properties

Antihypertensive drug that affects specific receptors of angiotensin II. Has a pronounced hypotensive effect, normalizes cardiac output and systolic pressure, reduces overall peripheral vascular resistance.

Composition:

Active substance :

  • valsartan;
  • hydrochlorothiazide.

Auxiliary components :

  • lactose monohydrate;
  • colloidal anhydrous silicon dioxide;
  • ICC;
  • magnesium stearate;
  • povidone;
  • sodium croscarmellose;
  • hypromellose;
  • macrogol;
  • oxide red (iron dye);
  • titanium dioxide.

Pharmacodynamics

Valsacor (H160) is an antihypertensive drug of combined action, which consists of 2 active components.

Valsartan (selective angiotensin II receptor antagonist) is a non-protein preparation intended for internal use. It has an antagonistic selective effect on the AT receptors. Blocking the AT-1 receptor, increases the plasma concentration of angiotensin II, which, in turn, stimulates the unblocked AT-2 receptors, balancing the effects associated with blockade. This active ingredient has no effect on ACE, does not potentiate the effects of substance P and bradykinin. Therefore, when taking the drug is unlikely to develop a dry cough. The drug does not interact and does not block the ion channels and receptors of hormones involved in the regulation of the cardiovascular system, lowers blood pressure without affecting the heart rate.

After taking a single dose of the drug antihypertensive effect develops within two hours and persists throughout the day. After 4-6 hours there is a maximum decrease in blood pressure. With the repeated use of the drug, maximal decrease in blood pressure occurs in 2-4 weeks, remaining at the reached level during long-term therapy.

An additional significant reduction in blood pressure is due to the combination of valsartan with hydrochlorothiazide. A sudden discontinuation of the drug is not accompanied by withdrawal syndrome.

The thiazide diuretic, hydrochlorothiazide, which disrupts the reabsorption of water, magnesium, potassium, chlorine and sodium ions in the distal nephron, delays the excretion of uric acid and calcium ions. The hypotensive effect of this active component is due to its ability to expand the arterioles. Virtually does not affect normal blood pressure. The development of diuretic effect is observed 1-2 hours after taking the drug and remains for 6-12 hours. The maximum decrease in blood pressure is observed after 4 hours. Antihypertensive effect occurs in 3-4 days, however, in order to achieve the most optimal therapeutic effect, it may take 3-4 weeks.

Pharmacokinetics

The drug after ingestion is rapidly absorbed into the blood, but the degree of its absorption can vary within wide limits. The average absolute bioavailability is 23%, the half-life is 2 hours. With a single daily use, there is a slight cumulation. In women and men plasma concentrations are the same. The connection with serum proteins (mainly with albumin) is 94-97%. The equilibrium volume of distribution of the drug is about 17 liters. Plasma clearance - 2l / h.

Valsartan H160 undergoes metabolism under the influence of the CYP2C9 isoenzyme. About 70% is excreted through the intestine, 30% through the kidneys. When taken with food AUC drug is reduced by 48%. At the same time, 8 hours after the application of the tablets, the plasma concentration of active components taken on an empty stomach or together with food is the same. Therefore, valsartan is allowed to use regardless of food intake.

The absorption of hydrochlorothiazide after is 60-80%. The maximum concentration in the blood is observed after 2 hours. Binding to plasma proteins - 40-70%. The active ingredient is not metabolized. About 95% is excreted by the kidneys in practically unchanged form. The half-life is 6-15 hours.

Patients with impaired renal function (renal clearance of about 30% of the total) correction of the doses of the drug is not required. Since the degree of binding of the active ingredient to plasma proteins is very high, its excretion during hemodialysis is unlikely.

In patients with obstructed bile ducts or biliary cirrhosis, the AUC of the drug is doubled.

In patients of advanced age there is a decrease in systemic clearance of hydrochlorothiazide.

Indications for use

Correction of arterial hypertension in patients on combined therapy.


Contraindications

  • Hypersensitivity to the components of the drug;
  • Severe violations of the liver (biliary cirrhosis, cholestasis);
  • Light and moderate liver disorders of non-biliary origin;
  • Clinical manifestations of hyperuricemia;
  • Severe renal impairment, anuria;
  • Age to 18 years;
  • Pregnancy and lactation;
  • Deficiency of lactase;
  • Intolerance to galactose;
  • Malabsorption syndrome;
  • Primary hyperaldosteronism;
  • Systemic lupus erythematosus ;
  • Procedure of hemodialysis.

Dosing and Administration

Valsacor H160 is a drug for internal use, which is recommended to be taken once a day, regardless of food intake. It is allowed to be used in combination with other antihypertensive agents.

Patients who were not able to achieve the target blood pressure level in the course of monotherapy with valsartan or hydrochlorothiazide failed to receive Valsacor H160 (160 / 12.5 mg once a day).

Side effect

Side effects with the drug Valsakor H 160 as a whole have a mild transition character.

From the CNS and PNS : general weakness, fatigue, dizziness, insomnia, asthenia. Seldom there is a headache, paresthesia, a depressive state, neuralgia. Seldom (in case of application after a heart attack myocardium) fainting occurs.

From the digestive system : often develops diarrhea. Sometimes there is indigestion, nausea, pain in the abdomen. Rarely - constipation, lack of appetite, gastroenteritis. Very rarely - jaundice, intrahepatic cholestasis, pancreatitis .

On the part of the respiratory system: nasopharyngitis, acute respiratory viral infection, rhinitis, inflammation of the paranasal sinuses, cough. Very rarely - ARDS (respiratory distress syndrome), accompanied by pneumonitis and pulmonary edema.

On the part of the cardiovascular system : chest pain, marked decrease in blood pressure, orthostatic hypotension. In rare cases, arrhythmia develops, peripheral edema.

On the part of the genitourinary system: increased frequency of urination, urinary tract infection, very rarely impotence (less than 1%), decreased libido, impaired renal function.

From the musculoskeletal system : pain in the back and limbs, arthritis, arthralgia, tendon ruptures, muscle cramps , myalgia (very rarely).

From the skin: very rarely - itching, hives , photosensitivity, alopecia, hypersensitivity reactions, lupus-like reactions, angioedema.

Other disorders: tinnitus, conjunctivitis , visual disturbances, increased sweating, nasal bleeding.


Drug Interactions

With the simultaneous administration of Valsacor H160 and potassium-sparing diuretics, ACE inhibitors, cyclosporine, heparin, potassium-containing dietary supplements, hypercalcemia may develop.

Simultaneous use of the drug and other antihypertensive drugs (including diuretics) increases the hypotensive effect.

With simultaneous administration with lithium preparations and antagonists of angiotensin receptors, a reversible increase in the serum of lithium ions is noted, which leads to an increase in its toxicity.

With simultaneous use with thiazide diuretics, the risk of developing orthostatic hypotension is potentiated.

When using insulin and other hypoglycemic agents, often a correction of their dose is required.

The simultaneous use of Valsacor H160 with corticosteroids, laxatives, antiarrhythmic drugs IA and III class, cardiac glycosides and neuroleptics, there is a risk of hypokalemia, hypomagnesemia, and piruetty arrhythmias.

When interacting with uricosuric agents, there is an increase in the blood concentration of uric acid and the development of reactions of hypersensitivity to allopurinol.

Nonsteroidal anti-inflammatory drugs can reduce hypotensive, natriuretic and diuretic effect.

The simultaneous use of Valsacor H160 with vitamin D and calcium preparations increases the blood content of the ions of this trace element.

special instructions

With special care, with regular monitoring of kidney function, patients with severe chronic renal failure in the decompensated stage should be treated, patients with hyponatremia and a reduced volume of circulating blood.

Leave conditions

Refers to medicines that are prescribed by a doctor.

Storage conditions

Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life

Shelf life of the drug is 3 years from the date of issue. After the expiration date indicated on the package, the drug should not be used.

The average price in pharmacies in Moscow

290.00 rubles.

Valsakor H160 analogues

Vasar N.;

Valps plus;

Valsartan-N-Zentiva;

Valsacor Hd 160;

Valsakor H320;

Valsakor H80;

Vanatex combi;

Dyokor 160;

Dyokor 80;

Corsair H;

Ko Diovan;

Sakord N.

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