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Valsakor N 160: instructions for use

ATX-C09DA03 code

Pharmacotherapeutic group : drugs that affect the renin-angiotensin system. Combined antihypertensives. Angiotensin II receptor antagonist + diuretic.

Dosage form : tablets.

Form release : biconvex tablets pink oval-shaped, film-coated.

Pharmacological properties

An antihypertensive drug that affects specific angiotensin II receptors. It has a pronounced hypotensive effect, normalizes cardiac output and systolic pressure, reduces the total peripheral vascular resistance.

Composition:

Active ingredient :

  • valsartan;
  • hydrochlorothiazide.

Auxiliary components :

  • lactose monohydrate;
  • colloidal anhydrous silica;
  • MCC;
  • magnesium stearate;
  • Povidone;
  • croscarmellose sodium;
  • hypromellose;
  • macrogol;
  • red oxide (iron dye);
  • titanium dioxide.

Pharmacodynamics

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

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

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

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

Thiazide diuretic, hydrochlorothiazide, which interferes with the reabsorption of water, magnesium, potassium, chlorine and sodium ions in the distal nephron, retards the elimination of uric acid and calcium ions. The hypotensive effect of this active ingredient is due to its ability to expand the arterioles. Virtually no effect on normal blood pressure. The development of the diuretic effect is observed 1-2 hours after taking the drug and lasts for 6-12 hours. The maximum decrease in blood pressure is observed after 4 hours. The antihypertensive effect occurs after 3-4 days, but it may take 3-4 weeks to achieve the most optimal therapeutic effect.

Pharmacokinetics

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

Valsartan H160 is metabolized by CYP2C9 isoenzyme. About 70% is excreted through the intestines, 30% through the kidneys. When taken with food, the AUC of the drug is reduced by 48%. At the same time, 8 hours after the use of tablets, the plasma concentration of the active components taken on an empty stomach or with food is the same. Therefore, Valsartan is allowed to use regardless of the meal.

Hydrochlorothiazide absorption after 60-80%. Maximum blood concentration values ​​are observed after 2 hours. Binding to plasma proteins - 40-70%. The active component is not metabolized. About 95% is excreted by the kidneys in virtually unchanged form. Half-life is 6-15 hours.

Patients with impaired renal function (renal clearance of about 30% of the total) do not require dose adjustment. Since the degree of binding of the active component with plasma proteins is very high, its removal during hemodialysis is unlikely.

In patients suffering from obstruction of the biliary tract or biliary cirrhosis, the AUC of the drug is increased by 2 times.

Older patients have a decrease in systemic clearance of hydrochlorothiazide.

Indications for use

Correction of arterial hypertension in patients undergoing combination therapy.


Contraindications

  • Hypersensitivity to the drug;
  • Severe abnormal liver function (biliary cirrhosis, cholestasis);
  • Mild and moderate violations of the liver non-biliary origin;
  • Clinical manifestations of hyperuricemia;
  • Severe renal impairment, anuria;
  • Age up to 18 years;
  • Pregnancy and lactation;
  • Lactase deficiency;
  • Galactose intolerance;
  • Malabsorption syndrome;
  • Primary hyperaldosteronism;
  • Systemic lupus erythematosus ;
  • Hemodialysis procedure.

Dosage and administration

Valsakor H160 is a drug for internal use, which is recommended to be taken 1 time per day, regardless of the meal. May be used in combination with other antihypertensive agents.

Patients who, in the course of monotherapy with valsartan or hydrochlorothiazide, failed to reach the target level of blood pressure, Valsacor H160 is recommended to be taken fixed (1 time per day 160 / 12.5 mg).

Side effect

Side effects when taking the drug Valsakor H 160 as a whole have a mild rolling character.

From the side of the central nervous system and PNS : general weakness, increased fatigue, dizziness, insomnia, asthenia. Rarely observed headache, paresthesia, depression, neuralgia. Very rarely (in the case of use after myocardial infarction), fainting occurs.

On the part of the digestive system : often develops diarrhea. Sometimes there is dyspepsia, 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, ARVI, rhinitis, inflammation of the paranasal sinuses, cough. Very rarely - ARDS (respiratory distress syndrome), accompanied by pneumonitis and pulmonary edema.

Since the cardiovascular system : chest pain, marked reduction in blood pressure, orthostatic hypotension. In rare cases, arrhythmia, peripheral edema develops.

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

On the part of the musculoskeletal system : pain in the back and limbs, arthritis, arthralgia, tendon ruptures, muscle cramps , myalgia (very rare).

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

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


Drug interactions

At the same time taking Valsakora H160 and potassium-saving diuretics, ACE inhibitors, cyclosporine, heparin, potassium-containing food additives may develop hypercalcemia.

The simultaneous use of the drug and other antihypertensive agents (including diuretics) enhances the hypotensive effect.

When taken simultaneously with lithium preparations and angiotensin receptor antagonists, a reversible increase in lithium ions in the blood serum is observed, which leads to an increase in its toxicity.

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

When using insulin and other hypoglycemic agents often require correction of their dose.

The simultaneous use of Valsakor H160 with corticosteroids, laxatives, antiarrhythmic drugs IA and Class III, cardiac glycosides and antipsychotics, there is a risk of developing hypokalemia, hypomagnesemia, as well as pirouette-type arrhythmias.

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

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

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

special instructions

With special care, with regular monitoring of renal function, therapy should be given to patients suffering from severe chronic renal failure in the decompensated stage, patients with hyponatremia and reduced blood volume.

Vacation conditions

Refers to prescription drugs.

Storage conditions

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

Shelf life

The shelf life of the drug for 3 years from the date of issue. After the expiration date indicated on the package, the drug is not allowed to use.

Average price in Moscow pharmacies

290.00 rubles.

Valsakora H160 analogues

Vasar H;

Valzap plus;

Valsartan-N-Zentiva;

Valsacor Hd 160;

Valsakor H320;

Valsakor H80;

Vanatex combi;

Diocorus 160;

Diokore 80;

Corsair N;

Ko Diovan;

Sacord N.

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