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Instructions for use Valsakor H80

Farm group: a drug for the treatment of hypertension

The form of release of the drug, its composition and packaging

Valsakor H80 is available in pill form. They are enclosed in a film shell pink, have a biconvex oval shape.

1 tablet of the drug contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide, as well as additional substances: MCC, lactose monohydrate, magnesium stearate, croscarmellose sodium, povidone, colloidal silicon dioxide.

The film shell has the following composition: hypromellose, titanium dioxide (E171), macrogol 4000, red iron oxide and yellow iron oxide (E172) as dyes.

The drug tablets are enclosed in blister packs of 14 pcs. on one sheet. Blisters are enclosed in cardboard packs of 2 and 7 pieces.

Mechanism of action

Valsakor H80 is a combination drug containing type II angiotensin receptor blocker and a diuretic substance of the thiazide structure.

Valsartan is a selective antagonist of angiotensin II receptors. Shows selective antagonism to the AT1 receptor subtype. The consequence of blocking these receptors is an increase in plasma angiotensin concentration and, accordingly, an increase in stimulation of AT2 receptors. It should be remembered that valsartan is not an AT1 receptor agonist and does not inhibit angiotensin-converting enzyme (kinase II), which neutralizes bradykinin. Therefore, there is almost no chance of developing dry cough, a characteristic side effect of ACE inhibitors. Valsartan does not exert a inhibitory or stimulating effect on other hormones, neurotransmitters or ionic transport.

The decrease in pressure in hypertension with the help of valsartan passes without changing the heart rate.

The hypotonic effect of valsartan develops within 120 minutes after taking a single dose of the drug. The maximum effect is achieved in 4-6 hours and lasts for a day, which allows you to come to a single dose - this greatly increases the patient's convenience and patient compliance. With the subsequent regular use of valsartna, the achievement of the most pronounced result is observed after 2-4 weeks of administration. The effect persists for a long time and does not depend on the dose of the drug. The combination with hydrochlorothiazide accelerates the achievement of the hypotensive effect.

Valsartan is characterized by the presence of withdrawal syndrome, so it is impossible to cancel the intake of this drug suddenly, as there is a sharp increase in pressure in the bloodstream.

Hydrochlorothiazide is a diuretic, has a thiazide structure. Acts on the distal renal tubules, namely, reduces the reabsorption into the blood of salt-forming ions such as sodium, potassium, chlorine and magnesium. Increases the concentration of these substances in the secondary urine, and accordingly decreases in the blood. It has a reverse effect on calcium ions and uric acid. The hypotonic effect of the drug is caused not only by a decrease in the concentration of salts and the volume of circulating blood, but also by the expansion of arterioles. At the same time, hydrochlorothiazide, in case of its administration at normal pressure, practically does not change the blood pressure numbers.

The first diuretic effect develops within an hour after administration, reaches a maximum after 4 hours and lasts up to 12 hours. With regular use, a stable hypotensive effect occurs after 3-4 days, a therapeutically significant result requires taking for 21-28 days.

Pharmacokinetics of the drug

Valsartan .

After taking the pill valsartan, it is rapidly absorbed in the intestine, but the degree of completeness of the drug in the systemic circulation varies greatly. The average bioavailability is approximately 23%. After 2 hours in the blood there is a maximum concentration, the cumulative effect is poorly pronounced. The speed and extent of absorption of the drug does not have gender differences.

The drug is 94-97% of the total amount in the blood is transported in a bound form with serum albumin. Plasma clearance is quite low - 2 liters per hour.

Taking the drug with or without food does not change the plasma concentration of the substance in the blood, and therefore does not affect the therapeutic effect. Therefore, valsartan can be taken regardless of the meal.

Metabolism of valsartan is carried out using CYP2C9 isoenzyme.

After 9 hours, the concentration of valsartan in plasma is reduced by 2 times due to its excretion through the intestines (70%) and kidneys (30%).

Hydrochlorothiazide.

The bioavailability of hydrochlorothiazide after oral administration varies from 60 to 80%, with the maximum concentration observed after 2 hours. Plasma albumin binds from 40 to 70% of the substance entering the bloodstream.

The drug is not subject to metabolic processes and is excreted mainly by the kidneys (over 95%). After 6-15 hours, the concentration of hydrochlorothiazide drops by half.

In patients with impaired renal excretory function, there is no need to adjust the dose, since renal clearance is less than a third of the total. Hemodialysis will not be effective, since valsartan is characterized by a high degree of binding to plasma proteins.

More than 80% of valsartan is excreted in the same form with the help of the intestine, therefore the liver does not take a significant part in the metabolism of the substance. Therefore, patients with impaired non-biliary liver function should not change the dosage. At the same time, people with biliary cirrhosis or blockage of the bile ducts require dose adjustments, since their valsartan AUC doubles.

It is noticed that elderly patients are subject to a more pronounced systemic effect of the drug in comparison with the young. However, the clinical significance of this phenomenon has not been established. Systemic clearance of diuretic in people of young and middle age is higher than in the elderly.

Who is recommended to take?

Valsakor H80 take, if necessary, combination therapy for hypertension.

When and who is not recommended to take?

  • In severe liver dysfunction with stopping of the bile outflow
  • In the absence of urination
  • In severe renal impairment
  • With a reduced level of potassium and sodium in the blood
  • With elevated levels of calcium and uric acid in the blood
  • During pregnancy and breastfeeding
  • Persons under the age of 18
  • In case of hypersensitivity to the drug components
  • When galactose intolerance

How to use?

Valsakor H80 tablets are taken independently of food 1 time per day. The drug can be used in the complex treatment of hypertension along with other antihypertensive drugs.

It is especially recommended for patients in whom monotherapy with valsartan or hydrochlorothiazide was ineffective. In this case, it is necessary to choose the optimal dose - Valsacor H80 1 tab 1 time per day or maximum 2 tablets per day (if a single dose does not bring normalization of blood pressure). You can also use Valsacor HD160 - 1 tablet per day.

The most pronounced hypotonic effect of valsakor H80 is not reached before 2-4 weeks of regular use. In the case when its level is insufficient (lower pressure is 100 or more mm of mercury.), It is acceptable to increase the dose to 160/25 mg, that is, taking 1 tablet of HD160 valsacor, but not earlier than 4-8 weeks after starting therapy .

Patients with renal insufficiency do not require dose adjustment.

In case of abnormal liver function, the maximum daily dose of valsacor H80 is 1 tablet per day.

Elderly patients should not change the dose.

Symptoms of drug overdose and their treatment

Symptoms of an overdose of valsartan are a sharp drop in blood pressure, up to dizziness, loss of consciousness, the development of collapse and a state of shock with possible death.

Overdose therapy: symptomatic measures - gastric lavage, induction of vomiting, take a horizontal position, fill the circulating blood volume, bring water and electrolyte balance back to normal. Hemodialysis is ineffective due to the high degree of drug binding to blood albumin.

Symptoms of hydrochlorothiazide overdose are associated with the loss of electrolytes: potassium, magnesium, sodium, and chlorine. Also, there is a sharp dehydration with the following symptoms: weakness, drowsiness, nausea, cardiac arrhythmia, muscle spasms. If a drug of the group of cardiac glycosides was taken together, an increase in arrhythmia is observed.

Symptomatic therapy.

Interaction with other drugs

The combined use of valsartan with the following drugs did not lead to a change in the efficacy or toxicity of these agents: warfarin, atenolol, digoxin, cimethine, indomethacin, glibenclamide, hydrochlorothiazide.

It does not interact with drugs inhibitors or cytochrome P450 intukers, as it is not metabolized in the liver.

Intake along with drugs that increase the level of potassium in the blood, threatens the development of hyperkalemia, so you should be careful.

The use of other antihypertensive drugs, as well as diuretic drugs can significantly enhance the hypotonic effect.

Reception of valsartan with lithium preparations leads to a pronounced increase in the concentration of these ions in the blood and an increase in their toxicity. Therefore, in this case, it is worth conducting a regular monitoring of the lithium content in the blood.

The combined use of thiazide diuretic with barbiturates, anesthetics and ethanol can lead to orthostatic hypotension.

It is necessary to adjust the dose of hypoglycemic agents in the case of joint administration with hydrochlorothiazide.

Antihypertensive drugs when taken together with hydrochlorothiazide lead to the summation of effects.

The group of cardiac glycosides together with hydrochlorothiazide aggravate arrhythmia caused by low potassium and magnesium levels.

The glucose-lowering effect of beta-blockers increases.

The use of drugs that remove uric acid together with hydrochlorothiazide leads to an increase in the concentration of acid in the blood. Therefore, you may need a correction doses of drugs.

The effect of muscle relaxants like tubocurarine is enhanced.

Antibiotics of the tetracycline group together with hydrochlorothiazide lead to an increase in the level of urea in the blood.

NSAIDs reduce the diuretic effect and can lead to the development of kidney function deficiency.

Taking calcium supplements leads to an increase in the concentration of this mineral in the blood, which distorts the results of the examination of the parathyroid glands.


Taking the drug during pregnancy and breastfeeding

Taking drugs related to angiotensin receptor blockers during pregnancy is strictly prohibited, as it can cause a number of toxic effects on the development of the fetus. If, nevertheless, the use of valsakor H80 in the process of pregnancy has been allowed, an ultrasound of the bones of the skull and kidneys of the fetus should be immediately carried out.

In the case of conception planning, a patient who regularly uses Valsacor H80 should find an alternative substitute for this purpose, be sure to take into account safety. If the fact of pregnancy was established while taking the drug, it is necessary to stop taking it immediately.

There is no reliable information about the release of valsartan into breast milk, but during the tests confirmed the ingestion of the drug in the milk of lactating rats. Also found the content of hydrochlorothiazide in breast milk when it is taken. Therefore, it is necessary to stop feeding if necessary to use Valsacor H80.

Side effects

: слабость, головокружение, утомляемость, бессонница, головные боли, депрессивные состояния, невралгия. From the side of the central nervous system : weakness, dizziness, fatigue, insomnia, headaches, depressive states, neuralgia.

: назофарингит , кашель, ринит, синусит. On the part of the respiratory system : nasopharyngitis, cough, rhinitis, sinusitis.

: резкое падение АД, нарушение ритма, боль в груди, отеки. From the side of the heart and blood vessels : a sharp drop in blood pressure, rhythm disturbance, chest pain, swelling.

: расстройство, диспепсические явления, нарушение аппетита, воспаление поджелудочной железы, остановка оттока желчи. On the part of the digestive tract : disorder, dyspeptic symptoms, anorexia, inflammation of the pancreas, stop the flow of bile.

: высыпания, фоточувствительность, облысение. On the part of the skin : rash, photosensitivity, baldness.

: боли в спине и в суставах конечностей, боли мышцах, воспаление суставов. On the part of the musculoskeletal system : pain in the back and in the joints of the limbs, muscle pain, inflammation of the joints.

: инфекции, учащение мочеиспускания, дисфункция почек. On the part of the urinary system : infections, increased urination, renal dysfunction.

: снижение полового влечения, импотенция. On the part of the genitals : decreased sexual desire, impotence.

: воспаление конъюнктивы, ухудшение зрения , шумы ушах. On the part of the senses : inflammation of the conjunctiva, blurred vision, noises of the ears.

Where and how to store?

Valsakor H80 is stored no more than 2 years from the date of manufacture in a dark, dry place at temperatures up to 30 ° C. Keep out of the reach of children.

Pharmacy sales terms

Valsakor H80 refers to the list of prescription drugs.

Valsakor H80 price

Valsakor H80 tablets 80 mg + 12.5 mg - 250-300 rubles.

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