Universal reference book for medicines
Product name: TANTORDIO (TANTORDIO)

Active substance: valsartan

Type: Angiotensin II receptor antagonist

Manufacturer: TORRENT PHARMACEUTICALS (India)

Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Antihypertensive agent.
It is a specific antagonist of angiotensin II receptors. It has a selective antagonistic effect on AT 1 -receptors, which are responsible for the realization of the effects of angiotensin II.
Due to the blockade of AT 1 -receptors, the plasma concentration of angiotensin II increases, which can stimulate unblocked AT 2 receptors.
Has no agonistic activity against AT 1 -receptors. The affinity of valsartan for AT 1 -receptors is approximately 20,000 times higher than for AT 2 -receptors.
Does not inhibit ACE.
It does not interact and does not block the receptors of other hormones or ion channels, which are important for the regulation of the functions of the cardiovascular system. Has no effect on the level of total cholesterol, TG, glucose and uric acid in the blood plasma.
The onset of antihypertensive action of valsartan after its administration inside in a single dose is observed within 2 hours after administration, the maximum effect is achieved within 4-6 hours.

PHARMACOKINETICS
After oral administration valsartan is rapidly absorbed from the digestive tract, the degree of absorption is characterized by individual differences.
Absolute bioavailability averages 23%. The pharmacokinetic curve of valsartan has a multiexponential character (T 1/2 in the? -phase <1 h and T 1/2 in the? -phase - about 9 h), the kinetics are linear.
With the course application of changes in pharmacokinetic parameters were not noted.

When taking valsartan with food, AUC is reduced by 48%, with about 8 hours after taking valsartan in plasma are the same in patients who took it with food and fasting.
The decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect.
When receiving valsartan 1 time / day, the cumulation is not significant.
The concentrations of valsartan in the blood plasma in women and men were the same.
The binding with plasma proteins, mainly with albumins, is 94-97%.
V d in the equilibrium state is about 17 liters.
The plasma clearance of valsartan is about 2 l / h.
It is excreted with feces - 70% and with urine - 30%, mostly unchanged.
With biliary cirrhosis or obstruction of the bile ducts, the vascartan AUC increases approximately 2-fold.

INDICATIONS
Treatment of arterial hypertension.

Treatment of chronic heart failure (IIHA functional class according to NYHA classification) in patients receiving traditional therapy with diuretics, digitalis preparations, as well as with ACE inhibitors or beta-blockers.

DOSING MODE
Take inside at a dose of 80 mg 1 time / day or 40 mg 2 times / day, daily.
If there is no adequate effect, the daily dose can be gradually increased.
The maximum daily dose is 320 mg in 2 divided doses.

SIDE EFFECT
From the cardiovascular system: arterial hypotension, postural dizziness, postural hypotension.

From the side of the central nervous system: dizziness, headache.

From the digestive system: diarrhea, nausea, increased bilirubin level.

From the urinary system: rarely - a violation of kidney function, increased levels of creatinine and urea nitrogen (especially in chronic heart failure).

From the side of metabolism: hyperkalemia.

On the part of the hematopoiesis system: neutropenia, reduction of hemoglobin and hematocrit.

Allergic reactions: rarely - angioedema, rash, itching, serum sickness, vasculitis.

Other: fatigue, general weakness, cough, pharyngitis, increased risk of developing viral infections.

CONTRAINDICATIONS
Pregnancy, hypersensitivity to valsartan.

PREGNANCY AND LACTATION
Valsartan is contraindicated in pregnancy.

It is not known whether valsartan is excreted in human milk.
Use during lactation (breastfeeding) is not recommended.
In experimental studies, it has been shown that valsartan is excreted in breast milk in rats.

APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with renovascular hypertension, which developed again due to stenosis of the renal artery, the level of urea and creatinine in the serum should be regularly monitored during the treatment period.
Data on safety of use in patients with SC less than 10 ml / min are absent.
Due to the inhibition of RAAS in susceptible patients, changes in renal function are possible.

APPLICATION FOR CHILDREN
Safety and effectiveness of valsartan in children is not established.

SPECIAL INSTRUCTIONS
In cases of hyponatremia and / or a decrease in bcc, as well as against the background of therapy with high doses of diuretics, in rare cases valsartan can cause severe arterial hypotension.
Before the start of treatment should be done correction of water-salt metabolism.
In patients with renovascular hypertension, which developed again due to stenosis of the renal artery, the level of urea and creatinine in the serum should be regularly monitored during the treatment period.
Data on safety of use in patients with SC less than 10 ml / min are absent.
With extreme caution apply in patients with violations of patency of the biliary tract.

Due to the inhibition of RAAS in susceptible patients, changes in renal function are possible.
With the use of ACE inhibitors and angiotensin receptor antagonists, oliguria and / or augmentation of azotemia were observed in patients with chronic heart failure of severe course, and acute renal failure with a risk of death was rare.
Safety and effectiveness of valsartan in children is not established.

Impact on the ability to drive vehicles and manage mechanisms

When using valsartan, it is advisable to use caution when driving and controlling machinery.

DRUG INTERACTION
With the simultaneous use of diuretics in high doses, it is possible to develop arterial hypotension.

With the simultaneous use of potassium-sparing diuretics, heparin, biologically active additives or substitutes for salt containing potassium, the development of hyperkalemia is possible.

With simultaneous use with indomethacin, a decrease in the antihypertensive effect of valsartan is possible.

At simultaneous application with lithium carbonate the case of development of lithium intoxication is described.

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