Walsakor - instructions for use, analogs, reviews and release forms (tablets 40 mg, 80 mg, 160 mg and 320 mg, H80 and H160, ND160) drugs to treat heart failure and reduce pressure in adults, children and pregnancy. Composition
In this article, you can read the instructions for using the drug Walsakor. There are reviews of visitors to the site - consumers of this medication, as well as opinions of physicians specialists on the use of Valsakor in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Valsakor in the presence of existing structural analogs. Use for the treatment of heart failure, hypertension and depression of pressure in adults, children, as well as during pregnancy and lactation. Composition of the preparation.
Walsakor antihypertensive agent. It is a specific antagonist of angiotensin receptors 2. It has a selective antagonistic effect on AT1 receptors, which are responsible for the realization of the effects of angiotensin 2.
Due to the blockade of AT1 receptors, the plasma concentration of angiotensin 2 increases, which can stimulate unblocked AT2 receptors. Has no agonistic activity against AT1 receptors. The affinity of Valsartan for AT1 receptors is about 20,000 times higher than that of AT2 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 inwards in a single dose is observed within 2 hours after administration, the maximum effect is achieved within 4-6 hours.
Hydrochlorothiazide (in the composition of Valsakor H80 and H160, ND160) is a thiazide diuretic whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium,water in the distal nephron; delays the excretion of calcium ions, uric acid. Has hypotensive effect, which is due to the expansion of arterioles. Virtually no effect on normal BP.
Diuretic effect develops 1-2 hours after taking the drug inside, reaches a maximum after 4 hours and persists for 6-12 hours. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.
Composition
Valsartan + excipients.
Valsartan + Hydrochlorothiazide + auxiliary substances (Valsacor H80 and H160, ND160).
Pharmacokinetics
Valsartan
After oral administration, Valsacor is rapidly absorbed from the digestive tract, the degree of absorption is characterized by individual differences. Absolute bioavailability averages 23%. 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 taking valsartan once a day, the cumulation is not very pronounced. 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%. 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.
Hydrochlorothiazide
After oral intake of hydrochlorothiazide is 60-80%. Binding to plasma proteins - 40-70%. Hydrochlorothiazide is not metabolized and is quickly excreted in the urine (more than 95%).
Indications
- treatment of hypertension (pressure reduction);
- treatment of chronic heart failure (2-4 functional class according to NYHA classification) in patients receiving traditional therapy with diuretics, digitalis preparations, as well as with ACE inhibitors or beta-blockers.
Forms of release
Tablets coated with 40 mg, 80 mg, 160 mg and 320 mg (Valsakor).
Tablets coated with 80 mg + 12.5 mg, 160 mg + 12.5 mg (Valsacor H80 and H160).
The tablets covered with a cover 160 mg + 25 mg (Valsakor ND160).
Instructions for use and dosage
Pills Valsacor
Take inside at a dose of 80 mg 1 time per day or 40 mg 2 times a 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.
H80 and H160 tablets
The drug is taken orally, regardless of food intake, the frequency of intake is 1 time per day.
Valsacor H160 can be combined with other antihypertensive agents. Treatment should be started with minimal doses of the drug.
Patients who did not achieve the target level of BP against monotherapy (valsartan 160 mg or hydrochlorothiazide at a dose of 12.5 mg) are recommended a fixed combination of doses - Valsacor H160 (160 / 12.5 mg) 1 time per day.
The maximum antihypertensive effect of the preparation Valsacor H160 (160 / 12.5 mg) develops within 2-4 weeks. If necessary (the level of diastolic blood pressure above 100 mm Hg on the background of monotherapy with valsartan), in order to achieve a more pronounced effect, it is possible to increase the dose to 160/25 mg (not earlier than 4-8 weeks) (1) once a day.
Patients with impaired renal function (QC more than 30 ml / min (0.5 ml / s)) do not need to change the dose of the drug.
Valsacor H160 is not recommended for patients with impaired liver function.The maximum recommended daily dose of valsartan in patients with mild or moderate impairment of liver function of non-biliary origin is 80 mg (1 tablet per day of the preparation Valsacor H80).
Older patients are not required to adjust the dose.
ND160 tablets
The drug is taken orally, regardless of food intake, the frequency of intake is 1 time per day.
Valsacor ND160 can be combined with other antihypertensive agents. Treatment should be started with minimal doses of the drug.
Patients who did not achieve the target level of BP against monotherapy (valsartan 160 mg or hydrochlorothiazide 25 mg) recommended a fixed combination of doses - Valsacor ND160 (160/25 mg) once a day.
The maximum antihypertensive effect of the drug Valsacor ND160 (160/25 mg) develops within 2-4 weeks.
Side effect
- general weakness;
- increased fatigue;
- asthenia;
- dizziness, incl. postural;
- insomnia;
- headache;
- depression;
- paresthesia;
- neuralgia;
- fainting (when used after a heart attack);
- nasopharyngitis;
- upper respiratory infections;
- rhinitis;
- sinusitis;
- cough;
- respiratory distress syndrome with pneumonitis and pulmonary edema;
- chest pain;
- marked decrease in blood pressure and orthostatic hypotension;
- arrhythmias;
- peripheral edema;
- diarrhea, constipation;
- nausea;
- dyspepsia;
- abdominal pain;
- decreased appetite;
- pancreatitis;
- intrahepatic cholestasis;
- jaundice;
- skin rash;
- photosensitivity;
- alopecia;
- pain in the back, limbs;
- stretching and tearing of ligaments and muscles or muscle tendons;
- arthritis;
- arthralgia;
- myalgia;
- muscle weakness;
- muscle cramps;
- decreased libido;
- impotence (less than 1%);
- urinary tract infection;
- increased frequency of urination;
- impaired renal function;
- impaired vision;
- noise in ears;
- conjunctivitis;
- angioedema;
- hives;
- skin rash;
- itching;
- hypersensitivity reactions, including serum sickness and necrotizing vasculitis;
- toxic epidermal necrolysis (Lyell's syndrome);
- lupus-like reactions;
- exacerbation of SLE flow;
- anemia, incl. hemolytic, leukopenia, agranulocytosis, neutropenia, thrombocytopenia (sometimes with purpura);
- bone marrow suppression;
- increased sweating;
- nose bleed.
Contraindications
- severe liver dysfunction;
- biliary cirrhosis and obstruction of the biliary tract (cholestasis);
- light and moderate violations of the liver function of non-biliary origin (for a given dose of the drug);
- anuria, marked renal dysfunction (CC less than 30 ml / min (0.5 ml / s));
- hemodialysis;
- hypokalemia, hyponatremia, hypercalcemia or hyperuricemia with clinical manifestations refractory to adequate therapy;
- intolerance to galactose, lactase deficiency lapp or syndrome of impaired glucose / galactose absorption;
- age under 18 years (effectiveness and safety of valsartan in children not established);
- pregnancy;
- lactation period;
- increased sensitivity to valsartan, hydrochlorothiazide, sulfonamide derivative and to other components of the drug.
Application in pregnancy and lactation
The use of angiotensin 2 receptor antagonists is not recommended in the first trimester of pregnancy. The drug is contraindicated in the 2nd and 3rd trimesters of pregnancy, as the use of 2 and 3 trimesters of pregnancy can cause fetotoxic effects (decreased kidney function, low blood pressure, slowing ossification of the fetal bones) and neonatal toxic effects (kidney failure, arterial hypotension, hyperkalemia).If, however, the drug was used in the 2nd and 3rd trimester of pregnancy, it is necessary to carry out ultrasound of the kidneys and bones of the fetal skull.
When planning pregnancy, it is recommended that the patient be transferred to alternative antihypertensive therapy, taking into account the safety profile.
When confirming the pregnancy, the drug Valsakor must be canceled as soon as possible.
There is no data on the isolation of valsartan in breast milk. However, it is known that valsartan penetrates the milk of lactating rats. Hydrochlorothiazide is excreted in breast milk. Therefore, if you need therapy with the drug Valsakor ND160 during lactation, breastfeeding should be abolished.
Use in children
Contraindicated in children and adolescents under the age of 18 years (effectiveness and safety of valsartan in children is not proven).
Application in elderly patients
Older patients are not required to adjust the dose.
special instructions
With hyponatremia and / or a decrease in BCC, as well as against the background of therapy with high doses of diuretics in rare cases, Valsacor 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.
Patients with impaired liver function are recommended to take no more than 80 mg of valsartan per day.
Valsacor N160 is not recommended for patients with primary hyperaldosteronism.
There are reports of an exacerbation of the systemic lupus erythematosus (SLE) with the use of thiazide diuretics.
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.
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 Interactions
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 Valsakor is possible.
At simultaneous application with lithium carbonate the case of development of lithium intoxication is described.
With thiazide diuretics, medicines such as ethanol (alcohol), barbiturates and opioid analgesics, can potentiate the risk of developing orthostatic hypotension.
Analogues of the drug Valsakor
Structural analogs for the active substance:
- Artinova;
- Valaar;
- Wales;
- Valsartan;
- Valsartan Zentiva;
- Valsartan N;
- Valsafors;
- Valsakor H80;
- Valsakor H160;
- Valsakor ND160;
- Diovan;
- Nortivan;
- Tantordio;
- Tareg.
Analogues on the pharmacological group (angiotensin 2 receptor antagonists:
- Amsaar;
- Amosartan;
- Angiakand;
- Aprovel;
- Artinova;
- Atacand;
- Bloktran;
- Vasotensis;
- Wales;
- Valsartan;
- Vylloset;
- Gisaar;
- Gizortan;
- Duopress;
- Zisakar;
- Ibertan;
- Irbesartan;
- Candecor;
- Candesartan;
- Cardomin;
- Cardosal;
- Cardosten;
- Cardostine;
- Karzartan;
- Ko Exforge;
- Co-span;
- Lacka;
- Lozap;
- Lozarel;
- Losartan;
- Lorist;
- Lorista H;
- Lortense;
- Losakor;
- Mycardis;
- Mykardis Plus;
- Naviten;
- Nortivan;
- Olimestra;
- Ordiss;
- Prezartan;
- Renikard;
- Tareg;
- Twentieth;
- Teveten;
- Firmas;
- Edarby;
- Exforge;
- Eprosartan mesylate.
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