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Valsartan tablets 80 mg No. 30

Compound

Active substance: valsartan 80 mg.
Excipients: microcrystalline cellulose 90.2 mg, croscarmellose sodium 5.5 mg, colloidal silicon dioxide 2.7 mg, magnesium stearate 1.6 mg. Film shell composition: Opadry Pink 6 mg, including polyvinyl alcohol 2.4 mg, macrogol-3350 - 1.463 mg, red iron oxide dye - 0.024 mg, yellow iron oxide dye - 0.013 mg, talc 0.888 mg, titanium dioxide 1.212 mg .

Pharmacokinetics

After oral administration, valsartan is rapidly absorbed from the gastrointestinal tract, the degree of absorption is characterized by individual differences. Absolute bioavailability averages 23%. The pharmacokinetic curve of valsartan has a multi-exponential character (T1/2 in the α-phase < 1 hour and T1/2 in the β-phase - about 9 hours), the kinetics are linear.

No changes in pharmacokinetic parameters were observed during course use.

When taking valsartan with food, the AUC decreases by 48%, while approximately 8 hours after administration, plasma concentrations of valsartan are the same in patients taking it with food and on an empty stomach. The decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect.

When taking valsartan once a day, the accumulation is insignificant. Plasma concentrations of valsartan were similar in women and men.

Binding to plasma proteins, mainly albumin, is 94-97%. Vd at equilibrium is about 17 liters.

Plasma clearance of valsartan is about 2 l/h. Excreted in feces - 70% and in urine - 30%, mainly unchanged.

In biliary cirrhosis or biliary obstruction, the AUC of valsartan increases approximately 2-fold.

Indications for use

Arterial hypertension;
chronic heart failure in patients receiving standard therapy with one or more drugs: diuretics, cardiac glycosides, ACE inhibitors or beta-blockers. The use of each of the listed drugs is not mandatory;
to improve the survival of patients after acute myocardial infarction complicated by left ventricular failure and/or left ventricular systolic dysfunction, in the presence of stable hemodynamic parameters.

Contraindications

Hypersensitivity to any component of the drug;
pregnancy, pregnancy planning;
lactation period;
age under 18 years;
severe liver dysfunction (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis;
simultaneous use of angiotensin II receptor antagonists, including valsartan, or ACE inhibitors with aliskiren in patients with diabetes mellitus.

With caution: With bilateral renal artery stenosis, stenosis of the artery of a single kidney, primary hyperaldosteronism, while following a diet with limited salt intake, in conditions accompanied by a decrease in circulating blood volume (BCV) (including diarrhea, vomiting), with mild liver failure and moderate severity of non-biliary origin without cholestasis, in case of renal failure (creatinine clearance less than 10 ml/min), including patients on hemodialysis (no clinical data), valsartan should be prescribed with caution;
mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, in patients after kidney transplantation. Chronic heart failure II-IV functional class according to the NYHA classification; simultaneous use of angiotensin II receptor antagonists, including valsartan, with other drugs that inhibit the RAAS, such as ACE inhibitors, etc. It is not recommended to use valsartan simultaneously with ACE inhibitors, since this combination therapy has no advantages over monotherapy with valsartan or an ACE inhibitor in terms of overall performance mortality from any cause.

Directions for use and doses

Take the tablets orally without chewing.
Arterial hypertension

The recommended starting dose of Valsartan is 80 mg once a day every day, regardless of the race, age and gender of the patient.

The antihypertensive effect develops in the first 2 weeks of treatment; the maximum effect is observed after 4 weeks. For those patients who fail to achieve an adequate therapeutic response, the daily dose of Valsartan can be increased to a maximum daily dose of 320 mg or additional diuretics must be used.

Chronic heart failure

The recommended starting dose of Valsartan is 40 mg 2 times a day daily. The dose of Valsartan should be gradually increased over at least 2 weeks to 80 mg 2 times a day, and if well tolerated, to 160 mg 2 times a day. In this case, it may be necessary to reduce the doses of concomitantly taken diuretics. The maximum daily dose of Valsartan is 320 mg in 2 divided doses.

To improve survival after myocardial infarction

Treatment should begin within 12 hours after myocardial infarction. The initial dose is 20 mg (1/2 tablet 40 mg) 2 times a day. The dose is increased by titration (40 mg, 80 mg, 160 mg 2 times a day) over the next few weeks until the target dose of 160 mg 2 times a day is reached. The maximum daily dose is 320 mg in 2 divided doses. As a rule, it is recommended to achieve a dose of up to 80 mg 2 times a day by the end of the second week of treatment. Achieving the maximum target dose of 160 mg 2 times a day is recommended by the end of the third month of therapy with Valsartan. Dose increases depend on tolerability of the drug during the titration period.

In the event of arterial hypotension accompanied by clinical manifestations or renal dysfunction, a dose reduction should be considered. Assessment of patients' condition in the period after myocardial infarction should include assessment of renal function.

Use in patients over 65 years of age

In elderly patients, no dose adjustment is required.

Patients with impaired renal function

In patients with impaired renal function, no dose adjustment is required. Currently, there are no clinical data on the use of the drug in patients with CC less than 10 ml/min.

Patients with liver dysfunction

In patients with mild or moderate liver dysfunction of non-biliary origin without cholestasis, the drug should be used with caution; the daily dose should not exceed 80 mg.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Best before date

3 years. Do not use after expiration date.

special instructions

With hyponatremia and/or a decrease in blood volume, as well as during therapy with high doses of diuretics, in rare cases, valsartan can cause severe arterial hypotension. Before starting treatment, violations of water-salt metabolism should be corrected.

In patients with renovascular hypertension secondary to renal artery stenosis, serum urea and creatinine levels should be regularly monitored during treatment. There are no data on the safety of use in patients with CC less than 10 ml/min.

Use with extreme caution in patients with bile duct obstruction.

Due to inhibition of the RAAS, changes in renal function are possible in susceptible patients. When using ACE inhibitors and angiotensin receptor antagonists in patients with severe chronic heart failure, oliguria and/or an increase in azotemia was observed, and acute renal failure with a risk of death rarely developed.

The safety and effectiveness of valsartan in children has not been established.

Description

Angiotensin II receptor antagonist.

Use in children

The safety and effectiveness of valsartan in children has not been established.

Pharmacodynamics

Antihypertensive agent. It is a specific angiotensin II receptor antagonist. It has a selective antagonistic effect on AT1 receptors, which are responsible for the effects of angiotensin II.

Due to the blockade of AT1 receptors, the plasma concentration of angiotensin II increases, which can stimulate unblocked AT2 receptors. Does not have agonist activity against AT1 receptors. The affinity of valsartan for AT1 receptors is approximately 20,000 times higher than for AT2 receptors.

Does not inhibit ACE. Does not interact with or block other hormone receptors or ion channels that are important for regulating the functions of the cardiovascular system. Does not affect the level of total cholesterol, TG, glucose and uric acid in the blood plasma.

The onset of the antihypertensive effect of valsartan after oral administration in a single dose is observed within 2 hours after administration, the maximum effect is achieved within 4-6 hours.

Side effects

Frequency of side effects: “very often” (1/10 or more); “often” (1/100 or more, less than 1/10); “infrequently” (1/1000 or more, less than 1/100); “rarely” (1/10000 or more, less than 1/1000), “very rarely” (less than 1/10000). For all adverse events identified in clinical practice and in the analysis of laboratory parameters (the frequency of which cannot be determined), the “frequency unknown” gradation was used.

Patients with arterial hypertension

From the hematopoietic system: frequency unknown - decrease in hemoglobin, hematocrit, neutropenia, thrombocytopenia.

From the immune system: frequency unknown - hypersensitivity reactions, including serum sickness.

Metabolic disorders: frequency unknown - increased potassium levels in the blood serum.

From the hepatobiliary system: frequency unknown - impaired liver function, including increased concentration of bilirubin in the blood plasma.

From the organ of hearing and labyrinthine disorders: infrequently - vertigo.

From the cardiovascular system: frequency unknown - vasculitis.

From the respiratory system: infrequently - cough.

From the gastrointestinal tract: infrequently - abdominal pain.

From the skin and subcutaneous tissue: very rarely - angioedema; skin rash, itching.

From the musculoskeletal system: frequency unknown - myalgia.

From the kidneys: frequency unknown - impaired renal function, increased concentration of creatinine in the blood serum.

Other: infrequently - increased fatigue.

Also, during clinical studies in patients with arterial hypertension, the following adverse events were observed, a cause-and-effect relationship with the drug was not established: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Patients who received the drug after myocardial infarction and/or CHF

From the hematopoietic system: frequency unknown - thrombocytopenia.

From the immune system: frequency unknown - hypersensitivity reactions, including serum sickness.

Metabolic disorders: uncommon - hyperkalemia.

From the nervous system: often - dizziness, postural dizziness; infrequently - fainting, headache.

From the organ of hearing and labyrinthine disorders: infrequently - vertigo.

From the cardiovascular system: often - marked decrease in blood pressure, orthostatic hypotension; infrequently - increased symptoms of CHF; frequency unknown - vasculitis.

From the respiratory system: infrequently - cough.

From the gastrointestinal tract: infrequently - nausea, diarrhea.

From the musculoskeletal system: rarely - rhabdomyolysis, frequency unknown - myalgia.

From the kidneys: often - renal dysfunction; uncommon - acute renal failure, increased serum creatinine concentration; frequency unknown - increased urea nitrogen content in the blood plasma.

General disorders: infrequently - asthenia, increased fatigue.

From the hepatobiliary system: frequency unknown - liver dysfunction.

Use during pregnancy and breastfeeding

Valsartan is contraindicated for use during pregnancy.

It is not known whether valsartan is excreted into breast milk in humans. Use during lactation (breastfeeding) is not recommended.

Experimental studies have shown that valsartan is excreted in breast milk in rats.

Interaction

Dual blockade of the RAAS when using angiotensin II receptor antagonists, ACE inhibitors or aliskiren
Concomitant use of angiotensin II receptor antagonists, including valsartan, with other drugs that affect the RAAS is associated with an increased incidence of arterial hypotension, hyperkalemia and renal dysfunction compared with monotherapy . It is recommended to monitor blood pressure, renal function and electrolyte levels in patients taking valsartan and other drugs that affect the RAAS.

It has been established that during monotherapy with valsartan there are no clinically significant interactions with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide.

Nonsteroidal anti-inflammatory drugs (NSAIDs): when used concomitantly with NSAIDs (including selective cyclooxygenase-2 (COX-2) inhibitors), the antihypertensive effect of valsartan may be reduced. When angiotensin II receptor antagonists are used concomitantly with NSAIDs, renal function may deteriorate and plasma potassium levels may increase. If it is necessary to use valsartan and NSAIDs simultaneously, before starting therapy, it is necessary to assess renal function and correct disturbances in water and electrolyte balance.

Lithium preparations: with the simultaneous use of ACE inhibitors and angiotensin II receptor antagonists simultaneously with lithium preparations, an increase in the content of lithium in the blood plasma and an increase in its toxic effect are observed. Valsartan is not recommended for use simultaneously with lithium preparations (experience with limited use). If it is necessary to simultaneously use Valsartan and lithium preparations, it is necessary to ensure control of the lithium content in the blood plasma.

Potassium preparations: simultaneous use of potassium-sparing diuretics (including spironolactone, triamterene, amiloride), potassium preparations or salts containing potassium may lead to an increase in serum potassium levels and, in patients with heart failure, to an increase in serum creatinine concentrations. If such combination treatment is considered necessary, caution should be exercised.

Transport proteins

According to the results of an in vitro study on liver cultures, valsartan is a substrate for the transporter proteins OATP1B1 and MRP2. Co-administration of valsartan with inhibitors of the OATP1B1 transport protein (rifampicin, cyclosporine) and with an inhibitor of the MRP2 transport protein (ritonavir) may increase the systemic exposure of valsartan (Cmax and AUC).

Overdose

Symptoms: in case of an overdose of Valsartan, the main manifestation is a pronounced decrease in blood pressure, which can lead to depression of consciousness, collapse and/or shock.
Treatment: symptomatic, the nature of which depends on the time elapsed since taking the drug and the severity of the symptoms. In case of accidental overdose, induce vomiting (if the drug has been taken recently) or perform gastric lavage. With a pronounced decrease in blood pressure, the usual method of therapy is intravenous administration of 0.9% sodium chloride solution; the patient should be placed with his legs elevated for the period of time necessary for therapy, and active measures should be taken to maintain the activity of the cardiovascular system, including regular monitoring of cardiac and respiratory activity. systems, volume of bcc and amount of urine excreted.

It is unlikely that valsartan can be removed from the body using hemodialysis.

Impact on the ability to drive vehicles and operate machinery

Use with caution in patients driving vehicles and engaging in activities that require increased attention and speed of motor and mental reactions (risk of dizziness or fainting).