Valsacor film-coated tablets 160 mg 84 pieces

Valsacor is a specific angiotensin II receptor antagonist. It is used to treat hypertension, myocardial infarction, and heart failure. 

Active ingredient: 1 film-coated tablet contains 40, 80, 160 or 320 mg of valsartan.

Excipients: lactose, microcrystalline cellulose, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), 160 mg and 320 mg, red iron oxide (E 172) – available in film-coated tablets of 80 mg, 160 mg and 320 mg.

“Valsacor” is available in the form of film-coated tablets for oral administration in a dosage of 160 mg. 

Biconvex, oval-shaped tablets of yellow-brown color, with a notch on one side. 

“Simple angiotensin II antagonist preparations.” 

“Valsacor” is a drug based on valsartan – a specific angiotensin II receptor antagonist. In patients with arterial hypertension, the use of “Valsacor” effectively reduced blood pressure without changing the heart rate. In most cases, the hypotensive effect occurs within 2 hours after a single dose of the drug and persists for 24 hours. Abrupt withdrawal of the drug does not lead to a sudden increase in blood pressure and does not cause other negative manifestations. 

In patients with arterial hypertension who took the drug for a long time, there was no effect of the drug on the concentration of total cholesterol and uric acid, as well as on the content of blood glucose and triglycerides. 

“Valsacor” reduces hospitalizations for heart failure. Its use leads to a decrease in heart failure symptoms and an improvement in the quality of life of patients. In addition, valsartan is effective in reducing mortality from cardiovascular diseases, and is also a prevention of recurrent myocardial infarction. 

After oral administration, the maximum concentration of the active substance in the blood is reached after 2-4 hours. The bioavailability of the drug is 23%. “Valsacor” can be used regardless of the time of eating. The ability to bind to blood proteins is 94–97%. 

The components of the drug are excreted from the body mainly through the biliary tract with feces and to a lesser extent with urine. The half-life is 6 hours. 

In elderly patients, the effect of the drug is more pronounced than in young people. Patients with impaired liver or kidney function do not need dose adjustment. 

Valsacor 160 mg tablets are indicated for:

• arterial hypertension (80 mg, 160 mg and 320 mg tablets);
• treatment of arterial hypertension in adults and children over 6 years of age;
• arterial hypertension (40 mg tablets);
• treatment of arterial hypertension in children aged 6 years and older;
• post-infarction condition (tablets 40 mg, 80 mg and 160 mg);
• treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent myocardial infarction;
• heart failure (tablets 40 mg, 80 mg and 160 mg);
• treatment of symptomatic heart failure when ACE inhibitors (ACEIs) cannot be used, or as add-on therapy to ACE inhibitors when β-blockers cannot be used.

Hypersensitivity to the active substance or to any of the components of the drug, severe liver dysfunction, biliary cirrhosis and cholestasis, pregnant women or women planning to become pregnant; simultaneous use of angiotensin receptor antagonists, including valsartan, or ACE inhibitors with aliskiren in patients with diabetes mellitus or impaired renal function.

It is not recommended to combine Valsacor with drugs containing potassium supplements, salt substitutes and potassium-sparing diuretics. If co-administration is necessary, it is necessary to monitor potassium levels to avoid hyperkalemia. 

The concomitant use of angiotensin receptor antagonists with aliskiren is contraindicated in patients with renal insufficiency. 

In patients with sodium and volume imbalance (patients receiving high doses of diuretics), symptomatic hypotension may occur after starting treatment with Valsacor, therefore the dose of the diuretic should be reduced before starting therapy.

Valsacor contains lactose, so the drug is contraindicated in patients with lactase deficiency, lactose intolerance, and glucose-galactose malabsorption. 

When angiotensin II antagonists are administered concomitantly with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, concomitant administration of angiotensin II antagonists and NSAIDs may lead to deterioration of renal function and a decrease in serum potassium. Therefore, it is recommended to monitor renal function at the beginning of treatment and to ensure adequate fluid intake.

Contraindicated.

Those planning a pregnancy should decide on the choice of alternative therapy. If pregnancy is detected during treatment with Valsacor, its administration should be immediately discontinued. 

Taking angiotensin 2 receptor antagonists during the second and third trimesters of pregnancy may lead to the development of phytotoxicity, resulting in renal failure, impaired renal function, delayed ossification of the skull bones, hyperkalemia and hypotension in the fetus. 

Newborns whose mothers took angiotensin II receptor antagonists during pregnancy should be monitored for hypotension. 

Given the lack of information on the possibility of using valsartan during lactation, taking the drug is not recommended at this time. It is necessary to choose drugs with proven safety. 

As with other antihypertensive agents, caution should be exercised when driving or operating machinery due to possible dizziness or weakness.

Take Valsacor regardless of meals, with water.

Valsartan should be used to treat hypertension in children aged 6 years and older.

Recommended dosage regimen according to the type of disease:

• arterial hypertension. Initial dose – 80 mg (1/2 tablet) 1 time per day. A pronounced hypotensive effect should be expected after 2 weeks of administration, the maximum after 4 weeks. In case of insufficient antihypertensive effect, a single dose may be increased to 160 mg, including the maximum – 360 mg. To achieve a better effect, it is possible to use it in combination with other antihypertensive agents; 
• recently suffered myocardial infarction. When the patient’s condition stabilizes, the drug can be taken 12 hours after the attack. The initial dose is 20 mg 2 times a day. Gradually, over several weeks, the dose is increased to 80 mg twice a day, and after 3 months to a maximum dose of 160 mg 2 times a day with good tolerance. If hypotension develops against the background of therapy or renal dysfunction, the dosage is reduced. Valsartan is undesirable to combine with ACE inhibitors; 
• heart failure. The recommended initial dose is 40 mg 2 times a day with a gradual increase to 80 mg and 160 mg. The interval between dose increases is 2 weeks. The maximum daily dose is 320 mg. 

Children over 6 years of age: for the treatment of heart failure, the initial dose is 40 mg once daily for children weighing less than 35 kg and 80 mg for children weighing more than 35 kg. The dose may be adjusted depending on the tolerability of the drug. The maximum dose for children is calculated according to the child’s body weight:

• 18–35 kg – 80 mg;
• 35–80 kg – 160 mg;
• 80-160 kg – 320 mg. 

Valsartan is not recommended for children aged 6 years and older with severe renal impairment (with a clearance of <30 ml/min and who are on dialysis) or hepatic impairment. 

Symptoms: Overdose with valsartan may cause severe hypotension, which may lead to depression of consciousness, vascular collapse and/or shock.

Treatment. Therapeutic measures depend on the time of administration and the type and severity of symptoms. The most important thing is to stabilize the circulatory status. In case of arterial hypotension, the patient should be placed in a supine position and blood volume should be corrected.

It is unlikely that the drug can be removed by hemodialysis.

In patients with arterial hypertension, the overall incidence of adverse reactions is consistent with the pharmacology of valsartan. The incidence of adverse reactions was not related to dose or duration of treatment and was independent of gender, age or race.

5 years.

Store below 30°C in the original packaging in order to protect from moisture. Keep out of the reach of children.

“Valsacor” tablets 160 mg No. 84 are packaged in blisters of 14 pieces. There are 6 blisters in a cardboard pack together with instructions for use.