Vamloset pills 10mg + 160mg №90

on 1 pill 5 mg + 80 mg

Core:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 6.94 mg, equivalent to Amlodipine 5.00 mg Valsartan A, substance granules 125.675 mg

[The active substance of the substance granules: Valsartan 80.00 mg

Auxiliary substances of the substance-granules: microcrystalline cellulose, croscarmellose sodium, povidone K-25, sodium lauryl sulfate]

Excipients: mannitol, Magnesium stearate, colloidal silicon dioxide

Shell film:

Opadry II white¹dye iron oxide yellow (E172)

on 1 pill 5 mg + 160 mg

Core:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 6.94 mg, equivalent to amlodipine 5.00 mg Valsartan A, substance granules 251.35 mg

[The active substance of the substance granules: Valsartan 160.00 mg

Auxiliary substances of the substance-granules: microcrystalline cellulose, croscarmellose sodium, povidone K-25, sodium lauryl sulfate]

Excipients: mannitol, magnesium stearate, colloidal silicon dioxide

Shell film:

Opadry II white¹dye iron oxide yellow (E172)

on 1 pill of 10 mg + 160 mg

Core:

Active ingredients:

Amlodipine besylate (amlodipine besylate) 13.88 mg, equivalent to amlodipine 10.00 mg

Valsartan A, substance granules 251.35 mg

[The active substance of the substance granules: Valsartan 160.00 mg

Auxiliary substances of the substance-granules: microcrystalline cellulose, croscarmellose sodium, povidone K-25, sodium lauryl sulfate]

Excipients: mannitol, magnesium stearate, colloidal silicon dioxide

Shell film:

Opadry II white¹dye iron oxide yellow (E172)

Therapeutic indications

Arterial hypertension (for patients who are recommended combination therapy).

Dosage and administration

Inside, drinking down with a small amount of water, 1 time per day, regardless of the meal time.

The recommended daily dose - 1 pill of Vamloset drug^®containing amlodipine / valsartan in a dose of 5/80 mg or 5/160 mg, or 10/160 mg, or 5/320 mg, or 10/320 mg.

The maximum daily dose is 5/320 mg (in terms of valsartan) or 10/160 mg (in terms of amlodipine) or 10/320 mg.

Start taking the drug Vamloset^® recommended with a dose of 5/80 mg 1 time per day. You can increase the dose in 1-2 weeks after the start of therapy.

Special patient groups

Elderly patients (over 65)

Patients over 65 years of age do not require dose adjustment. In patients of this category, if necessary, a decrease in the initial dose of the Vamloset drug is possible.^® containing the smallest dose of amlodipine, i.e., 1 pill containing amlodipine / valsartan in a dose of 5/80 mg or 5/160 mg.

Use in children and adolescents (under the age of 18)

Since the data on the safety and efficacy of the drug Vamloset^® in children and adolescents (under 18) is not enough, the drug is not recommended for use in patients in this category.

Patients with impaired renal function

For patients with impaired renal function of mild and moderate severity (CK -30 ml / min), the initial dose adjustment is not required.

Patients with impaired liver function

Due to the presence in the composition of valsartan and amlodipine the drug Vamloset^® should be used with caution in patients with impaired liver function and obstructive diseases of the biliary tract. In patients of this category, if necessary, a decrease in the initial dose of the Vamloset drug is possible.^® containing the smallest dose of amlodipine, i.e., 1 pill containing amlodipine / valsartan in a dose of 5/80 mg or 5/160 mg.

Contraindications

• Hypersensitivity to amlodipine, other derivatives of the dihydropyridine series, valsartan, as well as to other auxiliary components of the drug.
• Hereditary angioedema, or edema in patients on the background of prior therapy with APA II.
• Severe liver failure (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis.
• Severe renal failure (QC less than 30 ml / min), use in patients on hemodialysis.
• Planning for pregnancy, pregnancy and breastfeeding period.
• Severe arterial hypotension (systolic blood pressure less than 90 mmHg), collapse, shock (including cardiogenic shock).
• Obstruction of the outflow tract of the left ventricle (including severe aortic stenosis).
• Hemodynamically unstable heart failure after acute myocardial infarction.
• Primary hyper aldosteronism.
• Simultaneous use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and / or moderate or severe renal impairment (glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m² surface area of ​​the body).
• Simultaneous use with ACE inhibitors in patients with diabetic nephropathy.

The safety of the drug Vamloset^® in patients after transplanted kidney transplantation, as well as in children and adolescents under 18 years of age has not been established.

Carefully

Liver dysfunction of the lungs (5-6 points on the Child-Pugh scale) and moderate (7-9 points on the Child-Pugh scale) severity, as well as in obstructive diseases of the biliary tract, unilateral or bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, chronic heart failure (CHF), III-IV functional class according to NYHA classification, acute coronary syndrome, after acute myocardial infarction, hyperkalemia, hyponatremia, diet with restriction of salt intake, reduced circulary Blood guide (bcc) (in t. h. diarrhea, vomiting).

As with the use of other vasodilators, special care should be taken when applying to patients with mitral or aortic stenosis of mild to moderate degree and hypertrophic obstructive cardiomyopathy (GOKMP).

Special instructions and precautionary measures

Special notes

Patients with hyponatremia and / or a decrease in BCC

In patients with uncomplicated arterial hypertension, taking amlodipine / valsartan combination therapy, in 0.4% of cases severe arterial hypotension was observed.

In patients with activated RAAS (for example, in patients with dehydration and / or hyponatremia who take diuretics in high doses) while taking APA II, symptomatic arterial hypotension may develop. Before starting treatment, it is recommended to restore the sodium content and / or replenish the BCC, in particular, by reducing the dose of diuretics or initiate therapy under close medical supervision.

With the development of a pronounced decrease in blood pressure, the patient should be placed in a horizontal position with raised legs and, if necessary, an intravenous infusion of 0.9% sodium chloride solution should be administered intravenously. Therapy with Vamloset^® can be continued after stabilization of hemodynamic parameters.

Hyperkalemia

With the simultaneous use of potassium-sparing diuretics, potassium preparations, dietary supplements containing potassium, or other drugs that can increase the content of potassium in the blood plasma (eg, heparin), caution should be exercised. It is necessary to regularly monitor the content of potassium in the blood plasma.

Renal artery stenosis

Vamloset drug^® It should be used with caution in patients with arterial hypertension on the background of unilateral or bilateral stenosis of the renal artery or stenosis of the artery of a single kidney, taking into account the possibility of increasing serum concentrations of urea and creatinine.

Condition after kidney transplantation

The safety of using the amlodipine / valsartan combination in patients who have recently undergone kidney transplantation has not been established.

Liver dysfunction

Valsartan is mainly excreted unchanged with bile. Patients T_1/2 it is extended, and AUC - increases. Care should be taken when using the drug Vamloset^® patients with a lung (5-6 points on the scale of Child-Pugh) or moderate (7-9 points on the scale of Child-Pugh) impaired liver function or obstructive diseases of the biliary tract.

Renal dysfunction

Dose adjustment of the drug Vamloset^® in patients with mild and moderate renal impairment is not required. In patients with moderately impaired renal function, it is recommended to monitor the content of potassium and the concentration of creatinine in the blood plasma. The simultaneous use of ARA II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with impaired renal function (CC less than 60 ml / min).

Primary hyperaldosteronism

Given the defeat of the RAAS in primary hyper aldosteronism, these patients should not be prescribed ARA II, including valsartan.

Angioedema

Among patients with angioedema (including edema of the larynx and vocal cords, causing airway obstruction and / or swelling of the face, lips, pharynx, and / or tongue) during therapy with Vamloset^®, there have been cases of angioedema in history, including ACE inhibitors.With the development of angioedema should immediately discontinue the drug and exclude the possibility of re-use.

Heart failure / myocardial infarction

In patients whose renal function may depend on the activity of the RAAS (for example, in severe CHF), therapy with ACE inhibitors and ARA II is accompanied by oliguria and / or an increase in azotemia, and in rare cases, acute renal failure and / or death. Similar outcomes have been described with valsartan. In patients with CHF or myocardial infarction, renal function should always be evaluated.

In patients with CHF of the non-ischemic etiology of the III-IV functional class according to the NYHA classification, the use of amlodipine was accompanied by an increase in the incidence of pulmonary edema compared with placebo in the absence of a significant difference in the frequency of CHF deterioration between the two groups. Slow Calcium channel blockers, including amlodipine, should be used with caution in patients with CHF, as there may be an increased risk of cardiovascular complications and death.

Stenosis of the aortic valve of mild to moderate degree and the mitral valve, GOKMP

As with the use of any vasodilators, caution should be exercised in patients with mitral stenosis and mild to moderate aortic stenosis, GOKMP. The combination of amlodipine / valsartan was studied only in patients with arterial hypertension.

Interaction with other drugs

Vamloset drug^®

General drug interactions for the drug Vamloset^® (amlodipine / valsartan)

Simultaneous application requiring attention

Other antihypertensive drugs (for example, alpha-blockers, diuretics) and drugs that have hypotensive effects (for example, tricyclic antidepressants, alpha-blockers for the treatment of benign prostatic hyperplasia), may enhance the antihypertensive effect.

Drug Interactions for Amlodipine

Unwanted simultaneous use

Grapefruit or grapefruit juice

Simultaneous use of non rivers