Vamloset pills 5mg + 160mg №30

Composition

1 pill 5 mg + 80 mg contains:

Nucleus: Amlodipine besylate (amlodipine besylate) 6.94 mg, equivalent to amlodipine 5 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 41.00 mg, croscarmellose sodium 2.375 mg, povidone 1.50 mg, sodium lauryl sulfate 0.80 mg]

Excipients: mannitol 21.885 mg, Magnesium stearate 4.50 mg, colloidal silicon dioxide 1.00 mg

Film casing: Opadry II white * 3.50 mg, iron dye oxide yellow, E172 0.50 mg.

1 pill 5 mg + 160 mg contains:

Nucleus: amlodipine besylate (amlodipine besylate) 6.94 mg, equivalent to amlodipine 5 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 82.00 mg, croscarmellose sodium 4.75 mg, povidone 3.00 mg, sodium lauryl sulfate 1.60 mg]

Excipients: mannitol 50.71 mg, magnesium stearate 9.00 mg, colloidal silicon dioxide 2.00 mg

Film casing: Opadry II white * 7.00 mg, iron dye oxide yellow, E172 1.00 mg.

1 pill 10 mg + 160 mg contains:

Kernel: amlodipine besylate (amlodipine besylate) 13.88 mg, equivalent to amlodipine

10 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

82.00 mg, croscarmellose sodium 4.75 mg, povidone 3.00 mg, sodium lauryl sulfate 1.60 mg]

Excipients: mannitol 43.77 mg, magnesium stearate 9.00 mg, silicon dioxide colloidal 2.00 mg

Film casing: Opadry II white * 7.80 mg, iron dye oxide yellow, E172 0.20 mg.

Clinical data

Therapeutic indications

hypotensive combined agent (blocker of “slow” Calcium channels + angiotensin II receptor antagonist).

Dosage and administration

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

The recommended daily dose is 1 pill of Vamloset, containing the combination of amlodipine / valsartan at a dose of 5/80 mg, 5/160 mg, or 10/160 mg.

It is recommended to start taking the drug Vamloset 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.

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

Contraindications

• Hypersensitivity to amlodipine, other derivatives of the dihydropyridine series, valsartan or to other components of the drug;

• Severe liver failure (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis;
• Severe renal failure (creatinine clearance (CC) less than 30 ml / min), use in patients on hemodialysis;
• Severe arterial hypotension (systolic blood pressure less than 90 mm Hg), collapse, shock (including cardiogenic shock);
• Obstruction of the outflow tract of the left ventricle (including hypertrophic obstructive cardiomyopathy (GOKMP) and severe aortic stenosis);
• Hemodynamically unstable heart failure after acute myocardial infarction;
• Primary hyper aldosteronism.

• Pregnancy and breastfeeding period;

• Simultaneous use with aliskiren in patients with diabetes mellitus or renal dysfunction (QA less than 60 ml / min).

The safety of the use of Vamloset drug in patients after kidney transplantation, as well as children and adolescents under 18 years of age is not established.

Carefully: dysfunction of the liver is easy (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, impaired renal function and mild to moderate severity 30-50 ml / min), unilateral or bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, chronic heart failure (CHF) of the III-IV functional class according to the NYHA classification, hyperkalemia, hyponatremia, diet with restriction of salt intake, reduced volume circulating her blood (BCC) (including diarrhea, vomiting), use in patients with hereditary angioedema or edema in the background of previous therapy with angiotensin II receptor antagonists (APA II).

Also, as with the use of other vasodilators, special care should be taken when applying to patients with mitral and aortic stenosis of mild to moderate degrees.

Special instructions and precautionary measures

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.

Patients with activated RAAS (for example, patients with dehydration and / or hyponatremia who take diuretics in high doses), while taking angiotensin II receptor antagonists, may develop symptomatic arterial hypotension. 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 laid in a horizontal position with his legs elevated and, if necessary, intravenous infusion of 0.9% sodium chloride solution. 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 ions in the blood plasma.

Renal artery stenosis

The drug Vamloset should be used with caution in patients with arterial hypertension against a background of unilateral or bilateral stenosis of the renal artery or stenosis of the artery of a single kidney, given 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. Caution should be exercised when using the drug Vamloset patients with lung (5-6 points on the Child-Pugh scale) or moderate (7-8 points on the Child-Pugh scale) abnormal liver function or obstructive biliary tract diseases.

Renal dysfunction

Dose adjustment of the Vamloset drug 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 hyperaldosteronism, these patients should not be prescribed angiotensin II receptor antagonists, including valsartan.

Angioedema

Among patients with angioedema (including swelling of the larynx and vocal cords, causing airway obstruction and / or swelling of the face, lips, pharynx, and / or tongue) during drug therapy 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 angiotensin II receptor antagonists 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 it may increase the risk of cardiovascular complications and death.

Mild to moderate aortic valve stenosis and mitral valve

As with the use of any vasodilators, caution should be exercised in patients with mitral stenosis and mild to moderate aortic stenosis. 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 hypotensive effect.

Drug Interactions for Amlodipine

Unwanted simultaneous use

Grapefruit or grapefruit juice: simultaneous use is not recommended, given the possibility of increasing bioavailability in some patients and enhancing the hypotensive effect.

Simultaneous use requiring caution

Inhibitors of the isoenzyme CYP3A4

Simultaneous use with strong or moderate CYP3A4 isoenzyme inhibitors (protease inhibitors, Verapamil or diltiazem, azole antifungal drugs, macrolides, such as Erythromycin or Clarithromycin ) may lead to a significant increase in systemic exposure to amlodipine. In elderly patients, these changes are of clinical importance, therefore, medical supervision and dose adjustment are necessary.

Inductors of isoenzyme CYP3A4 (anticonvulsant drugs (for example, Carbamazepine , phenobarbital, phenytoin, phosphenytoin, primidone), rifampicin, herbal preparations containing St. John's wort hollow): should be used with caution, because with simultaneous use may reduce the concentration of amlodipine in the blood plasma.

Simvastatin

Simultaneous repeated use of amlodipine in a dose of 10 mg and Simvastatin at a dose of 80 mg, the exposure of simvastatin is increased by 77% compared to that of simvastatin monotherapy. Patients receiving amlodipine are recommended to use simvastatin in a dose of not more than 20 mg / day.

Dantrolene (intravenous): in animal experiments after oral administration of verapamil and intravenous dantrolene, cases of fatal ventricular fibrillation and cardiovascular insufficiency associated with hyperkalemia were observed.Given the risk of developing hyperkalemia, the simultaneous use of blockers of “slow” calcium channels should be avoided, including amlodipine, in patients prone to the development of malignant hyperthermia.

Simultaneous application requiring attention

Other

Amlodipine has no significant interaction in clinical studies. with abysic diuretics, alpha-adrenergic blockers, beta-adrenergic blocking agents, oxyacid inhibitors, abstinent substances, long-term interaction, Nitroglycerin for sublingual use, Digoxin , Warfarin , Atorvastatin , Sildenafil , Maalox (aluminum or magnesium-containing antiacid substances, or antidecid, aldenacil NSAIDs), antibiotics and hypoglycemic agents for prima inside.

Drug interactions for valsartan

Simultaneous use is contraindicated

The simultaneous use of ARA II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes and kidney dysfunction (CC less than 60 ml / min).

Unwanted simultaneous use

Lithium

Simultaneous use with lithium preparations is not recommended, since possible reversible increase in plasma lithium concentration