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Valz Combi 10mg+160mg, 28 film-coated tablets

Registration Certificate Holder

ACTAVIS GROUP PTC ehf. (Iceland)

Dosage form

Medicine - Valz Combi

Description

Film-coated tablets

white, oval, biconvex, engraved with “3” on one side and “LD” on the other side.

1 tab.

amlodipine besylate 13.9 mg, which corresponds to the content of amlodipine 10 mg valsartan 160 mg

Excipients

: microcrystalline cellulose (type 101) - 50.5 mg, povidone (K30) - 17 mg, croscarmellose sodium - 17 mg, microcrystalline cellulose (type 102) - 76.84 mg, talc - 4.08 mg, magnesium stearate - 2.04 mg.

Shell composition:

Opadry white 03B28796 (hypromellose - 6.4 mg, titanium dioxide (E171) - 3.2 mg, macrogol 400 - 0.64 mg) - 10.24 mg.

7 pcs. - blisters (4) - cardboard packs. 14 pcs. - blisters (2) - cardboard packs. 14 pcs. - blisters (7) - cardboard packs.

Indications

arterial hypertension in patients who are indicated for combination therapy with amlodipine and valsartan.

Contraindications for use

severe liver failure (more than 9 points on the Child-Pugh scale);
biliary cirrhosis and cholestasis;
severe renal failure (creatinine clearance <30 ml/min);
use in patients on hemodialysis;
severe arterial hypotension (systolic blood pressure <90 mm Hg);
collapse, shock (including cardiogenic shock);
obstruction of the outflow tract of the left ventricle (including hypertrophic obstructive cardiomyopathy and severe aortic stenosis);
hemodynamically unstable heart failure after acute myocardial infarction;
simultaneous use with aliskiren in patients with diabetes mellitus or impaired renal function (creatinine clearance less than 60 ml/min);
primary hyperaldosteronism;
pregnancy;
lactation period (breastfeeding);
hypersensitivity to amlodipine, other dihydropyridine derivatives, valsartan or other components of the drug.

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

This combination should be prescribed for liver dysfunction of mild (5-6 points on the Child-Pugh scale) and moderate (7-9 points on the Child-Pugh scale) severity; obstructive diseases of the biliary tract; renal dysfunction of mild to moderate severity (creatinine clearance 30-50 ml/min); unilateral or bilateral renal artery stenosis or stenosis of the artery of a single kidney; chronic heart failure FC III-IV according to NYHA classification; hyperkalemia; hyponatremia; following a diet with limited salt intake; decreased blood volume (including with diarrhea, vomiting); in patients with hereditary angioedema, or edema due to previous therapy with angiotensin II receptor antagonists; in patients with mild to moderate mitral and aortic stenosis.

pharmachologic effect

A combined antihypertensive drug containing: amlodipine (dihydropyridine derivative) and valsartan (angiotensin II receptor antagonist). The combination of these components has a mutually complementary hypotensive effect, which leads to a more pronounced decrease in blood pressure than when they are used separately.

The clinical effectiveness of the amlodipine/valsartan combination has been proven in patients with mild and moderate arterial hypertension (mean diastolic blood pressure ≥95 mm Hg and <110 mm Hg) without complications in comparison with placebo. The level of blood pressure reduction in the sitting position in arterial hypertension with diastolic blood pressure ≥110 mm Hg. Art. and <120 mm Hg. Art. comparable to the use of a combination of an ACE inhibitor and a thiazide diuretic. When using the combination of amlodipine/valsartan, comparable blood pressure control is achieved with a lower likelihood of developing peripheral edema in patients with previously achieved blood pressure control and severe peripheral edema during amlodipine therapy.

When taking the amlodipine/valsartan combination in a single dose, the hypotensive effect persists for 24 hours. The antihypertensive effect persists for a long time. Sudden cessation of drug use is not accompanied by a sharp increase in blood pressure (there is no withdrawal syndrome). Therapeutic effectiveness does not depend on the patient's age, gender, race or BMI.

Amlodipine

- a dihydropyridine derivative, a calcium channel blocker. Has antianginal and hypotensive effects. Inhibits the transmembrane transition of calcium ions into cardiomyocytes and smooth muscle cells of the vascular wall. The antihypertensive effect of amlodipine is due to a direct relaxing effect on the smooth muscle cells of the vascular wall. The mechanism of the antianginal action of amlodipine has not been fully studied, presumably it is associated with the following effects: causes dilation of peripheral arterioles, reducing peripheral vascular resistance (afterload), which leads to a decrease in myocardial oxygen demand; causes expansion of the coronary arteries and arterioles in both intact and ischemic areas of the myocardium, which increases the supply of oxygen to the myocardium, incl. in patients with Prinzmetal's angina. Amlodipine reduces the severity of left ventricular hypertrophy. It has no effect on myocardial contractility and conductivity, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases GFR, and has a weak natriuretic effect.

In patients with arterial hypertension, taking amlodipine 1 time per day provides a clinically significant decrease in blood pressure (lying and standing) within 24 hours. The antihypertensive effect develops slowly, and therefore the development of acute arterial hypotension is uncharacteristic. In patients with angina pectoris, taking amlodipine 1 time per day increases exercise tolerance, the time before the development of an angina attack and until ischemic depression of the ST segment, reduces the frequency of angina attacks and the need for taking nitroglycerin (short-acting forms).

The clinical effectiveness of amlodipine has been proven in patients with stable angina pectoris, vasospastic angina and angiographically confirmed lesions of the coronary arteries.

Amlodipine does not have any undesirable effects on lipid metabolism and does not cause changes in the lipid profile of the blood plasma. Amlodipine can be used in patients with bronchial asthma, diabetes mellitus and gout.

With a single oral dose, the effect of amlodipine begins within 2-4 hours and lasts for 24 hours. The maximum hypotensive effect is achieved no earlier than 4 weeks from the start of taking the drug. The hemodynamic effects of the drug remain unchanged with long-term use.

Valsartan

- a selective antagonist of angiotensin II receptors (type AT1) for oral administration. Selectively blocks receptors of the AT1 subtype, which are responsible for the effects of angiotensin II. An increase in plasma concentrations of angiotensin II due to blockade of AT1 receptors by valsartan may stimulate unblocked AT2 receptors, which counteract the effects of AT1 receptor stimulation. Valsartan does not have agonist activity against AT1 receptors. The affinity of valsartan for receptors of the AT1 subtype is approximately 20,000 times higher than for receptors of the AT2 subtype.

Valsartan does not interact with or block receptors of other hormones or ion channels involved in the regulation of the functions of the cardiovascular system.

Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. Due to the lack of influence on ACE, the effects of bradykinin or substance P are not potentiated, therefore, when using angiotensin II receptor antagonists, the development of a dry cough is unlikely. It has been proven that the incidence of dry cough during treatment with valsartan is significantly lower than when using ACE inhibitors. In the treatment of arterial hypertension, valsartan reduces blood pressure without affecting heart rate.

After oral administration of valsartan in a single dose, the hypotensive effect develops within 2 hours, and the maximum reduction in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours after its administration. With repeated use of valsartan, the maximum reduction in blood pressure, regardless of the dose, is achieved after 2-4 weeks and is maintained at the achieved level during long-term therapy. Sudden cessation of valsartan use is not accompanied by a significant increase in blood pressure or other adverse effects (withdrawal syndrome).

Drug interactions

Amlodipine/valsartan

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

Amlodipine

Concomitant use with grapefruit or grapefruit juice is not recommended, given the possibility of increased bioavailability in some patients and increased antihypertensive effects.

Concomitant use with strong or moderate inhibitors of the CYP3A4 isoenzyme (protease inhibitors, verapamil or diltiazem, azole antifungals, macrolide antibiotics such as erythromycin or clarithromycin) may lead to a significant increase in the systemic exposure of amlodipine. In elderly patients, these changes are of clinical significance, so medical supervision and dosage adjustment are necessary.

When used simultaneously with inducers of the CYP3A4 isoenzyme (anticonvulsants (for example, carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, herbal preparations containing St. John's wort) caution should be exercised, because a decrease in the concentration of amlodipine in blood plasma is possible.

Simultaneous repeated use of amlodipine at a dose of 10 mg and simvastatin at a dose of 80 mg increases the exposure of simvastatin by 77% compared with that of simvastatin monotherapy. For patients receiving amlodipine, it is recommended to use simvastatin at a dose of no more than 20 mg/day.

In experimental studies in animals, cases of fatal ventricular fibrillation and cardiovascular failure associated with hyperkalemia were observed after oral administration of verapamil and intravenous administration of dantrolene. Given the risk of developing hyperkalemia, simultaneous use of calcium channel blockers, incl. amlodipine, in patients prone to the development of malignant hyperthermia.

Clinical studies revealed no significant interactions with thiazide diuretics, alpha-blockers, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, Maalox (aluminum- or magnesium-containing antacids, simethicone) , cimetidine, NSAIDs, antibiotics and oral hypoglycemic drugs.

Valsartan

The simultaneous use of angiotensin II receptor antagonists, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus and impaired renal function (creatinine clearance less than 60 ml/min).

Simultaneous use with lithium preparations is not recommended, because a reversible increase in the concentration of lithium in the blood plasma and the development of intoxication is possible. If simultaneous use with lithium preparations is necessary, the concentration of lithium in the blood plasma should be carefully monitored.

If necessary, simultaneous use with drugs that affect potassium levels (potassium-sparing diuretics, potassium preparations, potassium-containing food supplements and other drugs and substances that can increase potassium levels in the blood serum (for example, heparin)), it is recommended to monitor the potassium level in the blood plasma .

When used simultaneously with NSAIDs, incl. selective COX-2 inhibitors, acetylsalicylic acid in a dose of more than 3 g/day and non-selective NSAIDs may weaken the antihypertensive effect, increase the risk of developing renal dysfunction and increase the potassium content in the blood plasma. At the beginning of therapy, it is recommended to evaluate renal function, as well as correct water and electrolyte imbalances.

According to the results of an in vitro study, valsartan is a substrate for the transporter proteins OATP1B1 and MRP2. Concomitant use of valsartan with OATP1B1 transporter protein inhibitors (eg, rifampicin, cyclosporine) and an MRP2 transporter protein inhibitor (eg, ritonavir) may increase the systemic exposure of valsartan (Cmax and AUC). This should be taken into account at the beginning and at the end of concomitant therapy.

Dosage regimen

The drug should be taken orally, 1 time/day, regardless of meals, with a small amount of water.

Recommended daily dose - 1 tablet. a drug containing a combination of amlodipine/valsartan at a dose of 5 mg/80 mg, 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg or 10 mg/320 mg.

The initial dose of the drug is 5 mg/80 mg 1 time/day. The dose can be increased 1-2 weeks after the start of therapy.

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

In patients with impaired renal function (creatinine clearance >30 ml/min)

no adjustment of the initial dose of the drug is required.
Patients with impaired liver function
should use the drug with caution.
The maximum daily dose of valsartan for mild to moderate liver failure
is 80 mg.
The drug is contraindicated in patients with severe liver failure, biliary cirrhosis and cholestasis
.

In elderly patients

no dose adjustment is required.

Side effect

WHO classification of the incidence of side effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/100) 10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data).

Amlodipine/valsartan

Infectious and parasitic diseases:

often - flu.

From the side of metabolism:

often - hypokalemia; uncommon - hypercalcemia, hyperlipidemia, hyperuricemia, hyponatremia.

From the nervous system:

often - headache; uncommon - loss of coordination, dizziness, postural dizziness, paresthesia, drowsiness; rarely - anxiety.

From the side of the organ of vision:

infrequently - visual impairment; rarely - visual impairment.

Hearing and labyrinth disorders:

infrequently - vertigo; rarely - tinnitus.

From the cardiovascular system:

uncommon - palpitations, tachycardia, orthostatic hypotension; rarely - marked decrease in blood pressure, fainting.

From the respiratory system:

often - nasopharyngitis; infrequently - cough, pain in the pharynx and larynx.

From the digestive system:

uncommon - diarrhea, nausea, abdominal discomfort, pain in the upper abdomen, constipation, dry mouth.

For the skin and subcutaneous tissues:

infrequently - erythema, skin rash; rarely - exanthema, hyperhidrosis, itching.

From the musculoskeletal system:

infrequently - arthralgia, swelling of the joints; rarely - muscle spasms, a feeling of heaviness throughout the body.

From the urinary system:

rarely - pollakiuria, polyuria.

From the genital organs and breast:

rarely - erectile dysfunction.

Allergic reactions:

rarely - hypersensitivity.

General disorders and disorders at the injection site:

often - asthenia, increased fatigue, swelling of the face, a feeling of a rush of blood to the skin of the face, edema, peripheral edema, pastiness; infrequently - anorexia, back pain.

In patients receiving the amlodipine/valsartan combination, peripheral edema was less common (5.8%) than in patients receiving amlodipine therapy alone (9%).

Amlodipine

Often:

drowsiness, dizziness, palpitations, abdominal pain, nausea, swelling of the ankles.

Infrequently:

insomnia, mood lability (including anxiety), depression, tremor, taste disturbance, fainting, hypoesthesia, visual impairment (including diplopia), tinnitus, marked decrease in blood pressure, shortness of breath, rhinitis, vomiting, dyspepsia , alopecia, purpura, skin discoloration, hyperhidrosis, itching, exanthema, myalgia, muscle cramps, pain, urinary dysfunction, increased frequency of urination, impotence, gynecomastia, chest pain, malaise, weight gain, weight loss.

Rarely:

confusion.

Very rarely:

leukopenia, thrombocytopenia, allergic reactions, hyperglycemia, muscle hypertonicity, peripheral neuropathy, myocardial infarction, arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, increased activity of liver enzymes (most often due to cholestasis), angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity.

Isolated cases of extrapyramidal syndrome have been described.
Valsartan
Frequency unknown:

decreased hemoglobin and hematocrit, neutropenia, thrombocytopenia, increased potassium content in the blood serum, increased activity of liver enzymes, increased concentration of bilirubin in the blood plasma, increased concentration of creatinine in the blood plasma, impaired renal function, including renal failure, angioedema, myalgia, vasculitis, hypersensitivity, including serum sickness.

special instructions

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

In patients with an activated RAAS (for example, in patients with dehydration and/or hyponatremia taking high doses of diuretics), symptomatic arterial hypotension may develop when taking angiotensin II receptor antagonists. Before starting treatment, sodium levels should be restored and/or BCC should be replenished, in particular by reducing the doses of diuretics, or therapy should be initiated under close medical supervision.

If a pronounced decrease in blood pressure develops, the patient should be transferred to a horizontal position with a low head and, if necessary, given an intravenous infusion of 0.9% sodium chloride solution. Therapy with the drug can be continued after stabilization of hemodynamic parameters.

Caution should be exercised when using potassium-sparing diuretics, potassium supplements, dietary supplements containing potassium, or other drugs that can increase plasma potassium levels (eg, heparin). It is necessary to regularly monitor the potassium content in the blood plasma.

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

In patients with moderate renal impairment, it is recommended to monitor potassium levels and creatinine concentrations in the blood plasma.

Considering the damage to the RAAS in primary hyperaldosteronism, patients in this group should not be prescribed angiotensin II receptor antagonists, incl. valsartan.

Among patients with angioedema (including swelling of the larynx and vocal cords, causing obstruction of the airways and/or swelling of the face, lips, pharynx and/or tongue) during drug therapy, there was a history of the development of angioedema, including .h. to ACE inhibitors. If angioedema develops, the drug should be discontinued immediately and the possibility of repeated use should be excluded.

In patients whose renal function may depend on the activity of the RAAS (for example, in severe chronic heart failure), 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 chronic heart failure or previous myocardial infarction, renal function should always be assessed.

In patients with chronic heart failure of non-ischemic etiology, class III-IV according to the NYHA classification, the use of amlodipine was accompanied by an increase in the incidence of pulmonary edema compared with placebo, with no significant difference in the incidence of worsening chronic heart failure between the two groups. Calcium channel blockers, incl. amlodipine should be used with caution in patients with chronic heart failure, because there may be an increased risk of cardiovascular complications and death.

The amlodipine/valsartan combination has been studied only in patients with arterial hypertension.
Effect on the ability to drive vehicles and operate machinery
When using the drug, care must be taken when driving vehicles and other technical devices that require increased concentration and speed of psychomotor reactions, because Dizziness, fatigue and nausea may develop.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

The use of this combination is contraindicated during pregnancy and lactation.

Use for renal impairment

Restrictions for impaired renal function - With caution.

The use of the drug is contraindicated in severe renal failure (creatinine clearance <30 ml/min); in patients on hemodialysis.

This combination should be prescribed with caution for mild to moderate renal dysfunction (creatinine clearance 30-50 ml/min); unilateral or bilateral renal artery stenosis or stenosis of the artery of a single kidney.

The safety of the drug in patients after kidney transplantation has not been established.

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

The use of the drug is contraindicated in severe liver failure (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis.

This combination should be prescribed with caution for mild (5-6 points on the Child-Pugh scale) and moderate (7-9 points on the Child-Pugh scale) liver dysfunction; obstructive diseases of the biliary tract.

Use in elderly patients

Restrictions for elderly patients - No restrictions.

In elderly patients, no dose adjustment is required.

Use in children

Restrictions for children - Contraindicated.

The safety of the drug in children and adolescents under 18 years of age has not been established.