Composition, form of production and packaging
The tablets covered with a film coat of a brownish-yellow color with possible dark impregnations, round, slightly biconcave, with a facet.
1 tab.
amlodipine besylate 6.94 mg,
which corresponds to the content of amlodipine 5 mg
valsartan A substance-granules 125.675 mg,
which corresponds to the content of valsartan 80 mg
Auxiliary substances of granule substance: microcrystalline cellulose - 41 mg, croscarmellose sodium - 2.375 mg, povidone - 1.5 mg, sodium lauryl sulfate - 0.8 mg.
Excipients: mannitol - 21.885 mg, magnesium stearate - 4.5 mg, silicon dioxide colloid - 1 mg.
The composition of the film shell: opedrai II white - 3.5 mg (polyvinyl alcohol - 40%, titanium dioxide (E171) - 25%, macrogol - 20.2%, talc - 14.8%), iron oxide oxide yellow (E172) - 0.5 mg.
14 pcs. - packings cellular planimetric (2) - packs cardboard.
Tablets covered with a film coat of brownish-yellow color with possible dark impregnations, oval, biconvex.
1 tab.
amlodipine besylate 6.94 mg,
which corresponds to the content of amlodipine 5 mg
valsartan A substance-granules 251.35 mg,
which corresponds to the content of valsartan 160 mg
Auxiliary substances of granule substance: microcrystalline cellulose - 82 mg, croscarmellose sodium - 4.75 mg, povidone - 3 mg, sodium lauryl sulfate - 1.6 mg.
Excipients: mannitol - 50.71 mg, magnesium stearate - 9 mg, silicon dioxide colloid - 2 mg.
The composition of the film shell: opadrai II white - 7 mg (polyvinyl alcohol - 40%, titanium dioxide (E171) - 25%, macrogol - 20.2%, talc - 14.8%), iron oxide yellow oxide (E172) - 1 mg.
7 pcs. - packings cellular planimetric (4) - packs cardboard.
The tablets covered with a film membrane brownish-yellow color, oval, biconcave.
1 tab.
amlodipine besylate 13.88 mg,
which corresponds to the content of amlodipine 10 mg
valsartan A substance-granules 251.35 mg,
which corresponds to the content of valsartan 160 mg
Auxiliary substances of granule substance: microcrystalline cellulose - 82 mg, croscarmellose sodium - 4.75 mg, povidone - 3 mg, sodium lauryl sulfate - 1.6 mg.
Excipients: mannitol - 43.77 mg, magnesium stearate - 9 mg, silicon dioxide colloid - 2 mg.
The composition of the film shell: opedrai II white - 7.8 mg (polyvinyl alcohol - 40%, titanium dioxide (E171) - 25%, macrogol - 20.2%, talc - 14.8%), iron oxide yellow oxide (E172) - 0.2 mg.
7 pcs. - packings cellular planimetric (4) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Combined antihypertensive drug containing active substances with a complementary mechanism for monitoring blood pressure. Amlodipine, a derivative of dihydropyridine, belongs to the class of slow calcium channel blockers (BCCC), valsartan - to the class of angiotensin II receptor antagonists. The combination of these components has a mutually complementary antihypertensive effect, which leads to a more pronounced decrease in blood pressure than with their separate application.
Amlodipine / Valsartan
The combination of amlodipine and valsartan additively dose-dependent in the therapeutic range of doses reduces blood pressure. When taking amlodipine / valsartan combination in a single dose, the hypotensive effect persists for 24 hours.
The clinical efficacy of the amlodipine / valsartan combination in patients with mild to moderate arterial hypertension (mean diastolic blood pressure of 95 mm Hg and <110 mm Hg) without complications was compared with placebo. The level of blood pressure lowering in the sitting position with arterial hypertension with diastolic blood pressure is 110 mm Hg. Art. and <120 mm Hg. Art. comparable with the use of a combination of an ACE inhibitor and a thiazide diuretic.
Antihypertensive effect persists for a long time. A sudden discontinuation of the drug is not accompanied by a sharp increase in blood pressure (there is no withdrawal syndrome).
The therapeutic effectiveness does not depend on the age, sex, race of the patient and body mass index.
When combined amlodipine / valsartan therapy is used, comparable blood pressure control is achieved with a lower probability of peripheral edema development in patients with previously achieved BP control and severe peripheral edema with amlodipine therapy.
Amlodipine
Amlodipine - a derivative of dihydropyridine, a blocker of slow calcium channels, has an antianginal and antihypertensive effect. Inhibits transmembrannoe intake of calcium ions in cardiomyocytes and smooth muscle cells of blood vessels. The mechanism of antihypertensive action of amlodipine is due to a direct relaxing effect on the smooth muscle of the vessels, which leads to a decrease in OPSS and blood pressure.
Amlodipine in therapeutic doses in patients with hypertension causes an expansion of the blood vessels, which leads to a decrease in blood pressure (in the supine and standing position). Reduction of blood pressure with prolonged use of amlodipine is not accompanied by a significant change in heart rate and the concentration of catecholamines in the blood plasma.
The concentration of amlodipine in the blood plasma correlates with the clinical effect, both in young patients and in elderly patients.
With arterial hypertension in patients with normal renal function, amlodipine in therapeutic doses leads to a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal blood flow without changing the filtration fraction or proteinuria.
Amlodipine, like other BCCs, in patients with normal left ventricular function causes a change in hemodynamic parameters of heart function at rest and under physical exertion (or stimulation): a slight increase in the cardiac index, without significantly affecting the maximum rate of increase in pressure in the left ventricle (dP / dt) or the final diastolic pressure and the final diastolic volume of the left ventricle. The use of amlodipine in the therapeutic range of doses does not cause a negative inotropic effect, even with simultaneous use with beta-blockers.
Amlodipine does not change the function of the sinoatrial node or AV-conduction in intact animals or humans. The use of amlodipine in combination with beta-blockers in patients with arterial hypertension or angina has not been associated with unwanted changes in the ECG.
The clinical efficacy of amlodipine in patients with stable angina pectoris, vasospastic angina and angiographically confirmed coronary artery disease was demonstrated.
Valsartan
Valsartan is a selective antagonist of angiotensin II receptors (type AT 1 ) for oral administration, non-protein nature.
Selectively blocks receptors of the subtype AT 1 , which are responsible for the effects of angiotensin II. An increase in the plasma concentration of angiotensin II due to blockade of AT 1 receptors under the action of valsartan can stimulate unlocked receptors of the AT2 subtype, which counteract the effects of AT 1 -receptor stimulation. Valsartan does not have agonistic activity against AT 1 -receptors. The affinity of valsartan for AT 1 subtype receptors is about 20,000 times higher than for AT 2 receptor subtypes.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. In connection with 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 dry cough is unlikely. It was proved that the frequency of development of dry cough in treatment with valsartan is much lower than with the use of ACE inhibitors.Valsartan does not interact and does not block the receptors of other hormones or ion channels involved in the regulation of the functions of the cardiovascular system.
When treating arterial hypertension, valsartan reduces blood pressure without affecting the heart rate.
After ingestion of valsartan in a single dose, the hypotensive effect develops within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan is maintained for 24 hours after its administration. With repeated use of valsartan, the maximum decrease in blood pressure, regardless of dose, is achieved in 2-4 weeks and is maintained at the achieved level during prolonged therapy. The sudden discontinuation of valsartan is not accompanied by a significant increase in BP or other adverse events (withdrawal syndrome).
PHARMACOKINETICS
The pharmacokinetics of amlodipine and valsartan is characterized by linearity.
Amlodipine / Valsartan
After ingestion of amlodipine / valsartan combination, C max of valsartan and amlodipine in blood plasma are reached after 3 hours and 6-8 hours, respectively. The rate and degree of absorption are equivalent to the bioavailability of valsartan and amlodipine when taken separately.
Amlodipine
Suction
After ingestion, amlodipine is slowly absorbed from the digestive tract. C max is reached after 6-12 hours. Absolute bioavailability is 64-80%. Bioavailability does not depend on food intake.
Distribution
V d is approximately 21 l / kg. According to the in vitro data, binding to plasma proteins is 97.5%.
C ss in blood plasma are achieved after prolonged oral administration for 7-8 days.
Metabolism
Amlodipine is intensively (about 90%) metabolized in the liver with the formation of inactive metabolites.
Excretion
Amlodipine is excreted from the blood plasma biphasic, with terminal T 1/2 from 30 to 50 hours. 10% of unchanged amlodipine and 60% of amlodipine in the form of metabolites is excreted in the urine.
Valsartan
Suction
After taking valsartan inside C max is achieved in 2-3 hours. The average absolute bioavailability is 23%. When valsartan is taken with food, there is a decrease in bioavailability (by AUC value) by about 40%, and C max - by about 50%. Approximately 8 hours after ingestion, the plasma concentrations of valsartan in the group of patients taking the drug with food and in the group taking the drug on an empty stomach are equalized. Reducing AUC is not clinically significant, so valsartan can be taken regardless of food intake.
Distribution
V d of valsartan during the equilibrium period after intravenous administration is about 17 liters, which indicates the lack of extensive distribution of valsartan in the tissues. Valsartan largely binds to serum proteins (94-97%), mainly with serum albumin.
Metabolism
Valsartan does not undergo a pronounced metabolism. Only about 20% of the dose is determined in the blood plasma in the form of metabolites. The hydroxyl metabolite is determined in the blood plasma at low concentrations (less than 10% of the valsartan AUC). This metabolite is pharmacologically inactive.
Excretion
Valsartan is biphasic:? -phase with T 1/2? less than 1 h and a? -phase with T 1/2? - about 9 hours. Valsartan is excreted mostly unchanged with bile through the intestine (about 83%) and with urine (about 13%). After iv introduction, the plasma clearance of valsartan is about 2 l / h and its renal clearance is 0.62 l / h (about 30% of the total clearance). T 1/2 of valsartan is 6 hours.
Pharmacokinetics in specific patient groups
No pharmacokinetic data on the use of the drug in children and adolescents under the age of 18 years.
Time to achieve C max in blood plasma amlodipine in young patients and elderly patients is the same. In elderly patients, clearance of amlodipine tends to decrease, which leads to an increase in AUC and T 1/2 . In elderly patients, the mean systemic exposure (AUC) of valsartan is somewhat more pronounced than in young patients. However, this was not clinically relevant. Given the good tolerability of amlodipine and valsartan in elderly patients and younger age, the usual dosing regimens are recommended.
In patients with renal insufficiency, the pharmacokinetic parameters do not change. The renal clearance of valsartan is only about 30% of the total clearance from blood plasma, so there is no correlation between renal function and systemic exposure (by AUC value) of valsartan. It is not required to change the initial dose in patients with mild and moderate renal insufficiency (QA 30-50 ml / min).
The experience of using the drug in patients with impaired liver function is limited. Patients with impaired liver function have reduced clearance of amlodipine, which increases the AUC by approximately 40-60%. The average bioavailability (by AUC value) of valsartan is doubled in patients with impaired liver function (5-6 points on the Child-Pugh scale) and moderate (7-9 on the Child-Pugh scale) compared to healthy volunteers of the corresponding age , sex and body weight.
INDICATIONS
- Arterial hypertension in patients who are shown combined therapy.
DOSING MODE
The drug should be taken orally, 1 time / day, regardless of food intake, with a small amount of water.
The recommended daily dose is 1 tablet. The drug VAMOLOSET, 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 Vamloset - 5 mg / 80 mg 1 time / day. You can increase the dose 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.
Amlodipine
Patients with impaired renal function are not required to adjust the dose.
Patients with a violation of liver function should be used with caution.
Elderly patients are not required to adjust dose and dosage regimen.
Valsartan
In patients with impaired renal function (CK> 30 ml / min), correction of the initial dose is not required.
Valsartan is contraindicated in patients with severe hepatic insufficiency, biliary cirrhosis and cholestasis . The maximum daily dose of valsartan for mild to moderate hepatic insufficiency is 80 mg. The drug Vamloset in a dose of 5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 and 10 mg / 320 mg is contraindicated.
In elderly patients, dose adjustment is not required.
SIDE EFFECT
Classification of the incidence of adverse events WHO: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1 / 10 000 to <1/1000), very rarely (from <1/10 000), the frequency is unknown (can not be estimated based on available data).
The drug Vamloset
Infectious and parasitic diseases: often - the flu.
From the side of metabolism: often - hypokalemia; infrequently - hypercalcemia, hyperlipidemia, hyperuricemia, hyponatremia.
From the nervous system: often - headache; infrequent - coordination disorder, dizziness, postural dizziness, paresthesia, drowsiness; rarely - anxiety.
From the side of the organ of vision: infrequently, vision deterioration; rarely - visual impairment.
From the side of the hearing organ and labyrinthine disturbances: infrequently - vertigo; rarely - noise in the ears.
From the side of the cardiovascular system: infrequently - a feeling of palpitations, tachycardia, orthostatic hypotension; rarely - marked decrease in blood pressure, fainting.
From the respiratory system: often - nasopharyngitis; infrequently - cough, pain in the throat and larynx.
From the digestive system: infrequently - diarrhea, nausea, a feeling of discomfort in the abdomen, pain in the upper abdomen, constipation, dry mouth.
From the skin and subcutaneous tissues: infrequently - erythema, skin rash; rarely - exanthema, hyperhidrosis, itchy skin.
From the musculoskeletal system: infrequently - arthralgia, back pain, swelling of the joints; rarely - muscle spasms, a sense of heaviness in the whole body.
From the urinary system: rarely - pollakiuria, polyuria.
From the genitals and the breast: rarely - erectile dysfunction.
Allergic reactions: rarely - hypersensitivity.
General disorders and disorders at the injection site: often - asthenia, fatigue, face swelling, a sensation of blood rush to the skin of the face, swelling, peripheral edema, pastoznost; infrequently - anorexia.
In patients receiving the amlodipine / valsartan combination, peripheral edema was less common (5.8%) than in patients receiving amlodipine alone (9%).
Amlodipine
On the part of the hematopoiesis system: very rarely - leukopenia, thrombocytopenia sometimes with purpura.
From the side of metabolism: very rarely - hyperglycemia.
Mental disturbances: infrequently - depression, insomnia / sleep disorders, mood lability; rarely confusion.
From the nervous system: often - dizziness, headache, drowsiness; infrequently - a taste disorder, paresthesia, fainting, tremor, hypoesthesia; very rarely - muscle hypertonia, peripheral neuropathy; frequency unknown - extrapyramidal disorders.
From the side of the organ of vision: infrequently - impaired vision, visual impairment.
From the side of the organ of hearing and labyrinthine disturbances: infrequently - noise in the ears.
From the cardiovascular system: often - a feeling of palpitations, a sensation of blood rush to the skin of the face, a pronounced decrease in blood pressure; very rarely - arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, vasculitis.
From the respiratory system: infrequently - dyspnea, rhinitis; very rarely - cough.
From the digestive system: often - nausea, a feeling of discomfort in the abdomen, pain in the upper abdomen; infrequently - a change in stool, diarrhea, dryness of the oral mucosa, dyspepsia, vomiting; rarely - gastritis, gingival hyperplasia, pancreatitis.
From the liver and bile ducts: very rarely - increased activity of liver enzymes (more often with cholestasis), increased bilirubin concentration in the blood plasma, hepatitis, intrahepatic cholestasis, jaundice.
From the skin and subcutaneous tissues: infrequently - alopecia, exanthema, erythema, photosensitivity reactions, pruritus, hyperhidrosis, purpura, skin rash, discoloration; very rarely - erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome.
On the part of the musculoskeletal system: often - swelling of the ankles; Infrequent - arthralgia, back pain, muscle cramps, myalgia.
From the urinary system: rarely - a violation of urination, nocturia, pollakiuria.
On the part of genitals and mammary glands: rarely - erectile dysfunction, gynecomastia.
General disorders and the site of injection: often - fatigue, peripheral edema; rarely - fatigue, discomfort, malaise, non-cardiogenic heartache and pain.
Laboratory and instrumental data: rare - decrease / increase in body weight.
Allergic reactions:very rarely - hypersensitivity reactions, urticaria, angioedema.
Valsartan
From hemopoiesis system: the frequency is unknown - decrease in hemoglobin and hematocrit, leukopenia, neutropenia, thrombocytopenia, sometimes with purpura.
On the part of the organ of hearing and labyrinth disorders: rare - vertigo.
Cardio-vascular system: the frequency is unknown - vasculitis.
The respiratory system: rarely - cough.
From the digestive system: rarely - a feeling of discomfort in the abdomen, pain in the upper abdomen.
Of the liver and biliary tract: frequency not known - elevated liver enzymes, increased bilirubin concentration in the blood plasma.
Skin and subcutaneous tissue disorders:the frequency is unknown - itching, skin rash.
On the part of the musculoskeletal system: the frequency is unknown - myalgia.
From the urinary system: frequency not known - increase in creatinine concentration in blood plasma, renal failure including acute renal failure.
General disorders and at the injection site: rarely - fatigue.
Laboratory and instrumental data: the frequency is unknown - an increase of potassium in the blood serum.
Allergic reactions: very rarely - hypersensitivity reactions; frequency is unknown - angioedema.
Adverse events previously reported with the use of each of the components may occur in the application of Vamloset drug, even if they have not been observed in clinical studies.
Amlodipine
Common: drowsiness, dizziness, palpitations, abdominal pain, nausea, ankle swelling.
Infrequently:insomnia, mood lability (including anxiety), depression, tremor, taste disturbance, syncope, hypoesthesia, visual disturbances (including diplopia), tinnitus, marked reduction of blood pressure, dyspnea, rhinitis, vomiting, dyspepsia , alopecia, purpura, skin discoloration, rash, pruritus, rash, myalgia, muscle cramps, pain, impaired urination, frequent urination, impotence, gynecomastia, chest pain, malaise, weight gain, weight loss.
Rare: confusion.
Rarely:leukopenia, thrombocytopenia, allergic reactions, hyperglycemia, muscular hypertonicity, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, elevated liver enzymes (often due cholestasis), angioneurotic edema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity.
Described isolated cases of extrapyramidal syndrome.
Valsartan
Frequency unknown: decrease in hemoglobin and hematocrit, neutropenia, thrombocytopenia, increased potassium content in blood serum, elevated liver enzymes, increased bilirubin concentration in the blood plasma, increased creatinine concentration in blood plasma, renal function, including renal failure, angioedema, myalgia , vasculitis, hypersensitivity including serum sickness.
CONTRAINDICATIONS
- severe liver failure (more than 9 points on the Child-Pugh);
- biliary cirrhosis and cholestasis;
- severe renal failure (CC less than 30 ml / min);
- Use in patients undergoing hemodialysis;
- marked hypotension (systolic blood pressure less than 90 mmHg);
- collapse, shock (including cardiogenic shock);
- obstruction of the left ventricular outflow tract (including hypertrophic obstructive cardiomyopathy (GOKMP) and severe aortic stenosis);
- hemodynamically unstable heart failure after acute myocardial infarction;
- simultaneous application of aliskiren in patients with diabetes or renal dysfunction (creatinine clearance less than 60 mL / min);
- primary aldosteronism;
- Pregnancy;
- the period of lactation (breastfeeding);
- hypersensitivity to amlodipine, other derivatives of dihydropyridine, valsartan or other components of the preparation.
Vamloset safety of the drug in patients after undergoing a kidney transplant, as well as children and adolescents under the age of 18 years have not been established.
Carefullyshould be administered the drug in human liver function light (5-6 points on the Child-Pugh) and mild (7-9 points on the Child-Pugh) severity; obstructive diseases of the biliary tract; renal mild and moderate severity function (CC 30-50 ml / min); unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; chronic heart failure III-IV NYHA functional class classification; hyperkalemia; hyponatremia; a diet with restriction of salt intake; reduced bcc (including diarrhea, vomiting); in patients with hereditary angioedema, or swelling in the background, previous therapy with angiotensin II receptor antagonists; in patients with mitral and aortic stenosis mild to moderate.
PREGNANCY AND LACTATION
Use of the drug is contraindicated in pregnancy Vamloset.
Considering the mechanism of action receptor antagonists of angiotensin II, one can not exclude the risk for the fetus when using the drug in the I trimester. Like any other drug, has a direct impact on the RAAS, Vamloset drug should not be used during pregnancy, and women planning pregnancy.
If the use of drugs acting on the RAAS, it is necessary to inform women of childbearing age about the potential risk of the negative impact of these drugs on the fetus during pregnancy.
When planning a pregnancy, it is recommended to transfer the patient to an alternative antihypertensive treatment based on the safety profile. If pregnancy occurs, discontinue use of the drug Vamloset and, if necessary, to transfer to alternative antihypertensive therapy.
Preparation Vamloset as other agents that have a direct impact on the RAAS contraindicated in II and III trimester of pregnancy because it may cause foetotoxic effects (renal failure, slowing ossification of bones of fetal skull oligohydramnios) and neonatal toxic effects (renal failure, hypotension , hyperkalemia) and fetal death. In the case of preparation of II and III trimester necessary to ultrasound fetal kidney and bone of the skull. Newborns whose mothers took the drug during pregnancy Vamloset should be monitored, because possible development of hypotension in the newborn.
Not recommended for use Vamloset medication during breastfeeding. If necessary, use Vamloset during lactation, breast-feeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use of the drug contraindicated with severe renal failure (creatinine clearance less than 30 mL / min).
Vamloset safety of the drug in patients after undergoing a kidney transplant is not installed.
Precautions should be prescribed with renal mild and moderate severity function (CC 30-50 ml / min); unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use of the drug is contraindicated in severe liver failure (more than 9 points on the Child-Pugh), biliary cirrhosis and cholestasis.
Precautions should be prescribed to light in the human liver function (5-6 points on the Child-Pugh) and mild (7-9 points on the Child-Pugh) severity of obstructive diseases of the biliary tract.
APPLICATION FOR CHILDREN
Vamloset safety of the drug in children and adolescents has not been established before the age of 18 years.
APPLICATION IN ELDERLY PATIENTS
Elderly patients correction dose and dosage regimen is required.
SPECIAL INSTRUCTIONS
Patients with hyponatremia and / or a decrease in BCC
in patients with uncomplicated hypertension receiving therapy with a combination of amlodipine / valsartan, 0.4% of the cases marked hypotension.
Patients with activated RAAS (e.g., in patients with dehydration and / or hyponatremia receiving diuretics in high doses) when receiving angiotensin II receptor antagonists may develop symptomatic hypotension. Before treatment to restore the sodium content and / or make up the bcc in particular by reducing the doses of diuretics or begin therapy under careful medical supervision.
With the development of significant decrease in blood pressure should be transferred to the patient in the horizontal position with a low headboard and, if necessary, to carry out on / in infusion of 0.9% sodium chloride solution. Vamloset drug therapy can be continued after stabilization of hemodynamic parameters.
Hyperkalemia
With simultaneous use of potassium-sparing diuretics, potassium preparations, dietary supplements or other potassium-containing preparations, capable to raise the potassium content in the blood plasma (e.g., heparin) with caution. Should regularly monitor the content of potassium in the blood plasma.
Stenosis of the renal artery
Vamloset drug should be used with caution in patients with hypertension on the background of unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, considering the possibility of increasing serum concentrations of urea and creatinine.
Condition after kidney transplantation
The safety of the combination of amlodipine / valsartan in patients who have recently had a kidney transplant, is not installed.
Abnormal liver function
Valsartan excreted mainly unchanged in bile. In patients with impaired hepatic function T 1/2lengthened, a AUC - increases. Caution must be exercised when using the drug Vamloset in patients with impaired liver function mild (5-6 points on the Child-Pugh) or moderately (7-8 points on the Child-Pugh) or obstructive diseases of the biliary tract.
Impaired Renal Function
Correction Vamloset dose in patients with impaired renal mild or moderate severity function is not required. In patients with moderate renal impairment is recommended to control the content of potassium and creatinine concentration in blood plasma. The simultaneous use of the angiotensin II receptor antagonists, including valsartan, ACE inhibitors or with aliskiren is contraindicated in patients with renal impairment (creatinine clearance less than 60 mL / min).
primary aldosteronism
Given defeat RAAS in primary hyperaldosteronism, patients in this group should not be administered angiotensin II receptor antagonists, including valsartan.
Angioedema
Among patients with angioedema (including edema of the larynx and the vocal cords, causing obstruction of the airway and / or swelling of the face, lips, pharynx and / or language) during therapy with the drug were observed Vamloset instructions on the development history of angioneurotic edema , including on ACE inhibitors. With the development of angioedema should stop the drug immediately and eliminate the possibility of re-use.
Heart failure / myocardial infarction
In patients of renal function which may depend on the activity of the RAAS (e.g., severe chronic heart failure), therapy of ACE inhibitors and antagonists of angiotensin II receptors is accompanied by oliguria and / or increase of azotemia, and in rare cases - acute renal failure and / or death . Similar outcomes have been described in the application of valsartan. In patients with chronic heart failure or myocardial infarction should always assess kidney function.
Patients with chronic heart failure nonischemic etiology III-IV functional class NYHA classification amlodipine accompanied by an increase in the incidence of pulmonary edema as compared to placebo with no significant difference in the frequency deterioration of chronic heart failure between the two groups. Blockers, slow calcium channels, including Amlodipine should be used with caution in patients with chronic heart failure patients, since possible increased risk of cardiovascular events and death.
Aortic stenosis mild to moderate mitral valve and
As with any vasodilators caution in patients with mitral stenosis and aortic stenosis mild to moderate degree.
The combination of amlodipine / valsartan has been studied only in patients with arterial hypertension.
Impact on the ability to drive vehicles and manage mechanisms
In applying the drug Vamloset care must be taken when driving and other technical devices, require high concentration and psychomotor speed reactions, since may develop dizziness, fatigue and nausea.
OVERDOSE
Data on overdose are not currently available.
Symptoms: an overdose with valsartan can expect a marked reduction in blood pressure and dizziness; amlodipine overdose may lead to a marked reduction of blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilatation (risk of severe and persistent hypotension, including the development of shock and death).
Treatment:symptomatic therapy, the nature of which depends on the time elapsed since administration of the drug, and the degree of severity of symptoms. In case of accidental overdose, induce vomiting (if the drug was recently adopted) or to gastric lavage. The use of activated carbon in healthy volunteers immediately or within 2 h after administration of amlodipine resulted in a significant reduction of its absorption. In marked decrease in blood pressure in patients receiving the drug Vamloset need to transfer the patient to a horizontal position with a low headboard, to take proactive measures to support the cardiovascular system, including regular monitoring of heart function and respiratory system, BCC and the volume allocated mo
