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Amlodipine, Valsartan

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2019-09-19
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Clinical Pharmacology

Combined antihypertensive drug containing active substances with complementary mechanism of blood pressure control. Amlodipine, a dihydropyridine derivative, belongs to the class of slow calcium channel blockers (BCCA), 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 in their separate use.

Indications

- Arterial hypertension in patients who have been shown combination therapy.

Composition

  • 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.

Amlodipine, Valsartan is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Vamloset pills
Exforge Novartis Switzerland pills

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Amlodipine, Valsartan

Dosage and Administration

The drug should be taken orally, 1 time / day, regardless of the meal, washed down with a small amount of water.

The recommended daily dose - 1 tab. Vamloset, containing amlodipine / valsartan combination in 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 Vamloset is 5 mg / 80 mg 1 time / day. You can increase the dose in 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 dose adjustment is not required.

Patients with impaired liver function should be used with caution.

Elderly patients dose adjustment and dosing regimen is not required.

Valsartan

In patients with impaired renal function (CC> 30 ml / min), an initial dose adjustment is not required.

Valsartan is contraindicated in patients with severe liver failure, biliary cirrhosis and cholestasis. The maximum daily dose of valsartan for mild to moderate hepatic insufficiency is 80 mg. Vamloset drug at a dose of 5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 and 10 mg / 320 mg is contraindicated.

Elderly patients dose adjustment is not required.

Adverse reactions

Classification of the incidence of side effects WHO: very often (≥1 / 10), often (≥1 / 100 to

Vamloset drug

Infectious and parasitic diseases: often - the flu.

Metabolism: often - hypokalemia; infrequently - hypercalcemia, hyperlipidemia, hyperuricemia, hyponatremia.

On the part of the nervous system: often - headache; infrequently - lack of coordination, dizziness, postural dizziness, paresthesia, drowsiness; rarely - anxiety.

On the part of the organ of vision: infrequently - visual impairment; rarely - visual impairment.

On the part of the organ of hearing and labyrinth disturbances: infrequently - vertigo; rarely tinnitus.

Since the cardiovascular system: infrequently - a feeling of heartbeat, tachycardia, orthostatic hypotension; rarely - marked reduction in blood pressure, fainting.

On the part of the respiratory system: often - nasopharyngitis; infrequently - cough, sore throat and larynx.

On the part of the digestive system: rarely - diarrhea, nausea, abdominal discomfort, pain in the upper abdomen, constipation, dry mouth.

From the skin and subcutaneous tissues: infrequently - erythema, skin rash; rarely - rash, hyperhidrosis, pruritus.

On the part of the musculoskeletal system: infrequently - arthralgia, back pain, swelling of the joints; rarely, muscle spasms, a feeling of heaviness throughout the body.

From the urinary system: rarely - pollakiuria, polyuria.

On the part of the genital organs and the breast: rarely - erectile dysfunction.

Allergic reactions: rarely - hypersensitivity.

General disorders and disorders at the injection site: often - asthenia, fatigue, swelling of the face, feeling of flushing to the skin of the face, edema, peripheral edema, pastosity; infrequently - anorexia.

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

Amlodipine

On the part of the hemopoietic system: very rarely - leukopenia, thrombocytopenia, sometimes with purpura.

On the part of metabolism: very rarely - hyperglycemia.

Mental disorders: infrequently - depression, insomnia / sleep disorders, mood lability; rarely - confusion.

On the part of the nervous system: often - dizziness, headache, drowsiness; infrequently - a violation of taste, paresthesia, syncope, tremor, hypoesthesia; very rarely - muscle hypertonus, peripheral neuropathy; frequency unknown - extrapyramidal disorders.

On the part of the organ of vision: infrequently - visual impairment, visual impairment.

On the part of the organ of hearing and labyrinth disorders: infrequently - tinnitus.

On the part of the cardiovascular system: often - a feeling of heartbeat, a feeling of a rush of blood 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.

On the part of the respiratory system: infrequently - shortness of breath, rhinitis; very rarely - cough.

On the part of the digestive system: often - nausea, abdominal discomfort, pain in the upper abdomen; infrequently - change of stool, diarrhea, dryness of the oral mucosa, dyspepsia, vomiting; rarely - gastritis, gingival hyperplasia, pancreatitis.

From the side of the liver and biliary tract: very rarely - increased activity of liver enzymes (more often with cholestasis), increased plasma bilirubin concentration, hepatitis, intrahepatic cholestasis, jaundice.

On the part of the skin and subcutaneous tissues: infrequently - alopecia, rash, erythema, photosensitivity reactions, pruritus, hyperhidrosis, purpura, skin rash, change in skin color; very rarely - erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome.

On the part of the musculoskeletal system: often - ankle swelling; infrequently - arthralgia, back pain, muscle spasms, myalgia.

On the part of the urinary system: infrequently - a violation of urination, nocturia, pollakiuria.

On the part of the genitals and mammary gland: infrequently - erectile dysfunction, gynecomastia.

General disorders and disorders at the injection site: often - increased fatigue, peripheral edema; infrequently - asthenia, discomfort, malaise, non-cardiogenic pain in the heart, pain.

Laboratory and instrumental data: infrequently - weight loss / increase in body weight.

Allergic reactions: very rarely - hypersensitivity reactions, urticaria, angioedema.

Valsartan

On the part of the hematopoietic 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 disturbances: infrequently - vertigo.

Since the cardiovascular system: the frequency is unknown - vasculitis.

On the part of the respiratory system: Infrequently - cough.

On the part of the digestive system: infrequently - a feeling of discomfort in the abdomen, pain in the upper abdomen.

On the part of the liver and biliary tract: the frequency is unknown - an increase in the activity of liver enzymes, an increase in plasma bilirubin concentration.

On the part of the skin and subcutaneous tissues: the frequency is unknown - itchy skin, skin rash.

On the part of the musculoskeletal system: the frequency is unknown - myalgia.

On the part of the urinary system: the frequency is unknown - increasing the concentration of creatinine in the blood plasma, impaired renal function, including acute renal failure.

General disorders and disorders at the injection site: infrequently - increased fatigue.

Laboratory and instrumental data: the frequency is unknown - an increase in the content of potassium in the serum.

Allergic reactions: very rarely - hypersensitivity reactions; frequency is unknown - angioedema.

The adverse events that were previously reported with each of the components used may occur with the use of the drug youloset, even if they were not observed in clinical studies.

Amlodipine

Often: 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, shortness of breath, rhinitis, vomiting , dyspepsia, alopecia, purpura, discoloration of the skin, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, impaired urination, increased urination, impotence, gynecomastia, chest pain, malaise, weight gain, weight loss.

Seldom: confusion of consciousness.

Very 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 (most often due to cholestasis), angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity.

Separate cases of extrapyramidal syndrome have been described.

Valsartan

Unknown frequency: decreased hemoglobin and hematocrit, neutropenia, thrombocytopenia, increased serum potassium, increased liver enzymes, increased plasma bilirubin, increased plasma creatinine, renal dysfunction, including renal failure, angioedema, myalgia , vasculitis, hypersensitivity, including serum sickness.

- severe liver failure (more than 9 points on the Child-Pugh scale);

- biliary cirrhosis and cholestasis;

- severe renal failure (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;

- simultaneous use with aliskiren in patients with diabetes mellitus or impaired renal function (QA less than 60 ml / min);

- primary hyper aldosteronism;

- pregnancy;

- lactation period (breastfeeding);

- Hypersensitivity to amlodipine, other derivatives of the dihydropyridine series, valsartan or to other components of the drug.

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

With caution, you should prescribe the drug for violations of the liver easy (5-6 points on the scale of Child-Pugh) and moderate (7-9 points on the scale of Child-Pugh) severity; obstructive biliary tract diseases; impaired renal function mild and moderate severity (CC 30-50 ml / min); unilateral or bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; chronic heart failure of the III-IV functional class according to NYHA classification; hyperkalemia; hyponatremia; compliance with a diet with restriction of consumption of table salt; reduced bcc (including with diarrhea, vomiting); in patients with hereditary angioedema or edema in the background of previous therapy with angiotensin II receptor antagonists; in patients with mitral and aortic stenosis of mild and moderate degree.

Drug interactions

Vamloset (Amlodipine / Valsartan)

Combinations requiring attention

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

Amlodipine

Unwanted combinations

Simultaneous use with grapefruit or grapefruit juice is not recommended, given the possibility of increasing the bioavailability in some patients and enhancing the antihypertensive effect.

Combinations that require caution

Simultaneous use with strong or mild inhibitors of the CYP3A4 isoenzyme (protease inhibitors, verapamil or diltiazem, antifungal drugs from the group of azoles, antibiotics from the group of macrolides, such as erythromycin or clarithromycin) can lead to a significant increase in systemic amlodipine exposure. In elderly patients, these changes are of clinical importance, therefore, medical supervision and dose adjustment are necessary.

With simultaneous use with CYP3A4 isoenzyme inducers (anticonvulsant drugs (for example, carbamazepine, phenobarbital, phenytoin, phosphenytoin, primidone), rifampicin, herbal preparations containing St. John's wort), be careful, because possible reduction in the concentration of amlodipine in the blood plasma.

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.Patients receiving amlodipine are recommended to use simvastatin in a dose of not more than 20 mg / day.

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

Combinations requiring attention

In clinical studies, no significant interaction with thiazide diuretics, alpha-blockers, beta-blockers, ACE inhibitors, long-acting nitrates, nitroglycerin for sublingual use, digoxin, warfarin, atorvastatin, sildenafilom, maalox, gluderoxemone, digoxin, warfarin, atorvastatin, sildenafilom, maalox, gluderoxemone, digoxin, warfarin, atorvastatin, sildenafilom, maalox, gluderoxemone, digoxin, warfarin, atorvastatin, sildenafilom, maalox, gluderox, gludenine, warfarin, atorvastatin, sildenafilom, maalox, ialoxytoxin, and gluoxamine, digoxin, warfarin, atorvastatin, sildenafilom, maalox, ialoxy, ethodin, digoxin, warfarin, atorvastatin, sildenafilom, maalox, ialoxytoxin, etc., have been identified. , cimetidine, NPVS, antibiotics and hypoglycemic drugs for prima inside.

Valsartan

Contraindications

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

Unwanted combinations

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

If necessary, the simultaneous use of drugs that affect potassium (potassium-saving diuretics, potassium preparations, potassium-containing dietary supplements and other drugs and substances that can increase the content of potassium in serum (eg, heparin)), it is recommended to monitor the content of potassium in the blood plasma .

Combinations that require caution

When used simultaneously with NSAIDs, incl. selective inhibitors of COX-2, 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 the function of the kidneys, as well as to correct the water and electrolyte balance disorders.

According to the results of an in vitro study, valsartan is a substrate for OATP1B1 and MRP2 carrier proteins. The simultaneous use of valsartan with inhibitors of the OATP1B1 carrier protein (for example, rifampicin, cyclosporine) and an inhibitor of the carrier protein MRP2 (for example, ritonavir) can increase the systemic exposure of valsartan (Сmax and AUC). This should be considered at the beginning and at the end of concurrent therapy.

When monotherapy with valsartan revealed no clinically significant interaction with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide.

Pregnancy and Lactation

The use of the drug Vamloset contraindicated in pregnancy. Given the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus cannot be ruled out with the use of the drug in the first trimester of pregnancy. Like any other drug that has a direct effect on the renin-angiotensin-aldosterone system (RAAS), you should not use Vamloset during pregnancy, and also women who are planning a pregnancy. When using agents that affect the RAAS. it is necessary to inform women of childbearing age about the potential risk of the negative effects of these drugs on the fetus during pregnancy.When planning pregnancy, it is recommended to transfer the patient to alternative antihypertensive therapy with regard to the safety profile. If pregnancy is diagnosed, you should stop taking Wamloset and ,. if necessary, transfer to alternative antihypertensive therapy.

Special instructions

Patients with hyponatremia and / or a decrease in BCC

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

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, the sodium content should be restored and / or replenished by the BCC, in particular, by reducing the doses of diuretics or initiating therapy under careful medical supervision.

With the development of a pronounced decrease in blood pressure, the patient should be transferred to a horizontal position with a low head and, if necessary, a 0.9% sodium chloride solution should be administered / infused. 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

The drug Vamloset 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, given the possibility of increasing serum concentrations of urea and creatinine.

Condition after kidney transplantation

The safety of the use of amlodipine / valsartan in patients who recently underwent kidney transplantation has not been established.

Liver dysfunction

Valsartan is excreted mainly unchanged with bile. In patients with impaired liver function, T1 / 2 is lengthened, and AUC is increased. Care should be taken when using the drug Vamloset in patients with impaired mild liver function (5-6 points on the Child-Puh scale) or moderate (7-8 points on the Child-Puh scale) or obstructive biliary tract diseases.

Renal dysfunction

Dose adjustment of the drug Vamloset in patients with impaired renal mild or moderate severity is not required. In patients with moderate renal impairment, it is recommended to monitor the potassium and creatinine concentrations in the blood plasma. The simultaneous use of angiotensin II receptor antagonists, 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, patients in this group should not be given angiotensin II receptor antagonists, incl. 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 treatment with Vamloset, there were indications of a history of angioedema, including on 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 kidney function may depend on the activity of the RAAS (for example, in severe chronic heart failure), treatment 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 myocardial infarction, renal function should always be evaluated.

In patients with chronic heart failure of the non-ischemic etiology of functional class III-IV according to the NYHA classification, amlodipine was associated with an increased incidence of pulmonary edema compared with placebo in the absence of a significant difference in the incidence of worsening chronic heart failure between the two groups. Slow calcium channel blockers, incl. amlodipine should be used with caution in patients with chronic heart failure, because 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, care should be taken in patients with mitral stenosis and mild to moderate aortic stenosis.

The combination of amlodipine / valsartan was studied only in patients with arterial hypertension.

Influence on ability to drive motor transport and control mechanisms

When using the drug Vamloset, care must be taken when driving vehicles and other technical devices that require high concentration of attention and speed of psychomotor reactions, since possible development of dizziness, fatigue and nausea.

  • Brand name: Vamloset
  • Active ingredient: Amlodipine, Valsartan
  • Dosage form: Film Coated pills
  • Manufacturer: Hoffmann la roch

Studies and clinical trials of Amlodipine, Valsartan (Click to expand)

  1. Development and validation of a highly sensitive and robust LC-ESI-MS/MS method for simultaneous quantitation of simvastatin acid, amlodipine and valsartan in human plasma: application to a clinical pharmacokinetic study
  2. Effects of valsartan/ hydrochlorothiazide and amlodipine on ambulatory blood pressure and plasma norepinephrine levels in high-risk hypertensive patients
  3. Trough:peak ratio and smoothness index in the evaluation of 24-h blood pressure control in hypertension: a comparative study between valsartan/hydrochlorothiazide combination and amlodipine
  4. Role of combination therapy in the treatment of hypertension: Focus on valsartan plus amlodipine
  5. Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy
  6. Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety
  7. Effect of valsartan or olmesartan addition to amlodipine on ankle edema in hypertensive patients
  8. Real-life safety and effectiveness of amlodipine/valsartan combination in the treatment of hypertension
  9. Erratum to: Real-Life Safety and Effectiveness of Amlodipine/Valsartan Combination in the Treatment of Hypertension
  10. Amlodipine/Valsartan Single-Pill Combination: A Prospective, Observational Evaluation of the Real-Life Safety and Effectiveness in the Routine Treatment of Hypertension
  11. Differential time effect profiles of amlodipine, as compared to valsartan, revealed by ambulatory blood pressure monitoring, self blood pressure measurements and dose omission protocol
  12. Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers
  13. The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg
  14. Combination therapy with amlodipine/valsartan in essential hypertension: a 52-week, randomised, open-label, extension study
  15. Effects of amlodipine and valsartan on vascular damage and ambulatory blood pressure in untreated hypertensive patients
  16. Effects of amlodipine and valsartan on oxidative stress and plasma methylarginines in end-stage renal disease patients on hemodialysis
  17. Antihypertensive efficacy of olmesartan medoxomil or valsartan in combination with amlodipine: A review of factorial-design studies
  18. Simultaneous spectrofluorimetric determination of amlodipine besylate and valsartan in their combined tablets
  19. Comparative effects of valsartan versus amlodipine on left ventricular mass and reactive oxygen species formation by monocytes in hypertensive patients with left ventricular hypertrophy
  20. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: The value randomised trial
  21. Rationale and design of the NAGOYA HEART Study: Comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance
  22. Efficacy of the Combination of Amlodipine and Valsartan in Patients With Hypertension Uncontrolled With Previous Monotherapy: The Exforge in Failure After Single Therapy (EX-FAST) Study
  23. Randomized, Double-Blind, Crossover Comparison of Amlodipine and Valsartan in African-Americans with Hypertension Using 24-Hour Ambulatory Blood Pressure Monitoring

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