Vamloset tabs 5mg + 80mg #30

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Vamloset user manual

You can buy Vamloset here

Vamloset is a combined drug with an antihypertensive effect.

Release form and composition

The dosage form of Vamloset is film-coated tablets: 5 mg + 80 mg - round, slightly biconvex, brownish-yellow with possible inclusions of dark color, with a chamfer; 5 mg + 160 mg - oval, biconvex, brownish-yellow with possible blotches of dark color; 5 mg + 320 mg - capsule-shaped, biconvex, orange-brown; 10 mg + 160 mg - oval, biconvex, brownish yellow; 10 mg + 320 mg - capsule-shaped, biconvex, brownish-yellow (7 pcs. In blister packs, in a cardboard bundle 2, 4, 8 or 14 packs; 10 pcs. In blister packs, in a carton box 3, 6, 9 or 10 packs; 14 pcs. In blisters, in a cardboard box 1, 2, 4 or 7 packs).
The active ingredients in 1 tablet (5 mg + 80 mg / 5 mg +160 mg / 5 mg + 320 mg / 10 mg + 160 mg / 10 mg + 320 mg):
    amlodipine - 5/5/5/10/10 mg (amlodipine besylate - 6.94 / 6.94 / 6.94 / 13.88 / 13.88 mg);
    valsartan - 80/160/320/160/320 mg (Valsartan A, substance-granules - 125.675 / 251.35 / 502.7 / 251.35 / 502.7 mg, including auxiliary components: microcrystalline cellulose - 41/82 / 164/82/164 mg; croscarmellose sodium - 2.375 / 4.75 / 9.5 / 4.75 / 9.5 mg; povidone - 1.5 / 3/6/3/6 mg; sodium lauryl sulfate - 0.8 / 1.6 / 3.2 / 1.6 / 3.2 mg).
Auxiliary components (5 mg + 80 mg / 5 mg + 160 mg / 5 mg + 320 mg / 10 mg + 160 mg / 10 mg + 320 mg):
    core: mannitol - 21.885 / 50.71 / 101.42 / 43.77 / 101.42 mg; magnesium stearate - 4.5 / 9/18/9/18 mg; colloidal silicon dioxide - 1/2/4/2/4 mg;
    shell: Opadry II white (a mixture of polyvinyl alcohol - 40%; titanium dioxide - 25%; talc - 14.8%; macrogol - 20.2%) - 3.5 / 7/14 / 7.8 / 14 mg; dye yellow iron oxide (E172) - 0.5 / 1 / 1.8 / 0.2 / 2 mg; dye red iron oxide (E172) - 0/0 / 0.2 / 0/0 mg.

Indications for use

Vamloset is prescribed for the treatment of arterial hypertension (if there is an indication for combination therapy).

Contraindications

Absolute:
    arterial hypotension in severe course (with systolic pressure <90 mm Hg), shock (including cardiogenic shock), collapse;
    renal failure in severe course (with creatinine clearance <30 ml / min), use in patients who are on hemodialysis;
    cholestasis, biliary cirrhosis, severe liver failure (> 9 points on the Child-Pugh scale);
    obstruction of the outflow tract of the left ventricle, including hypertrophic obstructive cardiomyopathy and severe aortic stenosis;
    primary hyperaldosteronism;
    hemodynamically unstable heart failure after acute myocardial infarction;
    conditions after renal transplantation (the effectiveness / safety of therapy for this group of patients has not been studied);
    combined use with aliskiren in patients with diabetes mellitus or impaired renal function (with creatinine clearance <60 ml / min);
    age under 18 years (the effectiveness / safety of therapy for this group of patients has not been studied);
    pregnancy and the period of breastfeeding;
    individual intolerance to the components of Vamloset, as well as other derivatives of the dihydropyridine series.
Relative (diseases / conditions in which the appointment of Vamloset requires caution):
    impaired hepatic function with mild (5-6 points on the Child-Pugh scale) and moderate (7-9 points on the Child-Pugh scale) severity;
    impaired renal function in mild to moderate severity (with creatinine clearance of 30-50 ml / min);
    obstructive biliary tract disease;
    chronic heart failure III – IV functional class according to NYHA classification;
    stenosis of an artery of a single kidney or unilateral / bilateral stenosis of the renal arteries;
    reduced circulating blood volume (BCC), including vomiting and diarrhea;
    hyponatremia, hyperkalemia, restriction of sodium chloride intake while dieting;
    mild to moderate mitral / aortic stenosis;
    hereditary angioedema or the development of edema against the background of previous use of angiotensin II receptor antagonists.


Method of administration and dosage

Vamloset is taken orally once a day with a small amount of water, regardless of the time of the meal.
Therapy should be started with a dose of 5 mg + 80 mg, if necessary, after 7-14 days, it may be increased.
It is recommended to take 1 tablet per day (in one of the possible dosages).
Options for the maximum permissible daily doses: for valsartan - 5 mg + 320 mg, for amlodipine - 10 mg + 160 mg or 10 mg + 320 mg.

Side effects of Vamloset

Frequency of occurrence of adverse reactions:> 10% - very often; > 1% and <10% - often; > 0.1% and <1% - infrequently; > 0.01% and <0.1% - rarely; <0.01% - very rare; with an unknown frequency - in cases where it is not possible to estimate the frequency of development based on the available data.

Vamloset

    immune system: rarely - hypersensitivity;
    cardiovascular system: infrequently - palpitations, orthostatic hypotension, tachycardia; rarely - fainting, a significant decrease in blood pressure;
    respiratory system: infrequently - cough, pain in the larynx / pharynx;
    digestive system: infrequently - pain in the upper abdomen, diarrhea, abdominal discomfort, nausea, constipation, xerostomia;
    parasitic / infectious diseases: often - nasopharyngitis, flu;
    metabolism and nutrition: often - hypokalemia; infrequently - hypercalcemia, anorexia, hyperlipidemia, hyponatremia, hyperuricemia;
    psyche: rarely - anxiety;
    nervous system: often - headache; infrequently - paresthesia, impaired coordination, postural dizziness, drowsiness, dizziness;
    skin and subcutaneous tissues: infrequently - erythema, skin rash; rarely - hyperhidrosis, exanthema, pruritus;
    organ of sight and hearing: infrequently - blurred vision, vertigo; rarely - visual impairment, tinnitus;
    kidneys and urinary tract: rarely - polyuria, pollakiuria;
    genitals and mammary gland: rarely - erectile dysfunction;
    connective and musculoskeletal tissue: infrequently - back pain, arthralgia, joint swelling; rarely - a feeling of heaviness throughout the body, muscle spasms;
    general disorders: often - swelling of the face, asthenia, fatigue, pastiness, a feeling of flushing, peripheral edema, edema.

Amlodipine

    cardiovascular system: often - a feeling of palpitations / flushing of the face, a significant decrease in blood pressure; very rarely - arrhythmias (including bradycardia, atrial fibrillation and ventricular tachycardia), myocardial infarction, vasculitis;
    digestive system: often - a feeling of discomfort in the abdomen, nausea, pain in the upper abdomen; infrequently - dyspepsia, diarrhea, changes in stool, xerostomia, vomiting; rarely - pancreatitis, gingival hyperplasia, gastritis;
    immune system: very rarely - hypersensitivity;
    respiratory system: infrequently - rhinitis, shortness of breath; very rarely - cough;
    blood and lymphatic system: very rarely - leukopenia, thrombocytopenia (in some cases with purpura);
    metabolism and nutrition: very rarely - hyperglycemia;
    psyche: infrequently - sleep disturbances / insomnia, depression, mood swings; rarely - confusion;
    nervous system: often - headache, dizziness, drowsiness; infrequently - tremor, paresthesia, taste disturbances, fainting, hypesthesia; very rarely - peripheral neuropathy, muscle hypertonia, neuropathy; with an unknown frequency - extrapyramidal disorders;
    kidneys and urinary tract: infrequently - nocturia, urinary disorders, pollakiuria;
    genitals and mammary gland: infrequently - gynecomastia, erectile dysfunction;
    organ of sight and hearing: infrequently - deterioration / impairment of vision, tinnitus;
    liver and biliary tract: very rarely - intrahepatic cholestasis, increased activity of liver enzymes (in most cases in combination with cholestasis), hepatitis, increased plasma concentration of bilirubin in the blood, jaundice;
    musculoskeletal and connective tissue: often - ankle swelling; infrequently - myalgia, back pain, arthralgia, muscle spasms;
    skin and subcutaneous tissues: infrequently - photosensitivity, pruritus, alopecia, exanthema, erythema, hyperhidrosis, skin rash, purpura, discoloration of the skin; very rarely - exfoliative dermatitis, erythema multiforme, urticaria, angioedema, Stevens-Johnson syndrome;
    instrumental / laboratory data: infrequently - increase / decrease in weight;
    general disorders: often - peripheral edema, increased fatigue; infrequently - malaise, asthenia, noncardiogenic pain in the heart, discomfort, pain.

Valsartan

    cardiovascular system: with unknown frequency - vasculitis;
    digestive system: infrequently - a feeling of discomfort in the abdomen, pain in the upper abdomen;
    immune system: very rarely - hypersensitivity;
    respiratory system: infrequently - cough;
    blood and lymphatic system: with an unknown frequency - neutropenia, decreased hematocrit and hemoglobin, leukopenia, thrombocytopenia (in some cases with purple);
    organ of hearing: infrequently - vertigo;
    kidneys and urinary tract: with an unknown frequency - an increase in the plasma concentration of creatinine in the blood, impaired renal function, including acute renal failure;
    liver and biliary tract: with an unknown frequency - increased activity of liver enzymes / plasma concentration of bilirubin in the blood;
    connective and musculoskeletal tissue: with an unknown frequency - myalgia;
    skin and subcutaneous tissues: with an unknown frequency - skin rash / itching, angioedema;
    instrumental / laboratory data: with an unknown frequency - an increase in serum potassium in the blood;
    general disorders: infrequently - increased fatigue.

Additional information on active ingredients

In patients who received amlodipine in combination with valsartan, peripheral edema was observed more rarely than with amlodipine monotherapy.
Possible violations previously reported with the use of each of the active ingredients:
    amlodipine: often - drowsiness, palpitations, dizziness, abdominal pain, ankle swelling, nausea; infrequently - insomnia, mood swings (including anxiety), depression, tremors, taste disturbances, hypesthesia, fainting, visual disturbances (including diplopia), tinnitus, a significant decrease in blood pressure, shortness of breath, muscle cramps, purpura, rhinitis, vomiting, alopecia, dyspepsia, discoloration of the skin, hyperhidrosis, myalgia, pruritus, exanthema, pain, urinary disorders, impotence, increased urination, gynecomastia, chest pain, malaise, weight gain / loss; rarely - confusion; very rarely - myocardial infarction, leukopenia, allergic reactions, thrombocytopenia, hyperglycemia, muscle hypertonia, peripheral neuropathy, arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, increased photosensitivity, desiccation hepatic enzymes, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria, angioedema; in some cases - extrapyramidal syndrome;
    valsartan: with an unknown frequency - a decrease in hematocrit and hemoglobin, neutropenia, thrombocytopenia, an increase in serum potassium in the blood, an increase in the activity of hepatic enzymes / plasma concentration of bilirubin in the blood, impaired renal function, angioedema, increased concentration of creatinine in the blood plasma (including renal failure ), vasculitis, myalgia, hypersensitivity reactions, including serum sickness.


Special instructions for Vamloset

With hyponatremia / decrease in BCC, symptomatic arterial hypotension may occur. Before the start of the course, it is necessary to restore the sodium content / replenish the BCC, therapy begins under close medical supervision.
In cases of a pronounced decrease in blood pressure, the patient must be laid in a horizontal position, raising his legs, if necessary, a 0.9% sodium chloride solution is administered (by intravenous infusion). After the hemodynamic parameters stabilize, the treatment can be continued.
When using Vamloset, due to the likelihood of dizziness, nausea and fatigue when driving, caution is required.

Drug interactions

Vamloset

Combinations requiring attention: other drugs with an antihypertensive effect, including diuretics, alpha-blockers, and drugs that have an antihypertensive effect, including tricyclic antidepressants, alpha-blockers used in the treatment of benign prostatic hyperplasia, - an increase in the hypotensive effect.

Amlodipine

Undesirable combinations: grapefruit juice / grapefruit - the likelihood of an increase in bioavailability in some patients and an increase in the hypotensive effect.
Combinations requiring caution:
    inhibitors (strong or moderate) of the CYP3A4 isoenzyme, including protease inhibitors, diltiazem or verapamil, azole antifungals, macrolides such as clarithromycin or erythromycin: significant increase in systemic exposure to amlodipine; in elderly patients, such disorders are clinically significant, therefore, dose adjustment and medical supervision are required for them;
    simvastatin: a significant increase in its exposure (it is not recommended to exceed a dose of 20 mg of simvastatin per day);
    inducers of the CYP3A4 isoenzyme - drugs with an anticonvulsant effect, including phosphenytoin, carbamazepine, phenytoin, phenobarbital, primidone, as well as rifamycin, phytopreparations containing St. John's wort: the likelihood of a decrease in the plasma concentration of amlodipine in the blood;
    dantrolene (intravenous): the likelihood of a violation of the cardiovascular system (cardiovascular failure associated with hyperkalemia, fatal ventricular fibrillation); in patients with a tendency to develop malignant hyperthermia, the combination is not recommended.

Valsartan

Contraindicated combinations: aliskiren - combined use is contraindicated in diabetes mellitus and impaired renal function (with creatinine clearance <60 ml / min).
Undesirable combinations:
    lithium: the likelihood of a reversible increase in the plasma concentration of lithium in the blood and the development of intoxication; in cases of the need for combined use with lithium preparations, careful monitoring of the plasma concentration of lithium in the blood is required;
    potassium preparations, potassium-sparing diuretics / nutritional supplements and other drugs / substances that can lead to an increase in serum potassium in the blood, including heparin: in cases of need for combined use, monitoring of plasma potassium in the blood is required.
Combinations requiring caution:
    non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid in a daily dose of 3000 mg or more, and other non-selective NSAIDs: weakening the hypotensive effect, increasing the likelihood of impaired renal function and an increase in plasma potassium in the blood; at the beginning of the course, an assessment of renal function is shown, as well as correction of violations of water and electrolyte metabolism;
    transporter protein inhibitors, including ritonavir, rifampicin, cyclosporin: an increase in systemic exposure to valsartan, which should be taken into account at the beginning / at the end of combination therapy.

Terms and conditions of storage

Store Vamloset at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 3 years.

Terms of sell

You can buy Vamloset without a prescription from a doctor.