Vamloset
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 362 rub.
Buy
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 blisters, in a cardboard bundle 2, 4, 8 or 14 packs; 10 pcs. In blisters, 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 are indications 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 the drug, 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 and 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
The incidence of adverse reactions:> 10% - very often; > 1% and 0.1% and 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, lack of 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 - edema of the face, asthenia, fatigue, pastiness, a feeling of flushing of the face, 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 disorders / insomnia, depression, mood swings; rarely - confusion of consciousness;
- 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 receiving amlodipine in combination with valsartan, peripheral edema was observed in more rare cases 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 of consciousness; very rarely - myocardial infarction, leukopenia, allergic reactions, thrombocytopenia, hyperglycemia, muscle hypertonia, peripheral neuropathy, arrhythmias (including bradycardia,ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, photosensitivity, gingival hyperplasia, jaundice, hepatitis, increased liver enzyme activity, 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
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, 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, it is necessary to control the plasma potassium in the blood.
Combinations requiring caution:
- nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid in a daily dose of 3000 mg and other non-selective NSAIDs: weakening the hypotensive effect, increasing the likelihood of impaired renal function and increasing the plasma potassium content 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.
Analogs
Analogs of Vamloset are: Amlodipine + Valsartan, Exforge, NARUNEL, Exfotanz.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Vamloset: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Vamloset 5 mg + 80 mg film-coated tablets 30 pcs. 362 r Buy |
|
Vamloset 5 mg + 160 mg film-coated tablets 28 pcs. 410 RUB Buy |
|
Vamloset tablets p.p. 5mg + 160mg 30 pcs. 426 r Buy |
|
Vamloset 5 mg + 160 mg film-coated tablets 30 pcs. 426 r Buy |
|
Vamloset 10 mg + 160 mg film-coated tablets 30 pcs. 461 r Buy |
|
Vamloset 5 mg + 80 mg film-coated tablets 90 pcs. 794 r Buy |
|
Vamloset 5 mg + 160 mg film-coated tablets 90 pcs. 906 r Buy |
|
Vamloset 10 mg + 160 mg film-coated tablets 90 pcs. 1026 RUB Buy |
|
Vamloset tablets p.p. 5mg + 160mg 90 pcs. 1151 RUB Buy |
| See all offers from pharmacies |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
