Vamloset 5mg coated pills + 80mg N30
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Active ingredients
Amlodipine + Valsartan
Release form
Pills
Composition
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. Excipients: mannitol - 21.
Indications
- Arterial hypertension in patients who have been shown combination therapy.
Contraindications
- 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) .st.) - collapse, shock (including cardiogenic shock) - obstruction of the outgoing tract of the left ventricle (including hypertrophic obstructive cardiomyopathy (GOKMP) and severe aortic stenosis) - hemodynamically unstable heart failure after acute second myocardial infarction - simultaneous use with aliskiren in patients with diabetes or renal dysfunction (CC less than 60 ml / min) - primary hyperaldosteronism - pregnancy - lactation (breastfeeding) - hypersensitivity to amlodipine, other derivatives of dihydropyridine, 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 light (5-6 points on the scale of Child-Pugh) and moderate (7-9 points on the scale of Child-Pugh) severity of obstructive diseases of the biliary tract disorders of the kidney mild and moderate severity (CC 30- 50 ml / min) unilateral or bilateral stenosis of the renal arteries or stenosis of the artery of the only renal chronic heart failure of the III-IV functional class according to NYHA hypokalemia and hyponatomy and compliance with the diet with the restriction of consumption solisnizhennom constant bcc (including diarrhea, vomiting) in patients with hereditary angioedema, edema or previous therapy on the background of angiotensin receptor antagonists Hy patients with mitral stenosis and aortic mild to moderate degree.
Dosage and administration
The drug should be taken orally, 1 time / day, regardless of the meal, 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), no initial dose adjustment is 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. The drug Vamloset 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.
Side effects
Classification of the incidence of side effects WHO: very often (1/10), often (from 1/100 to less than 1/10), infrequently (from 1/1000 to less than 1/100), rarely (from 1/10 000 to less than 1/1000) ), very rarely (from less than 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. Metabolism: often - hypokalemia; infrequently - hypercalcemia, hyperlipidemia, hyperuricemia, hyponatremia. From 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 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 mammary gland: rarely - erectile dysfunction. Allergic reactions: rarely - hypersensitivity. General disorders and disorders at the injection site: often - asthenia, fatigue, swelling of the face, feeling of a rush of blood to the skin of the face, swelling, 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, hypesthesia; very rarely - muscle hypertonus, peripheral neuropathy; frequency unknown - extrapyramidal disorders. On the part of the organ of vision: infrequently - visual impairment, blurred vision. On the part of the organ of hearing and labyrinth disturbances: infrequently - tinnitus. Since 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.On the part 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. From 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. Allergic reactions: very rarely - hypersensitivity reactions, urticaria, angioedema. Valsartan From the side of the hemopoietic 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 - increased activity of liver enzymes, increasing the concentration of bilirubin in the blood plasma. 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 - an increase in 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 the use of each of the components may occur with the use of the drug Youmoset, even if they were not observed in clinical studies. Amlodipine Often: drowsiness, dizziness, feeling of heartbeat, abdominal pain, nausea, ankle swelling. Infrequently: insomnia, mood lability (including anxiety), depression, tremor, taste disturbance, syncope, hypoesthesia, visual disturbances (including diplopia), tinnitus, marked reduction in blood pressure, shortness of breath, rhinitis, vomiting , dyspepsia, alopecia, purpura, discoloration of the skin, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, urinary disturbance, increased urination, impotence, gynecomastia, chest pain, malaise, weight gain, weight loss. Rarely: confusion. 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. Isolated cases of extrapyramidal syndrome have been described. Valsartan Frequency unknown: decreased hemoglobin and hematocrit, neutropenia, thrombocytopenia, increased serum potassium, elevated liver enzymes, elevated plasma bilirubin, elevated plasma creatinine, impaired renal function, including renal failure, angioedema, myalgia, vasculitis, hypersensitivity, including serum sickness.