Valodip tablets p/o 5mg/160mg №10×3

Name:
Valodip. International non-proprietary nameAmlodipine / Valsartan Amlodipine / Valsartan. Dosage form Film-coated tablets. Composition Tablets, film-coated, 5 mg / 80 mg: amlodipine 5 mg (as amlodipine besylate); valsartan 80 mg (as valsartan A granules). Film-coated tablets, 5 mg/160 mg: amlodipine 5 mg (as amlodipine besylate); valsartan 160 mg (as valsartan A granules). Film-coated tablets, 10 mg/160 mg: amlodipine 10 mg (as amlodipine besylate); valsartan 160 mg (as valsartan A granules). Excipients: microcrystalline cellulose, croscarmellose sodium, povidone K25, sodium lauryl sulfate, mannitol, magnesium stearate, anhydrous colloidal silicon dioxide, polyvinyl alcohol, partially hydrolyzed, E171 titanium dioxide, macrogol, talc, yellow iron oxide E172.
Description:
Film-coated tablets, 5 mg/80 mg: round, slightly biconvex film-coated tablets, brownish-yellow, with possible dark inclusions, beveled. Film-coated tablets, 5 mg / 160 mg: oval, biconvex film-coated tablets, brownish yellow, with possible dark blotches. Film-coated tablets, 10 mg / 160 mg: oval, biconvex film-coated tablets, light brownish-yellow color. Pharmacotherapeutic group Angiotensin II antagonists and calcium channel blockers. ATX code: C09DB01. Pharmacological properties A combined antihypertensive drug containing two active substances with a complementary mechanism for controlling blood pressure (BP). Amlodipine, a derivative of dihydropyridine, belongs to the class of “slow” calcium channel blockers (BCCC), valsartan belongs to the class of angiotensin II receptor antagonists. The combination of these components has a mutually complementary hypotensive effect, which leads to a more pronounced decrease in blood pressure compared to that when they are used separately. Indications for use Arterial hypertension (for patients who are indicated for combination therapy). Contraindications • Hypersensitivity to amlodipine, other dihydropyridine derivatives, valsartan or other components of the drug. • Severe liver failure, biliary cirrhosis or cholestasis. • Severe renal failure (glomerular filtration rate (GFR) < 30 ml / min / 1.73 m2), use in patients on hemodialysis. • Simultaneous use of angiotensin receptor antagonists, including valsartan, or angiotensin-converting enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal insufficiency (GFR < 60 ml / min / 1.73 m2). • Second and third trimesters of pregnancy. • Severe arterial hypotension • 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. Dosing and Administration Inside, with a small amount of water, regardless of the meal time. The recommended dose is 1 tablet per day. Valodip film-coated tablets 10 mg/160 mg is recommended for patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or Valodip film-coated tablets 5 mg/160 mg. If it is necessary to change doses, an individual selection of individual components of the drug is recommended. Patients taking valsartan and amlodipine alone may be switched to Valodip containing the same doses of the components. Elderly patients (65 years and older) Caution should be exercised when increasing doses. Patients with renal insufficiency Valodip is contraindicated in patients with severe renal insufficiency. Dose adjustment is not required in patients with mild or moderate renal insufficiency. In moderately severe renal failure, monitoring of potassium and creatinine levels is recommended. Patients with renal insufficiency (GFR < 60 ml / min / 1.73 m2) are contraindicated in the simultaneous use of Valodip and aliskiren. Patients with diabetes Patients with diabetes are contraindicated in the simultaneous use of Valodip and aliskiren. Patients with hepatic impairment Valodip is contraindicated in patients with severe hepatic impairment. Particular caution is necessary when prescribing the drug to patients with impaired liver function or obstructive disorders of the biliary tract. The maximum recommended dose of valsartan for patients with mild or moderate hepatic impairment without cholestasis is 80 mg. Special recommendations for the use of amlodipine in this category of patients have not been established. Children There are no data on the safety and efficacy of the drug in patients under 18 years of age. Side effects Classification of the incidence of side effects - very often ≥1/10 - often from ≥1/100 to <1/10 - infrequently from ≥1/1000 to <1/100 - rarely from ≥1/10000 to <1/1000 - very rarely from <1/10000 - the frequency is unknown - cannot be estimated on the basis of the available data Infectious and parasitic diseases: often - nasopharyngitis, influenza. From the immune system: rarely - hypersensitivity. From the side of metabolism: often - hypokalemia; infrequently - hypercalcemia, hyperlipidemia, hyperuricemia, hyponatremia. Mental disorders: rarely - anxiety. From the nervous system: often - headache; infrequently - impaired coordination, dizziness, postural dizziness, paresthesia, drowsiness. On the part of the organ of vision: infrequently - visual impairment; rarely - visual impairment. On the part of the organ of hearing and balance: infrequently - vertigo; rarely - tinnitus. From the side of the cardiovascular system: infrequently - palpitations, tachycardia, orthostatic hypotension; rarely - fainting, marked decrease in blood pressure. From the respiratory system: infrequently - cough, pain in the pharynx and larynx. From the digestive system: infrequently - anorexia, diarrhea, nausea, abdominal discomfort, pain in the upper abdomen, constipation, dryness of the oral mucosa. From the skin and subcutaneous tissues: infrequently - erythema, skin rash; rarely - exanthema, hyperhidrosis, pruritus. From the musculoskeletal system: infrequently - arthralgia, back pain, swelling of the joints; rarely - muscle spasms. From the urinary system: rarely - pollakiuria, polyuria. From the reproductive system and mammary gland: rarely - erectile dysfunction. General reactions: often - asthenia, fatigue, swelling of the face, a feeling of a rush of blood to the skin of the face, edema, peripheral edema, pastosity; rarely - a feeling of heaviness throughout the body. Additional information In patients treated with the combination amlodipine/valsartan, peripheral edema was less common (5.8%) than in patients treated with amlodipine alone (9%). Buy Valodip tablets p/o 5mg/160mg No. 10x3 Price for Valodip tablets p/o 5mg/160mg No. 10x3