Amlokard-Sanovel 5 mg N30 Tb

AMLOKARD-SANOVEL, 5 mg  tablets

Amlokard Sanovel composition

 Active ingredient:    In 1 tablet, there is an amount of amlodipine equivalent to 5 mg of amlodipine  besylate. Excipients: microcrystalline cellulose, anhydrous dicalcium phosphate, sodium  starch glycolate, magnesium stearate.    

Indications:

 • Arterial hypertension (both as monotherapy and in combination with other antihypertensive agents); • Ischemic heart disease: —   symptomatic treatment of chronic stable angina pectoris (as in monotherapy, as well as in combination with antianginal agents). — stable angina pectoris and vasospastic angina pectoris (Prinzmetal  angina)  (both as monotherapy and in combination with other antihypertensive agents).

Contraindications:

 Severe arterial hypotension; — high sensitivity to the components of the product; — high sensitivity to other derivatives of dihydropyridine;  — obstruction of the outflow tract of the left ventricle (including severe aortic stenosis); — shock, including cardiogenic; — hemodynamically unstable heart failure after myocardial infarction.  

  Use during pregnancy and lactation:

 Pregnancy category C. The safety of amlodipine use during pregnancy  and during lactation   has not been established, therefore use during pregnancy  is possible only if,  the benefit to the mother  outweighs the risk to the fetus  and the newborn.   There is no information about the excretion of amlodipine into breast milk, therefore during lactation it is necessary to stop taking the product or feeding with breast milk.  

Amlokard Sanovel iusage instructions, dosage

 For arterial hypertension and angina pectoris, the average starting dose of the product is 5 mg once daily; depending on the patient’s individual response, this dose can be increased up to a maximum dose of 10 mg.  The tablets should be taken orally once daily with a sufficient amount of water.  When used concomitantly with thiazide diuretics, beta-adrenoblockers, or ACE inhibitors, no change in the amlodipine dosing regimen is required.  Special patient groups  Patients with impaired liver function  For patients with mild to moderate impairment of liver function, specific doses of the product have not been established; therefore, treatment of these patients should be started with the lowest dose while observing precautionary measures, and the dose should be titrated gradually in the future. The pharmacokinetics of amlodipine have not been studied in patients with severe hepatic impairment. In patients with severe hepatic impairment, amlodipine treatment should be started with the lowest dose and the dose should be titrated gradually in the future.  Patients with impaired kidney function  In renal failure, it is recommended to use amlodipine at usual doses, but it is important to consider the possibility of a slight increase in the T1/2 value. Amlodipine is not eliminated by dialysis.  Children  In children aged 6 to 17 years, the recommended daily dose is 2.5–5 mg once daily. No studies have been conducted with the use of higher doses in children. To achieve a 2.5 mg dosing of the product, the 5 mg tablet must be split in half. To achieve a 5.0 mg dosing of the product, the 10 mg tablet must be split in half.  The efficacy and safety of the product have not been studied in children under 6 years of age.   Elderly patients are recommended to use the product at average therapeutic doses; no dose adjustment is required.