Amlodipine, Perindopril

AM-Aliter tablets are indicated for arterial hypertension and / or coronary heart disease (if treatment with perindopril and amlodipine is necessary).

Structure

Active ingredients: perindopril, amlodipine;

1 tablet contains perindopril tert-butylamine - 4 mg, which is equivalent to 3.338 mg of perindopril and amlodipine besilate 13.870 mg, which is equivalent to 10 mg of amlodipine;

Excipients: lactose monohydrate, microcrystalline crospovidone cellulose; sodium bicarbonate; silicon dioxide colloidal magnesium stearate.

Contraindications

• hypersensitivity to active substances (or to any other ACE inhibitors, or to dihydropyridine derivatives) or to an auxiliary substance;
• a history of angioedema associated with previous treatment with ACE inhibitors;
• congenital or idiopathic angioedema;
• severe arterial hypotension;
• shock, including cardiogenic shock;
• obstruction of the exit from the left ventricle (for example, severe aortic stenosis);
• heart failure after acute myocardial infarction with unstable hemodynamics;
• pregnancy or pregnancy planning;
• simultaneous use with drugs that contain the active substance aliskiren, for patients with diabetes mellitus or renal failure (glomerular filtration rate <60 ml / min / 1.73 m2);
• simultaneous use with sacubitrile / valsartan;
• extracorporeal treatments that result in blood contact with negatively charged surfaces;
• significant bilateral renal artery stenosis or artery stenosis of a single kidney.

Mode of application

For oral use.

Adults should be prescribed 1 tablet per day once, preferably in the morning before meals. The tablet is not subject to section.

The dose should be selected individually for each patient, taking into account the indications for use, the course of the disease and blood pressure indicators. The maximum daily dose is 1 tablet of 8 mg / 10 mg per day.

AM-Aliter can be prescribed to patients with creatinine clearance ≥ 60 ml / min and should not be prescribed to patients with creatinine clearance <60 ml / min. Such patients are advised to individually select the dose of each of the components of the drug separately.

With good tolerance, the dose of amlodipine is the same for patients of young and old age. For elderly patients, the usual dosage regimen is recommended, but the dose should be increased with caution.

Application features

Pregnant women

The use of the drug AM-Aliter is contraindicated during pregnancy.

Children

AM-Aliter is not recommended for children due to the lack of research involving this group of patients.

Drivers

Caution is recommended, especially at the beginning of treatment.

Overdose

No cases of overdose of the drug AM-Aliter have been reported.

Side effects

The most common adverse reactions with the separate use of perindopril and amlodipine are: swelling, drowsiness, dizziness, headache (especially at the beginning of treatment), taste perversion (dysgeusia), paresthesia, visual impairment (including double vision), tinnitus, palpitation, hot flashes, hypotension (and related symptoms), shortness of breath, cough, abdominal pain, nausea, vomiting, dyspepsia, defecation rhythm change, diarrhea, constipation, itching, rash, joint swelling (ankle swelling), soft muscle spasms, fatigue, asthenia .

Interaction

Concomitant use is contraindicated.

Aliskiren. In patients with diabetes mellitus, or in patients with impaired renal function, the risk of hyperkalemia, impaired renal function and cardiovascular morbidity and mortality increases.

In vitro treatment methods.Extracorporeal treatments that result in blood contact with negatively charged surfaces, such as dialysis or hemofiltration using certain membranes with high hydraulic permeability (e.g. polyacrylonitrile) and apheresis of low density lipoproteins using dextran sulfate, due to the increased risk of anaphylactoid reactions severe degree. If necessary, such treatment should consider the use of a different type of dialysis membrane or the use of another class of antihypertensive agents.

Sacubitrile / Valsartan. The simultaneous use of perindopril with sacubitrile / valzartan is contraindicated, since the simultaneous inhibition of neprilysin and ACE can lead to an increased risk of angioedema. Sacubitril / valsartan should not be used until 36 hours after the last dose of perindopril has been taken. Perindopril therapy should be started no earlier than 36 hours after taking the last dose of sacubitrile / valsartan.

Storage conditions

Store at a temperature not exceeding 30 ° C in the original packaging.

Keep out of the reach of children.

Shelf life is 2 years.