Lisinopril, amlodipine (De-Kriz) 10 mg + 20 mg – [30 tablets]

Description

De-Criz Pharmacodynamics
A combination drug containing the active ingredients: lisinopril and amlodipine.
Amlodipine is a dihydropyridine derivative, a “slow” calcium channel blocker (CMCB), has hypotensive and antianginal effects. It blocks “slow” calcium channels, reduces transmembrane transition of calcium ions into the cell (more in vascular smooth muscle cells than in cardiomyocytes). Antianginal action is due to the dilation of coronary and peripheral arteries and arterioles:
– in angina reduces the severity of myocardial ischemia by dilating the peripheral arterioles, reduces total peripheral vascular resistance, reduces the afterload on the heart, and reduces myocardial oxygen demand;
– expanding coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases the flow of oxygen to the myocardium (especially in vasospastic angina); prevents coronary artery spasm (including that caused by smoking).

Indications
Essential hypertension (patients who are indicated for combination therapy).

Contraindications
– Hypersensitivity to lisinopril and/or other ACE inhibitors;
– Hypersensitivity to amlodipine and/or other dihydropyridine derivatives;
– Hypersensitivity to other drug components;
– history of angioedema, including against the background of ACE inhibitors use;
– hereditary Quincke’s edema or idiopathic angioedema;
– left ventricular outflow tract obstruction (including severe aortic stenosis, hypertrophic obstructive cardiomyopathy), hemodynamically significant mitral stenosis;
– severe arterial hypotension (systolic BP less than 90 mmHg);
– Shock (including cardiogenic);
– hemodynamically unstable heart failure after acute myocardial infarction;
– concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and/or moderate or severe renal dysfunction (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 body surface area);
– concomitant use with neutral endopeptidase inhibitors (e.g. drugs containing Sacubitril) due to the high risk of angioedema;
– concomitant use with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy;
– pregnancy and breastfeeding;
– under 18 years of age (efficacy and safety have not been established).

Dosage and administration

• Orally, regardless of meals.
• De-Criz® is available in dosages of 5 mg + 10 mg and 10 mg + 20 mg.
• Recommended starting dose of De-Criz® is 1 tablet 5 mg + 10 mg once daily. Maximal daily dose of De-Criz® is 1 tablet 10 mg + 20 mg.
• Diuretics should be discontinued 2-3 days before the beginning of therapy with De-Criz® .
• If diuretics cannot be stopped, the recommended starting dose is ½ tablet of De-Criz® at a dose of 5 mg + 10 mg.
• Patients with renal insufficiency
  Recommended dose for patients with renal failure is ½ tablet of De-Criz® in dose of 5 mg + 10 mg.
• During the drug treatment it is necessary to monitor renal function, potassium and sodium content in blood serum. In case of worsening of renal function, the drug should be discontinued and replaced with lisinopril and amlodipine at adequate doses.
• Patients with hepatic impairment
  Amlodipine excretion may be delayed in patients with hepatic impairment. The recommended dose in patients with hepatic impairment is ½ tablet of De-Criz® at a dose of 5 mg + 10 mg.
• Patients of advanced age (older than 65 years)
• No age-related changes in efficacy or safety profile for amlodipine and lisinopril have been found in clinical studies. The dosing regimen should be determined on an individual basis using lisinopril and amlodipine in monotherapy to determine the optimal maintenance dose. De-Criz® is indicated only in patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 10 mg and 5 mg or 20 mg and 10 mg, respectively.
• Use the drug only according to the indication, route of administration, and dosage indicated in the instructions for use of the drug.