Ramipril, indapamide (Konsilar-D24) 0.625 mg + 2.5 mg – [60 capsules]

Description

Consilar-D24 Pharmacodynamics
Combined hypotensive drug containing a diuretic from the group of sulfonamide derivatives – indapamide and angiotensin-converting enzyme inhibitor (ACE) – ramipril. The pharmacological effect of the combination is due to the combination of individual properties of each of the components, which in turn reinforce each other’s action. The drug has antihypertensive, diuretic and vasodilatory actions.
CONSILAR D24 has a pronounced dose-dependent antihypertensive effect on both systolic and diastolic blood pressure (BP). Antihypertensive effect does not depend on the age and body position of the patient. It does not affect lipid and carbohydrate metabolism, including in patients with diabetes.
The antihypertensive effect lasts for 24 hours.
Stable BP lowering is achieved during 1 month during use of CONSILAR D24 without increase in heart rate (HR). Discontinuation of treatment does not lead to development of “withdrawal” syndrome.

Indications
Mild to moderate degree arterial hypertension.

Contraindications
-Hypersensitivity to indapamide, ramipril, other ACE inhibitors, sulfonamide derivatives and excipients included in the preparation;
-history of angioedema (hereditary or idiopathic, or associated with prior therapy with ACE inhibitors);
-hemodynamically significant renal artery stenosis (bilateral or unilateral, in case of a single kidney);
-Severe arterial hypotension or conditions with unstable hemodynamic parameters;
-concomitant use with angiotensin II receptor antagonists in patients with diabetic nephropathy;
-hemodynamically significant aortic or mitral valve stenosis, or hypertrophic obstructive cardiomyopathy (HCMP);
-Primary hyperaldosteronism;
-Severe renal insufficiency (CKR less than 30 ml/min);
-hemodialysis;
-Nephropathy treated with glucocorticosteroids, nonsteroidal anti-inflammatory drugs, immunomodulators and/or other cytotoxic drugs;
-chronic heart failure in decompensation stage (insufficient experience in clinical use);
hemodialysis or hemofiltration using some negatively charged membranes, such as high-strength polyacrylonitrile membranes (risk of hypersensitivity reactions);
– LDL apheresis using dextran sulfate (risk of hypersensitivity reactions);
-Desensitization therapy for hypersensitivity reactions to venoms of hymenopteran insects, such as bees, wasps;
-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);
-acute stage of myocardial infarction in patients with conditions such as:
severe chronic heart failure (NYHA functional class IV);
unstable angina pectoris;
Life-threatening ventricular arrhythmias;
“pulmonary” heart;
-Severe liver failure (including encephalopathy);
-hypokalemia;
-concomitant use with drugs that can cause “pirouette” type arrhythmia;
-concomitant use of drugs that prolong the QT interval (experience of clinical use is insufficient);
concomitant use with potassium-saving diuretics, potassium and lithium preparations and in patients with hyperkalemia;
-azotemia, anuria;
-Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
-Pregnancy, breastfeeding;
-Age less than 18 years (efficacy and safety not established).

Dosage and administration

• Orally, once a day, preferably in the morning.
  The capsules should be swallowed whole and with plenty of water.
• The dose is adjusted depending on the therapeutic effect and tolerability of the drug by the patient.
• KONSILAR-D24 treatment is usually prolonged and its duration is determined by a physician in each case.
  If not prescribed otherwise, the following dosage regimens are recommended in case of normal renal and hepatic function.
• The initial dose is 1 capsule of 0.625 mg + 2.5 mg, once in the morning. If at taking CONSILAR-D24 at this dose for 2 weeks or more it is not possible to normalize BP, the dose can be increased up to 1 capsule with a dosage of 1.25 mg + 5 mg of CONSILAR-D24 daily.
• If the daily dose of 1.25 mg + 5 mg is not sufficiently antihypertensive, a new therapy regimen should be chosen.
• Maximal daily dose is 2 capsules with 1.25 mg + 5 mg once a day.
  CONSILAR-D24 use in special groups of patients
• Patients with kidney dysfunction
  No dose adjustment is required in case of a CKG of 60 ml/min or more.
• For patients with CKD 30-60 ml/min the starting dose is 0.625 mg + 2.5 mg per day, maximum daily dose is 1.25 mg + 5 mg. Treatment should be started with a selection of doses of indapamide and ramipril in monotherapy.
• In severe renal failure (CKR less than 30 ml/min), use of CONSILAR-D24 is contraindicated.
• Patients with liver dysfunction
  For patients with liver dysfunction, the maximum daily dose is 1 capsule of 0.625 mg + 2.5 mg. Close medical supervision is required at the beginning of treatment.
  In severe hepatic insufficiency, use of CONSILAR-D24 is contraindicated.
• Elderly patients (over 65 years old).
  In elderly patients before start of taking CONSILAR-D24 preparation, renal function and plasma potassium content should be estimated. CONSILAR-D24 can be used only when renal function is normal or in case of insignificant renal dysfunction. The dose should be adjusted to the degree of BP decrease, especially in case of decreased BCC and electrolyte loss, as well as in chronic heart failure (functional class IV according to NYHA classification). Such measures allow avoiding a sharp decrease of BP.
• The initial dose is 1 capsule of 0.625 mg + 2.5 mg per day.