Perindopril, indapamide (Noliprel A forte) 5 mg + 1.25 mg – [30 tablets]

Description

Noliprel A Forte Pharmacodynamics
The medicinal product Noliprel A forte is a combination drug containing indapamide and perindopril arginine. The pharmacological properties of the drug Noliprel A forte combine the individual properties of each of the components.
Mechanism of action
Noliprel A forte.
The combination of perindopril and indapamide enhances the antihypertensive effect of each.
Indapamide
Indapamide belongs to the group of sulfonamides, with pharmacological properties similar to thiazide diuretics. Indapamide inhibits reabsorption of sodium ions in the cortical segment of the Genle loop, which leads to increased renal excretion of sodium ions, chlorine and, to a lesser extent, potassium and magnesium ions, thereby increasing diuresis and reducing blood pressure (BP).
Perindopril
Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (angiotensin-converting enzyme (ACE) inhibitor). ACE, or kininase II, is an exopeptidase that both converts angiotensin I into the vasoconstrictor angiotensin II and degrades bradykinin, which has a vasodilator effect, into an inactive heptapeptide.
As a result, perindopril:
– Reduces aldosterone secretion;
– by the principle of negative feedback, it increases plasma renin activity;
– with prolonged use it reduces total peripheral vascular resistance (TPRR), which is mainly due to the effect on the vessels in the muscles and kidneys. These effects are not accompanied by retention of sodium ions and fluid or development of reflex tachycardia.
Perindopril normalizes myocardial function by reducing preload and postload. The study of hemodynamic parameters in patients with chronic heart failure (CHF) revealed:
– decreased filling pressure in the left and right ventricles of the heart;
– decreased PEEP;
– increased cardiac output;
– enhancement of muscular peripheral blood flow.

Indications
Essential hypertension.
In patients with arterial hypertension and diabetes mellitus type 2 to reduce the risk of microvascular complications (from the kidneys) and macrovascular complications from cardiovascular disease

Contraindications
Indapamide
– Hypersensitivity to the active ingredient or any other sulfonamide.
– Severe renal impairment (creatinine clearance (CK) below 30 ml/min).
– Hepatic encephalopathy.
– Severe hepatic impairment.
– Hypokalemia.
– Concomitant use with non-antiarrhythmic drugs that may cause pirouette-type polymorphic ventricular tachycardia is not reasonable (see section “Interaction with other medicinal products”). – Breast-feeding period (see section “Administration during pregnancy and breast-feeding”).
– Childhood under 18 years of age (efficacy and safety have not been established).
Perindopril
– Hypersensitivity to the active substance or any other ACE inhibitors.
– History of angioedema (Quincke’s edema) against ACE inhibitors (see section “Special Precautions”).
– Hereditary / idiopathic angioedema.
– Pregnancy and breastfeeding (see section “Administration during pregnancy and breastfeeding”).
– Concomitant use with aliskiren and medicinal products containing aliskiren in patients with diabetes mellitus and/or moderate or severe renal impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 body surface area) (see sections “Pharmacodynamics” and “Interaction with other medicinal products”).
– Co-administration with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy (see section “Cautions”).
– Concomitant use with the combination valsartan + sacubitril (see sections “Interaction with other medicinal products” and “Cautions”). – Extracorporeal therapy leading to blood contact with negatively charged surfaces (see section “Interaction with other medicinal products”).
– Severe bilateral stenosis of the renal arteries or stenosis of the artery of the only functioning kidney (see section “Special indications”).
– Childhood under 18 years of age (efficacy and safety not established).
Noliprel® A forte
– Hypersensitivity to any of the excipients (see section “Composition”).
– Because of insufficient clinical experience, Noliprel® A forte should not be used in patients on hemodialysis with certain types of high-flow membranes, or in patients with untreated decompensated heart failure.
– Childhood under 18 years of age (efficacy and safety have not been established). – Lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome (the drug contains lactose).

Dosage and administration

• Orally, preferably in the morning, before a meal.
• Essential hypertension.
  1 tablet of the drug Noliprel® A forte 1 time per day.
• If possible, administration of the drug is started with a selection of doses of single-component drugs. In case of clinical necessity, Noliprel® A forte combination therapy may be considered immediately after monotherapy.
• In patients with arterial hypertension and type 2 diabetes mellitus, to reduce the risk of microvascular complications (renal side) and macrovascular complications from cardiovascular diseases
• It is recommended to start therapy with indapamide/perindopril combination at a dose of 0.625 mg/2.5 mg (drug Noliprel® A) once daily. After 3 months of therapy, on condition of good tolerability, the dose can be increased – 1 tablet of Noliprel® A forte once daily.
• Special patient groups
• Elderly patients
  The drug should be administered after monitoring of renal function and blood pressure.
• Renal dysfunction
  Noliprel® A forte is contraindicated in patients with severe renal dysfunction (CK values below 30 ml/min).
• In patients with moderate renal impairment (CKD 30-60 ml/min), it is recommended to start therapy with the required doses of drugs (as monotherapy) contained in Noliprel® A forte.
• Patients with a CKR equal to or greater than 60 ml/min do not require dose adjustment. Regular monitoring of plasma creatinine and potassium concentrations is required during therapy.
• Impaired hepatic function (see sections “Contraindications”, “Special indications” and “Pharmacokinetics”)
  Noliprel® A forte is contraindicated in patients with severe hepatic impairment.
  No dosage adjustment is required in patients with moderate hepatic impairment.
• Children and adolescents
  Noliprel® A forte is contraindicated in children and adolescents below 18 years of age because of lack of data about safety and efficacy in this age group.