Lercamen-10 coated tablets 10 mg. №28

Description

Lercamen-10 Storage
active substance: lercanidipine;

1 film-coated tablet contains 10 mg of lercanidipine hydrochloride, which is equivalent to 9.4 mg of lercanidipine;

Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), povidone, magnesium stearate, shell Opadry OY-SR-6497, which includes: hypromellose, talc, titanium dioxide (E 171), polyethylene glycol, iron E 172).

Lercamen-10 Dosage form
Film-coated tablets.

Main physical and chemical properties: yellow round biconvex tablets, film-coated, with a line for separation on one side. The dividing line is for breaking only to make it easier to swallow the tablet, it is not intended to separate the tablet at the dose level.

Lercamen-10 Pharmacotherapeutic group
Selective calcium antagonists with the main effect on blood vessels. Dihydropyridine derivatives. ATX code C08C A13.

Pharmacological properties
Pharmacodynamics.

Lercamen-10 Mechanism of action

Lercanidipine is a calcium antagonist of the dihydropyridine group, which inhibits the transmembrane influx of calcium into heart and smooth muscle cells. The mechanism of its antihypertensive action is due to a direct relaxing effect on vascular smooth muscle, resulting in reduced total peripheral resistance.

Pharmacodynamic effects

Despite the short half-life of lercanidipine, it has a prolonged antihypertensive effect due to the high coefficient of membrane distribution and is devoid of negative inotropic action due to its high vascular selectivity. Because vasodilation caused by lercanidipine hydrochloride occurs gradually, acute hypotension with reflex tachycardia in patients with hypertension is rare.

As with other asymmetric 1,4-dihydropyridines, the antihypertensive effect of lercanidipine is mainly due to its (S) -enantiomer.

Clinical efficacy and safety

The clinical efficacy and safety of lercanidipine 10 to 20 mg once daily were evaluated in double-blind placebo-controlled clinical trials (1,200 patients receiving lercanidipine and 603 patients receiving placebo) and in long-term uncontrolled clinical trials with the active drug comparison comparing 3676 patients with hypertension.

Most clinical trials have been performed in patients with mild to moderate essential hypertension (including elderly patients and patients with diabetes mellitus) who received lercanidipine as monotherapy or in combination with ACE inhibitors, diuretics, or beta-blockers.

In addition to clinical trials to confirm therapeutic indications, another small uncontrolled but randomized study was performed in patients with severe hypertension (mean ± standard deviation of diastolic blood pressure was 114.5 ± 3.7 mm Hg). .). In this study, blood pressure returned to normal in 40% of 25 patients at a dose of lercanidipine hydrochloride 20 mg once daily and in 56% of 25 patients at a dose of 10 mg of lercanidipine hydrochloride twice daily. In a double-blind, randomized controlled trial in patients with systolic hypertension, lercanidipine hydrochloride effectively reduced systolic blood pressure from a mean of 172.6 ± 5.6 mm Hg. Art. to a value of 140.2 ± 8.7 mm Hg. Art.

No clinical trials have been performed in children.