Zocardis Plus (zofenopril calcium, hydrochlorothiazide) coated tablets 30/12.5 mg. №28

Description

Zocardis Plus (zofenopril calcium, hydrochlorothiazide) coated tablets 30/12.5 mg. №28

Composition

active substances: zofenopril calcium, hydrochlorothiazide;

1 film-coated tablet contains zofenopril calcium 30 mg, equivalent to zofenopril 28.7 mg, and hydrochlorothiazide 12.5 mg;

Excipients: microcrystalline cellulose, lactose monohydrate, corn starch, hypromellose, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E 171), polyethylene glycol 400, polyethylene glycol 6000, iron oxide red (E 17).

Dosage form

Film-coated tablets.

Main physical and chemical properties: pastel red, round, slightly convex tablets on both sides, film-coated, with a line for distribution on one side.

The separation line is intended only to facilitate the breaking of the tablet for easier swallowing, and not to separate it at the dose level.

Pharmacotherapeutic group

ACE inhibitors and diuretics. ATX code C09B A15.

Pharmacological properties

Zocardis Plus is a combination drug consisting of zofenopril, an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide, a thiazide diuretic. The mechanisms of action of both substances complement each other and their antihypertensive effect is enhanced.

Zofenopril is a sulfhydryl ACE inhibitor that inhibits an enzyme that catalyzes the conversion of angiotensin I to angiotensin II, a peptide with vasoconstrictor activity. This leads to a decrease in vasoconstrictor activity and decreased aldosterone secretion. The latter can lead to an increase in the concentration of potassium in the serum with the simultaneous excretion of sodium and fluid. The rupture of the negative feedback between angiotensin II and renin secretion leads to increased plasma renin activity. The mechanism of lowering zofenopril blood pressure is based on the primary inhibition of the renin-angiotensin-aldosterone system. ACE is identical to kininase II, an enzyme that catalyzes the breakdown of bradykinin, a potent vasodilator peptide. This obviously plays a role in the therapeutic effect of ACE inhibitors.

Hydrochlorothiazide is a diuretic and antihypertensive agent. It affects the reabsorption of electrolytes in the distal part of the renal tubules. Hydrochlorothiazide enhances the excretion of sodium and chlorine in approximately equal amounts. Natriuresis may be accompanied by loss of potassium and bicarbonate. Presumably due to blockade of the renin-angiotensin-aldosterone system, co-administration of hydrochlorothiazide with zofenopril restores potassium loss associated with the diuretic. Diuresis begins within 2 hours after taking hydrochlorothiazide, reaches a maximum in about 4 hours and lasts about 6-12 hours.

Indication:

• essential hypertension of mild and moderate severity;
• this combination drug is indicated in patients with an inadequate response to zofenopril monotherapy.

Contraindication:

• pregnancy or pregnancy planning;
• hypersensitivity to zofenopril or to any other ACE inhibitor;
• hypersensitivity to hydrochlorothiazide or to other sulfonamide derivatives;
• hypersensitivity to any of the excipients listed in the “Composition”;
• history of angioneurotic edema associated with prior ACE inhibitor therapy;
• concomitant use with sacubitril / valsartan therapy. Treatment with Zocardis Plus should not be started earlier than 36 hours after the last dose of sacubitril / valsartan;
• hereditary / idiopathic angioneurotic edema;
• severe liver dysfunction;
• severe renal impairment;
• bilateral renal artery stenosis or stenosis of the renal artery to a single kidney.

Method of application and dosage

It is recommended that the doses of the individual components (ie zofenopril and hydrochlorothiazide) be adjusted before using the fixed-dose medicinal product.

If necessary, it is possible to directly replace single drugs with a drug with a fixed combination.

For patients without impaired water-electrolyte metabolism, the usual effective dose is 1 tablet 1 time per day.

Zocardis Plus is not recommended for use in patients with suspected impaired water-electrolyte metabolism.

Children

The drug is not recommended for use in children due to a lack of data on safety and efficacy.

Overdose

Symptoms of overdose are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances, renal failure.

Side effects:

Nervous system disorders: dizziness, headache;

Respiratory, thoracic and mediastinal disorders: cough.