Zocardis 30 (zofenopril calcium) coated tablets 30 mg. №28

Description

Zocardis 30 (zofenopril calcium) coated tablets 30 mg. №28

Composition

active substance: 1 film-coated tablet contains zofenopril calcium 30 mg, equivalent to 28.7 mg zofenopril;

excipients:

• core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica;
• film coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, polyethylene glycol 6000.

Dosage form

Film-coated tablets.

Main physical and chemical properties: white, round, convex tablets on both sides, film-coated.

Pharmacotherapeutic group

Angiotensin-converting enzyme (ACE) inhibitors, monocomponent.
ATX code C09A A15.

Pharmacological properties

The mechanism of action of the drug Zocardis 30 in hypertension and acute myocardial infarction is mainly due to inhibition of the renin-angiotensin-aldosterone system in blood plasma. Inhibition of ACE (Ki 0.4 nM in rabbit lungs for zofenoprilat salt with arginine) leads to a decrease in plasma angiotensin II levels, resulting in decreased vasoconstrictive activity and aldosterone secretion. At the same time, with a slight decrease in the level of the latter, some increase in the concentration of potassium in the serum is possible, which is accompanied by loss of sodium and fluid. Due to the inhibition of the effect of angiotensin II on renin secretion, renin activity in blood plasma increases. Plasma ACE activity decreased by 53.4% ​​and 74.4% 24 hours after a single oral dose of 30 mg and 60 mg zofenopril calcium, respectively.

Indications

It is used in the treatment of essential hypertension of mild or moderate severity.

In addition, it is used in the first 24 hours in the treatment of acute myocardial infarction, which is accompanied by unaccompanied signs of acute heart failure and is characterized by stable hemodynamics, but only if the patient has not received thrombolytic treatment.

Contraindications

The drug Zocardis 30 should not be used if the patient has previously been diagnosed with intolerance to zofenopril calcium and other ACE inhibitors. The drug should be discontinued if the patient has previously developed ACE inhibitors while developing angioneurotic edema or has a history of hereditary or idiopathic angioneurotic edema.

The drug is not prescribed if the patient suffers from severe liver dysfunction. Absolute contraindications to the use of the drug are pregnancy and lactation, bilateral bilateral renal artery stenosis or unilateral if the patient has one kidney.

Use during pregnancy and breastfeeding

Contraindicated.

Method of application and dose

The drug Zocardis 30 is intended for oral administration regardless of food. The dose of the drug is selected by the doctor individually taking into account the therapeutic response of the patient’s body to its introduction.

In the treatment of hypertension, the dose is selected taking into account the level of blood pressure. The dose is increased at intervals of at least four weeks.

Patients who do not show symptoms of water or salt depletion in the initial dosage receive 15 mg of the drug once a day. The dosage is increased until the blood pressure level normalizes. In most cases, the effective therapeutic dose is 30 mg. The highest daily dose is 60 mg.

Overdose

The use of the drug in high doses may cause the patient to develop severe hypotension, stupor, shock, bradycardia, electrolyte disturbances and renal dysfunction.

At detection of symptoms of acute poisoning the patient is shown constant control of level of electrolytes and creatinine in blood serum, gastric lavage and appointment of correct treatment. In severe cases, the introduction of drugs to increase blood plasma volume is indicated.

Side effects

Dizziness, headache, cough, dyspeptic disorders, angioneurotic edema, local allergic reactions, muscle cramps, fatigue, asthenia, hypoglycemia, depression, change of consciousness, insomnia, disorientation, paresthesia, disturbance of taste, disturbance of taste ears and dry mouth.