Universal reference book for medicines
Product name: ZOCARDIS® 30 (ZOCARDIS® 30)

Active substance: zofenopril

Type: ACE inhibitor

Manufacturer: BERLIN-CHEMIE AG / MENARINI GROUP (Germany) manufactured by A.Menarini Manufacturing Logistics and Services (Italy)
Composition, form of production and packaging
Zokardis ® 7.5

The tablets covered with a cover of white color, round, slightly convex from both parties.

1 tab.

Zofenopril calcium 7.5 mg

Excipients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, colloidal silicon dioxide.

Composition of the membrane: hypromellose, titanium dioxide, macrogol 400, macrogol 600.

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
Zocardis ® 30

The tablets covered with a cover of white color, oval, with a bilateral notch for division.

1 tab.

Zofenopril calcium 30 mg

Excipients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, colloidal silicon dioxide.

Composition of the membrane: hypromellose, titanium dioxide, macrogol 400, macrogol 600.

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

ACE inhibitor, antihypertensive drug.
The mechanism of action is associated with a decrease in the formation of angiotensin II from angiotensin I. Reduction of angiotensin II leads to a direct reduction in the release of aldosterone, while reducing OPSS, systolic and diastolic blood pressure, post-and preload on the myocardium. Expands arteries more than veins, with a reflex increase in heart rate is not noted. Reduces the degradation of bradykinin, increases the synthesis of prostaglandin.
The hypotensive effect is more pronounced with a high plasma renin concentration than with a normal or reduced concentration of plasma.
Reduction of blood pressure in the therapeutic range does not affect cerebral circulation, blood flow in the vessels of the brain is maintained at a sufficient level and against a background of reduced blood pressure. Strengthens coronary and renal blood flow.
With prolonged use, hypertrophy of the left ventricle of the myocardium and myocytes of the walls of arteries of the resistive type decreases, prevents the progression of heart failure and slows down the development of dilatation of the left ventricle.
Improves the blood supply of the ischemic myocardium. Reduces the aggregation of platelets. Zofenopril is a prodrug. the free sulfhydryl compound (zofenoprilat), which is formed as a result of thioether hydrolysis, has an active activity.
After ingestion, the hypotensive effect develops after 1 hour, reaches a maximum after 4-6 hours, and lasts up to 24 hours. In some cases, in order to achieve the optimal reduction in blood pressure, therapy is needed for several weeks.
With heart failure, a noticeable clinical effect is observed with long-term treatment (6 months or more).
PHARMACOKINETICS

Suction and distribution

After ingestion zofenopril calcium quickly and completely absorbed from the digestive tract and undergoes an almost complete transformation into zofenoprilat.

C max zofenoprilata in blood plasma is achieved 1.5 hours after taking Zokaridis.
The binding with plasma proteins for zofenopril is 88%.
Metabolism and excretion

Zofenopril is rapidly metabolized in the liver with the formation of an active metabolite of zofenoprilat.
T 1/2 of zofenoprilat is 5.5 hours, the total clearance is 1300 ml / min. Zofenoprilat is excreted mainly by the kidneys - 69%, through the intestine - 26%.
INDICATIONS

- mild and moderate arterial hypertension;

- Acute myocardial infarction with symptoms of heart failure in patients with stable hemodynamic parameters and not receiving thrombolytic therapy.

DOSING MODE

Tablets are taken orally regardless of food intake (before, during or after a meal), with a sufficient amount of liquid.

Arterial hypertension

Patients with normal liver and kidney function

Adults to achieve the optimal level of AD therapy should start with a dose of 15 mg (2 tablespoons of 7.5 mg or 1/2 tablets of 30 mg) 1 time / day and gradually, with insufficient severity of the hypotensive effect, increase the dose at intervals of 4 weeks .

The average dose is 30 mg 1 time / day (4 tablets of 7.5 mg or 1 tablet of 30 mg).

The maximum daily dose is 60 mg (8 tablets of 7.5 mg or 2 tablets of 30 mg).
Multiplicity of admission - 1-2 times / day.
Patients with water-electrolyte balance disorders

Before the appointment of ACE inhibitors, correction of water-electrolyte metabolism and elimination of diuretic therapy 2-3 days before the start of the ACE inhibitor are required.
In this case, the initial dose of Zokardis is 15 mg / day. If cancellation of diuretics and normalization of water-electrolyte balance is impossible, then the initial dose of Zokaridis should be 7.5 mg / day.
Patients with impaired renal function or who are on hemodialysis

Dosage correction is necessary.
With CK> 45 ml / min dose adjustment is not carried out, with CC <45 ml / min dose should be reduced to 1/2 the average therapeutic dose 1 time / day.
The initial dose for patients on dialysis is 1/4 the dose used for patients with normal renal function.

Elderly patients

With normal kidney function correction of the dosing regimen in the elderly is not required.
Elderly patients with a CS <45 mL / min are recommended to have 1/2 an average therapeutic dose.
Patients with hepatic impairment

In patients with mild to moderate hepatic insufficiency, the initial dose of Zokardis ® is 1/2 dose, used in patients with normal liver function.

Patients with a severe degree of impaired liver function Zokardis ® are not prescribed.

Acute myocardial infarction

Treatment with Zokardis ® begins within 24 hours after the onset of the first symptoms of myocardial infarction and continues for 6 weeks, with the following scheme:

Time period Dosing regimen

1st and 2nd day of 7.5 mg every 12 hours

3rd and 4th day of 15 mg every 12 hours

from the 5th day and onwards to 30 mg every 12 hours

In case of excessive decrease of blood pressure at the beginning of treatment or during the first 3 days after myocardial infarction, the initial dose does not increase or cancel the drug.

After 6 weeks of therapy, therapy may be discontinued in patients without evidence of left ventricular failure or heart failure.
To correct left ventricular failure or heart failure, as well as hypertension, treatment can be continued for a long time.
Dosage in elderly patients with acute myocardial infarction

Zokardis ® should be used with caution in patients with myocardial infarction older than 75 years .

SIDE EFFECT

From the cardiovascular system: excessive decrease in blood pressure, orthostatic collapse;
rarely - chest pain, angina pectoris, myocardial infarction (usually associated with marked decrease in blood pressure), arrhythmias (atrial brady or tachycardia, atrial fibrillation), palpitations, thromboembolism of the pulmonary artery branches, pain in the heart, fainting.
From the central nervous system and peripheral nervous system: dizziness, headache, weakness, insomnia, anxiety, depression, confusion, increased fatigue, drowsiness (2-3%);
very rarely (when used in high doses) - nervousness, paresthesia.
From the senses: rarely - violations of the vestibular apparatus, hearing and vision impairment, tinnitus.

On the part of the digestive system: dry mouth, anorexia, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, abdominal pain), increased activity of hepatic transaminases, hyperbilirubinemia, intestinal obstruction, pancreatitis, liver dysfunction, biliary tract disorders, hepatitis, jaundice.

On the part of the respiratory system: an unproductive dry cough;
very rarely - interstitial pneumonitis, bronchospasm, dyspnea, rhinorrhea, pharyngitis.
From the hemopoietic system: in some cases, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.

From the urinary system: increased levels of creatinine and urea, impaired renal function, proteinuria.

On the part of laboratory indicators: hypercreatinemia, increased urinary levels, increased activity of AST, ALT, hyperbilirubinemia, hyperkalemia, hyponatremia, in some cases, reduction of hematocrit and decrease in hemoglobin, increased ESR, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.

Allergic reactions: rarely - skin rash, angioedema (facial, extremities, lips, tongue, glottis and / or larynx), dysphonia, polymorphic erythema, exfoliative dermatitis;very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), pemphigus, pruritus, urticaria, photosensitivity, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis.

CONTRAINDICATIONS

- angioedema, associated with the use of ACE inhibitors, in the anamnesis;

- porphyria;

- pronounced violations of the liver function;

- Pregnancy;

- lactation (breastfeeding);

- age under 18 years (effectiveness and safety not established);

- severe renal failure;

- Hypersensitivity to zofenopril and other ACE inhibitors.

Caution should be used Zokardis ® with primary hyperaldosteronism, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney, hyperkalemia, condition after kidney transplantation, aortic stenosis, mitral stenosis (with hemodynamic disorders), idiopathic hypertrophic subaortal stenosis, connective tissue diseases, cerebrovascular diseases, diabetes mellitus, renal failure (proteinuria more than 1 g / day), liver failure, with simultaneous use with it
unodepressantami, in the elderly (over 75 years), in psoriasis.
Care should be taken when prescribing the drug to patients with reduced BCC (as a result of diuretic therapy, with restricted consumption of table salt, hemodialysis, diarrhea and vomiting),
increased risk of sudden and pronounced blood pressure lowering after the use of an ACE inhibitor even in the initial dose.
PREGNANCY AND LACTATION

Zokardi ® is contraindicated for use in pregnancy and lactation (breastfeeding).

When using the drug, women of childbearing age should use reliable methods of contraception.
Zofenopril calcium is excreted in breast milk.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function or who are on hemodialysis need a dosage adjustment of Zokaridis.
With CK> 45 ml / min dose adjustment is not carried out, with CC <45 ml / min dose should be reduced to 1/2 the average therapeutic dose 1 time / day.
The initial dose for patients on dialysis is 1/4 the dose used for patients with normal renal function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with mild and moderate hepatic insufficiency, the initial dose of Zokardis is half the dose used in patients with normal liver function.

Patients with a severe degree of impaired liver function Zokardis is not prescribed.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

Zokardis ® should be used with caution in patients with myocardial infarction older than 75 years .

SPECIAL INSTRUCTIONS

Transient significant decrease in blood pressure is not a contraindication for the continuation of treatment with the drug after stabilization of blood pressure.
In the case of a re-expressed decrease in blood pressure should reduce the dose or cancel the drug.
With the development of excessive reduction, the patient's blood pressure is transferred to a horizontal position with a low headboard, if necessary, 0.9% sodium chloride solution and plasma substitutes are introduced.

The use of high-flow dialysis membranes increases the risk of anaphylactic reactions.
Correction of the dosing regimen on days free from dialysis should be performed depending on the level of blood pressure. Before and after treatment with ACE inhibitors, control of blood pressure level, blood counts (hemoglobin, potassium, creatinine, urea, AST, ALT), protein level in urine is necessary.
It should be carefully monitored for patients with severe heart failure, coronary artery disease and cerebrovascular disease, in which a sharp decrease in blood pressure can lead to myocardial infarction, stroke or renal dysfunction.
Sudden abolition of treatment does not lead to the syndrome of "withdrawal" (a sharp rise in blood pressure).
Patients with angioedema have a history of increased risk of developing it with ACE inhibitors.

In patients with reduced renal function, the single dose should be reduced or the intervals between doses should be increased.

The patient should be warned about the need to exercise caution when performing physical exercises in hot weather (the risk of dehydration and excessive BP decrease due to a decrease in BCC).

Before conducting surgical interventions (including dental), the surgeon / anesthesiologist should be warned about the use of ACE inhibitors.

For newborns and infants who have been exposed to the intrauterine effect of ACE inhibitors, careful monitoring is recommended to detect a marked decrease in blood pressure, oliguria, hyperkalemia and neurological disorders that are possible due to a decrease in renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors.
In oliguria it is necessary to maintain BP and renal perfusion by introducing appropriate fluids and vasoconstrictors.
During the use of the drug, it is not recommended to drink alcoholic beverages.
alcohol increases the hypotensive effect of the drug.
Simultaneous use of hypoglycemic agents increases the risk of developing hypoglycemia.

Impact on the ability to drive vehicles and manage mechanisms

During the selection of the therapeutic dose, it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions,
possibly dizziness (especially after taking an initial dose of an ACE inhibitor in patients taking diuretics).
OVERDOSE

Symptoms: marked decrease in blood pressure (up to the development of collapse, myocardial infarction, acute impairment of cerebral circulation or thromboembolic complications), convulsions, stupor.

Treatment: the patient is transferred to a horizontal position with a low headboard.
In mild cases - gastric lavage and intake of saline, in more severe cases - measures aimed at stabilizing blood pressure (iv injection of 0.9% sodium chloride solution, plasma substitutes); if necessary - the introduction of angiotensin II, hemodialysis.
DRUG INTERACTION

When combined, the hypotensive effect of ACE inhibitors can enhance other antihypertensive agents, diuretics, general anesthetic agents, analgesics-antipyretics, ethanol.

With simultaneous administration with NSAIDs, hypotensive effect of zofenopril can be reduced.

With a simultaneous appointment with potassium-sparing diuretics, hyperkalemia may develop.

With a simultaneous appointment with lithium salts, a slowdown in lithium removal is noted.

When combined, immunosuppressants, allopurinol, cytostatics increase the hematotoxicity of zofenopril.

With a simultaneous appointment with hypoglycemic agents, the risk of hypoglycemia increases.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of no higher than 25 ° C (tablets 7.5 mg) or at a temperature of no higher than 30 ° C (tablets 30 mg).
Shelf life - 3 years.
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