ZOCARDIS PILLS 7.5MG

Dosage form

Coated tablets

Composition

1 coated pill contains: Zofenopril Calcium 75 mg

Auxiliary substances: Lactose monohydrate, Magnesium stearate, microcrystalline cellulose, corn starch, colloidal silicon dioxide

- The composition of the shell Hypromellose, titanium dioxide, macrogol 400, macrogol 600

Packing

In the blister 14 tablets. In packing 2 blisters.

Mechanism of action

Zocardis - an ACE inhibitor, an antihypertensive drug.

The mechanism of action is associated with a decrease in the formation of angiotensin II from angiotensin I. A decrease in the content of angiotensin II leads to a direct decrease in the release of aldosterone, while the congestion of systolic and diastolic BP, post- and preload on the myocardium decreases.

Expands the arteries to a greater extent than the veins, while the reflex increase in heart rate is not observed. Reduces the degradation of bradykinin, increases the synthesis of prostaglandin. The hypotensive effect is more pronounced with a high concentration of renin in the blood plasma than with a normal or reduced concentration. A decrease in blood pressure in the therapeutic range does not affect the cerebral circulation, the blood flow in the vessels of the brain is maintained at a sufficient level and against the background of low blood pressure.Enhances coronary and renal blood flow.

With prolonged use, left ventricular myocardial hypertrophy and myocytes of resistive-type artery walls are reduced, prevents progression of heart failure and slows down the development of left ventricular dilatation. Improves blood supply to ischemic myocardium. Reduces platelet aggregation. Zofenopril is a prodrug, because activity is free sulfhydryl compound (zofenoprilat), formed as a result of thioester hydrolysis.

After ingestion, the hypotensive effect develops after 1 h, reaches a maximum after 4-6 h and lasts up to 24 h. In some cases, therapy for several weeks is necessary to achieve optimal reduction of blood pressure. In heart failure, a noticeable clinical effect is observed with prolonged treatment (6 months or more).

Indications and usage

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

Contraindications

- Angioedema associated with the use of ACE inhibitors, in history.
- Porphyria.
- Severe abnormal liver function.
- Pregnancy.
- Lactation (breastfeeding).
- Age up to 18 years (efficacy and safety have not been established).
- Renal failure severe.

- Hypersensitivity to zofenopril and other ACE inhibitors.

Caution should be applied Zocardis in the following cases:

- Primary hyper aldosteronism.
- Bilateral renal artery stenosis.
- Stenosis of the artery of the only kidney.
- Hyperkalemia.
- Condition after kidney transplantation.
- Aortic stenosis.
- Mitral stenosis (with impaired hemodynamics).
- Idiopathic hypertrophic subaortic stenosis.
- Diseases of the connective tissue.
- Cerebrovascular diseases.
- Diabetes.
- Proteinuria more than 1 g / day.
- Liver failure.
- Simultaneous use with immunosuppressants.
- In the elderly (over 75 years).
- With psoriasis.

Care must be taken when prescribing the drug to patients with reduced BCC (as a result of diuretic therapy, while limiting salt intake, hemodialysis, diarrhea and vomiting), because increased risk of sudden and pronounced decrease in blood pressure after the use of an ACE inhibitor, even in the initial dose.

Pregnancy and Breastfeeding

Zocardis is contraindicated for use during 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.

For newborns and babies whose mothers took ACE inhibitors, it is recommended that careful monitoring be carried out in order to timely detect a pronounced decrease in blood pressure, oliguria, hyperkalemia and neurological disorders,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 blood pressure and renal perfusion by injecting appropriate fluids and vasoconstrictor agents.

Dosage and administration

Tablets are taken orally, regardless of the meal (before, during or after a meal), drinking plenty of fluids.

- In adults with arterial hypertension, in order to achieve an optimal level of blood pressure, therapy should be started at a dose of 15 mg (2 pills of 7.5 mg) 1 time / day and gradually, with insufficient severity of the hypotensive effect, increase the dose every 4 weeks. The average dose is 30 mg 1 time / day (4 pills of 7.5 mg). The maximum daily dose is 60 mg (8 pills of 7.5 mg). The multiplicity of reception 1-2 times / day.

- In case of violations of water and electrolyte balance: Before the appointment of ACE inhibitors, correction of water and electrolyte metabolism and the cancellation of the therapy with diuretics for 2-3 days before the start of taking the ACE inhibitor is required. In this case, the initial dose of Zocardis is 15 mg / day. If the cancellation of diuretics and the normalization of water-electrolyte balance is impossible, then the initial dose of Zocardis should be 7.5 mg / day.

- In acute myocardial infarction as part of combination therapy, Zocardis is prescribed for 24 hours after the first symptoms of myocardial infarction occur and continue for 6 weeks, using the following scheme: Period of time Dosing regimen 1 and 27.5 mg day every 12 hours; 3rd and 4th day; 15 mg every 12 hours from the 5th day and then 30 mg every 12 hours. If blood pressure drops too much 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 treatment, therapy may be discontinued in patients without signs of left ventricular failure or heart failure. For the correction of left ventricular failure or heart failure, as well as hypertension, treatment can be continued for a long time. Zocardis should be used with caution in patients with myocardial infarction over 75 years.

- Use for impaired renal function: Patients with impaired renal function or who are on hemodialysis require dose adjustment of Zocardis. With creatinine clearance (CK)> 45 ml / min dose adjustment is not carried out, with CK

- Use in elderly patients: With normal kidney function, the correction of the dosing regimen in the elderly is not required.

- Use in violation of liver function: In patients with mild to moderate hepatic insufficiency, the initial dose of Zocardis is half the dose used in patients with normal liver function. Patients with severe hepatic impairment do not prescribe Zocardis.

For ease of dosing, you can use the drug Zocardis tab.po. 30 mg pack. 28 Berlin-Chemie AG / Menarini Group.

Adverse reactions

- From the side of cardiovascular system: Excessive decrease in blood pressure, orthostatic collapse; rarely - chest pain, stenocardia, myocardial infarction (usually associated with a pronounced decrease in blood pressure), arrhythmias (atrial brady- or tachycardia, atrial fibrillation), palpitations, pulmonary embolism, pain in the region of the heart, fainting.

- From the side of the central nervous system and peripheral nervous system: Dizziness, headache, weakness, insomnia, anxiety, depression, confusion, fatigue, drowsiness (2-3%); very rarely (when used in high doses) - nervousness, paresthesias.

- On the part of the senses: Rarely - disorders of the vestibular apparatus, impairment of hearing and vision, tinnitus.

- On the part of the digestive system: Dry mouth, anorexia, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, abdominal pain), increased liver transaminase activity, hyperbilirubinemia, intestinal obstruction , pancreatitis, abnormal liver function, disorders of the biliary tract , hepatitis, jaundice.

- On the part of the respiratory system: Unproductive dry cough; very rarely - interstitial pneumonitis, bronchospasm, shortness of breath, rhinorrhea, pharyngitis.

- From the side of the hematopoietic system: In some cases, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.

- From the urinary system: increased creatinine and urea, renal dysfunction, proteinuria.

- From the laboratory parameters: Hyperkalemia, hyponatremia; in some cases - a decrease in hematocrit and hemoglobin, increased ESR.

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

A transient pronounced decrease in blood pressure is not a contraindication for the continuation of drug treatment after stabilization of blood pressure. In case of repeated pronounced decrease in blood pressure, reduce the dose or discontinue the drug.

The use of high-flow dialysis membranes increases the risk of Anaphylactic reactions. Correction of the dosing regimen in the days free from dialysis should be carried out depending on the level of blood pressure.

When using the drug, it is necessary to carefully monitor patients with heart failure, coronary heart disease and cerebrovascular diseases, in whom a sharp decrease in blood pressure can lead to myocardial infarction, stroke or renal dysfunction.

Sudden cancellation of treatment does not lead to withdrawal syndrome (a sharp rise in blood pressure).

In patients with angioedema in the history of anamnesis, there is an increased risk of its development when taking ACE inhibitors.

The patient should be warned about the need to be careful when doing physical exercises in hot weather (the risk of dehydration and an excessive decrease in blood pressure due to a decrease in BCC).

Before performing surgical interventions (including dental) it is necessary to warn the surgeon / anesthesiologist about the use of ACE inhibitors.

During the use of the drug is not recommended to drink alcohol.

- Control of laboratory parameters: Before and after treatment with ACE inhibitors, control of blood pressure, hemoglobin, potassium, creatinine, urea, liver enzyme activity in the blood, and protein content in the urine is necessary.

- Use for violations of the liver: In patients with mild and moderate liver failure, the initial dose of Zocardis is half the dose used in patients with normal liver function. Patients with severe hepatic impairment do not prescribe Zocardis.

- Application for violations of renal function: Patients with impaired renal function or who are on hemodialysis need a dose adjustment of Zocardis. With creatinine clearance (CK)> 45 ml / min dose adjustment is not carried out, with CK

- Impact on the ability to drive vehicles and control mechanisms In the period of selection of a therapeutic dose, it is necessary to refrain from engaging in potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions, becausedizziness is possible (especially after taking the initial dose of an ACE inhibitor while using diuretics).

When combined, the hypotensive effect of ACE inhibitors can be enhanced by other antihypertensive drugs, diuretics, general anesthesia drugs, analgesics, antipyretics, ethanol.

With simultaneous appointment with NSAIDs , the hypotensive effect of zofenopril may be reduced; with potassium-sparing diuretics - hyperkalemia; with lithium salts - slowing the removal of lithium.

With the combined use of immunosuppressants, Allopurinol , cytotoxic drugs increase the hematotoxicity of zofenopril, hypoglycemic agents increase the risk of hypoglycemia.

- Symptoms: pronounced decrease in blood pressure (up to the development of collapse, myocardial infarction, acute cerebrovascular accident or thromboembolic complications), convulsions, stupor.
- Treatment: the patient is transferred to a horizontal position with a low head. In mild cases - gastric lavage and ingestion of saline, in more severe cases - measures aimed at stabilizing blood pressure (in / in the introduction of a 0.9% sodium chloride solution, plasma substitutes); if necessary, the introduction of angiotensin II, hemodialysis.

- The drug should be stored at a temperature not higher than 25 ° C.
- Keep out of reach of children.
- Do not use after expiration date.

3 years.

Zocardis