Zokardis Tab n / a film about 7.5mg 28 pc

Description

Composition
Active substance:
1 tablet contains: 7.5 mg of zofenopril calcium.
Excipients:
Lactose monohydrate, magnesium stearate, microcrystalline cellulose, corn starch, colloidal silicon dioxide. sheath: hypromellose, titanium dioxide, macrogol 400, macrogol 600.
Product form:
Tablets, coated tablets, 7.5 mg.
At 7 or 14 tablets in a blister made of PVC / aluminum foil.
1 or 2 blisters together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to zofenopril and other ACE inhibitors, history of angioneurotic edema associated with treatment with ACE inhibitors, porphyria expressed human liver function, pregnancy, lactation, at the age of 18 years (efficacy and safety have not been established), severe renal insufficiency.
Caution should be used Zokardis® 7.5 in primary hyperaldosteronism, bilateral renal artery stenosis, stenosis of the artery to a solitary kidney, hyperkalemia, condition after kidney transplantation; aortic stenosis, mitral stenosis (with impaired hemodynamics), idiopathic hypertrophic subaortic stenosis, connective tissue diseases, cerebrovascular diseases, diabetes, renal disease (proteinuria greater than 1 g / day), liver failure, patients a diet with salt restriction or being on hemodialysis, while admission to immunosuppressants and saluretikami in the elderly (over 75 years), psoriasis.
Care must be taken when administered to patients with reduced circulating blood volume (as a result of diuretic therapy, while limiting the consumption of salt, hemodialysis, diarrhea and vomiting) – increased risk of sudden and pronounced blood pressure lowering even after applying the initial dose of ACE inhibitor.
Dosage
7.5 mg
Indications
Arterial hypertension is mild or moderate severity.
Acute myocardial infarction with signs or symptoms of heart failure in patients with stable haemodynamics and receiving thrombolytic therapy.
Interaction with other drugs
Hypotensive action of ACE inhibitors can be enhanced by other antihypertensives, diuretics, general anesthetics, analgesics and antipyretics, ethanol.
When concomitant administration of zofenopril with nonsteroidal anti-inflammatory drugs may reduce the hypotensive effect of zofenopril; potassium-sparing diuretics – hyperkalemia; with lithium salts – slowing lithium excretion.
Immunosuppressants, allopurinol, cytostatics reinforce haematotoxicity. Hypoglycemic agents – increase the risk of hypoglycemia.
Overdose
Symptoms: marked reduction of blood pressure until the development of collapse, myocardial infarction, acute stroke or thromboembolic complications, convulsions, stupor.
Treatment: the patient is transferred to a horizontal position with a low headboard. In mild cases shown gastric lavage ingestion and brine, in more severe cases – actions to stabilize blood pressure: intravenous injection of 0.9% sodium chloride solution, plasma expanders, if necessary nutshell angiotensin II, hemodialysis (elimination rate enalaprilat – 62 ml / min).
pharmachologic effect
Pharmacological group:
Angiotensin-converting enzyme inhibitor (ACE inhibitor).
Pharmacodynamics:
Zofenopril – antihypertensive drug, its mechanism of action is associated with a decrease in the formation of angiotensin I angiotensin II, reduction of which leads to a direct decrease in aldosterone release. This decreases total peripheral vascular resistance, systolic and diastolic blood pressure, post – and the preload on the myocardium. Artery expands to a greater extent than the vein, the reflex increase in heart rate (HR) were not observed. Reduces the degradation of bradykinin, increases the synthesis of prostaglandin.
The hypotensive effect is more pronounced at high plasma renin concentration than during normal or reduced concentration. Lowering blood pressure (BP) in the therapeutic range has no effect on cerebral blood flow, cerebral blood flow in vessels is maintained at a sufficient level and background decreased BP. Strengthens the coronary and renal blood flow.
With prolonged use of reduced left ventricular hypertrophy and myocyte walls resistive arteries prevents the progression of heart failure and slows the development of left ventricular dilation. It improves blood flow to the ischemic myocardium. Reduces platelet aggregation. Zofenopril calcium is a prodrug as an active inhibitor is the free sulfhydryl compound – zofenoprilat – which result from hydrolysis of the thioester.
onset of antihypertensive effect during ingestion – 1 h, reaching a maximum after 4-6 hours and lasts up to 24 hours in some patients to achieve optimal blood pressure level needed therapy for a few weeks.. In heart failure, a significant clinical effect observed in long-term treatment – 6 months or more.
Pharmacokinetics:
Zofenopril calcium is rapidly and completely absorbed from the gastrointestinal tract after oral administration and undergoes an almost complete conversion to zofenoprilat, whose maximum concentration in blood reached 1.5 hours after oral administration of the drug dose Zokardis®
Approximately 88% of zofenopril calcium is bound to plasma proteins. Zofenopril is rapidly metabolized in the liver to form the active metabolite zofenoprilat.
Zofenoprilat half-life is 5.5 hours and total body clearance is 1300 ml / min after oral administration of zofenopril calcium. Zofenoprilat derived mainly kidneys – 69%, through the intestine – 26%.
Pregnancy and breast-feeding
Preparation Zokardis® 7.5 can not be used during pregnancy and should not be used in women of childbearing age in the absence of effective contraception. Because zofenopril calcium is released in breast milk, the drug should not be used to nursing mothers.
Conditions of supply of pharmacies
On prescription.
side effects
Cardio-vascular system: excessive fall in blood pressure, orthostatic collapse, rarely – chest pain angina, myocardial infarction (usually associated with a marked decrease in blood pressure), arrhythmia (atrial or bradi- tachycardia, atrial fibrillation), palpitations, thromboembolism of pulmonary artery branches, pain in the heart, fainting.
Central nervous system: dizziness, headache, fatigue, insomnia, anxiety, depression, confusion, fatigue, sleepiness (2-3%), rarely with high doses – nervousness, paresthesia.
From the sensory organs: rarely disorders of the vestibular apparatus, hearing and visual impairment, tinnitus.
On the part of the digestive tract: dry mouth, anorexia, dyspepsia (nausea, diarrhea or constipation, vomiting, abdominal pain), ileus, pancreatitis, liver dysfunction and biliary excretion, hepatitis, jaundice.
The respiratory system: nonproductive dry cough, very rare: interstitial pneumonitis, bronchospasm, dyspnea, rhinorrhea, pharyngitis.
Allergic reactions: seldom: skin rash, angioneurotic edema of face and extremities, lips, tongue, glottis and / or throat, dysphonia, erythema multiforme, exfoliative dermatitis, very rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria , photosensitivity, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis.
From the laboratory parameters: giperkreatinemiya, increased urea content, increased activity of “liver” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia. There have been, in some cases, decrease in hematocrit and hemoglobin, increased erythrocyte sedimentation rate, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.
From the urinary system: renal dysfunction, proteinuria.
special instructions
Transient marked decrease in blood pressure is not a contraindication for the continuation of treatment after stabilization of blood pressure. In case of repeated pronounced decrease in blood pressure, the dose should be reduced or eliminated product.
With the development of excessive reduction in blood pressure of the patient to the supine position with a low headboard administered 0.9% sodium chloride solution and plazmozameschayuschie preparations, if necessary.
Application vysokoprotochnyh dialysis membranes increases the risk of an anaphylactic reaction. Correction of dosing regimen in days free from dialysis, must be carried out depending on the blood pressure level. Before and after the treatment with ACE inhibitors is necessary to monitor blood pressure, blood parameters (hemoglobin, potassium, creatinine, urea, the activity of “liver” enzymes), protein in the urine.
Should be carefully observed for patients with severe heart failure, coronary heart disease and diseases of the brain, in which a sharp decrease in blood pressure can lead to heart attack, stroke, or renal dysfunction. The sudden cancellation of treatment does not lead to the syndrome of “lifting” (a sharp rise in blood pressure).
In patients with an indication for the development of angioedema in history, there is an increased risk of developing cancer while taking ACE inhibitors.
For newborns and infants who have been exposed in utero ACE inhibitors should be closely monitored for early detection of significant decrease in blood pressure, oliguria, hyperkalemia and neurological disorders, possible due to the reduction of renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors. When oliguria need to maintain blood pressure and renal perfusion by introducing the liquids and vasoconstrictors.
In patients with renal function decline, reduce single dose or increase the interval between doses of the drug.
During the selection of a therapeutic dose should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and speed of psychomotor reactions, because dizziness, especially after the initial dose of ACE inhibitor in patients receiving diuretics.
Use caution when exercising in hot weather (risk of development of dehydration and excessive loss of blood pressure due to a decrease in blood volume). Prior to surgery (including dental), you must notify the surgeon / anesthetist on the use of ACE inhibitors.
During treatment is not recommended to drink alcohol, because Alcohol enhances the hypotensive effect of the drug.
Concomitant use of hypoglycemic agents, increasing the risk of hypoglycemia.
Storage conditions
At temperatures above 25 ° C, stored in reach of children !.
Dosing and Administration
7.5 Zokardis® administered orally, regardless of mealtime (before, during or after meals), drinking plenty of fluids.
When hypertension
Patients with normal renal and hepatic function
To achieve optimum blood pressure treatment should begin with 2 tablets of the preparation Zokardis® 7.5, 1 received once a day and gradually, with insufficient severity of hypotensive effect, increase dose at intervals of 4 weeks.
Generally, an effective dose of 4 tablets of the preparation Zokardis® 7.5, 1 received once a day.
The maximum daily dose of eight tablets Zokardis® 7.5 formulation per day, taken in single or divided into two doses every 4 tablets.
Patients with impaired water-salt balance
Initial therapy of ACE inhibitors requires adjustment saline and / or aqueous deficits termination ongoing diuretic therapy for 2-3 days before receiving an ACE inhibitor and begins with a dose of 2 tablets of the preparation Zokardis® 7.5 1 times per day. If this is not possible, you should start with a dose of 1 tablet of the drug Zokardis® 7.5 per day.
Patients with renal impairment or hemodialysis
Patients with mild renal impairment (creatinine clearance (CC)> 45 ml / min) no dose reduction is required. Patients with moderate and severe renal impairment (creatinine clearance
The starting dose for patients undergoing dialysis is 1/4 the dose employed for patients with normal renal function.
Dosage in elderly patients
In elderly patients with normal CK does not require correction. In elderly patients with CC
Dosage in hepatic dysfunction
Patients with mild to moderate dysfunction of liver initial dose of 7.5 Zokardis® drug is half of the dose used in patients with normal liver function.
In patients with severe liver dysfunction Zokardis® 7.5 should not be used.
Acute myocardial infarction (in combination therapy).
Treatment with 7.5 Zokardis® should begin within 24 hours after onset of symptoms of myocardial infarction and continued for 6 weeks.
Should apply the following dosing scheme: 1st and 2nd day 1 tab. Zokardis® 7.5 every 12 hours 3rd and 4th day 2 pi. Zokardis® 7.5 every 12 hours from the 5th day onwards Table 4. Zokardis® 7.5 every 12 hours.
In case of excessive reduction in blood pressure at the start of treatment or during the first 3 days after myocardial infarction, the initial dose does not increase or overturned.
After 6 weeks of therapy may be discontinued in patients without signs of left ventricular dysfunction or heart failure. For correction of left ventricular dysfunction or heart failure, and hypertension treatment can be continued for a long time.
Dosage in elderly patients
Zokardis® 7.5 should be used with caution in patients with myocardial infarction, older than 75 years.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist