Vitopril. table. 20 mg. 30 tablets
Vitopril. table. 20 mg. 30 tablets
o High blood pressure (hypertension) alone or in combination with other blood pressure lowering drugs
o Heart failure - in addition to the non-potassium-sparing diuretics (water) and if necessary to digitalis
o Acute myocardial infarction in patients with stable cardiovascular dysfunction (hemodynamically stable) within 24_ hours of acute myocardial infarction to prevent the development of impaired left ventricular function or sardachna failure and improve survival in their usual standard treatment of acute infarct
When you must not take Vitopril?
Vitopril should not be used in the following conditions:
narrowing of the renal artery - bilateral (bilateral) or one-sided - in patients with one kidney
Hypersensitivity to lisinopril, to other ACE inhibitors or any of the ingredients
tendency to tissue edema (hereditary (inherited) / idiopathic angioedema) and data to previous angioedema with ACE inhibitors (see "Warnings") • condition after kidney transplantation
severe renal dysfunction (renal failure - creatinine clearance <30 ml / min)
narrowing of the aortic or mitral valve, and other obstructions of the left ventricular output, eg. hypertrophic cardiomyopathy if it obstructs the blood flow
Patients with unstable cardiovascular function (hemodynamically unstable patients) after acute myocardial infarction
Systolic blood pressure <100 mmHg before treatment with lisinopril
pregnancy (see "What has to be observed during pregnancy and lactation?")
Concurrent use of lisinopril and high flux membranes - from poliakrilnitrilnatriy-2-metilalilsulfonat (eg AN69) in the emergency dialysis. Risk of life-threatening hypersensitivity reaction (anaphylactic reaction) to shock. This combination should be avoided by the use of other drugs (but not ACE inhibitors) for the treatment of hypertension and heart failure or other use of hemodialysis membranes (see "Warnings").
What has to be observed during pregnancy and lactation?
During pregnancy and lactation Vitopril treatment should be performed (see "Contraindications").
Before using Vitopril by women of childbearing age should exclude the presence of pregnancy. During treatment Vitopril in these women is necessary to take adequate contraception. Women who become pregnant during treatment Vitopril, should discuss with their doctor how to pass on any new medication that is safe for the fetus, since Vitopril can cause serious birth defects, especially if taken in the last six months of bremennostta.ASE inhibitors can pass into breast milk and their effect on the nursing infant has not been studied. Breast-feeding should be discontinued during treatment with Vitopril.
Precautions for use and warnings:
What precautions should I observe?
It is recommended to start treatment with lisinopril should be done in hospital patients:
combination therapy or high-dose diuretics (> 80 mg Furosemid)
hypovolemic (low blood volume) or hyponatremia (serum sodium <130 mmol / 1)
an existing hypotension (low blood pressure)
with unstable heart failure
treatment with high doses of vasodilators (vasodilators)
over 70 years of age
Especially at the beginning of treatment and at risk patients (patients with renal impairment or collagen diseases), and in those on concomitant immunosuppressive cytotoxic antineoplastic drugs allopurinol or procainamide need monitoring of serum electrolytes, creatinine and blood count.
Low blood pressure (hypotension ')
It is possible, especially after the first dose, Vitopril cause a significant decrease in blood pressure. Symptomatic low blood pressure as a consequence of treatment with lisinopril is rare in patients with uncomplicated hypertension. Symptomatic hypotension is more likely in dehydrated or electrolytic failure patients with diuretic therapy in low-salt diet when vomiting or diarrhea, or after dialysis. This hypotension was reported mainly in patients with significant heart failure, accompanied or not by renal failure in patients treated with the so-called loop diuretics in high doses in patients with hyponatremia (reduced sodium in the blood) or functional renal failure. In these patients, treatment with Vitopril should be done under strict medical supervision in hospital with low doses and careful dose adjustment. At the same time should be monitored renal function and serum potassium. If possible, treatment with diuretics to preustanovi.Podobni considerations are valid also for patients with ischemic heart disease (angina pectoris), or diseases of the cerebral vessels (cerebrovascular diseases), where very low blood pressure can lead to heart udar.Pri cerebral infarction or presence of low blood pressure (hypotension), the patient should be placed in the supine position and, if necessary, accept oral or intravenous fluids obemozamestvashti. Atropine may be required for conditions associated with bradycardia (slow heart rate). After successfully passing the treatment of hypotension after the first dose of the medicine and stabilizing blood pressure, administration of lisinopril may continue. If symptomatic hypotension develops in patients with heart failure, it is necessary dose reduction and / or discontinuation of lisinopril and / or discontinuation of diuretitsi.Pri appropriate option 2 to 3 days before beginning therapy with lisinopril existing treatment diuretic should be discontinued.
Low blood pressure (hypotension ') in acute myocardial infarction, treatment with lisinopril should not. be initiated in patients with acute myocardial infarction who are at risk of serious deterioration of cardiovascular status (hemodynamically unstable) after treatment with a vasodilator (sadorazshiryavyashto medicine). This applies to patients with systolic blood pressure lower than 100 mmHg, or those with cardiogenic shock. The maintenance dose should be reduced to 5 or temporarily 2,5 mg, if the systolic blood pressure lower than 100 mmHg. Treatment with lisinopril in patients with acute myocardial infarction may lead to severe hypotension. If hypotension is constant (systolic blood pressure below 90 mmHg for more than 1 hour), treatment with lisinopril should be preustanovi.Patsienti with severe heart failure after acute myocardial infarction, lisinopril should accept only if they are hemodynamically stabilni.Visoko blood pressure due to diseases of the renal vessels (renovascular hypertension / renal artery stenosis - see "Contraindications") in patients with
high blood pressure due to disease of the renal vessels (renovascular hypertension) and available bilateral or unilateral (single kidney) renal artery stenosis lisinopril adoption leads to increased risk of very low blood pressure and kidney failure. Concomitant treatment with diuretics may increase this risk. Renal failure may be accompanied only by a slight change in serum creatinine, even in patients with unilateral renal artery stenosis. Therefore, these patients need early treatment be started under close medical supervision in hospital with low doses and gradual dose increases. Existing diuretic therapy should be discontinued and renal function should be monitored during the first weeks of treatment.
Lisinopril is contraindicated in patients with severe renal insufficiency (creatinine clearance below 30 ml / min) and in patients on dialysis (see "Ex otivopokazaniya"). Patients with renal, failure lisinopril should be used with caution. They may need to reduce the dose or increase the interval between doses (see "Dosage"). Treatment with lisinopril can cause renal failure mainly in patients with severe heart failure or pre-existing treatment with lisinopril kidney disease (including renal artery stenosis). Renal failure associated with lisinopril therapy is usually transient early diagnosis and appropriate lechenie.Pri Some hypertensive patients with no apparent existing kidney disease are identified elevated serum urea and creatinine levels when lisinopril has been given concomitantly with a diuretic. Then you may need to reduce the dose of ACE inhibitor and / or discontinuation of the diuretic and to discuss the possibility of undiagnosed renal artery stenoza.Patsienti with acute myocardial infarction should not start treatment with lisinopril 20 if they have symptoms of abnormal in renal function defined by serum creatinine concentration> 177 mmol / 1 [2.0 mg / dl] and / or proteinuria (excess excretion of protein in urine)> 500 mg / day. If a patient develops renal insufficiency (serum creatinine clearance <30 mi / min or doubling of baseline serum creatinine concentrations) during treatment with lisinopril, lisinopril intake should be discontinued.
Patients on hemodialysis
Treatment with Lisinopril is contraindicated in patients on chronic hemodialysis (see "Contraindications"). Concurrent use of Vitopril and poliakrilnitrilnatriy-2-metilalilsulfonat highly permeable membranes - (eg AN69) in the emergency dialysis or hemofiltration, the risk of life-threatening reaction hypersensitivity (anaphylactic) reaction to shock. The first symptoms of this reaction are swelling of the face, flushing, hypotension and dyspnea. Symptoms usually appear within a few minutes after the start of hemodialysis. These patients should be dialyzed using other membranes or using other medications to treat hypertension, or heart failure (see "Contraindications").
Increased serum potassium (hyperkalemia)
During treatment with lisinopril may increase serum concentrations of potassium (hyperkalemia), especially in the presence of renal and / or heart failure. The use of potassium-sparing diuretics or potassium intake preparations as adjunctive therapy is generally not recommended, because this can cause a significant increase in serum potassium. If concomitant use of the above products shown, serum potassium levels should be monitored periodically during treatment.
Elderly patients are affected more sensitive than Vitopril compared with younger patients. Therefore, treatment of the elderly should be done with caution. For patients over 65 years is recommended lower starting dose (2,5 mg lisinopril) and control of blood pressure and renal function, especially in early treatment.
Since safety and effectiveness in children have not been established, treatment of children with lisinopril not preporachva.Parvichen aldosteronism (a condition in which increased secretion of the hormone aldosterone by the adrenal gland) Patients with primary aldosteronism generally will not respond to blood pressure lowering drugs act by inhibiting the renin-angiotensin system. They should not be treated with lisinopril.
Protein excretion in the urine (proteinuria)
Patients with pre-existing treatment with lisinopril renal failure and those receiving relatively high doses of lisinopril may rarely get proteinuria. Patients with clinically significant proteinuria (more than 1 g of protein excretion in the urine per day) can take Vitopril only after careful consideration of the expected benefit / risk potential when given regular clinical and laboratory kontrol.LDL-lipid apheresis (purification of lipoproteins low density in patients with high blood cholesterol) hyposensitivity treatment (specific immunotherapy ") Life-threatening anaphylactic reactions are possible in patients treated with ACE inhibitors undergoing LDL (low density lipoprotein)-apheresis with ??????????????.?????????????????? anaphylactic reactions (eg, low blood pressure, shortness of breath (dyspnea), nausea, allergic skin reactions) can occur in patients using lisinopril in time. specific immunotherapy (hyposensitization) against poisoning from insects (eg, bees / wasps). In cases it is necessary LDL-apheresis or specific immunotherapy (hiposensibilizirashto treatment) against the poisoning of insects, lisinopril should be replaced with another drug for treatment of hypertension or heart failure (but not with other ACE inhibitors).
Swelling of the tissues / angioneurotic edema (see "Contraindications")
Swelling of the face, extremities, lips, tongue, glottis and / or larynx has been reported rarely in patients treated with ACE inhibitors, including. lisinopril. Swelling of the tissues can occur at any time during treatment. In case of swelling of tissues Vitopril intake should be immediately discontinued and the patient should be placed under medical emergency kontrol.V where swelling is confined to the face and lips, the condition generally - recover without specific treatment, although to eliminate the symptoms are recommended to take antihistamines.
Patients with a history of angioedema, which is not associated with the intake of ACE inhibitors have an increased risk after taking ACE inhibitor develop angioedema.
Angioedema, with involvement of the tongue, glottis, larynx can be life threatening. There is an urgent treatment including 0,3-0,5 mg subcutaneous epinephrine or adrenaline 0,1 mg slowly intravenously, after appropriate dilution, in both control blood pressure and ECG. Such patients should be taken to hospital. A medical control within 12 to 24 hours to complete disappearance of simptomite.Obstruktsiya (blockage) of the output of the left ventricle (aortic stenosis / hypertrophic cardiomyopathy), ACE inhibitors should be used with caution in patients with outlet obstruction of the left camera. In case of hemodynamically significant obstruction, lisinopril is contraindicated.
Changes in blood count (neutropenia / agranulopitoza)
Treatment with ACE inhibitors rarely associated with reducing the number to the complete disappearance of white blood cells (neutropenia or agranulocytosis) in patients with high blood pressure. These changes are rare in patients with uncomplicated hypertension and of course much more frequently in patients with renal failure, especially when accompanied with connective tissue disease (such as systemic lupus erythematosus or scleroderma) or in patients concomitantly treated with immunosuppressive drugs (immunosuppressive drugs). In such patients, periodic monitoring of white blood cells. Neutropenia and agranulocytosis are reversible after discontinuation of ACE inhibitori.Patsienti obtained during treatment with Vitopril symptoms such as fever, swollen lymph nodes, and / or sore throat, you should consult a physician immediately and explore their WBC.
There are reports of cough associated with ACE inhibitors such as lisinopril. The cough is persistent, unproductive and resolves after discontinuation of therapy.
Surgery / Anesthesia
Lisinopril block secondary formation of angiotensin II after compensatory renin release in patients undergoing major surgical interventions or ^ of anesthesia (general anesthesia) with drugs that lower blood pressure. The result is severe hypotension which can be corrected by infusion of 'volume substitute (see "Drug Interactions").
What should I observe when participating in traffic and when operating machinery and during no new ground?
Effect of lisinopril on ability to drive has not been studied. It should be borne in mind that the ability to participate actively in traffic to run machines or work without proper support, can sometimes be reduced because of dizziness or weakness.
Composition of the medicinal product:
Each tablet contains:
Active substance: 21.78 mg lisinopril dihydrate, equivalent to 20 mg lisinopril
Excipients: mannitol, calcium hydrogen phosphate dihydrate, maize strach, strach pregelatinised, silica colloidal anhydrous, magnesium stearate - mannitol, calcium hydrogen phosphate dihydrate, cornstarch, pregelatinized starch, colloidal silicon dioxide, magnesium stearate
Pharmaceutical form: Original pack of 30 tablets Original pack of 100 tablets ACE inhibitor (angiotensin-converting enzyme)
Which other drugs known to interfere with the effect of their action or Vitopril affected by Vitopril?
Life and stability of the medicinal product:
The date of expiry date is printed on the blister and carton opakovka.Ne use the product after this date!
How should I store Vitopril?
Do not store above 30 ° C.
Keep out of reach of children!