Linipril . 20 mg. 30 tablets
Linipril . 20 mg. 30 tablets
Linipril is a product of the group of so-called. ACE inhibitors. Its therapeutic effect is in reducing high blood pressure, but in lower doses to help treat heart failure.
Hypertension (high blood pressure);
In the complex therapy of heart failure.
In addition to standard therapy for acute myocardial infarction in the first 24 hours of its occurrence in hemodynamically stable patients (normal blood pressure).
INFORMATION REQUIRED BEFORE USE
Hypersensitivity to the active substance or to any of the ingredients contained in the product;
History of angioneurotic edema (swelling of the tongue, the mouth and / or throat) with previous treatment with an ACE inhibitor or in patients with congenital or idiopathic angioedema;
Pregnancy and lactation
SPECIAL PRECAUTIONS FOR USE
Allergy / angioneurotic edema:
Angioneurotic edema (swelling of the face, extremities, lips, tongue and / or throat) have been reported infrequently in patients treated with ACE inhibitors, including lisinopril. In this case, the application of Linipril should be discontinued immediately and appropriate therapy and provide patient supervision until complete and sustained resolution of symptoms. In case of limited edema of the face and lips, the condition can recover without treatment, but can be used anti-allergic (eg antihistamines) to relieve symptoms. Angioedema, combined with swelling of the throat and vocal cords, can be life-threatening. When it is accompanied by obstruction (narrowing) of the airways should immediately conduct appropriate therapy, eg. adrenaline administration and take appropriate measures to airway clearance. Patients with a history of preceding angioedema unrelated to ACE inhibitors may be at increased risk of developing at treatment with an ACE inhibitor.
Black patients are at increased risk of angioedema with ACE inhibitors compared with those of Caucasians. Desensitization (therapy to limit some of the symptoms of allergic diseases):
Patients receiving ACE inhibitors during the therapy may occur permanent anaphylactoid reactions (a type of allergic reaction). These effects can be avoided by ACE inhibitors temporarily discontinued. Hypotension (low blood pressure)
There was extreme fall in blood pressure during treatment with lisinopril. As a possible reason for this phenomenon is considered impaired salt content decreased volume of circulating blood, treatment with potent diuretics, patients on hemodialysis. Rarely occurs in patients with uncomplicated form of hypertension. Excessive hypotension has been observed in patients with severe congestive heart failure with or without associated renal insufficiency, and can occur with oliguria (decreased urine output) and / or progressive azotemia (increase of residual nitrogen units), rarely with acute renal failure, including fatal. Due to the risk of sudden sharp drop in blood pressure in these groups of patients, therapy should be initiated under medical supervision. These patients need to be monitored during the first two weeks of therapy and when increasing the dose of Linipril and / or diuretic. This behavior also applies to patients suffering from ischemic heart disease or cerebrovascular disease, where the sharp drop in blood pressure could result in myocardial infarction or cerebrovascular accident. In the event of a sharp drop in blood pressure, the patient should be placed in a horizontal position and need to apply a saline infusion. Transient decrease in blood pressure is not a contraindication to further Linipril in adequate doses.
Renovascular hypertension / renal artery stenosis:
There is a risk of extremely low blood
pressure and the development of renal failure in patients with renovascular hypertension and present bilateral stenosis of the renal arteries or arterial stenosis in a solitary kidney treated with Lisinopril.
Narrowing of the aortic and / or mitral valve and hypertrophic cardiomyopathy:
ACE inhibitors should be used with caution in patients with outflow left ventricular blood flow, it is not desirable for their use in hemodynamically significant obstruction.
It is necessary to assess renal function prior to initiation of treatment with Linipril ®.
Impaired renal function:
In hypertensive patients with unilateral or bilateral renal artery stenosis may experience increases in blood urea nitrogen and serum creatinine. This is usually reversible after discontinuation of Linipril ®. In these cases, monitoring of renal function of patients in the first few weeks of Linipril .
There is slight and transient increase in nitrogen bodies in the blood of hypertensive patients with pre-existing renal vascular disease, which occurs more often if Linipril ® is co-administered with a diuretic. These patients may require a dose adjustment, and
discontinuing diuretic therapy.
Cases of anaphylactoid (allergic type) reactions in dialysis patients treated concomitantly with an ACE inhibitor. During Linipril is not recommended during hemodialysis and hemofiltration high flux membranes. In such patients should be considered the possibility of using a different type of dialysis membrane or another antihypertensive drug class. Hyperkalemia (serum potassium):
Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements and / or potassium-containing salt substitutes, which should be used with caution in combination with Linipril .
Primary aldosteronism (a disorder of the adrenal glands): Patients with primary aldosteronism were not affected by treatment with antihypertensive drugs from the group of ACE inhibitors, as is Linipril . Surgery / Anesthesia:
In patients under major surgery or during anesthesia with agents leading to blood pressure reduction, Linipril may aggravate the manifestations of hypotension which can be corrected by infusion of water-salt solutions. Changes in the blood (neutropenia and agranulocytosis): Such changes occur rarely in uncomplicated patients but honors in patients with impaired renal function, especially in those with systemic connective tissue diseases (lupus erythematosus, scleroderma) or immunosuppressive therapy (immunosuppressive drugs). They are reversible and disappear after cessation of therapy. In such patients, periodic monitoring of the leukocyte number.
When treated with ACE inhibitors may be observed occurrence of cough. Typical of it is that it is dry, persistent and resolves after discontinuation of therapy.
DRUG INTERACTIONS AND OTHER
Administration of diuretics enhances antihypertensive (blood pressure lowering) effect of Linipril . A sharp fall in blood pressure in early Linipril in patients treated with diuretics.
These effects Linipril can be prevented if you discontinue diuretic or increasing salt intake at baseline. If you need to continue treatment with diuretic therapy be initiated at a reduced dose Linipril under medical supervision.
There is increasing serum potassium during Linipril ®. Risk factors for Renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride, etc..), Potassium supplements or potassium-containing salt substitutes.
Analgetshtite and anti-inflammatory drugs (eg, acetylsalicylic acid, indomethacin.) May reduce the antihypertensive effectiveness Linipril co-administered.
Lithium: Diuretics and ACE inhibitors reduce renal excretion of lithium and increase the risk of lithium toxicity. The effects of lithium toxicity are reversible Linipril ®. Concurrent use of lithium Linipril ® products and need frequent monitoring of serum lithium. Alkohohalat is increasing antihypertensive effect of ACE inhibitors. Sympathomimetic may reduce the antihypertensive effect of ACE inhibitors.
In conjunction Linipril applications with propranolol, hydrochlorothiazide, nitrates and / or digoxin did not result in clinically relevant pharmacological interactions.
WARNINGS in special patient groups
Use in children:
No studies on efficacy and safety in children.
Use in the elderly:
Clinical trials investigating the effectiveness and safety of lisinopril administration on the elderly and younger showed no differences, but because there is a higher serum level of lisinopril, caution is advised when treating elderly patients. Hemodialysis patients:
The method of Linipril in patients on hemodialysis is determined according to the degree of renal impairment and creatinine clearance.
Pregnancy and lactation
Use in pregnancy:
ACE inhibitors can cause injury and death to the fetus if given to pregnant women. When pregnancy during Linipril ® to prompt discontinuation of the product.
The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with damage to the fetus and newborn, including hypotension, underdeveloped skull, anuria, reversible or irreversible renal failure and death. Cases with oligohydramnios (excess amniotic fluid), probably due to decreased fetal renal function. In such cases, oligohydramnios combined with contractures of the limbs of the fetus, maxillofacial deformities and immaturity of the lung. These adverse effects do not appear to result from intrauterine exposure of the fetus, which is limited in the first quarter. Mothers whose embryos and fetuses are exposed to the action of ACE inhibitors only during the first trimester should be informed. If the patient treated Linipril ® pregnant need immediate discontinuation of drug.
Infants with a history of in utero exposure to the action of Linipril ® should be carefully examined for hypotension, oliguria and hyperkalemia.
Lisinopril, which crosses the placenta can be removed from the neonatal circulation by peritoneal dialysis or exchange transfusion.
Use during lactation:
Lisinopril passes into breast milk. If its application is necessary, the patient should stop nursing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
In early Linipril can be a temporary occurrence of fatigue and dizziness, which can affect the ability to drive and use machines.
INFORMATION FOR PROPER USE DOSAGE AND METHOD OF USE
A prescription. Administered orally.
The starting dose in patients not previously treated with other blood pressure lowering products is 5 mg once daily in the morning. Possible adjustment of dosage depending on the degree of effect on blood pressure. The usual maintenance dose is 10-20 mg once daily. Optimum effect is achieved after 2 to 4 weeks of treatment. Doses over 40 mg do not always lead to higher impact. In this case, it is recommended that combination therapy with low-dose diuretic, which has an additional effect. The maximum daily dose should not exceed 80 mg.
Patients treated with diuretics:
In the case of prior treatment with diuretics, it should be stopped 2-3 days prior to Linipril ®, to avoid eventual symptomatic hypotension. Initial therapeutic dose in these cases should not exceed 5 mg, it is desirable medical supervision during therapy to achieve a lasting stabilization of blood pressure.
Renal vascular hypertension:
In patients with renal vascular hypertension or bilateral stenosis of the renal arteries, as well as narrowing of the artery to a solitary kidney early Linipril can cause excessive strong therapeutic effect. Therefore, the recommended initial dose of 2,5 mg followed by a gradual increase until an optimal maintenance dose.
In the complex therapy of heart failure:
Administered concurrently with diuretics and digitalis drugs. The initial therapeutic dose is 2,5 mg in the morning followed by a gradual increase until an optimal maintenance dose of 5-10 mg once daily. Not recommended total daily dose exceeds 20 mg.
Acute myocardial infarction in haemodynamically stable patients (normal blood pressure)
For the treatment of acute myocardial infarction Linipril ® should be used in addition to standard therapy, including with symptomatic applied nitrates.
In hemodynamically stable patients, treatment can begin within 24 hours of infarction. The first dose should be 5 mg Linipril ®, followed by 5 mg after 24 hours, 10 mg after 48 hours, then 10 mg once daily.
Patients with a low systolic blood pressure (less than 120 mmHg) at baseline or during the first 3 days after the infarct should be treated with a lower dose - 2,5 mg. In the presence of hypotension (systolic BP less than 100 mmHg), the daily dose should be 5 mg with maximum reduction if necessary to 2,5 mg. If hypotension (systolic arterial pressure below 90 mmHg for more than 1 hour), although dose reduction to 2,5 mg per day Linipril ® should be discontinued.
Treatment should continue for six weeks. The lowest maintenance dose is 5 mg daily. Patients with heart failure should continue treatment. Dosage in renal impairment:
Dosage in patients with impaired renal function is determined according to the creatinine clearance.
Dosage in the elderly:
Although there were no significant differences in efficacy and side effects, caution is required in determining the dose for the treatment of elderly patients, because there is a higher serum levels with equivalent doses of lisinopril. Children:
This product is not recommended for children. Its safety and efficacy have not been established.
In clinical overdose, symptomatic and supportive treatment. Linipril therapy should be discontinued and the patient should be put under strict medical supervision. Therapeutic measures depend on the nature and severity of clinical symptoms and include measures to reduce the passage of drug into the blood and accelerate its elimination from the body. Typical symptoms of overdose are very low blood pressure, electrolyte imbalance and kidney failure. If a severe hypotension, the patient should be placed in the supine position and be rapidly infused the right amount of saline. Lisinopril can be removed by hemodialysis. A regular monitoring of serum electrolytes and creatinine.
Lisinopril is generally well tolerated. Established side effects are usually mild and transient, and in most cases do not require interruption of therapy, the most common are dizziness, vertigo, headache, fatigue, cough.
Cough, rhinitis, sinusitis, bronchitis, dyspnea sometimes, rarely bronchospasm. Also been reported isolated cases of severe lung injury (pneumonitis, respiratory distress, pulmonary edema).
Anaphylactoid reactions, chest discomfort, chills, flushing, malaise, fatigue.
Sydova Cardiovascular System:
Rare cases of angina pectoris, myocardial infarction, transient ischemic TIA or cerebrovascular accident, which are secondary to a sharp drop in blood pressure. Other possible events: the occurrence of orthostatic hypotension (when standing), palpitations, arrhythmias, and rarely peripheral edema.