Lizinopril - instructions for use, dose, side effects, contraindications

Pregnancy and lactation:Application of the drug Lisinopril contraindicated during pregnancy, in women planning pregnancy, as well as in women of reproductive age who do not use reliable methods of contraception.
Women of reproductive age who take the drug Lisinopril should apply reliable methods of contraception.
When diagnosing pregnancy, the drug Lisinopril should be canceled as soon as possible.
Lizinopril penetrates the placenta.
The use of ACE inhibitors during pregnancy is accompanied by an increased risk of anomalies from the cardiovascular and nervous systems of the fetus. In addition, against the background of taking ACE inhibitors during pregnancy, cases of low blood pressure, premature birth, birth of children with arterial hypotension, kidney pathology (including acute kidney failure), hypoplasia of the skull bones, contractures of the limbs, craniofacial deformities, lung hypoplasia, delay intrauterine development, an open arterial duct, as well as cases of intrauterine fetal death and newborn death. Often, anhydration is diagnosed after the fetus has been irreversibly damaged. Newborns who have been exposed to ACE inhibitors in utero should be monitored for the purpose of identifying arterial hypotension, oliguria, and hyperkalemia.When oliguria occurs, blood pressure and renal perfusion should be maintained.
There is no data on the penetration of lisinopril into breast milk. A drug Lisinopril should not be prescribed during breastfeeding.

Dosing and Administration:Inside, once a day in the morning, regardless of food intake, preferably at the same time.
Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs): in patients with arterial hypertension, patients who do not receive other antihypertensive drugs are prescribed 5 mg once a day. In the absence of therapeutic effect, the dose is increased every 2-3 days by 5 mg to an average therapeutic dose of 20 mg / day. The usual maintenance daily dose is 20 mg. The maximum daily dose is 40 mg. To fully develop the effect may take 2-4 weeks, which should be taken into account when increasing the dose. If the use of the drug Lisinopril in the maximum dose does not cause a sufficient therapeutic effect, it is possible additional appointment of another antihypertensive drug.
Patients who received pre-diuretics, they must be canceled 2-3 days before the start of the drug. If it is not possible to cancel diuretics, the initial dose of the drug Lisinopril should not be more than 5 mg / day, should also monitor the kidney function and the content of potassium ions in the blood serum.
If necessary, you can resume reception of diuretics in the future.
In patients with renovascular hypertension or other conditions with increased activity of RAAS (hypovolaemia, diet with restriction of consumption of table salt, cardiac decompensation or severe hypertension), the initial dose of the drug Lisinopril is 2.5-5 mg / day (requires control of blood pressure, kidney function, the content of potassium ions in the blood serum).
The maintenance dose is set depending on the dynamics of blood pressure.
Chronic heart failure (as part of combination therapy for the treatment of patients taking cardiac glycosides and / or diuretics): an initial dose of 2.5 mg / day, with a gradual increase of 2.5 mg 3-5 days to 5-10 mg / day. The maximum daily dose is 20 mg. If possible, the dose of the diuretic should be reduced before the drug is taken Lisinopril.
Early treatment of acute myocardial infarction (in the first 24 hours, with stable indices of hemodynamics for maintaining these parameters and preventionleft ventricular dysfunction and heart failure): in the first 24 hours after the onset of the first symptoms of acute myocardial infarction with stable hemodynamic parameters (systolic pressure not lower than 100 mm Hg) - 5 mg, then 5 mg after 1 day, 10 mg after two day and then 10 mg once a day.
At the beginning of treatment or within the first 3 days after acute myocardial infarction, a lower dose of 2.5 mg is prescribed in patients with low systolic blood pressure (120 mm Hg or lower). In the case of a decrease in blood pressure (systolic blood pressure is less than or equal to 100 mm Hg), the daily dose of 5 mg, if necessary, is temporarily reduced to 2.5 mg. In the case of a long pronounced decrease in blood pressure (systolic blood pressure below 90 mm Hg for more than 1 hour), drug treatment is discontinued.
Diabetic Nephropathy (a decrease in albuminuria in patients with type 1 diabetes mellitus with normal BP and in patients with type 2 diabetes mellitus with hypertension): an initial dose of 10 mg / day, which if necessary is increased to 20 mg / day to achieve the target values of diastolic blood pressure. Chronic renal failure The dose is determined depending on the clearance of creatinine (CC): with KK 30-70 ml / min - 5-10 mg / day, with KK - 10-30 ml / min - 2.5-5 mg / day, less 10 ml / min, including patients on hemodialysis - 2.5 mg / day.The maintenance dose is determined depending on blood pressure (under the control of kidney function, the content of potassium ions and sodium in the blood). The maximum daily dose is 40 mg.

Special instructions:The pronounced decrease in blood pressure on the background of treatment most often occurs with a decrease in the volume of circulating blood caused by diuretic therapy, restriction of consumption of table salt, dialysis, diarrhea, vomiting, or in patients with severe renin-dependent hypertension. This effect is not a contraindication for further administration of the drug.
In patients with chronic heart failure, severe arterial hypotension can lead to
impaired renal function.
In some patients with chronic heart failure with normal or low blood pressure Lisinopril can also cause an additional reduction in blood pressure. This effect is also not a contraindication for the further administration of the drug.
In patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, an increase in the concentration of urea nitrogen in the blood and serum creatinine was observed in the treatment of ACE inhibitors in some cases.These changes were almost always reversible and disappeared after the withdrawal of the ACE inhibitor. These complications are especially characteristic for patients with an existing impaired renal function. If the patient also has Renovascular hypertension, the risk of severe arterial hypotension and renal failure increases. In this category of patients, treatment should begin with smaller doses of the drug Lisinopril under medical supervision.
Since the simultaneous use of diuretics is an additional risk factor for the development of arterial hypotension, they should be canceled and during the first week to monitor the function of the kidneys.
An increase in the concentration of urea nitrogen in the blood and serum creatinine was also noted in patients with hypertension without concomitant renal impairment, especially with simultaneous use of the drug Lisinopril and diuretics. These abnormalities were mild, and the rates returned to normal after drug withdrawal Lisinopril or diuretic.
In patients with acute myocardial infarction, drug therapy Lisinopril should not be started if there are signs of impaired renal function, manifested in an increase in plasma creatinine levels above 177 μmol / L and / or proteinuria above 500 mg / day. If the violation of kidney function develops on the background of taking the drug Lisinopril (the concentration of creatinine in the blood plasma is higher than 265 μmol / l or doubled with respect to the values before the start of therapy), the doctor should consider the possibility of discontinuing the drug Lisinopril.
Treatment with drug Lisinopril with acute myocardial infarction is carried out against the background of standard therapy (thrombolytics, acetylsalicylic acid (as an antiplatelet agent), beta-blockers). A drug Lisinopril it is possible to apply with a solution of nitroglycerin for intravenous administration or with nitroglycerin for administration by therapeutic transdermal systems.
It is not recommended to use the drug Lisinopril in patients who underwent acute myocardial infarction, if systolic blood pressure does not exceed 100 mm Hg.
When using drugs that reduce blood pressure in patients with extensive surgery or during general anesthesia, Lisinopril can block the formation of angiotensin II, secondary to the compensatory release of renin. Before surgery (including dental surgery), follow the
stop taking the drug for 24 hours and inform the surgeon / anesthesiologist about the use of an ACE inhibitor.
Based on the results of epidemiological studies, it is assumed that simultaneous administration of ACE inhibitors and insulin, as well as hypoglycemic drugs for oral administration may lead to the development of hypoglycemia. The greatest risk of development is observed during the first weeks of combination therapy, as well as in patients with impaired renal function. Patients with diabetes require
careful monitoring of glycemia, especially during the first month of therapy with an ACE inhibitor.
Before beginning treatment, it is necessary to compensate for the loss of fluid and salts.
In patients with risk factors for symptomatic arterial hypotension (patients who follow a diet with restricted consumption of table salt with or without hyponatremia, patients with hypovolemia or who are receiving diuretic therapy), it should be possible to adjust the condition data as far as possible before starting treatment with the drug Lisinopril.
Risk factors for the development of hyperkalemia include chronic renal failure, diabetes mellitus, and simultaneous use of potassium-sparing diuretics (spironolactone, triamterene or amiloride), potassium or salt substitutes containing potassium ions, as well as the use of drugs that are associated with an increase in serum potassium concentration (eg, heparin). It is recommended to periodically monitor the content of potassium ions in the blood plasma.
Angioedema of the face, extremities, lips, tongue, mucous membranes, epiglottis and / or larynx was noted with the use of ACE inhibitors, including the drug Lisinopril. This side effect can occur at any stage of therapy. In such cases, it is necessary to urgently cancel the use of the drug and prescribe adequate therapy. The patient should be under the supervision of a physician until the symptoms of the edema are completely regressed. It should be borne in mind that even in cases where there is only swelling of the tongue, the patient should also be under the supervision of a doctor, since therapy with antihistamines and corticosteroids may not be sufficient.Angioedema with involvement of the larynx can lead to death.
Patients who have previously undergone surgical intervention on the respiratory organs have a higher risk of developing angioedema of the larynx or tongue.
Patients who have had angioedema not associated with the administration of ACE inhibitors are at greater risk of developing such a complication with the administration of ACE inhibitors.
In patients taking ACE inhibitors during desensitization to the hymenoptera (wasps, bees), the emergence of a life threatening anaphylactoid reaction is extremely rare. It is necessary to temporarily stop treatment with an ACE inhibitor before starting the course of desensitization.
Anaphylactoid reactions can also develop with the use of ACE inhibitors in patients who have undergone apheresis of low-density lipoproteins by absorption with dextran sulfate or with simultaneous hemodialysis using high-flow membranes (including AN69®). Therefore, similar combinations should be avoided, using either other antihypertensive drugs, or alternative membranes for hemodialysis.
Dry cough appearing when using ACE inhibitors, is counter-productive, persistent and extends after
allopurinol or procainamide, or these risk factors are at the same time, especially in patients with impaired renal function. In these patients, in some cases, may develop infections that are resistant to antibiotics. In the case of drug use Lisinopril in such patients, regular monitoring of blood leukocytes should be performed.
When you see any symptoms of infection (eg, sore throat, fever), the patient should seek immediate medical attention, as they may be a manifestation of neutropenia.
In connection with the danger of developing dizziness or weakness, Lisinopril should be used with caution in patients who control transport and engage in activities that require high concentration and fast motor responses.

Form release / dosage:Tablets of 2.5, 5, 10, 20, 30, 40 mg.

Packaging:14 pieces, blisters, packs cardboard.

Storage conditions:At a temperature of no higher than 25 ° C.

Shelf life:2 years.

Terms of leave from pharmacies:On prescription

Registration number:LP-001207

Date of registration:15.11.2011 / 28.08.2013

Expiration Date:15.11.2016

The owner of the registration certificate:Aurobindo Pharma Co., Ltd.Aurobindo Pharma Co., Ltd. India

Manufacturer: & nbsp

AUROBINDO PHARMA, Ltd. India

Representation: & nbspAurobindo Pharma, ZAOAurobindo Pharma, ZAO

Information update date: & nbsp2016-11-15

Illustrated instructions

Instructions

Lisinopril (Lisinopril)