Instructions for use LIPRAZID
In patients with dehydration and electrolyte imbalance due to previous diuretic treatment, arterial hypotension may occur after taking Liprazide. To prevent it, diuretics should be stopped 2-3 days before starting Liprazide treatment.
Before prescribing Liprazide, patients should be informed about possible signs of angioedema (difficulty swallowing and breathing, swelling of the face, limbs, eyes, lips, tongue) in order to promptly stop taking the drug and seek medical help.
Liprazide is prescribed with caution to patients with hyperkalemia, aortic stenosis, impaired function or progressive liver disease.
Caution should be exercised when using Liprazide in patients who are planning to undergo surgery under anesthesia.
Caution should be exercised when prescribing Liprazide to patients with impaired renal function, hypovolemia (there is a risk of developing hypotension), collagenosis, persons on a diet with limited sodium content and on hemodialysis. Treatment of these patients should begin with the administration of lower doses of the drug.
The effectiveness and tolerability of the drug is the same in patients of different age groups, but when using the drug in elderly people, it should be taken into account that in patients of this group the elimination of lisinopril and hydrochlorothiazide from the body slows down.
The drug should be used with particular caution in patients with coronary artery disease and with cerebrovascular disorders, since severe hypotension in them can lead to the development of myocardial infarction or ischemic stroke.
The drug is prescribed with caution to patients with mitral and/or aortic stenosis, an obstructive form of hypertrophic cardiomyopathy.
In patients with severe heart failure, ACE inhibitors can cause arterial hypotension, sometimes oliguria, and azotemia.
In patients with renal artery stenosis, when taking ACE inhibitors, the level of glomerular filtration may decrease, which leads to further impairment of renal function, therefore prescribing the drug to such patients is not recommended. Taking Liprazide is also not recommended for patients with renal failure with CC < 30 ml/min.
Chronic use of hydrochlorothiazide reduces uric acid excretion and may contribute to the development of gout.
Hydrochlorothiazide may reduce glucose tolerance, so patients with diabetes need to adjust the dose of hypoglycemic agents, including insulin.
Patients with hypovolemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia should restore fluid and electrolyte balance before starting treatment and regularly monitor serum electrolyte levels.
Hydrochlorothiazide may reduce urinary calcium excretion, causing a slight increase in serum calcium concentrations. Significant hypercalcemia may be a sign of hidden hyperparathyroidism, so it is recommended to discontinue thiazide diuretics until parathyroid function is examined.
In patients taking ACE inhibitors, certain types of membrane filters for hemodialysis, hemofiltration or apheresis (polyacrylonitrile, methylsulfonate) may cause anaphylactic reactions.
During treatment with Liprazide, exposure to the sun should be limited (risk of developing photosensitivity).
During treatment with Liprazide, alcohol consumption is not recommended.
Use in pediatrics
The effectiveness and safety of the drug in childhood and adolescence have not been studied, therefore Liprazide should be used only for the treatment of adults.
Impact on the ability to drive vehicles and operate machinery
Due to the risk of arterial hypotension, it is not recommended to drive vehicles or operate other machinery for several hours after taking the drug.
The question of the ability to engage in activities that require concentration and speed of psychomotor reactions should be decided only after assessing the patient’s individual response to the drug.
Liprazid 20 tablets 20mg/12.5mg No. 10x3
Name
Liprazid 20 tablets 20 mg 12.5 mg No. 10x3
Basic physical and chemical properties
Liprazid 10 is a round tablet with a biconvex surface, light yellow in color with a brownish tint. Marbling and inclusions from yellow to brown are allowed on the surface of the tablets. Liprazid 20 is a round tablet with a biconvex surface, pink in color. Marbling and inclusions of red-brown color are allowed on the surface of the tablets.
Compound
active ingredients: lisinopril and hydrochlorothiazide; composition: 1 tablet of Liprazide 10 contains lisinopril - 10 mg, which corresponds to lisinopril dihydrate - 10.89 mg and hydrochlorothiazide - 12.5 mg; 1 tablet of Liprazide 20 contains lisinopril - 20 mg, which corresponds to lisinopril dihydrate - 21.78 mg and hydrochlorothiazide - 12.5 mg; excipients: Liprazide 10 - mannitol (E 421), corn starch, magnesium stearate, yellow iron oxide (E 172), calcium hydrogen phosphate dihydrate. Liprazide 20 - mannitol (E 421), corn starch, magnesium stearate, red iron oxide (E 172), calcium hydrogen phosphate dihydrate.
Pharmacotherapeutic group
Drugs affecting the renin-angiotensin system. ACE inhibitors in combination with other drugs. ACE inhibitors and diuretics. ATS code C09B A03.
Indications
Mild to moderate arterial hypertension in patients whose condition is already adequately controlled by simultaneous administration of lisinopril and hydrochlorothiazide in the same doses as Liprazide.
Contraindications
Hypersensitivity to lisinopril, hydrochlorothiazide, other components of the drug or other ACE inhibitors; hypersensitivity to sulfonamide derivatives; history of hereditary or idiopathic angioedema (Quincke's edema); history of angioedema caused by taking ACE inhibitors; bilateral renal artery stenosis or renal artery stenosis of a single kidney; mitral or aortic stenosis, hypertrophic cardiomyopathy with severe hemodynamic disturbances; acute myocardial infarction with unstable hemodynamics; cardiogenic shock; severe renal (creatinine clearance
Precautionary measures
Non-melanoma skin cancer. Increased risk of non-melanoma skin cancer (NMSC)
basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)
with increasing cumulative dose of hydrochlorothiazide was demonstrated in two pharmacoepidemiological studies based on data from the Danish National Cancer Registry. The photosensitizing effect of hydrochlorothiazide may act as a possible mechanism for the development of this pathology. Patients taking hydrochlorothiazide alone or in combination with other drugs should be informed of the risk of developing NMSC, especially with long-term use, the need for regular skin checks, and to promptly report any suspicious skin growths, any changes in skin lesions or moles . To reduce the risk of developing skin cancer, patients should be advised of possible preventative measures, such as limiting exposure to sunlight and UV radiation, and if exposed, the need for adequate skin protection. It is necessary to examine suspicious skin lesions as soon as possible, including histological examination of biopsy material. Patients with a history of NMSC may also need to reconsider the use of hydrochlorothiazide. Symptomatic hypotension and previous treatment with diuretics. In patients with dehydration and electrolyte imbalance due to previous diuretic treatment, or with dehydration of a different origin (excessive sweating, prolonged vomiting, profuse diarrhea), symptomatic arterial hypotension may occur after taking Liprazide. To prevent it, the use of diuretics must be stopped 2-3 days before starting Liprazide treatment. If this is not possible, treatment should begin with a dose of 5 mg (in terms of lisinopril). In patients at increased risk of symptomatic hypotension, treatment should be initiated under medical supervision and with periodic monitoring of serum electrolyte levels. In case of arterial hypotension, the patient should be in a supine position, and if necessary, saline solution should be administered intravenously. A temporary hypotensive reaction is not a contraindication to further treatment; to further restore the effective blood volume and blood pressure (BP), it is necessary to reduce the dose or switch to monotherapy with one of the active components of the drug. When changing the dose, monitoring should be especially careful. Electrolyte imbalance. As with any diuretic treatment, patients should periodically determine serum electrolyte levels. Thiazides, including hydrochlorothiazide, can cause water and electrolyte imbalance (hypokalemia, hyponatremia, hypochloremic alkalosis). Symptoms of water and electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle weakness, hypotension, oliguria, tachycardia, and gastrointestinal disorders such as nausea and vomiting. In hot weather, patients prone to edema may develop hyponatremia. Chloride deficiency is usually mild and does not require treatment. Thiazides may increase renal excretion of magnesium, which may lead to hypomagnesemia. Aortic stenosis/hypertrophic cardiomyopathy. ACE inhibitors should be prescribed with caution to patients with left ventricular outflow tract obstruction. Prescribe with caution to patients with coronary heart disease or cerebrovascular disease, since a pronounced decrease in blood pressure can cause myocardial infarction or cerebrovascular stroke. Surgery/general anesthesia. Caution should be exercised when using Liprazide in patients who are planning to undergo surgery under anesthesia, since during major surgical interventions and the use of other drugs that cause a decrease in blood pressure, lisinopril, by blocking the formation of angiotensin II, can cause a pronounced, unpredictable decrease in blood pressure. Hypotension of this origin can be eliminated by compensation of intravascular fluid. Metabolic and endocrine effects. Thiazide therapy may reduce glucose tolerance. Doses of antidiabetic agents, including insulin, may need to be adjusted. Thiazides may reduce urinary calcium excretion and cause a transient and slight increase in serum calcium. Hypercalcemia may indicate hidden hyperparathyroidism. Thiazides should be discontinued before parathyroid function tests are performed. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Thiazide diuretic therapy may precipitate hyperuricemia and/or gout in some patients. However, lisinopril may increase the excretion of uric acid and thus may reduce the hyperuricemic effect of hydrochlorothiazide. Patients with diabetes mellitus. In diabetic patients taking oral antidiabetic agents or insulin, careful glycemic control should be exercised, especially during the first month of ACE inhibitor therapy. Manifestation of latent diabetes is possible. Hypersensitivity/angioedema. Angioedema of the face, upper and lower extremities, lips, tongue, epiglottis and/or larynx has rarely been reported in patients taking ACE inhibitors, including lisinopril. This can happen at any time during therapy. In such cases, the use of Liprazide should be stopped immediately, appropriate treatment should be administered and the patient should be closely monitored until symptoms disappear completely. Even in cases where swelling is limited only to the tongue and there are no signs of respiratory distress, the patient's condition should be monitored, since treatment with antihistamines and corticosteroids may not be sufficient. Very rarely, deaths due to angioedema of the larynx or tongue have been reported. If swelling extends to the tongue, vocal cords, or larynx, airway obstruction may occur, especially in patients who have previously undergone respiratory surgery. In such cases, it is necessary to take emergency treatment measures (administration of adrenaline (epinephrine) and/or maintaining airway patency). The patient should be under medical supervision until symptoms disappear completely and permanently. Patients with a history of angioedema not related to ACE inhibitor therapy may be at risk of developing angioedema while receiving an ACE inhibitor. Patients receiving thiazide therapy may experience hypersensitivity reactions (with or without a history of allergies or asthma). The use of the drug may worsen the course of connective tissue diseases, including systemic lupus erythematosus. Patients on hemodialysis. The use of lisinopril/hydrochlorothiazide is not indicated in patients with renal failure requiring hemodialysis. It is also not prescribed to patients with a transplanted kidney. The development of anaphylactic reactions has been reported in patients who underwent hemodialysis using high-precision membranes (for example AN 69) and simultaneously used ACE inhibitors. These patients may need to use a different type of dialysis membrane or a different class of antihypertensive drug. Anaphylactoid reactions during low-density lipoprotein (LDL) apheresis. Life-threatening anaphylactoid reactions have rarely developed in patients treated with ACE inhibitors during low-density lipoprotein (LDL) apheresis using dextran sulfate absorption. To avoid these reactions, ACE inhibitors should be suspended before each apheresis procedure. Anaphylactoid reactions during desensitizing therapy. Patients receiving ACE inhibitors during desensitization with an allergen from hymenoptera venom (for example, bee venom) developed anaphylactoid reactions. If such patients refrained from taking ACE inhibitors during desensitization, no reactions were observed, but accidental administration of ACE inhibitors provoked anaphylactoid reactions. Cough. A nonproductive/persistent cough is characteristic, which is observed when taking ACE inhibitors and disappears after discontinuation of therapy. Cough caused by an ACE inhibitor must be differentiated from cough caused by other diseases. Salt-free diet. The drug should be prescribed with caution to patients on a salt-free diet. Renal dysfunction. Thiazides may be inappropriate diuretics for use in patients with renal impairment and are ineffective when creatinine clearance is 30 mL/min or lower (moderate to severe renal impairment). Liprazide should not be administered to patients with renal impairment (creatinine clearance less than 80 ml/min), unless dose titration of the individual active substances of the drug is used to achieve an acceptable dose that is present in the combination. Some patients with arterial hypertension without obvious signs of damage to the blood vessels of the kidneys may experience a slight temporary increase in serum urea and creatinine levels, especially when lisinopril was used concomitantly with diuretics. This occurs more often in patients with pre-existing kidney dysfunction. This condition requires dose reduction and/or discontinuation of the diuretic and/or Liprazide. In some patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney, ACE inhibitors increase serum urea and creatinine levels; Typically, these effects disappear after stopping the medications. The likelihood of such events is especially high in patients with renal failure. The presence of renovascular hypertension increases the risk of developing severe arterial hypotension and renal failure. Treatment of such patients should begin under medical supervision with low doses and subsequently with careful titration of the dose. Since diuretics may precipitate the condition described above, renal function should be carefully monitored during the first weeks of treatment with lisinopril/hydrochlorothiazide. Liver diseases. Thiazides should be used with caution in patients with impaired liver function or progressive liver disease, since minor changes in water-salt and electrolyte balance can cause sudden hepatic coma. Very rarely, a syndrome that begins with cholestatic jaundice or hepatitis and progresses to liver necrosis, sometimes fatal, has been associated with the use of ACE inhibitors. The mechanism of this syndrome is unknown. If patients taking ACE inhibitors develop jaundice or significantly increase the activity of liver enzymes, the drug should be discontinued and the patient should be kept under medical supervision until symptoms disappear. Elderly persons. Treatment begins with the lower limit of the dose of Liprazide (10 mg + 12.5 mg) due to the fact that the likelihood of deterioration in liver, kidney and heart function is higher due to concomitant diseases and the use of other medications. When selecting doses, safety precautions (monitoring renal function) should be observed. Neutropenia/agranulocytosis. Neutropenia/agranulocytosis, thrombocytopenia and anemia may develop in patients taking ACE inhibitors. With normal renal function and in the absence of complications, neutropenia rarely develops. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of ACE inhibitors. Liprazide should be used with particular caution in patients with connective tissue disease with vascular manifestations, those receiving treatment with immunosuppressants, allopurinol or procainamide, or a combination of these factors, especially in the presence of pre-existing renal impairment. Some of these patients develop severe infections that sometimes do not respond to intensive antibiotic therapy. When using Liprazide in this group of patients, periodic monitoring of leukocytes is recommended, and the patient should be warned about the need to inform the doctor of any signs of infection. Hyperkalemia. In some patients, when taking ACE inhibitors, including lisinopril, an increase in serum potassium concentrations was noted. Risk factors for hyperkalemia include renal failure or diabetes mellitus, concomitant use of potassium-sparing diuretics, dietary supplements containing potassium or potassium salt substitutes, or other drugs that cause an increase in serum potassium concentrations (eg, heparin). If taking the above drugs during treatment with ACE inhibitors is determined to be necessary, regular monitoring of serum potassium levels is recommended. Lithium. Concomitant use of lithium and lisinopril is generally not recommended. Dual blockade of the renin-angiotensin-aldosterone system (RAAS). Double blockade of the RAAS with simultaneous use of ACE inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), direct renin inhibitors (for example, aliskiren) is associated with an increased risk of arterial hypotension, hyperkalemia, and renal dysfunction (including acute renal disease). failure) compared to monotherapy. If this combination is necessary, blood pressure, renal function and blood electrolytes should be carefully monitored in patients taking lisinopril and other drugs that affect the RAAS. The use of aliskiren in combination with BRAN or ACE inhibitors is contraindicated in patients with diabetes mellitus or impaired renal function (GFR
Children
Contraindicated for children.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy is contraindicated, since hydrochlorothiazide reduces maternal plasma volume, uteroplacental blood supply and penetrates the placental barrier. There is a risk of the fetus developing fetal or neonatal jaundice, thrombocytopenia and other harmful effects. Epidemiological data on the risk of teratogenicity when taking ACE inhibitors in the first trimester of pregnancy do not allow us to make a final conclusion, but a slight increase in risk cannot be excluded. Except in cases where therapy with ACE inhibitors should be considered irreplaceable and justified, patients planning pregnancy should be switched to alternative antihypertensive therapy with drugs with a proven safety profile for pregnant women. If pregnancy occurs, the ACE inhibitor should be discontinued immediately and, if necessary, alternative antihypertensive therapy should be prescribed. Newborns whose mothers took ACE inhibitors should be carefully monitored due to the possibility of arterial hypotension, oliguria and hyperkalemia developing in such newborns. Since there is no information regarding the use of lisinopril/hydrochlorothiazide during breastfeeding, the drug is contraindicated in women who are breastfeeding. Alternative antihypertensive therapy with drugs with a proven safety profile is recommended for breastfeeding women, especially when feeding a newborn or premature infant.
The ability to influence the reaction rate when driving a vehicle or working with other mechanisms
Due to the risk of adverse reactions such as dizziness (especially at the beginning of treatment), confusion, and arterial hypotension, it is not recommended to drive vehicles or operate other mechanisms until the patient’s individual response is determined.
Interaction with other drugs
Lisinopril with: direct renin inhibitors (for example, aliskiren-containing drugs), ARB II: the risk of arterial hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) increases. Combination of ACE inhibitors, incl. lisinopril, with aliskiren-containing drugs is contraindicated in patients with diabetes mellitus or impaired renal function (GFR
Directions for use and dosage
The drug is prescribed taking into account the doses of lisinopril or hydrochlorothiazide, which were used in monotherapy. The dose and duration of treatment are selected individually depending on the therapeutic effect and severity of the disease. The usual dose is 1 tablet of Liprazide 10 or Liprazide 20 per day. The drug should be taken at approximately the same time every day. If the desired therapeutic effect is not achieved within 2-4 weeks, the dose should be increased to 2 tablets. The maximum daily dose (in terms of lisinopril) is 40 mg. Renal failure Liprazide 10 or Liprazide 20 should not be used as initial therapy in these patients. Thiazides are not usually used in patients with impaired renal function; they are not effective when creatinine clearance is 30 ml/min or lower (i.e., with moderate to severe renal impairment). In patients with creatinine clearance > 30 and
Overdose
Symptoms associated with an overdose of ACE inhibitors: arterial hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough. To treat an overdose, administration of saline is recommended. In case of arterial hypotension, the patient should be placed on his back with his legs elevated. If necessary, infusion of angiotensin II and/or intravenous catecholamines is possible. If the drug has been used recently, measures should be taken to eliminate lisinopril (stimulating vomiting, gastric lavage, administration of absorbents and sodium sulfate). Lisinopril can be removed from the body by hemodialysis. Therapy with cardiac stimulants is indicated in the event of bradycardia that is resistant to treatment with other therapeutic agents. Vital signs, serum electrolyte balance, and creatinine concentrations should be continuously monitored. Symptoms caused by an overdose of hydrochlorothiazide: increased diuresis, depression of consciousness (including coma), convulsions, paresis, arrhythmia, renal failure. Bradycardia or vagal reactions can be eliminated by the use of atropine. In the case of concomitant use of digitalis drugs, hypokalemia may develop, which increases the risk of arrhythmia.
Best before date
3 years. The expiration date is the last day of the month indicated on the packaging. Do not use the drug after the expiration date indicated on the package!
Storage conditions
Store in original packaging to protect from light at temperatures not exceeding 25 °C. If the blister pack is removed from the pack, it must be protected from light. Keep out of the reach of children.
Package
10 tablets in a blister made of polyvinyl chloride film and aluminum foil, coated on one side with thermovarnish and printed on the other side. 3 blisters along with instructions for medical use of the drug in a cardboard pack.
Vacation conditions
On prescription.
