Lizinopril 10 NL KRKA 10 mg / 12.5 mg tablet number 30

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer -
Registration certificate UA/12685/01/01
The main medicament Lisinopril
morion code 228831

Lisinopril 10 NL KRKA (Lisinopril 10 NL KRKA) user's manual

Composition

active ingredients: 1 tablet contains 10 mg of lisinopril in the form of lisinopril dihydrate and 12.5 mg of hydrochlorothiazide or 20 mg of lisinopril in the form of lisinopril dihydrate and 12.5 mg of hydrochlorothiazide

auxiliary substances: mannitol (E 421), calcium hydrophosphate dihydrate, corn starch, croscarmellose sodium, magnesium stearate.

Lizinopril 10 NL KRKA: iron oxide red (E172), iron oxide yellow (E 172).

Dosage form.

Pills.

Pharmacological group

ACE inhibitors and diuretics. ATS code C09B A03.

Indications

Lizinopril 10 NL KRKA or lisinopril 20 NL KRKA are indicated for the therapy of mild and moderate arterial hypertension in patients whose condition was stabilized as a result of the use of lisinopril and hydrochlorothiazide separately in the same proportions.

Contraindications.

  • Hypersensitivity to any ingredient in the drug or to any sulfanilamide preparations.
  • Anuria.
  • Presence in the anamnesis of angioedema, associated with previous treatment with ACE inhibitors, hereditary or idiopathic angioedema.
  • Childhood.
  • Hemodynamically significant aortic or mitral stenosis or hypertrophic cardiomyopathy with obstruction of outflow tracts.
  • Patients with unstable hemodynamics after acute myocardial infarction, cardiogenic shock.
  • Stenosis of the renal artery (bilateral or unilateral).
  • Primary hyperaldosteronism.
  • Hypokalemia.
  • The period of breastfeeding.
  • Pregnant women or women planning to become pregnant (see the section on "Application during pregnancy and lactation").

Method of administration and dose.

essential hypertension

The usual dose of lisinopril 10 NL KRKA or LYZINOPRIL 20 NL KRKA is 1 tablet, which is taken once a day. If the desired therapeutic effect can not be achieved with this dosage for 2-4 weeks, the dose can be increased to 2 tablets Lizinopril 10 NL KRKA in the case of taking Lysinopril 10 NL KRKA or 2 tablets Lizinopril 20 NL KRKA in case of taking Lysinopril 20 NL KRKA, which are accepted once a day.

Patients who take diuretics

Symptomatic hypotension may occur after starting Lysinopril 10 NL KRKA or LISINOPRIL 20 NL KRKA; this is likely in patients with dehydration and / or impaired salt balance as a result of previous intake of diuretics. Reception of diuretics should be discontinued 2-3 days before the start of therapy with lisinopril 10 NL KRKA or LIZINOPRIL 20 NL KRKA. If this is not possible, treatment should be started only with lisinopril in a dose of 2.5 mg. To do this, use another preparation of lisinopril with the possibility of this dosing.

The maximum daily dose of lisinopril is 80 mg.

Dose adjustment for renal dysfunction

Thiazides can not be used as diuretics to patients with impaired renal function and are ineffective at creatinine clearance values of 30 ml / min or lower (moderate or severe renal failure).

Patients with a creatinine clearance> 30 and <80 ml / min can use Lysinopril 10 NL KRKA or LYZINOPRIL 20 NL KRKA, but only after titrating the individual components.

Older patients do not need any dose adjustment.

Adverse Reactions

  • Very often (³1 / 10).
  • Often (³1 / 100 - <1/10).
  • Infrequently (³1 / 1000 - <1/100).
  • Rarely (³1 / 10000 - <1/1000).
  • Very rarely (<1/10000), the frequency is unknown.

Within each group in frequency, adverse reactions are presented in order of decreasing severity.

Frequent reported adverse reactions were cough, dizziness, hypotension and headache, which can occur in 1-10% of patients.

lisinopril

often infrequently rarely Rarely
On the part of the blood and lymphatic system Reduction of hemoglobin, decrease in hematocrit Suppression of bone marrow, anemia, thrombocytopenia, leukopenia, neutropenia, agranulotsy-toz, hemolytic anemia, lymphadenopathy, autoimmune diseases
From the side of metabolism and digestion hypoglycemia
mental disorders Changes in mood, symptoms of depression confusion
From the nervous system Seizures, headache, loss of consciousness Paresthesia, vertigo, taste disorder, sleep disturbance
From the side of the cardiovascular system Orthogonal effects (including ortotyh political hypotension) Myocardial infarction or stroke may be secondary to excessive hypotension in high-risk patients, palpitations, tachycardia, Raynaud's syndrome Heart palpitations, discomfort in the sternum
On the part of the respiratory system, chest and mediastinal organs Cough, chest pain rhinitis Bronchospasm, sinusitis, allergic alveolitis, eosinophilic pneumonia
From the gastrointestinal tract Diarrhea, vomiting Nausea, abdominal pain and digestive disorders Dry mouth Pancreatitis, angioedema, intestinal edema
From the hepatobiliary system * Increased level of hepatic enzymes and bilirubin Hepatitis hepatocellular or cholestatic, jaundice and liver failure
From the skin and subcutaneous tissues ** rashes pruritus Hypersensitivity / angioneurotic edema of the face, extremities, lips, tongue, glottis and / or larynx, urticaria, alopecia, psoriasis Increased sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous lymphocytoma
From the side of the kidneys and urinary tract Impaired renal function Uremia, acute renal failure, proteinuria Oliguria / anuria
On the part of the reproductive system and mammary glands impotence gynecomastia
General violations and violations introduction Fatigue, asthenia
on research Increased urea in the blood, serum creatinine, hyperkalemia hyponatremia

* Very rarely reported that in some patients such an undesirable reaction as hepatitis progressed to hepatic insufficiency.Patients receiving a combination of lisinopril and hydrochlorothiazide and in which jaundice develops or signs of elevation of the liver enzymes should stop using a combination of lisinopril and hydrochlorothiazide and prolong the stay under control.
** A complex of symptoms has been reported that may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia / arthritis, positive antinuclear factor analysis (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, rash , photosensitivity or other skin manifestations.

Hydrochlorothiazide (frequency unknown)

Infections and invasions Sialdenite
On the part of the blood and lymphatic system Leukopenia, neutropenia / agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, oppression of bone marrow function
From the side of metabolism and digestion Anorexia, hypercalcemia, glucosuria, hyperuricemia, electrolyte imbalance (including hyponatremia and hypokalemia), increased cholesterol and triglycerides, gout
mental disorders Anxiety, depression, sleep disorders
From the nervous system Loss of appetite, paresthesia, dizziness
From the side of the organs of sight Xantopsy, temporary blurred vision
From the organs of hearing vertigo
From the side of the cardiovascular system Postural hypotension, necrotizing angiitis (vasculitis, cutaneous vasculitis)
On the part of the respiratory system, chest and mediastinal organs Respiratory failure (including pneumonitis and pulmonary edema)
From the gastrointestinal tract Stomach irritation, diarrhea, constipation, pancreatitis
From the digestive system Jaundice (intrahepatic cholestatic jaundice)
From the skin and subcutaneous tissues Photosensitivity, rash, skin lupus-like reactions, reactivation of cutaneous lupus, urticaria, anaphylactic reactions, toxic epidermal necrolysis
From the side of the kidneys and urinary tract Impaired renal function, interstitial nephritis
General violations and violations introduction Fever, weakness

Overdose

Symptoms

Lisinopril

Symptoms of an overdose of ACE inhibitors arterial hypotension, circulatory shock, electrolyte balance disorder, renal failure, hyperventilation, tachycardia, bradycardia, dizziness, anxiety, cough.

Hydrochlorothiazide

Frequent manifestations and symptoms that have been observed are those that were caused by a decrease in electrolytes (hypokalemia, hypochloraemia, hyponatremia) and dehydration due to excessive diuresis. When using digitalis, hypokalemia can cause an exacerbation of cardiac arrhythmias, tachycardia, arterial hypotension, shock.

Treatment.

When symptomatic hypotension occurs symptomatic therapy and control of vital signs are prescribed. The patient should be placed in a horizontal position and lift his legs. If necessary, substitution of fluid loss by the introduction of saline is recommended. Constantly you need to monitor important indicators of life, blood pressure, the concentration of electrolytes and creatinine in the blood with correction if necessary. Lizinopril can be withdrawn from the systemic circulation by hemodialysis. Therapy with lisinopril 10 NL KRKA or LYZINOPRIL 20 NL KRKA must be discontinued, the patient is followed by careful medical supervision with control of the kidney function.

Use during pregnancy and lactation

Pregnancy

The drug is contraindicated to apply to pregnant women or women planning a pregnancy. If during pregnancy, this drug is confirmed pregnancy, its use must be stopped immediately and, if necessary, replaced with another drug approved for use in pregnant women.

Breastfeeding period

Since there is no information on the use of lisinopril 10 NL KRKA or LYZINOPRIL 20 NL KRKA during the period of breastfeeding, taking these medications is contraindicated. During this period, preference is given to alternative drugs with the best established safety profile, especially when feeding newborns and premature infants.

Children

The drug is not used in pediatric practice.

Application features

Hypotension and electrolyte / fluid imbalance

As with the use of other antihypertensive drugs, some patients may experience symptomatic hypotension. It is rare in patients with uncomplicated arterial hypertension, but is more likely in patients with fluid imbalance or electrolyte imbalance, for example, dehydration, hyponatremia, hypochloraemic alkalosis, hypomagnesemia or hypokalemia, which can be caused by diuretic therapy, salt restriction, dialysis, intercurrent diarrhea or vomiting. Such patients should periodically perform an analysis of the level of electrolytes in the blood at appropriate intervals.

Particular attention should be paid to the use of drugs in patients with coronary heart disease or cerebrovascular disease, in which excessive drop in blood pressure can lead to myocardial infarction or stroke.

When hypotension arises, the patient should be placed in a horizontal position and, if necessary, intravenously injected saline. Transient arterial hypotension is not a contraindication for the further use of the drug. After the normalization of blood pressure due to increased blood volume, it is possible to restore therapy with a lower dosage or the use of the respective individual components of the drug.

Stenosis of the aortic valve / hypertrophic cardiomyopathy

Like all vasodilators, ACE inhibitors should be used with caution in treating patients with left ventricular outflow obstruction.

Impaired renal function

Thiazides can not be used as diuretics in patients with impaired renal function. Thiazides are ineffective at creatinine clearance values of 30 ml / min or lower (moderate or severe renal failure).

Lizinopril 10 NL KRKA or lisinopril 20 NL KRKA should not be taken to patients with renal insufficiency (creatinine clearance 80 ml / min) until the results of titration of individual components indicate the possibility of using the doses contained in the combination tablet.

In some patients with hypertension without obvious signs of an existing kidney disease, a usually small and temporary increase in blood urea and serum creatinine levels develops if lisinopril is taken concomitantly with diuretics. If this occurs during the therapy with lisinopril 10 NL KRKA or LISINOPRIL 20 NL KRKA, the combined therapy should be discontinued. It is possible to restore the therapy at a lower dosage or use the appropriate individual components of the drug.

In some patients with bilateral renal artery stenosis or renal artery stenosis of one kidney, an increase in serum urea and serum creatinine was observed in the treatment with ACE inhibitors, usually the reverse after discontinuation of therapy.

liver disease

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, because with minor deviations in the fluid and electrolyte balance, hepatic coma may occur.

Metabolic and endocrine effects

Thiazide therapy can affect the tolerability of glucose. It may be necessary to adjust the dose of antidiabetics, including insulin.

Thiazides can reduce the excretion of calcium in the urine and cause a temporary and insignificant increase in serum calcium levels. Noticeable hypercalcemia may be evidence of latent hyperparathyroidism. Before performing parathyroid gland tests, you should stop taking thiazides.

An increase in the level of cholesterol and triglycerides can be associated with therapy with thiazide diuretics.

Thiazide therapy can cause hyperuricemia and / or gout in some patients. However, lisinopril can increase the level of uric acid in the urine and thus reduce the hyperuricemic effect of hydrochlorothiazide.

Hypersensitivity / angioedema

Patients treated with an ACE inhibitor, including lisinopril, rarely had angioedema, swelling of the face, extremities, lips, tongue, glottis and / or larynx. In this case, the use of lisinopril 10 NL KRKA or lisinopril 20 NL KRKA must immediately stop and establish a careful observation until the symptoms disappear completely before discharging the patient. In cases of swelling of the face and lips, the condition can improve without treatment, but the use of antihistamines can be helpful in alleviating the symptoms.

Angioedema of the larynx can be lethal. If the tongue, glottis, or larynx is swollen, which can cause airway obstruction, immediate emergency therapy (which may include subcutaneous administration of 1: 1000 epinephrine (epinephrine) solution (0.3-0.5 mL) and / or ensuring free airway patency).

ACE inhibitors often cause angioedema in patients of the Negroid race, than in representatives of other races.

Patients with a history of angioedema, not associated with the use of ACE inhibitors, have an increased risk of angioedema due to ACE inhibitors.

In patients taking thiazides, hypersensitivity reactions can occur with the presence or absence of a history of allergy or bronchial asthma. With the use of thiazides, exacerbation or activation of systemic lupus erythematosus was reported.

Anaphylactoid reactions during desensitization with Hymenoptera venom

In patients who took ACE inhibitors during the desensitization procedure with venom of Hymenoptera (for example, to aspen or bee venom), anaphylactoid reactions were rarely observed, posing a threat to life. These reactions were prevented by temporarily discontinuing the administration of ACE inhibitors before each desensitization procedure.

Patients on hemodialysis

The use of lisinopril 10 NL KRKA or LISINOPRIL 20 NL KRKA is not indicated in patients who require dialysis due to renal failure. Often, patients who underwent dialysis using high permeability membranes (eg AN 69) and concomitant treatment with ACE inhibitors, had anaphylactoid reactions. For such patients, it is necessary to consider the possibility of using other types of dialysis membranes or another class of antihypertensive agents.

Cough

With the use of ACE inhibitors, a cough was reported. This cough is unproductive, persistent and disappears after discontinuing therapy. Cough caused by ACE inhibitors should be considered as part of a differentiated diagnosis of cough.

Surgical intervention / anesthesia

In patients after surgery and in those receiving antihypertensives during anesthesia, lisinopril can block the formation of angiotensin II due to compensatory renin release. In the event of hypotension is considered a consequence of this arrangement, it is possible to apply treatment by increasing the circulating blood volume.

Use in elderly patients

Lisinopril is equally effective in elderly patients (65 years and older) and young patients with hypertension. Monotherapy lisinopril was as effective in reducing diastolic blood pressure as monotherapy hydrochlorothiazide or atenolol. During clinical studies age does not affect the tolerability of lisinopril.

In clinical studies the efficacy and tolerability of lisinopril and hydrochlorothiazide, which were introduced in parallel, both were similar in elderly patients and in younger patients with hypertension.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Lisinopril 10 NL Krka or lisinopril 20 NL Krka may adversely affect the ability to drive and perform tasks associated with an increased risk of injury, especially at the beginning of treatment, so it is necessary to individually determine a dose and mode of administration of the drug does not threaten the safety of the patient at these activities.

Interaction with other drugs and other interactions

Serum Potassium

potassium loss effect induced thiazide diuretics are generally attenuated due Kalisberegate lisinopril effect. Supplementation with potassium sparing drugs, or salts containing potassium, especially in patients with impaired renal function, may lead to a significant increase in serum potassium levels. If simultaneous reception Lisinopril 10 NL KRKA or Lisinopril 20 NL Krka and any of these means considered appropriate, they should be used carefully and frequently monitor the serum potassium level.

Oral antidiabetics

Epidemiological studies show that concurrent use of ACE inhibitors and antidiabetic drugs (insulin, oral hypoglycemic agents) can enhance the effect of lowering blood glucose in a risk of hypoglycemia. This symptom is more likely to occur during the first weeks of combined treatment and in patients with renal insufficiency.

Lithium

Li, as a rule, should not be given together with diuretics or ACE inhibitors. Diuretics are drugs and ACE inhibitors reduce renal clearance of lithium and cause a high risk of lithium toxicity. It is necessary to read the instructions for use of lithium preparations before use of such preparations.

other drugs

Indomethacin can reduce the antihypertensive effect of a concomitant reception Lisinopril

10 NL KRKA or Lisinopril 20 NL Krka. In some patients with impaired renal function, NSAIDs, simultaneous ACE inhibitors may lead to further deterioration of kidney function. Such effects are generally reversible. The antihypertensive effect of 10 NL KRKA Lisinopril or Lisinopril 20 NL Krka can be enhanced by simultaneous administration of other drugs that can cause orthostatic hypotension.

non-depolarizing muscle relaxants

Thiazides may increase sensitivity to tubocurarine.

other diuretics

Diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with lisinopril 10 NL Krka or lisinopril 20 NL Krka. If this is not possible, treatment should be started with lisinopril alone application.

Other antihypertensive drugs

The simultaneous use of these drugs can enhance the hypotensive effect Lisinopril 10 NL KRKA or Lisinopril 20 NL Krka. Simultaneous application of glyceryl trinitrate other nitrates or other vasodilators may further reduce blood pressure.

Allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide

The simultaneous use of ACE inhibitors may cause an increased risk of leukopenia.

cardiac glycosides

There is an increased risk of toxicity caused by the use of digitalis preparations and thiazide, which can cause hypokalemia.

Pharmacological properties.

Pharmacodynamics.

10 lisinopril and lisinopril KRKA NL 20 NL KRKA - is combined with a fixed dose formulations containing lisinopril, an ACE inhibitor (ACEI) and hydrochlorothiazide, thiazide diuretik.Oba component have complementary mechanisms of action and additional hypotensive effect.

Lisinopril - a peptidyl dipeptidase inhibitor. It inhibits ACE (ACE), which is a catalyst for the conversion of angiotensin I to the vasoconstrictor peptide, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE reduces the concentration of angiotensin II, which leads to a decrease in vasoconstrictor activity and aldosterone secretion. Reduction of the latter can lead to an increase in the concentration of potassium in serum. Lisinopril lowers blood pressure, primarily due to the inhibition of the renin-angiotensin. However, the antihypertensive agent is lisinopril even in hypertensive patients with low renin. ACE is identical kininazy II, an enzyme that promotes the disintegration of bradykinin. It remains uncertain, essential elevated levels of bradykinin,strong vasodilator peptide in therapeutic effects of lisinopril.

Hydrochlorothiazide - a diuretic drug. It affects mechanism reabsorption of electrolytes distal renal tubules and increases the excretion of sodium and chloride in approximately equivalent amounts. Natriuresis is accompanied by some loss of potassium and bicarbonate. The mechanism of the antihypertensive effect of thiazide unknown. Thiazides usually do not affect the normal blood pressure.

additional decrease in blood pressure can occur in combination with other antihypertensive agents.

Pharmacokinetics.

There is no clinically significant pharmacokinetic interaction between lisinopril and hydrochlorothiazide. Combination tablet is bioequivalent to a concomitant reception of the individual components.

lisinopril

After oral administration of lisinopril maximum serum concentration occurs within approximately 7:00. The average degree of absorption of lisinopril is approximately 25% of significant relative variability (6-60%).

Food intake does not affect the absorption of lisinopril.

Lisinopril does not bind to other serum proteins.

Lisinopril does not penetrate the blood-brain barrier.

Lisinopril does not undergo metabolism, it appears completely unchanged in the urine. Following multiple administration of lisinopril has an effective half-life of 12.6 hours. Reduced serum concentrations has a prolonged terminal phase, which does not affect the accumulation of the drug. This final phase may is saturated binding to ACE and is not proportional to the dose.

Impaired renal function reduces the excretion of lisinopril kidney, but such reduction becomes clinically important only when the glomerular filtration rate below 30 ml / min.

Elderly patients have higher blood levels of concentration and high values of area under "concentration in plasma-time" curve than younger patients. Lisinopril can be derived by dialysis.

Hydrochlorothiazide

When the level of hydrochlorothiazide in plasma were observed for at least 24 hours, I had a half-life range 5,6-14,8 hours.

Hydrochlorothiazide crosses the placental barrier and does not penetrate the blood-brain barrier.

At least 61% of the dose is excreted unchanged within 24 hours. After ingestion hydrochlorothiazide diuresis begins within 2:00, peaks after about 4:00 and lasts 6-12 hours.

pharmaceutical characteristics:

Basic physical and chemical properties:

  • Lisinopril 10 NL Krka - round, biconvex, peach-colored, with "LH" marking;
  • Lisinopril 20 NL Krka - round, biconvex tablets of white color with a notch on one side, marked "LH".

Notch is not intended to separate tablets.

Shelf life

3 years.

Storage conditions

Store at a temperature not higher than 25 ° C. Keep out of reach of children.

Packaging

14 tablets in a blister, 1, 2 or 4 blisters per box
10 tablets in a blister, 2, 3 or 6 blister packs in a cardboard box.

Category of leave

On prescription.


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