Active substanceHydrochlorothiazide + LysinoprilHydrochlorothiazide + Lysinopril
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    Boznalek, AO     Bosnia and Herzegovina
  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active substances: lisinopril 5 mg and hydrochlorothiazide 12.5 mg; Excipients: mannitol 130.5 mg, pregelatinized starch 5.00 mg, sodium hydrogenorthophosphate 4.00 mg, magnesium stearate 1.00 mg, talc 2.00 mg, starch (dry) 10.00 mg.

    Description:White or almost white, round, biconvex tablets with an extruded heart shape on one side and with a dividing line on the other side of the tablet.
    Pharmacotherapeutic group:Hypotensive combined agent (angiotensin-converting enzyme inhibitor + diuretic)
    ATX: & nbsp

    C.09.B.A.03   Lizinopril in combination with diuretics

    Pharmacodynamics:

    Listril® Plus is a combination of an angiotensin-converting enzyme inhibitorlisinopril) and a diuretic (hydrochlorothiazide).Has antihypertensive and diuretic effect.

    Lysinopril: The ACE inhibitor reduces the formation of angiotensin II from angiotensin I. Reducing angiotensin II leads to a direct reduction in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandin. Reduces the overall peripheral vascular resistance, arterial pressure (BP), preload, pulmonary capillary pressure, causes an increase in the minute volume of blood and increased tolerance to stress in patients with heart failure. Expands arteries more than veins. Some effects are explained by the effect on tissue retin-angiotensin systems. With prolonged use, myocardial hypertrophy and the walls of arteries of resistive type decrease. Improves the blood supply of the ischemic myocardium. ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure.The beginning of the action after 1 hour, the maximum effect is determined after 6-7 hours, the duration is -24 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, stable action develops after 1-2 months.

    Hydrochlorothiazide: A thiazide diuretic whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron; delays the excretion of calcium ions, uric acid. Has antihypertensive properties; the hypotensive effect develops due to the expansion of arterioles. Virtually does not affect normal blood pressure. Diuretic effect occurs in 1-2 hours, reaches a maximum after 4 hours and lasts 6-12 hours. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

    Lizinopril and hydrochlorothiazide, if used simultaneously, have an additive antihypertensive effect.

    Indications:Arterial hypertension (in patients who are shown combined therapy).
    Contraindications:Hypersensitivity to the drug, other ACE inhibitors and sulfonylamide derivatives, anuria, severe renal failure (creatinine clearance less than 30 ml / min), angioedema (including history of ACE inhibitors), hemodialysis using high-permeabilized membranes, hypercalcemia , hyponatremia, porphyria, precoma, hepatic coma, diabetes mellitus (severe forms), pregnancy, lactation, age under 18 years (efficacy and safety not established).
    Carefully:Two-sided stenosis of the renal arteries. aortic stenosis / hypertrophic cardiomyopathy, single-kidney artery stenosis with progressive azotemia, condition after kidney transplantation, renal failure (creatinine clearance less than 30 ml / min), primary hyperaldosteronism, hypotension, bone marrow hypoplasia, hyponatremia (increased risk of arterial hypotension patients on a low-salt or salt-free diet), conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting), joint disease tion tissue (systemic lupus erythematosus, scleroderma), diabetes, gout.Hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular insufficiency, severe chronic heart failure, hepatic insufficiency, elderly age.
    Dosing and Administration:

    Take in, once a day.

    Arterial hypertension

    The dose is set individually. The recommended dose is 1-2 tablets once a day.

    Doses in renal failure

    In patients with creatinine clearance greater than 30 and less than 80 ml / min, the drug can be used only after titrating the dose of individual components of the drug. The recommended initial dose of lisinopril in uncomplicated renal failure is 5-10 mg.

    Prior therapy with diuretics

    Symptomatic hypotension can occur after taking the initial dose of the drug. Such cases are more common in patients who have had a loss of fluid and electrolytes due to previous treatment with diuretics. Therefore it is necessary stop diuretics 2-3 days before starting treatment with Listril® Plus (see Special instructions).

    Side effects:

    In most patients, side effects were mild and transient.The most frequent were: dizziness, headache.

    Side effects that were less common:

    From the cardiovascular system: marked decrease in blood pressure, chest pain, rarely - orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, violation of atrioventricular conduction, myocardial infarction.

    From the digestive tract: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste change, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.

    From the nervous system: lability of mood, violation of concentration, paresthesia, fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely - asthenic syndrome, confusion.

    From the respiratory system - dyspnoea, bronchospasm, apnea.

    From the skin - urticaria, sweating, hair loss, photosensitivity.

    Allergic reactions: angio-neurotic edema of the face, extremities, lips, tongue, epiglottis and / or larynx (see "Special instructions"), skin rashes, itching, fever, vasculitis, positive results on antinuclear antibodies, increased ESR, eosinophilia.

    From the hematopoiesis: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, hematocrit, erythrocytopenia).

    From the genitourinary system - uremia, oliguria / anuria, impaired renal function, acute renal failure, decreased potency.

    Laboratory indicators: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloraemia, hyperuricemia, hyperglycemia, increased levels of urea and creatinine, rarely - increased activity of "hepatic" transaminases, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance.

    Other: dry cough, arthralgia / arthritis, myalgia, impaired renal fetus development, exacerbation of gout.

    Overdose:

    Symptoms: marked decrease in blood pressure.

    Treatment: cause vomiting and / or rinse the stomach, symptomatic therapy aimed at correcting dehydration and disturbances of the water-salt balance. When arterial hypotension is introduced isotonic solution. Control of urea, creatinine and electrolytes in blood serum, as well as diuresis.

    Interaction:

    With simultaneous application:

    with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes, containing potassium - increases the risk of hyperkalemia, especially in patients with impaired renal function;

    with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol - strengthening of hypotensive action;

    with non-steroidal anti-inflammatory drugs (indomethacin and others), estrogens - reduction of antihypertensive action of lisinopril; with lithium preparations - slowing down the excretion of lithium from the body (increased cardiotoxic and neurotoxic action of lithium);

    with antacids and colestyramine - decrease in absorption in the gastrointestinal tract. Strengthens the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic agents, norepinephrine, epinephrine and antidotal drugs, increases the effects (including side effects) of cardiac glycosides, the action of peripheral muscle relaxants, reduces the excretion of quinidine. Reduces the effect of oral contraceptives.

    Special instructions:

    Symptomatic hypotension

    Most often, a marked decrease in blood pressure occurs with a decrease in the volume of circulating blood caused by diuretic therapy, a decrease in the amount of salt in the food, dialysis, diarrhea, or vomiting (cf."Interaction with other drugs" and "Side effect"). In patients with chronic heart failure with simultaneous renal failure or without it, development is possible, symptomatic hypotension. It is more often detected in patients with severe forms of heart failure, as a result of the use of large doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment should begin under the strict supervision of a physician. Similar rules should be adhered to when assigning patients with coronary heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke. Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.

    Impaired renal function

    In patients with chronic renal failure, a marked decrease in blood pressure after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function.

    Cases of acute renal failure are noted.

    In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney receiving ACE inhibitors, there was an increase in urea and serum creatinine, usually reversible after discontinuation of treatment.It was more common in patients with renal insufficiency.

    Hypersensitivity / Angioedema

    Angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx was rarely seen in patients treated with ACE inhibitors, including lisinopril, which can occur in any period of treatment. In this case, treatment with lisinopril should be stopped as soon as possible and for the patient to establish an observation until the symptoms regress completely. In cases where the edema appeared only on the face and lips, the condition usually passes without treatment, however, it is possible to prescribe antihistamines.

    Angioedema with edema of the larynx can be fatal. When the tongue, epiglottis or larynx are covered, airway obstruction may occur, therefore, appropriate therapy should be performed immediately (0.3-0.5 ml epinephrine (adrenaline) 1: 1000 subcutaneously) and / or measures to ensure airway patency.

    Patients who have had a history of angioedema, who are not associated with previous treatment with ACE inhibitors, may be at increased risk of developing it during treatment with an ACE inhibitor (see Contraindications).

    Cough

    When an ACE inhibitor was used, a cough was noted. Cough is dry, / prolonged, which disappears after discontinuing treatment with an ACE inhibitor. With a differential diagnosis of cough, one must also consider a cough caused by the use of an ACE inhibitor.

    Patients on dialysis

    Anaphylactic reaction was noted in patients undergoing hemodialysis using dialysis membranes with high permeability, which simultaneously take ACE inhibitors. In such cases, one should consider the possibility of using another type of membrane for dialysis or another antihypertensive agent.

    Surgery / General Anesthesia

    When using a means of reducing blood pressure in patients with extensive surgery or during general anesthesia, lisinopril, blocking the formation of angiotensin II, can lead to a marked decrease in blood pressure, which can be eliminated by increasing the volume of circulating blood.

    Before surgery (including dentistry), it is necessary to alert the surgeon / anesthesiologist about the use of ACE inhibitors.

    Potassium in the serum

    In some cases, hyperkalemia was noted.

    Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, the use of potassium drugs or drugs that cause an increase in the concentration of potassium in the blood (eg, heparin), especially in patients with impaired renal function.

    In patients who have a risk of symptomatic hypotension (on a low-salt or salt-free diet) with or without hyponatremia, as well as in patients who received high doses of diuretics, the above conditions must be compensated for before the treatment is started (loss of fluid and salts).

    Metabolic and endocrine effects

    Thiazide diuretics can influence glucose tolerance, so dosage of antidiabetic drugs should be adjusted.

    Thiazide diuretics can reduce the release of calcium in the urine and cause hypercalcemia. Expressed hypercalcemia may be a symptom of latent hyperparathyroidism, it is recommended that treatment with thiazide diuretics be stopped before the parathyroid function test.

    During the treatment with Listril® Plus, regular monitoring of blood plasma potassium, glucose, urea, fat and creatinine is necessary.

    During the period of treatment it is not recommended to drink alcoholic beverages, since alcohol enhances the hypotensive effect of the drug.

    Care should be taken when doing physical exercises, hot weather (the risk of dehydration and excessive blood pressure lowering due to a decrease in the volume of circulating blood).

    Effect on the ability to drive transp. cf. and fur:During the treatment period, one should refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, since dizziness is possible, especially at the beginning of the course of treatment.
    Form release / dosage:
    Tablets 5 mg + 12.5 mg.
    Packaging:

    10 tablets in an aluminum strip. 3 strips or 10 strips are packed in a cardboard box with instructions for use.

    Sample not for sale: 4 or 10 tablets in an aluminum foil strip. 1 strip with instructions for use in a cardboard box.

    Storage conditions:Store in a dry place at a temperature not exceeding 30 ° C. Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000937
    Date of registration:04.08.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India
    Information update date: & nbsp11.04.2018
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