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

    Liten H 10 mg + 12.5 mg

    Active substances: lisinopril dihydrate 10.888 mg (respectively, lisinopril 10 mg) and hydrochlorothiazide 12.5 mg.

    Excipients: calcium hydrogen phosphate dihydrate 109.1 mg, mannitol 41.2 mg, corn starch 28 mg, pregelatinized starch 4 mg, magnesium stearate 3.1 mg, talc 2 mg, silicon dioxide colloidal anhydrous 1 mg, iron oxide yellow C.I.77492, E172 0.5 mg.

    Liten H 20 mg + 12.5 mg

    Active substances: lisinopril dihydrate 21.776 mg (respectively, lisinopril 20.00 mg) and hydrochlorothiazide 12.5 mg.

    Excipients: calcium hydrogen phosphate dihydrate 111 mg, mannitol 41.2 mg, corn starch 28 mg, pregelatinized starch 4.5 mg, magnesium stearate 3.1 mg, talc 2 mg, silicon dioxide colloidal anhydrous 1 mg, iron oxide yellow CI77492, E172 0.136 mg, iron oxide red C.1.77491, E172 0.045 mg.

    Description:

    Tablets 10 mg + 12.5 mg

    From light yellow to yellow, hexagonal tablets with a smooth surface, solid edges and a risk in the middle.

    Tablets 20 mg + 12.5 mg

    From pale pink to pink, hexagonal tablets with a smooth surface, solid edges and a risk in the middle.

    Pharmacotherapeutic group:Hypotensive combined agent (angiotensin-converting enzyme inhibitor + diuretic)
    ATX: & nbsp

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

    Pharmacodynamics:

    Liten H is a combination of an angiotensin-converting enzyme inhibitor (lisinopril) 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 renin-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 hours, duration - 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. Lisinopril 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-proton membranes, hypercalcemia , hyponatremia, porphyria, precoma, hepatic coma, diabetes mellitus (severe forms), pregnancy, lactation, age under 18 years (efficacy and safety not established).
    Carefully:
    Aortic stenosis / hypertrophic cardiomyopathy,bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney 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 in patients , on a low-salt or salt-free diet), conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting), connective tissue diseases (systemic lupus erythematosus, scleroderma), diabetes mellitus, gout, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular insufficiency, severe chronic heart failure, hepatic insufficiency, advanced age.
    Dosing and Administration:

    Take in, once a day.

    Arterial hypertension

    1 tablet Litane H 10 mg once a day. If necessary, the dose can be increased to Litane H 20 mg once a day.

    Doses in renal failure

    In patients with creatinine clearance greater than 30 ml / min 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 to stop taking diuretics 2-3 days before the beginning of treatment by Liton H (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:

    Co 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.

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

    Co side of 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.

    Co side of the respiratory system - dyspnea, bronchospasm, apnea.

    Co skin - urticaria, sweating, hair loss, photosensitivity.

    Allergic reactions: angioedema, swelling 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.

    Co sides of hemopoiesis: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, hematocrit, erythrocytopenia).

    Co the side of 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, a decrease in glucose tolerance. Other: dry cough, arthralgia / arthritis, myalgia, impaired renal fetus development, exacerbation of gout.

    Overdose:

    Symptoms: marked decrease in blood pressure.

    Treatment: induce 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 colestramine - 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, pronounced blood pressure occurs when the volume of circulating blood decreases due to diuretic therapy, a decrease in the amount of salt in the food, dialysis, diarrhea, or vomiting (see "Interaction with Other Drugs" and "Side-Effects"). 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 heart 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, prescription of antihistamines is possible. Antineurotic edema 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 have an 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 a different 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 can block the formation of angiotensin II.

    The pronounced decrease in blood pressure which is considered a consequence of this mechanism 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 before the start of treatment (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 Lyten H, regular monitoring of the 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 performingexercise in hot weather (the risk of dehydration and excessive blood pressure decrease 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 of 10 mg + 12.5 mg and 20 mg + 12.5 mg.
    Packaging:
    For 10 tablets in a blister of PVC / aluminum foil. For 2 or 3 blisters together with instructions for use in a cardboard bundle.
    Storage conditions:
    Store in a dry place at a temperature of no higher than 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:LSR-001809/08
    Date of registration:17.03.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Boznalek, AOBoznalek, AO Bosnia and Herzegovina
    Manufacturer: & nbsp
    BOSNALIJEK, d.d. Bosnia and Herzegovina
    Representation: & nbspBOSNALEK AO BOSNALEK AO Bosnia and Herzegovina
    Information update date: & nbsp11.04.2018
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