Lystra PLUS

Active material: Gidroxlorotiazid, Lisinopril
When ATH: C09BA03
CCF: Antihypertensive drugs
ICD-10 codes (testimony): I10
When CSF: 01.09.16.03
Manufacturer: TORRENT PHARMACEUTICALS Ltd. (India)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills white or nearly white, round, lenticular, embossed with heart shape on one side, and the dividing line – another.

Excipients: mannitol, pre-gelatinized starch, sodium hydrogen phosphate, magnesium stearate, talc, starch (dry).

10 PC. – strips (3) – packs cardboard.
10 PC. – strips (10) – packs cardboard.

Pharmacological action

Combined antihypertensive drug. It has antihypertensive and diuretic effect.

Lisinopril – ACE inhibitor, reduces the formation of angiotensin II from angiotensin I.

Reducing the content of angiotensin II leads to a direct reduction in aldosterone release. It reduces the degradation of bradykinin, and increases the synthesis of prostaglandin. Reduces PR, FROM, preload, pulmonary capillary pressure, It causes an increase in cardiac output and increased exercise tolerance in patients with heart failure. It expands the artery to a greater extent, than veins.

Some effects are explained by the influence on the tissue renin-angiotensin system. Prolonged use reduces myocardial hypertrophy and arterial walls resistive type. It improves blood flow to ischemic myocardium. ACE inhibitors prolong survival in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients, myocardial infarction without clinical symptoms of heart failure.

Valid through 1 no, maximum effect is determined by 6-7 no, duration – 24 no. When hypertension effect observed in the first days after the start of treatment, stable operation is developed through 1-2 of the month.

Gidroxlorotiazid – tiazidnый diuretic, the effect of which is associated with the violation of reabsorption of sodium ions, Chlorine, Potassium, magnesium and water in the distal nephron. Delays excretion of calcium ions, Uric acid. It has antihypertensive properties: hypotensive action develops due to the expansion of arterioles. Almost no effect on normal blood pressure. The diuretic effect after 1-2 no, reaches through 4 h and lasts for 6-12 no. The antihypertensive effect occurs within 3-4 day, but in order to achieve optimum therapeutic effect may require 3-4 of the week.

Lisinopril and Hydrochlorothiazide while the application have an additive antihypertensive effect.

Pharmacokinetics

Lisinopril

Absorption, distribution, metabolism

After oral lisinopril is slowly absorbed from the gastrointestinal tract. Absorption averages 30%. Lisinopril – primary active ACE inhibitor, It is not metabolized in the liver. C_max in plasma is approximately 7 no. Plasma protein binding is negligible – 5%.

Deduction

Excreted unchanged in the urine. In patients with normal renal function T_1/2 is 12 no. Lisinopril is excreted from the body by hemodialysis.

Gidroxlorotiazid

Absorption

Once inside 60-80% hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract.

Deduction

About 95% hydrochlorothiazide is excreted unchanged by the kidneys almost completely. T_1/2 is 5.6-14.8 no. A small amount of the drug is excreted in the bile.

Hydrochlorothiazide crosses the placental barrier, excreted in breast milk.

Testimony

- Arterial hypertension (patients, which shows the combination therapy).

Dosage regimen

The drug is taken orally 1 time / day.

At hypertension the dose is individually. The recommended dose is 1-2 tab. 1 time / day.

At renal failure (CC 30-80 ml / min) drug can be used only after titration of each component drug alone. The recommended initial dose of lisinopril at uncomplicated kidney failure is 5-10 mg.

At previous therapy with diuretics after receiving the initial dose of the drug can occur, symptomatic hypotension. Such cases are more common in patients with loss of fluids and electrolytes due to prior treatment with diuretics. Therefore, you should stop taking the diuretic for 2-3 days before the start of treatment Listrilom^® Plus.

Side effect

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

Side effects, rarer:

Cardio-vascular system: marked reduction in blood pressure, chest pain; rarely – orthostatic hypotension, tachycardia, bradycardia, symptoms of heart failure, violation of AV-conduction, myocardial infarction.

From the digestive system: nausea, vomiting, stomach ache, dry mouth, diarrhea, dyspepsia, anorexia, change in taste, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.

From the central and peripheral nervous system: mood lability, impaired concentration, paresthesia, fatigue, drowsiness, jerking of the limbs and lips; rarely – asthenic syndrome, confusion.

The respiratory system: dyspnoea, bronchospasm, apnea.

From the urinary system: uremia, oligurija / anurija, impairment of renal function, acute renal failure.

From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, gematokrita, erythropenia).

Allergic reactions: hives, photosensitivity, angioneurotic edema of the face, limbs, lips, language, epiglottis and / or larynx, skin rashes, itch, fever, vasculitis, positive for antinuclear antibodies, increased erythrocyte sedimentation rate, eozinofilija.

Laboratory findings: hyperkalemia and / or hypokalemia, giponatriemiya, gipomagniemiya, chloropenia, hyperuricemia, giperglikemiâ, increase in urea and creatinine; rarely – increase in liver transaminases, giperʙiliruʙinemija, hypercholesterolemia, hypertriglyceridemia, reduced glucose tolerance.

Other: dry cough, arthralgia, arthritis, myalgia, worsening of gout, reduced potency, Sweating, alopecia, Developmental disorders of the kidneys of the fetus.

Contraindications

- Anurija;

- Severe renal insufficiency (CC<30 ml / min);

- Angioedema (incl. a history of the use of ACE inhibitors);

- Hemodialysis using membranes vysokoprotochnyh;

- Hypercalcemia;

- Giponatriemiya;

- Porphyria;

- Prek;

- Pechenochnaya coma;

- Diabetes (severe);

- Pregnancy;

- Lactation (breast-feeding);

- Childhood and adolescence up 18 no (efficacy and safety have not been established);

- Hypersensitivity to the drug;

- Hypersensitivity to other ACE inhibitors;

- Hypersensitivity to sulfonamides derivatives.

FROM caution use in patients with bilateral renal artery stenosis, Aortic stenosis / hypertrophic cardiomyopathy, stenosis of the artery to a solitary kidney with progressive azotemia, condition after kidney transplantation, renal failure (CC>30 ml / min), primary hyperaldosteronism, hypotension, hypoplasia of the bone marrow, giponatriemii (increased risk of hypotension in patients, are on a salt-free diet or malosolevoy), states, accompanied by a decrease in the bcc (incl. diarrhea, vomiting), connective tissue diseases (incl. SLE, scleroderma), diabetes, podagre, hyperuricemia, hyperkalemia, CHD, cerebrovascular insufficiency, severe chronic heart failure, hepatic insufficiency, in elderly patients.

Pregnancy and lactation

Do not use this drug during pregnancy and breastfeeding.

Cautions

Symptomatic hypotension

Most often marked decrease in blood pressure occurs with a decrease in the bcc, caused by diuretic therapy, reducing the amount of salt in the food, dializom, diarrhea or vomiting.

In patients with chronic heart failure with / without renal insufficiency may develop symptomatic hypotension. Most often, it is diagnosed in patients with severe heart failure due to the use of high doses of diuretics, hyponatremia or impaired renal function. In these patients, treatment should start under close medical supervision.

Such rules must be followed for the appointment of the drug to patients with coronary artery disease, cerebrovascular insufficiency, in which the sharp decline in blood pressure can lead to heart attack or stroke.

Transient arterial hypotensive response is not a contraindication to receiving the next dose.

Impaired renal function

In patients with chronic renal failure marked reduction of blood pressure after initiation of therapy with ACE inhibitors may result in further deterioration of renal function.

In patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, ACE inhibitor, It showed an increase of urea and creatinine in the serum, usually reversible upon discontinuation of treatment. More common in patients with renal insufficiency.

Hypersensitivity / Angioedema

Angioedema can occur at any time during treatment. In this case, treatment with lisinopril should be discontinued immediately and the patient under surveillance until complete regression of symptoms. In cases, when swelling appeared only on the face and lips, the condition often goes away without treatment, However, you can assign antihistamines.

Cough

When using ACE inhibitors may cause dry, prolonged cough, which disappears after discontinuation of treatment. In the differential diagnosis of cough and cough should be considered, resulting from the use of an ACE inhibitor.

Surgery / general anesthesia

In the application of funds, lowering 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 bcc.

Before surgery (including dentistry) should notify the surgeon / anesthesiologist on the use of ACE inhibitors.

Potassium serum

Perhaps the development of hyperkalemia. Risk factors for the development of hyperkalemia: renal failure, diabetes, the use of drugs or medications Potassium, causing an increase in the potassium concentration in the blood (B t.ch heparin), especially in patients with impaired kidney.

In patients at risk of symptomatic hypotension (are on a salt-free diet or malosolevoy) with / without hyponatremia, and in patients, receiving high doses of diuretics, loss of fluids and salts before treatment must be compensated.

Metabolic and endocrine effects

Thiazide diuretics may affect glucose tolerance, therefore it is necessary to adjust the dose of antidiabetic drugs. Thiazide diuretics may reduce calcium excretion in the urine and cause hypercalcemia. Marked hypercalcaemia may be a sign of hidden hyperparathyroidism, it is recommended to discontinue treatment thiazide diuretics before the test to assess the function of the parathyroid glands.

During treatment Listrilom^® Plus requires regular monitoring of plasma potassium, Glucose, urea, fats and creatinine; it is not recommended to drink alcohol, because alcohol enhances the hypotensive effect of the drug.

Caution must be exercised during exercise, hot weather (the risk of dehydration and excessive reduction of blood pressure due to lower BCC).

Effects on ability to drive vehicles and management mechanisms

During treatment should refrain from driving vehicles and Occupation potentially hazardous activities, require high concentration and speed of psychomotor reactions, as dizziness, especially at the beginning of treatment.

Overdose

Symptoms: marked reduction in blood pressure.

Treatment: induce vomiting and / or gastric lavage, symptomatic therapy, aimed at correcting the dehydration and violations of water-salt balance. If hypotension is recommended to introduce an isotonic solution. Monitor the concentration of urea, Electrolytes and creatinine in blood serum, indicators diuresis.

Drug Interactions

With the simultaneous use of the drug Lystra^® Plus:

– with potassium-sparing diuretics (incl. spironolactone, triamterene, amilorid), potassium supplements, salt substitutes, containing potassium, increased risk of hyperkalemia, especially in patients with impaired renal function;

– with vasodilators, ʙarʙituratami, fenotiazinami, tricyclic antidepressants, Ethanol enhances the hypotensive effect;

– NSAIDs (incl. Indomethacin), estrogen reduced antihypertensive effect of lisinopril;

– with lithium slows excretion of lithium from the body, resulting in enhanced cardiotoxic and neurotoxic effect of lithium;

– kolestiraminom with antacids and reduced absorption of lisinopril in the digestive tract.

Lystryl^® Plus enhances the neurotoxicity salicylates, reduces the effect of oral hypoglycemic agents, norepinephrine, epinephrine and protivopodagricakih funds, enhances the effects of (including side) cardiac glycosides, effects of peripheral muscle relaxants, reduces the excretion of quinidine.

Lystryl^® Plus reduces the effect of oral contraceptives.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dry place at temperatures no higher than 30 ° C. Shelf life – 3 year.