Universal reference book for medicines
Product name: LISTRIL® PLUS (LISTRIL® PLUS)

Active substance: hydrochlorothiazide, lisinopril

Type: Antihypertensive drug

Manufacturer: TORRENT PHARMACEUTICALS (India) promotion of the drug in the Russian Federation DR.
REDDY`S LABORATORIES (India)
Composition, form of production and packaging
Tablets are
white or almost white, round, biconvex, with a squeezed heart shape on one side and a dividing line on the other.

1 tab.

lisinopril 5 mg

hydrochlorothiazide 12.5 mg

Excipients: mannitol, pregelatinized starch, sodium hydrophosphate, magnesium stearate, talc, starch (dry).

10 pieces.
- Strips (3) - packs of cardboard.
10 pieces.
- Strips (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Combined antihypertensive drug.
Has antihypertensive and diuretic effect.
Lizinopril - an ACE inhibitor, reduces the formation of angiotensin II from angiotensin I.

Reducing the content of angiotensin II leads to a direct decrease in the release of aldosterone.
Reduces the degradation of bradykinin and increases the synthesis of prostaglandin. Reduces OPSS, AD, 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 onset of action after 1 hour, the maximum effect is determined after 6-7 hours, duration - 24 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, stable effect develops after 1-2 months.

Hydrochlorothiazide is a thiazide diuretic whose action is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, and water ions in the distal nephron.
Delays excretion of calcium ions, uric acid. Has antihypertensive properties: hypotensive effect develops due to the expansion of arterioles.Virtually no effect on normal blood pressure. Diuretic effect occurs in 1-2 hours, reaches a maximum after 4 hours and lasts for 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 with simultaneous application have an additive antihypertensive effect.

PHARMACOKINETICS

Lisinopril

Absorption, distribution, metabolism

After ingestion, lisinopril is slowly absorbed from the digestive tract.
Absorption on average is 30%. Lizinopril - the primary active inhibitor of ACE, is not metabolized in the liver. C max in blood plasma is reached after about 7 hours. Binding to plasma proteins is insignificant - 5%.
Excretion

It is excreted unchanged in the urine.
In patients with normal renal function, T 1/2 is 12 hours. Lysinopril is excreted from the body during hemodialysis.
Hydrochlorothiazide

Suction

After ingestion, 60-80% of hydrochlorothiazide is rapidly absorbed from the digestive tract.

Excretion

About 95% of hydrochlorothiazide is excreted unchanged almost completely by the kidneys.
T 1/2 is 5.6-14.8 hours. A small amount of the drug is excreted with bile.
Hydrochlorothiazide penetrates the placental barrier, excreted in breast milk.

INDICATIONS

- Arterial hypertension (in patients who are shown combined therapy).

DOSING MODE

The drug should be taken orally 1 time / day.

With arterial hypertension, the dose of the drug is determined individually.
The recommended dose is 1-2 tablets. 1 time / day.
With renal failure (KK 30-80 ml / min), the drug can be used only after titrating the dose of each component of the drug separately.
The recommended initial dose of lisinopril in uncomplicated renal failure is 5-10 mg.
With previous therapy with diuretics after taking the initial dose of the drug, symptomatic arterial hypotension may occur.
Such cases are more common in patients with fluid loss and electrolytes due to previous treatment with diuretics. Therefore, you should stop taking diuretics 2-3 days before the start of treatment Listril Plus.
SIDE EFFECT

In most patients, side effects were mild and transient.
The most frequent were: dizziness, headache.
Side effects that occurred less often:

From the cardiovascular system: a marked decrease in blood pressure, chest pain;
rarely - orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, violation of AV-conduction, myocardial infarction.
On the part of the digestive system: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste change, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice.

From the side of the central nervous system and peripheral nervous system: lability of mood, impaired concentration, paresthesia, fatigue, drowsiness, convulsive twitching of the muscles of the extremities and lips;
rarely - asthenic syndrome, confusion.
On the part of the respiratory system: dyspnea, bronchospasm, apnea.

From the urinary system: uremia, oliguria / anuria, impaired renal function, acute renal failure.

On the part of the hematopoiesis system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hemoglobin, hematocrit, erythrocytopenia).

Allergic reactions: urticaria, photosensitivity, angioedema, facial edema, extremities, lips, tongue, epiglottis and / or larynx, skin rashes, itching, fever, vasculitis, positive results on antinuclear antibodies, increased ESR, eosinophilia.

Laboratory parameters: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloraemia, hyperuricemia, hyperglycemia, increased urea and creatinine levels;
rarely - increased activity of hepatic transaminases, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, a decrease in glucose tolerance.
Other: dry cough, arthralgia, arthritis, myalgia, exacerbation of gout, decreased potency, sweating, alopecia, impaired fetal kidney development.

CONTRAINDICATIONS

anuria;

- renal failure of severe degree (CK <30 ml / min);

- angioedema (including anamnesis from the use of ACE inhibitors);

- hemodialysis using high-flow membranes;

- hypercalcemia;

- hyponatremia;

- porphyria;

- Prekoma;

- hepatic coma;

- diabetes mellitus (severe forms);

- Pregnancy;

- lactation period (breastfeeding);

- children and adolescents under 18 years old (no effectiveness or safety);

- hypersensitivity to the components of the drug;

- Hypersensitivity to other ACE inhibitors;

- Hypersensitivity to sulfanylamide derivatives.

Caution should be applied to the drug with bilateral renal artery stenosis, aortic stenosis / hypertrophic cardiomyopathy, stenosis of the artery of a single kidney with progressive azotemia, a condition after kidney transplantation, kidney failure (KK> 30 ml / min), primary hyperaldosteronism, arterial hypotension, bone marrow hypoplasia , hyponatremia (increased risk of developing arterial hypotension in patients on a low-salt or salt-free diet), conditions accompanied by a decrease in BCCincluding diarrhea, vomiting), connective tissue diseases (including SLE, scleroderma), diabetes mellitus, gout, hyperuricemia, hyperkalemia, ischemic heart disease, cerebrovascular insufficiency, severe chronic heart failure, hepatic insufficiency, in elderly patients .

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and during breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated use of the drug in anuria, severe renal failure (CK <30 ml / min).

Caution should be applied to the drug with bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney with progressive azotemia, a condition after kidney transplantation, and kidney failure (QC <30 ml / min).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated use of the drug in porphyria, precoma, hepatic coma.

With caution , use the drug for liver failure.

APPLICATION FOR CHILDREN

Contraindicated use in childhood and adolescence to 18 no (efficacy and safety not established).

APPLICATION IN ELDERLY PATIENTS

With caution should be used in elderly patients.

SPECIAL INSTRUCTIONS

Symptomatic hypotension

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

In patients with chronic heart failure with or without renal failure, symptomatic arterial hypotension may develop.
More often it is detected in patients with severe forms of heart failure due to the use of large doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment should be started under the strict supervision of a physician.
Similar rules should be adhered to when prescribing the drug for patients with IHD, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

Transient arterial 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.

In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney treated with 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 may occur in any period of treatment.
In this case, the treatment with lisinopril should be stopped immediately and the patient should be monitored until the symptoms regress completely. In cases where edema occurs only on the face and lips, the condition often passes without treatment, but it is possible to prescribe antihistamines.
Cough

With the use of ACE inhibitors, a dry, prolonged cough may occur, which disappears after discontinuation of treatment.
With a differential diagnosis of cough, one should also consider a cough caused by the use of an ACE inhibitor.
Surgery / General Anesthesia

When using agents that reduce blood pressure in patients with extensive surgical intervention 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 BCC.

Before surgery (including dentistry), a surgeon / anesthesiologist should be warned about the use of ACE inhibitors.

Potassium in the serum

Perhaps the development of hyperkalemia.
Risk factors for the development of hyperkalemia: renal insufficiency, diabetes mellitus, the use of potassium drugs or drugs that cause an increase in the concentration of potassium in the blood (including heparin), especially in patients with impaired function kidney.
In patients with risk of symptomatic arterial hypotension (on a low-salt or salt-free diet) with / without hyponatremia, as well as in patients receiving high doses of diuretics, loss of fluid and salts before treatment should be compensated.

Metabolic and endocrine effects

Thiazide diuretics can influence glucose tolerance, so dosages of antidiabetic medications 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;
It is not recommended to drink alcoholic beverages, since alcohol enhances the hypotensive effect of the drug.
Care should be taken when performing physical exercises, hot weather (the risk of dehydration and excessive blood pressure lowering due to a decrease in BCC).

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, 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.

OVERDOSE

Symptoms: marked decrease in blood pressure.

Treatment: should cause vomiting and / or rinse the stomach, conduct symptomatic therapy aimed at correcting dehydration and violations of the water-salt balance.With arterial hypotension, it is recommended to inject an isotonic solution.
Control the concentration of urea, creatinine and electrolytes in the blood serum, diuresis.
DRUG INTERACTION

With simultaneous application of Listril ® Plus:

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

- with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol, hypotensive effect is enhanced;

- with NSAIDs (including indomethacin), estrogen reduces the antihypertensive effect of lisinopril;

- with lithium preparations, lithium removal from the body is slowed down, which increases the cardiotoxic and neurotoxic effect of lithium;

- With antacids and colestyramin, suction of lisinopril in the digestive tract decreases.

Listril ® Plus enhances 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.

Listril ® Plus reduces the effect of oral contraceptives.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry place at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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