Expiration date: 04/2025

Product form, composition and packaging

Tablets are beige-pink in color, round, lenticular, with the dividing line on one side.

1 tablet contains:

lisinopril 10 mg

hydrochlorothiazide 12.5 mg

Excipients: calcium hydrophosphate, mannitol, corn starch, starch prezhelatinizirovanny, dye iron oxide red, dye iron oxide yellow, magnesium stearate, purified water.

Clinical and pharmacological group: Antihypertensive drug

Pharmaco-therapeutic group: Hypotensive combined agents (ACE blocker+diuretic)

Indications

• arterial hypertension (in patients, which shows the combined therapy).
  

Dosage regimen

Assign inside, 1 time / day.

When hypertension is prescribed for 1 tab. (10 mg+12.5 mg) 1 times/day. If necessary, the dose can be increased to take 1 tab. (20 mg+12.5 mg) 1 times/day.

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

Symptomatic hypotension may occur after taking the initial dose. Such cases are more common in patients who have had fluid and electrolyte loss due to previous diuretic treatment. Therefore, it is necessary to discontinue diuretics 2-3 days before starting treatment with Literatica.

Side effect

In most patients, adverse reactions were mild and transient.

Most often: dizziness, headache.

Adverse reactions, which were less common, are listed below.

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.

From the digestive system: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste change, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice, rarely - increased activity of hepatic transaminases, hyperbilirubinemia.

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

Respiratory system: dyspnea, bronchospasm, apnea, dry cough.

Dermatological reactions: urticaria, sweating, hair loss, photosensitization.

Allergic reactions: angioedema of the face, limbs, lips, tongue, epiglottis and/or larynx, skin rashes, itching, fever, vasculitis, positive results on antinuclear antibodies, increased ESR, eosinophilia.

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

From the urinary system: uremia, oliguria/anuria, impaired renal function, acute renal failure, increased levels of urea and creatinine.

Part of the reproductive system: low potency.

From the musculoskeletal system: arthralgia / arthritis, myalgia.

Metabolism: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hyperuricemia, hyperglycemia, gout exacerbation, rarely - hypercholesterolemia, hypertriglyceridemia, reduced glucose tolerance.

Other: impaired development of the kidneys of the fetus.

Contraindications to use

• anuria,
  
• expressed kidney failure (KK less 30 ml/min),
  
• angioedema (including a history of ACE inhibitors),
  
• hemodialysis using high-flow membranes,
  
• hypercalcemia,
  
• hyponatremia,
  
• porphyria,
  
• precoma, hepatic coma,
  
• diabetes mellitus (severe forms),
  
• pregnancy,
  
• lactation,
  
• age up to 18 years (efficacy and safety not established),
  
• hypersensitivity to the components of the drug,
  
• hypersensitivity to other ACE inhibitors and sulfonamide derivatives.
  

Caution: aortic stenosis/hypertrophic cardiomyopathy, bilateral renal artery stenosis, stenosis of artery only kidneys with progressive azotemia, condition after kidney transplantation, renal failure (QC more 30 ml/min), primary aldosteronism, arterial hypotension, bone marrow hypoplasia, hyponatremia (increased risk of hypotension in patients on malosolenoj or salt-free diet), state, accompanied by a decrease in BCC (including diarrhea, vomiting), connective tissue diseases (systemic lupus erythematosus, scleroderma), diabetes, gout, hyperuricemia, hyperkalemia, coronary artery disease, cerebrovascular insufficiency, severe chronic heart failure, liver failure, old age.

Use during pregnancy and breast-feeding

Contraindicated use of the drug during pregnancy and lactation (breastfeeding).

Application in violation of liver function

With caution: liver failure.

Application for violations of renal function

In patients with CC >, 30 ml / min and<, 80 ml / min, the drug can be used only after titration of the dose of individual components of the drug. The recommended initial dose of lisinopril in uncomplicated renal insufficiency is 5-10 mg.

Do not use with anuria, severe renal failure (KK less 30 ml/min).

Use in children

Contraindications: age up to 18 years (efficacy and safety have not been established).

Use in elderly patients

With caution: old age.

Special instruction

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 food, dialysis, diarrhea or vomiting. In patients with chronic heart failure with simultaneous renal failure or without it, it is possible to develop symptomatic hypotension. It is more common in patients with severe 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 doctor. Such rules should be followed when appointing patients with coronary artery disease, cerebrovascular insufficiency, in which a sharp decrease in blood PRESSURE can lead to myocardial infarction or stroke.

A transient hypotensive response is not a contraindication to receiving the next dose.

In patients with chronic heart failure, a marked decrease in blood PRESSURE after treatment with ACE inhibitors can lead to further deterioration of renal function.

Cases of acute renal failure were noted.

In patients with bilateral renal artery stenosis or stenosis of artery only kidneys, treated with ACE inhibitors, noted increasing urea and creatinine in the serum, usually reversible after discontinuation of treatment. It was more common in patients with renal insufficiency.

Angioedema of the face, limbs, lips, tongue, epiglottis and/or larynx (can occur at any time of treatment) was rare in patients treated with ACE inhibitors, including lisinopril. In this case, treatment with lisinopril should be stopped as soon as possible and the patient should be monitored until complete regression of symptoms. In cases where swelling occurs only on the face and lips, the condition often goes without treatment, however, it is possible to prescribe antihistamines. Angioedema with laryngeal edema can be fatal. When the tongue, epiglottis or larynx are covered, airway obstruction may occur, so appropriate therapy (0.3-0.5 ml epinephrine /epinephrine/ 1:1000 p/K) and/or measures to ensure airway patency should be carried out immediately.

Patients who have a history of angioedema, not associated with previous treatment with ACE inhibitors, may be at increased risk of its development during treatment with ACE inhibitor.

With the use of ACE inhibitors was noted to cough. Cough dry, long, which disappears after discontinuation of treatment with ACE inhibitor. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of ACE inhibitor.

Anaphylactic reaction was also noted in patients subjected to hemodialysis using dialysis membranes with high permeability, which simultaneously take ACE inhibitors. In such cases, it is necessary to consider the possibility of using another type of membrane for dialysis or other antihypertensive agent.

When using drugs that reduce blood PRESSURE in patients with extensive surgery or during General anesthesia, lisinopril can block the formation of angiotensin II.

The marked decrease in blood PRESSURE, which is considered a consequence of this mechanism, can be eliminated by increasing the BCC.

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

In some cases, hyperkalemia was noted.

Risk factors for hyperkalemia include kidney failure, diabetes, potassium supplementation, 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 are at risk of symptomatic hypotension (who are 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 treatment (loss of fluid and salts).

Thiazide diuretics can affect glucose tolerance, so it is necessary to adjust the dose of antidiabetic drugs.

Thiazide diuretics can reduce the excretion of calcium in the urine and cause hypercalcemia. Expressed hypercalcemia may be a symptom of latent hyperparathyroidism, it is recommended to stop treatment with thiazide diuretics before the test to assess the function of the parathyroid glands.

During the period of drug treatment Litrelik requires regular monitoring in plasma potassium, glucose, urea, lipids and creatinine.

During treatment is not recommended to drink alcohol, as ethanol increases the hypotensive effect of the drug.

Caution should be exercised when exercising, hot weather (risk of dehydration and excessive reduction of blood PRESSURE due to lower BCC).

Impact on the ability to drive and operate machinery

During treatment, patients should refrain from driving and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions, as possible dizziness, especially at the beginning of treatment.

Overdose

Symptoms: marked decrease in blood PRESSURE.

Treatment: artificial vomiting and / or gastric lavage, symptomatic therapy aimed at correcting dehydration and disorders of water-salt balance. When hypotension should be administered isotonic solution. It is necessary to control urea, creatinine and electrolytes in the blood serum, as well as diuresis.

Drug interaction

With simultaneous use 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.

While the use of vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol increases the hypotensive effect.

While the use of NSAIDs (indomethacin and others), estrogen reduces the antihypertensive effect of lisinopril.

With simultaneous use with lithium drugs, there is a slowdown in the excretion of lithium from the body (increased cardiotoxic and neurotoxic effects of lithium).

While the use of antacids and kolestiraminom reduced absorption from the gastrointestinal tract.

The drug increases the neurotoxicity of salicylates.

The drug reduces the effect of oral hypoglycemic agents, norepinephrine, epinephrine and anti-podagric agents.

The drug enhances the effects (including side) of cardiac glycosides, the action of peripheral muscle relaxants.

The drug reduces the excretion of quinidine.

Reduces the effectiveness of oral contraceptives.