Co-Diroton, 20mg+12.5mg pills, 30pcs

Composition

1 tablet contains lisinopril dihydrate 21.77 mg, which corresponds to the content of lisinopril 20 mg;

hydrochlorothiazide 12.5 mg

Pharmacological action

Co-Diroton has antihypertensive and diuretic effects.

Indications

Arterial hypertension (in patients who are indicated for combination therapy).

Use during pregnancy and lactation

The use of lisinopril during pregnancy is contraindicated. If pregnancy is established, the drug should be discontinued as soon as possible.

Taking ACE inhibitors in the second and third trimesters of pregnancy has an adverse effect on the fetus (there may be a pronounced decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull bones, intrauterine death). There are no data on the negative effects of the drug on the fetus when used during the first trimester.

Newborns and children who have been exposed to intrauterine ACE inhibitors are recommended to be monitored for timely detection of a pronounced decrease in blood pressure, oliguria, and hyperkalemia.

During treatment with the drug, it is necessary to stop breastfeeding.

Contraindications

Hypersensitivity (including to other ACE inhibitors and sulfonamide derivatives), anuria, angioedema (including in the anamnesis from the use 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 have not been established).

With caution. Aortic stenosis, hypertrophic cardiomyopathy, bilateral renal artery stenosis, single kidney artery stenosis with progressive azotemia, post-kidney transplant condition, CRF (creatinine clearance greater than 30 ml/min), severe CRF (creatinine clearance less than 30 ml/min), primary hyperaldosteronism, hypotension, bone marrow hypoplasia, hyponatremia (increased risk of hypotension in patients on low-salt or low-salt therapy). diarrhoea, vomiting), connective tissue diseases (SLE, scleroderma), diabetes mellitus, gout, hyperuricemia, hyperkalemia, liver failure, cerebrovascular insufficiency, severe CHF, and the elderly.

Side effects

are Common: dizziness, headache.

Less frequent ones. 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 AV conduction, myocardial infarction.

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

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

From the respiratory system: dyspnoea, bronchospasm, apnea.

Skin disorders: urticaria, sweating, alopecia, photosensitivity.

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

Hematopoietic disorders: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decreased Hb, hematocrit, erythropenia).

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

Laboratory parameters: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia, hyperglycemia, increased urea and creatinine in blood plasma, rarely — increased activity of “hepatic” transaminases, hyperbilirubinemia, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance.

Other services: dry cough, arthralgia/arthritis, myalgia, impaired fetal kidney development, exacerbation of gout, vasculitis.

Interaction

When used concomitantly with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, the risk of hyperkalemia increases, especially in patients with impaired renal function. Therefore, they can be co-administered only on the basis of an individual doctor’s decision, with regular monitoring of serum potassium levels and kidney function. When used concomitantly with vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol, an increase in the hypotensive effect is noted.

When used concomitantly with NSAIDs (Indometacin and others), estrogens, a decrease in the antihypertensive effect of lisinopril is noted.

When used concomitantly with lithium preparations, the elimination of lithium from the body slows down (increased cardiotoxic and neurotoxic effects of lithium).

When used concomitantly with antacids and colestyramine, absorption in the gastrointestinal tract decreases.

The drug increases the neurotoxicity of salicylates, weakens the effect of hypoglycemic drugs for oral use, norepinephrine, epinephrine and anti-gouty drugs, increases the effects (including side effects) of cardiac glycosides, the effect of peripheral muscle relaxants, reduces the excretion of quinidine.

Reduces the effect of oral contraceptives.

Ethanol enhances the antihypertensive effect of the drug. When taking methyldopa at the same time, the risk of developing hemolysis increases.

How to take, course of use and dosage

Assign inside 1 tab. 1 time/day. If the proper therapeutic effect is not achieved within 2-4 weeks, the dose of the drug can be increased to 2 tablets. 1 time/day.

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

Symptomatic hypotension may occur after taking the initial dose of the drug. Such cases are more common in patients who have had fluid and electrolyte loss due to previous diuretic treatment. Therefore, you should stop taking diuretics 2-3 days before starting treatment with the drug.

Overdose

Symptoms: marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.

Treatment: symptomatic therapy, intravenous fluid use, blood pressure control; therapy aimed at correcting dehydration and disorders of the water-salt balance. Control of urea, creatinine and electrolytes in the blood serum, as well as diuresis.

Special instructions

Most often, a marked decrease in blood pressure occurs with a decrease in fluid volume 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, a pronounced decrease in blood pressure is possible. It is more often detected in patients with severe class of chronic heart failure, as a result of the use of high doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment should be started under the strict supervision of a doctor. Such rules should be followed when prescribing to patients with CHD, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

Transient arterial hypotension is not a contraindication for further use of the drug. Before starting treatment, if possible, the sodium concentration should be normalized and / or the lost volume of fluid should be replenished, and the effect of the initial dose of the drug on the patient should be carefully monitored.

In patients with chronic heart failure, a marked decrease in blood pressure after starting treatment with ACE inhibitors may lead to further deterioration of renal function. Cases of acute renal failure have been reported.

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

Angioedema of the face, extremities, lips, tongue, epiglottis, and / or larynx has been reported rarely in patients treated with ACE inhibitors, including lisinopril, which may occur during any period of treatment. In this case, treatment with lisinopril should be stopped as soon as possible and the patient should be monitored until the symptoms fully regress. In cases where only the face and lips are swollen, the condition most often passes without treatment, however, antihistamines may be prescribed. Angioedema with laryngeal edema can be fatal. When the tongue, epiglottis, or larynx is affected, airway obstruction may occur, so appropriate therapy should be given immediately (0.3-0.5 ml of epinephrine (epinephrine)solution).1: 1000 p / s) and / or measures to ensure airway patency.

Patients who have a history of angioedema that is not associated with previous treatment with ACE inhibitors may have an increased risk of developing angioedema during treatment with an ACE inhibitor.

When using an ACE inhibitor, cough was noted. The cough is dry and prolonged, which disappears after discontinuation of treatment with an ACE inhibitor. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of an ACE inhibitor.

Anaphylactic reaction has also been observed in patients undergoing hemodialysis using high-permeability dialysis membranes (AN69®), who are simultaneously taking ACE inhibitors. In such cases, a different type of dialysis membrane or other antihypertensive agent should be considered.

When using blood pressure-lowering drugs in patients undergoing extensive surgery or during general anesthesia, lisinopril may block the formation of angiotensin II.

A pronounced 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 anesthesiologist about the use of ACE inhibitors. In some cases, hyperkalemia was observed. Risk factors for developing hyperkalemia include renal failure, diabetes mellitus, taking potassium supplements or drugs that cause an increase in blood potassium concentrations (for example, heparin), especially in patients with impaired renal function.

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

Thiazide diuretics can affect glucose tolerance, so it is necessary to adjust the dose of hypoglycemic agents for oral use. Thiazide diuretics can reduce the excretion of calcium by the kidneys and cause hypercalcemia. Severe hypercalcemia may be a symptom of latent hyperparathyroidism. It is recommended to discontinue treatment with thiazide diuretics before performing a parathyroid function test.

During treatment with the drug, regular monitoring of blood plasma potassium, glucose, urea, lipids is necessary.

During the treatment period, it is not recommended to consume alcoholic beverages, because alcohol increases the hypotensive effect of the drug. Caution should be exercised when exercising, in hot weather (risk of dehydration and excessive blood pressure reduction due to BCC reduction).

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, you should refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, since dizziness is possible, especially at the beginning of the course of treatment.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Lisinopril, Hydrochlorothiazide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets