Irumed, tablets 10 mg, 30 pcs.

Irumed is an ACE inhibitor. It is an antihypertensive drug. The mechanism of action is associated with inhibition of ACE activity, which leads to suppression of angiotensin II formation from angiotensin I and a direct reduction of aldosterone release. It reduces bradykinin degradation and increases prostaglandin synthesis.

Lysinopril reduces RPS, BP, preload, pulmonary capillary pressure, causes an increase in the minute blood volume and increases exercise tolerance in patients with chronic heart failure. Lisinopril has a vasodilator effect, with a greater degree of arterial dilatation than vein dilatation. Some effects are attributed to the effect on tissue renin-angiotensin systems. It improves the blood supply to the ischemic myocardium. Long-term use reduces myocardial hypertrophy and resistive arterial wall hypertrophy.

The use of ACE inhibitors in patients with heart failure leads to increased life expectancy; in patients who have had myocardial infarction without clinical manifestations of heart failure it slows the progression of left ventricular dysfunction.

The onset of action is noted 1 hour after taking the drug, the maximum effect is noted after 6-7 hours, the duration of action is 24 hours. In case of arterial hypertension the effect is noted in the first days after the start of treatment, the stable effect develops after 1-2 months.

Indications

– arterial hypertension, including renovascular (as monotherapy or in combination with other antihypertensive agents);
– chronic heart failure (in combination therapy);
– acute myocardial infarction (in patients with stable hemodynamic indices during the first day);
– diabetic nephropathy.

Active ingredient

Composition

1 tablet contains lisinopril dihydrate (in terms of lisinopril anhydrous) 10 mg.

How to take, the dosage

The drug is prescribed orally. Food intake does not affect absorption, so the drug can be taken before, during or after meals. The frequency of administration is 1 time per day (approximately at the same time).

In the treatment of essential hypertension, a starting dose of 10 mg is recommended. The average maintenance dose is 20-40 mg/day. The maximum daily dose is 80 mg.

Patients taking diuretics should select the dose individually, taking into account that such patients may have hyponatremia or reduced circulating blood volume, which may lead to symptomatic hypotension. Treatment with diuretics should be discontinued 2-3 days before treatment with Irumed and, if necessary, should be resumed after adjustment of Irumed dose depending on the clinical situation. In patients where treatment with diuretics cannot be discontinued, Irumed is prescribed at an initial dose of 5 mg/day, increasing it further depending on the therapeutic effect and tolerability of the drug. If necessary, treatment with diuretics may be resumed.

Interaction

In concomitant use of Irumed with potassium-saving diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes containing potassium, the risk of hyperkalemia increases, especially in patients with impaired renal function.

Simultaneous use of Irumed with diuretics results in a marked decrease in BP.
Simultaneous use of Irumed with other antihypertensive drugs results in an additive effect.
Simultaneous use of Irumed with NSAIDs and estrogens reduces the antihypertensive effect of lisinopril.
Simultaneous use of Irumed with lithium slows down excretion of lithium from the body.
Simultaneous use of Irumed with antacids and colestyramine reduces absorption of lisinopril in the GI tract.

No significant pharmacokinetic interactions were found when lisinopril was used together with propranololol, digoxin or hydrochlorothiazide.

Special Instructions

It should be taken into account that a pronounced decrease in BP occurs with a decrease in fluid volume caused by diuretic therapy, with reduction of salt in food, with dialysis and in patients with diarrhea or vomiting. In patients with chronic heart failure with concomitant renal failure or without it the development of symptomatic arterial hypotension is possible, which was found more often in patients with severe heart failure, as a consequence of using high doses of diuretic, hyponatremia or impaired renal function. In such patients, treatment should be started under strict medical supervision (with caution, select the dosage of the drug and diuretics). The same tactics should be followed when prescribing Irumed to patients with CHD, cerebrovascular insufficiency in whom a sharp decrease of BP may lead to myocardial infarction or stroke.

In case of a pronounced BP decrease, the patient should be placed in a horizontal position and if necessary, 0.9% sodium chloride solution should be administered intravenously. A transient hypotensive reaction is not a contraindication for the next dose of the drug.
During the use of Irumed some patients with chronic heart failure but with normal or decreased BP may have a decrease in BP which is usually not a reason for discontinuing the treatment. If the arterial hypotension becomes symptomatic, it is necessary to decrease the dose of the drug or discontinue treatment with Irumed.

In acute myocardial infarction standard therapy (thrombolytics, acetylsalicylic acid, beta-adrenoblockers) is indicated. Irumed can be used together with intravenous or transdermal nitroglycerin systems.
In patients with chronic heart failure, a marked decrease in BP after starting treatment with ACE inhibitors may lead to further deterioration of renal function. There have been cases of acute renal failure against the background of ACE inhibitors administration. In patients with bilateral renal artery stenosis or stenosis of the artery of the only kidney receiving ACE inhibitors, an increase in serum urea and creatinine was noted, usually reversible after discontinuation of treatment (more common in patients with renal failure).
Patients taking ACE inhibitors, including lisinopril, have rarely developed angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx, and it may develop during any period of treatment. In such cases, treatment with Irumed should be discontinued as soon as possible and the patient should be monitored until symptoms have completely resolved. However, in cases where the swelling is limited to the face and lips and the condition usually resolves without treatment, antihistamines may be prescribed.

If angioedema spreads to the tongue, epiglottis or larynx, airway obstruction may occur, so appropriate therapy and/or measures to ensure airway patency should be given immediately. It has been observed that patients of the Negro race taking ACE inhibitors developed angioedema more frequently than patients of other races. Patients who have a history of previous angioedema unrelated to previous treatment with ACE inhibitors may have an increased risk of developing it during treatment with Irumed.

Patients taking ACE inhibitors during desensitization to hymenoptera (wasps, bees, ants and other hymenopterans) may very rarely develop an anaphylactoid reaction. This can be avoided by temporarily stopping treatment with an ACE inhibitor before each desensitization.

It should be considered that patients taking ACE inhibitors who are on hemodialysis using high permeability dialysis membranes may develop anaphylactic reactions. In such cases, another type of dialysis membrane or another antihypertensive medication should be considered.

When using ACE inhibitors, cough (dry, prolonged, which disappears after discontinuation of ACE inhibitor treatment) is noted. In the differential diagnosis of cough, the cough caused by the use of an ACE inhibitor should also be considered.

When BP-lowering drugs are used in patients undergoing major surgery or during general anesthesia, lisinopril may block angiotensin II formation, secondary to compensatory renin release. A pronounced decrease in BP, which is thought to be a consequence of this mechanism, can be corrected by increasing circulating blood volume.

In some cases, hyperkalemia has been noted. The risk factors for development of hyperkalemia include renal insufficiency, diabetes mellitus and concomitant use of potassium-saving diuretics (spironolactone, triamterene or amiloride), potassium drugs or salt substitutes containing potassium, especially in patients with impaired renal function. If it is necessary to use these combinations, serum potassium levels should be monitored regularly.

In patients who are at risk of symptomatic hypotension (who are on a low-salt or no-salt 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).

Influence on driving and operating machinery

There are no data on the effect of Irumed, used in therapeutic doses, on the ability to drive vehicles and operate machinery, but it should be noted that dizziness may occur.

Contraindications

– angioedema in anamnesis (including. in case of using ACE inhibitors);
– hereditary Quincke’s edema;
– age less than 18 years old (efficacy and safety have not been determined);
– pregnancy;
– hypersensitivity to lisinopril and other ACE inhibitors;

. The drug should be administered with caution in aortic stenosis, hypertrophic cardiomyopathy, bilateral renal artery stenosis, artery stenosis of the only kidney with progressive azotemia, post renal transplantation condition, primary hyperaldosteronism, arterial hypotension, bone marrow hypoplasia, hyponatremia (increased risk of arterial hypotension in patients on low-salt or no-salt diet), hyperkalemia, conditions accompanied by decreased circulating blood volume (includingIncluding diarrhea, vomiting), diseases of connective tissue (including systemic lupus erythematosus, scleroderma), diabetes, gout, hyperuricemia, CHD, cerebrovascular insufficiency, elderly patients.

Side effects

The following side effects have been noted most frequently: dizziness, headache, nausea, diarrhea, fatigue, cough.
The following side effects have been rarely reported.

Cardiovascular system: marked BP decrease, chest pain, orthostatic hypotension, tachycardia, bradycardia, worsening of heart failure symptoms, AV conduction disorder, myocardial infarction.

Digestive system disorders: abdominal pain, dry mouth, dyspepsia, anorexia, change in taste, pancreatitis, hepatocellular or cholestatic hepatitis, jaundice, increased liver transaminases activity, hyperbilirubinemia.

CNS disorders: mood lability, confusion, paresthesias, somnolence, convulsive twitching of muscles of extremities and lips, asthenic syndrome, confusion.

Respiratory system: dyspnea, bronchospasm, apnea.

Skin disorders: urticaria, sweating, hair loss, photosensitization.

Blood organs: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decrease in hematocrit, erythrocytopenia).

Urinary system disorders: uremia, oliguria/anuria, renal dysfunction, acute renal failure, decreased potency.

Allergic reactions: angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx, skin rash, itching, fever, positive results of antinuclear antibody test, increased CRP, eosinophilia, leukocytosis.

Other: hyperkalemia, hyponatremia, hyperuricemia, arthralgia, myalgia.
Most patients had mild and transient side effects.

Overdose

Symptoms: pronounced decrease in BP.

Treatment: Injection of vomiting and/or gastric lavage is necessary, further symptomatic therapy aimed at correction of dehydration and water-salt balance disorders is carried out.

In case of arterial hypotension an isotonic solution should be administered, vasopressors are prescribed. Hemodialysis may be used.

Symptoms: marked decrease in BP.

Pregnancy use

The use of Irumed is contraindicated in pregnancy. Lisinopril crosses the placental barrier.

If pregnancy occurs, treatment with Irumed should be stopped immediately, unless the benefit to the mother exceeds the potential risk to the fetus (the patient should be informed about the potential risk to the fetus). Administration of ACE inhibitors in the second and third trimesters of pregnancy may cause fetal and neonatal death.

Newborns may develop skull hypoplasia, oligohydramnios, skull and facial bone deformities, pulmonary hypoplasia, and impaired renal development. Newborns and infants whose mothers took ACE inhibitors during pregnancy should be closely monitored for the timely detection of a marked decrease in BP, oliguria, and hyperkalemia.

There are no data on lisinopril penetration into maternal milk. Breast-feeding should be stopped during treatment with the drug Irumed.

Similarities