Monopril

width = Monopril (active ingredient - fosinopril) is an antihypertensive agent representing a group of angiotensin-converting enzyme (ACE inhibitors).

To date, ACE inhibitors are among the most widely used in the treatment of hypertension, heart failure and coronary heart disease drugs. The key to a happy resolution of problems with the cardiovascular system is the ability of ACE inhibitors to block the work of the renin-angiotensin-aldosterone system (RAAS).

Monopril has several advantages over its "associates" in pharmacological "niche which is supported by a powerful evidence base of its effectiveness in the treatment of cardiovascular pathology.

Clinical and pharmacological group

ACE inhibitor.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much does Monopril cost? The average price in pharmacies is at the level of500 rubles.

Form of issue and composition

Monopril is released in the form of tablets: biconvex, almost white or white, with a risk on one side, practically odorless; on the other side - engraving (tablets of 10/20 mg) "158" or "609" (in blisters for 10 or 14 pieces, 1 or 2 blisters in a cardboard pack).

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The composition of 1 tablet includes:

Active substance: fosinopril sodium - 10 or 20 mg;
Auxiliary components: sodium stearyl fumarate, povidone, crospovidone, microcrystalline cellulose, anhydrous lactose.

Pharmacological effect

ACE inhibitor. Fosinopril is an ester, from which an active fosinoprilate compound is formed in the body as a result of hydrolysis under the action of esterases.

Fosinopril, due to the specific linkage of the phosphate group with ACE, prevents the conversion of angiotensin I into vasoconstrictor angiotensin II, as a result of this vasopressor activity and secretion of aldosterone decrease. The latter effect can lead to a slight increase in the content of potassium ions in the serum (an average of 0.1 meq / L) with the simultaneous loss of sodium and liquid ions. Fosinopril inhibits the metabolic degradation of bradykinin, which has a powerful vasopressor effect; due to this, the antihypertensive effect of the drug can be enhanced.

In heart failure, the beneficial effects of monopril are achieved mainly by suppressing the renin-aldosterone system. Suppression of ACE leads to a decrease in both preload and postload on the myocardium.

In patients with heart failure, the drug improves well-being and increases tolerance to physical stress, reduces the severity of heart failure and reduces the frequency of hospitalizations for cardiac insufficiency. The drug is effective without the simultaneous use of digoxin.

Indications for use

According to the instructions, Monopril is prescribed for:

Heart failure - as part of combined treatment;
Arterial hypertension - as a monotherapy or in combination with thiazide diuretics.

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Contraindications

Monopril is not prescribed in such cases:

during lactation;
during pregnancy;
in the presence of lactose deficiency, congenital lactose intolerance and glucose-galactose malabsorption;
patients under the age of 18 (due to the lack of clinical data on the safety and efficacy of Monopril);
if a history of idiopathic and hereditary angioedema (including situations after taking other ACE inhibitors);
if the patient has an individual intolerance of the main active and auxiliary components of the drug;
if a history of increased sensitivity to any other ACE inhibitors is indicated.

Caution Monopril is prescribed for:

bipolar stenosis of the arteries of the kidneys;
stenosis of the aorta;
conditions after kidney transplantation;
gout;
hemodialysis;
renal failure;
hyponatremia;
desensitization;
in old age;
suppression of hematopoiesis in the bone marrow;
Conditions that are associated with a decrease in the total volume of blood;
diets with salt restriction;
systemic lesions of connective tissues;
cerebrovascular diseases;
diabetes mellitus;
heart failure (chronic type 3-4 degrees);
ischemic heart disease;
hyperkalemia.

Use in pregnancy and lactation

When taking the product during pregnancy, it is possible to form malformations of the fetus, a sharp decrease in blood pressure in the fetus and newborn, kidney failure in the fetus, hypochlorism, hypoplasia of various bones of the skull, lung hypoplasia, contracture of the hands and feet. Admission of the product in later periods can also provoke intrauterine fetal death. Fosinoprilat is absorbed into breast milk, so if you need monopril, breastfeeding is stopped.

If mothers took monopril during pregnancy, careful monitoring of the content of the newborn potassium, the amount of urine and blood pressure is necessary.

Dosage and route of administration

The instructions for use indicate that Monopril is prescribed orally. The dose is set individually.

With arterial hypertension, the recommended initial dose is 10 mg 1 time / day. The dose should be selected depending on the dynamics of blood pressure lowering. Doses vary from 10 to 40 mg once a day. In the absence of sufficient hypotensive effect, additional prescription of diuretics is possible.

If treatment with Monopril is initiated against a background of diuretic therapy, then its initial dose should not exceed 10 mg with regular medical monitoring of the patient's condition.

The maximum daily dose is 40 mg.

In chronic heart failure, the recommended initial dose is 10 mg 1 time / day. Treatment begins under compulsory medical supervision. If the drug at reception in an initial dose is well transferred, the dose can be gradually increased with weekly intervals, up to 40 mg 1 time / day (the maximum daily dose). The drug should be administered in combination with a diuretic. Simultaneous use of digoxin is not necessary.

Since the removal of the drug from the body occurs in two ways, correction of doses to patients with impaired renal or hepatic function is usually not required.

Differences in efficacy and safety of treatment with Monopril in patients aged 65 years and older and younger patients are not observed, so dose adjustment for elderly patients is usually not it takes. However, it is impossible to exclude a greater susceptibility in some elderly patients to the drug, due to possible overdose phenomena due to delayed excretion of the drug.

Side effects

During the application of the drug Monopril, the following side effects on the part of systems and organs are possible:

Sense organs: earache, taste change, tinnitus, visual and hearing impairment;
Musculoskeletal system: myalgia, muscle weakness in the limbs, arthritis, musculoskeletal pain;
Lymphatic system: inflammation of the lymph nodes;
Metabolism: exacerbation of gout;
Allergic reactions: itching, dermatitis, skin rash, angioedema;
Digestive system: diarrhea, pancreatitis, cholestatic jaundice, vomiting, nausea, anorexia, glossitis, stomatitis, intestinal obstruction, hepatitis, pancreatitis, abdominal pain, constipation, flatulence, dysphagia, dryness of the oral mucosa, impaired appetite, bleeding, weight change body;
Cardiovascular system: orthostatic hypotension, syncope, palpitation, myocardial infarction, impaired cardiac conduction, marked decrease blood pressure to the skin of the face, increased blood pressure, peripheral edema, tachycardia, arrhythmia, angina pectoris, cardiac arrest, sudden death;
Respiratory system: dry cough, dyspnea, pharyngitis, laryngitis, pneumonia, bronchospasm, pulmonary infiltrates, sinusitis, rhinorrhea, nosebleeds, dysphonia, tracheobronchitis;
Urinary system: proteinuria, polyuria, renal insufficiency, oliguria, pathology of the prostate (adenoma, hyperplasia);
Central and peripheral nervous system: cerebral ischemia, imbalance, weakness, stroke, headache, memory impairment, dizziness; confusion, anxiety, sleep and memory disorders, paresthesia, drowsiness, depression;
Influence on the fetus: reduction in arterial pressure of the fetus and newborns, hyperkalemia, oligohydramnion, hypoplasia lungs, dysplasia of the fetus, hypoplasia of the skull bones, limb contracture, impaired renal function;
Laboratory indicators: increased urea concentration, hyperbilirubinemia, hyponatremia, hypercreatininemia, increased hepatic activity enzymes, hyperkalemia; increase in erythrocyte sedimentation rate, neutropenia, leukopenia, decrease in hematocrit and hemoglobin concentration, eosinophilia;
Other: hyperhidrosis, fever, violation of sexual function.

Overdose

Symptoms: severe depression of pressure, aetiology, shock, disturbance of water-mineral balance, acute course of renal failure, stupor.

Therapy: stop taking Monopril, rinsing the stomach, using sorbents, vasopressor drugs, intravenous saline injection, then symptomatic and supportive therapy. Hemodialysis is ineffective.

special instructions

Before the beginning of treatment it is required to conduct an analysis of previous antihypertensive therapy, the degree of increase in blood pressure, restriction of ration for salt and / or fluid and other clinical circumstances. If possible, the previous antihypertensive therapy should be discontinued a few days before the Monopril treatment begins.

To reduce the likelihood of arterial hypotension, diuretics should be discontinued 2-3 days before treatment with Monopril.

Before and during treatment, it is necessary to monitor blood pressure, kidney function, potassium ion, creatinine, urea concentration, electrolyte concentration and hepatic enzyme activity in the blood.

Cough. With the use of ACE inhibitors, including fosinopril, there was an unproductive, persistent cough that occurs after the abolition of therapy. When cough occurs in patients taking ACE inhibitors, this therapy should be considered as a possible cause in the context of differential diagnosis.
Edema of the intestinal mucosa. During the administration of ACE inhibitors, edema of the intestinal mucosa was rarely observed. Patients complained of abdominal pain (with nausea and vomiting may not be), in some cases, the edema of the intestinal mucosa appeared without edema of the face, the activity of C1-esterase was normal. Symptoms disappeared after the cessation of the use of ACE inhibitors. Swelling of the intestinal mucosa should be included in the differential diagnosis of patients taking ACE inhibitors who complain of abdominal pain.
Angioedema. The development of angioedema of the extremities, face, lips, mucous membranes, tongue, pharynx or larynx in patients with Monopril was reported. When swelling of the tongue, throat or larynx, airway obstruction may develop with possible fatal outcome. In such cases, it is necessary to stop taking the drug and carry out urgent measures, including subcutaneous injection of a solution of epinephrine (adrenaline) (: 000), as well as the adoption of other urgent measures therapy. In most cases, edema of the face, oral mucosa, lips and extremities discontinuation drug led to the normalization of the condition; However, sometimes an appropriate therapy was required.
Anaphylactic reactions during desensitization. In two patients, during the desensitization of the Hymenoptera with the use of an ACE inhibitor enalapril, life-threatening anaphylactoid reactions were noted. In the same patients, these reactions were avoided by the timely suspension of the ACE inhibitor; however, they appeared again after the involuntary resumption of the ACE inhibitor. Care should be taken when desensitizing patients taking ACE inhibitors.
Anaphylactic reactions during dialysis using high permeability membranes. Anaphylactic reactions can develop in patients taking ACE inhibitors during hemodialysis with highly permeable membranes, as well as during the apheresis of low-density lipoproteins with adsorption to dextran sulfate. In these cases, the use of dialysis membranes of a different type or the use of antihypertensive drugs of another class should be considered.
Arterial hypotension. Patients with uncomplicated form of hypertension may develop arterial hypotension due to the use of the drug Monopril.
Neutropenia / agranulocytosis. Perhaps the development of agranulocytosis and suppression of bone marrow function during treatment with ACE inhibitors. These cases are noted more often in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (SLE or scleroderma). Before the beginning of therapy with ACE inhibitors and during the treatment, the leukocytes and leukocyte formula (1 once a month in the first 3-6 months of treatment and in the first year of use in patients with an increased risk neutropenia).
Symptomatic arterial hypotension with ACE inhibitors often develops in patients on the background of intensive diuretic treatment, a diet related to restriction of table salt, or dialysis. Transient arterial hypotension is not a contraindication for the use of the drug after carrying out measures to restore the BCC.
It may be necessary to reduce the dose of a diuretic in patients with normal or low blood pressure who were previously treated with diuretics or who have hyponatraemia. Arterial hypotension per se is not a contraindication for the further use of Monopril in chronic heart failure.
In patients with chronic heart failure, treatment with ACE inhibitors can cause excess antihypertensive the effect that can lead to oliguria or azotemia and, in rare cases, to acute renal failure with lethal outcome. Therefore, in the treatment of chronic heart failure with Monopril, careful monitoring of patients, especially during the first 2 weeks of treatment, as well as with any increase in the dose of Monopril or diuretic.
Some reduction in systemic BP is a common and desirable effect at the beginning of the drug in chronic heart failure. The degree of this decrease is maximal at early stages of treatment and stabilizes within one or two weeks from the start of treatment. BP usually returns to baseline without reducing therapeutic effectiveness.
In patients with impaired liver function, there may be an increased concentration of fosinopril in the blood plasma. With cirrhosis of the liver (including alcohol), the apparent overall clearance of fosinoprilat is reduced, and the AUC is approximately 2 times higher than in patients without liver function disorders.
Violation of the function of the liver. In rare cases, with the use of ACE inhibitors, there is a syndrome, the first manifestation of which is cholestatic jaundice. Then follows the fulminant necrosis of the liver, sometimes with a fatal outcome. The mechanism of development of this syndrome has not been studied. When there is noticeable icterus and a marked increase in the activity of liver enzymes, treatment with Monopril should be discontinued and appropriate treatment should be prescribed.
In patients with severe chronic heart failure, kidney function may depend on the activity of the renin-angiotensin-aldosterone system, so treatment with ACE inhibitors may be accompanied by oliguria and / or progressive azotemia, and in rare cases - acute renal failure and lethal outcome.
Hyperkalemia. There have been cases of an increase in the content of potassium ions in the blood serum of patients taking ACE inhibitors, incl. fosinopril. The risk group in this regard is made up of patients with renal insufficiency, type 1 diabetes, and also those receiving potassium-sparing diuretics, potassium-containing food additives or other drugs that increase the potassium ion content in the blood serum (e.g., heparin).
Impaired renal function. In patients with arterial hypertension with unilateral or bilateral stenosis of the renal arteries or stenosis of the artery a single kidney during treatment with ACE inhibitors can increase the concentration of blood urea nitrogen and creatinine blood serum. These effects are usually reversible and pass after discontinuation of treatment. It is necessary to monitor kidney function in such patients in the first weeks of treatment. In some patients, an increase in the concentrations of blood urea nitrogen and serum creatinine (usually small and transient) can be observed even without an obvious violation of kidney function with the simultaneous use of the drug Monopril and diuretics. It may be necessary to reduce the dose of Monopril.
Surgical interventions / general anesthesia. ACE inhibitors can enhance the antihypertensive effect of agents used for general anesthesia. Before surgery (including dentistry), a physician / anesthesiologist should be warned about the use of ACE inhibitors. Caution should be exercised when performing physical exercises or in hot weather due to the risk of dehydration and arterial hypotension due to a decrease in BCC.

Influence on ability to drive vehicles and mechanisms

Care must be taken when driving vehicles or doing other work that requires increased attention, as dizziness may occur.

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Drug Interactions

Estrogens weaken the antihypertensive effect of Monopril because of its ability to retain water.
With the simultaneous use of ACE inhibitors with lithium salts, the lithium content of serum and the risk of developing lithium intoxication may be increased, therefore Monopril and lithium preparations should be used simultaneously. caution. A careful monitoring of the lithium content in serum is recommended.
Simultaneous use of antacids (including aluminum or magnesium hydroxide), as well as simethicone can reduce the absorption of fosinopril, so these drugs should be taken at intervals of at least 2 h).
Potassium preparations, potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the risk of hyperkalemia. In patients with heart failure, diabetes mellitus, concomitantly taking potassium-sparing diuretics, potassium, potassium-containing salt substitutes or other agents that cause hyperkalemia (eg, heparin), ACE inhibitors increase the risk of increasing the potassium ion content in blood serum.
With simultaneous use of Monopril with diuretics, especially at the beginning of diuretic therapy, and also in combination with a strict diet, limiting the intake of table salt, or with dialysis, there may be a marked decrease in blood pressure, especially in the first hour after taking the initial dose preparation Monopril.
Hypotensive drugs, opioid analgesics, medicines for general anesthesia increase the antihypertensive effect of Monopril.
Fosinopril enhances the hypoglycemic effect of derivatives of sulfonylurea, insulin, the risk of developing leukopenia with simultaneous use with allopurinol, cytostatic agents, immunosuppressants, procainamide.
It is known that indomethacin NSAIDs can reduce the antihypertensive effect of ACE inhibitors, especially in patients with arterial hypertension and low renin activity in blood plasma. A similar effect may have other NSAIDs, for example, acetylsalicylic acid, and selective inhibitors of COX-2. In patients older than 65 years, with hypovolemia (including when treated with diuretics), with impaired renal function, concurrent administration of NSAIDs (including selective inhibitors of COX-2) and ACE inhibitors (including fosinopril) can lead to impaired renal function, up to acute renal insufficiency. Usually this state is reversible. Kidney function in patients taking fosinopril and NSAIDs should be closely monitored.
Bioavailability of the drug with simultaneous use with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propanthelin bromide, digoxin and warfarin are not changes.

Reviews

We picked up some responses from people who took Monopril:

Galina. I drink monopril already a lot of le, when the pressure rises I immediately feel it, my head begins to hurt, a strong palpitation. Here my dear monprilchik is going to save me. I used to drink the italy producer. At present, I bought the production of polish, I do not know what the smell is the same, but I'm afraid to be treated. I do not know what they put there.
Michael. Monopril was prescribed to me by a cardiologist with a diagnosis of hypertension for daily administration. I accept 8 years. There are no hypertensive crises. I take 1 tablet of 20 mg at night. None of the side effects indicated in the annotation is observed. The pressure is kept in the range of 130/80.

Analogues

The Monopril preparation has direct analogues with fosinopril substance: Fosicard (295 rubles), Fosinopril (240 rubles), Fozinopril-Teva (145 rubles).

Other representatives of the ACE inhibitor group:

Perineva is a domestic preparation of perindopril, is prescribed for chronic ischemia of the heart muscle, cerebrovascular disease. Provides cardioprotective properties. The average cost is 360 rubles.
Amprilan is a preparation produced in Slovenia, the main active ingredient is ramipril. In addition to the treatment of hypertension, it is used to correct hemodynamic disorders in myocardial infarction, stroke of unknown pathogenesis, and kidney disease. The price is 250-430 rubles.
Irumed is a preparation manufactured in Croatia, the active ingredient is lisinopril. Gives a good effect in the treatment of congestive heart failure and hypertension caused by kidney pathology. The cost is 110-200 rubles.
Berlipril is a German medicinal product, enalapril is used as the main component. The drug is well suited to relieve the first time hypertension, has no significant side effects. The average price is 190 rubles.

Before using analogues, consult your doctor.