Monopril (active ingredient - fosinopril) is an antihypertensive agent that represents a group of angiotensin-converting enzyme inhibitors (ACE inhibitors).
Today, ACE inhibitors are among the most widely used drugs in the treatment of arterial hypertension, heart failure and coronary heart disease. The key to a happy resolution of problems with the cardiovascular system is the ability of an ACE inhibitor to block the work of the renin-angiotensin-aldosterone system (RAAS).
Monopril has a number of advantages over its "colleagues" in the pharmacological "niche", which is supported by a strong evidence base of its effectiveness in the treatment of cardiovascular pathology.
Clinical and pharmacological group
Pharmacy sales terms
It is released on prescription.
How much does Monopril cost? The average price in pharmacies is at the level of 500 rubles.
Release form and composition
Monopril is produced in the form of tablets: biconvex, almost white or white, with a risk on one side, with almost no odor; on the other side - engraving (pills 10/20 mg) "158" or "609" (in blisters of 10 or 14 pcs .; 1 or 2 blisters in a carton box).
The composition of 1 tablet includes:
- Active ingredient: fosinopril sodium - 10 or 20 mg;
- Auxiliary components: sodium fumarate, povidone, crospovidone, microcrystalline cellulose, anhydrous lactose.
ACE inhibitor. Fozinopril is an ester from which the active compound fosinoplatat is formed in the body as a result of hydrolysis under the action of esterases.
Fosinopril, due to the specific connection of the phosphate group with ACE, prevents the conversion of angiotensin I into the vasoconstrictor substance angiotensin II, as a result of which vasopressor activity and aldosterone secretion are reduced. The latter effect can lead to a slight increase in the content of potassium ions in the serum (average of 0.1 meq / l) with the simultaneous loss of sodium ions and fluids by the body. Fozinopril inhibits the metabolic degradation of bradykinin, which has a powerful vasopressor effect; due to this, the antihypertensive effect of the drug may increase.
In heart failure, the positive effects of Monopril are mainly achieved by suppressing the renin-aldosterone system. Suppression of ACE leads to a decrease in both preload and afterload on the myocardium.
In patients with heart failure, the drug improves well-being and increases exercise tolerance, reduces the severity of heart failure, and reduces the frequency of hospitalizations for heart failure. The drug is effective without the simultaneous use of digoxin.
Indications for use
According to the instructions Monopril prescribed for:
- Heart failure - as part of a combination treatment;
- Hypertension - as monotherapy or in combination with thiazide diuretics.
Monopril is not appointed in such cases:
- during lactation;
- during pregnancy;
- in the presence of lactose deficiency, congenital lactose intolerance and glucose-galactose malabsorption;
- patients under 18 years of age (due to the lack of clinical data on the safety and efficacy of Monopril);
- if the history is idiopathic and hereditary angioedema (including situations after taking other ACE inhibitors);
- if the patient has an individual intolerance to the main active and auxiliary components of the drug;
- if history shows hypersensitivity to any other ACE inhibitors.
Monopril is prescribed with caution when:
- bipolar renal artery stenosis;
- aortic stenosis;
- conditions after kidney transplantation;
- renal failure;
- in old age;
- suppression of blood formation in the bone marrow;
- conditions that are associated with a decrease in total blood volume;
- salt restricted diets;
- systemic lesions of connective tissue;
- cerebrovascular diseases;
- heart failure (chronic type 3-4 degrees);
- coronary heart disease;
Use during pregnancy and lactation
When taking the product during pregnancy, it is possible to form fetal malformations, a sharp decrease in blood pressure in the fetus and newborn, renal failure in the fetus, lack of water, hypoplasia of various bones of the skull, hypoplasia of the lungs, contractures of the arms and legs. Reception of a product on the late periods can also provoke intrauterine fetal death. Fozinoprilat is absorbed into breast milk, so if you need monopril intake, breastfeeding is stopped.
If mothers took monopril during pregnancy, careful monitoring of the potassium content of the newborn, the amount of urine and blood pressure is necessary.
Dosage and method of use
The instructions for use indicated that monopril prescribed inside. Dose set individually.
- In hypertension, the recommended initial dose is 10 mg 1 time per day. The dose should be selected depending on the dynamics of blood pressure reduction. Doses vary from 10 to 40 mg 1 time / day. In the absence of a sufficient hypotensive effect, it is possible to further assign diuretics.
If treatment with Monopril is started on the background of diuretic therapy, its initial dose should be no more than 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 mandatory medical supervision. If the drug is well tolerated when taken in the initial dose, the dose can be gradually increased at weekly intervals, up to 40 mg 1 time / day (maximum daily dose). The drug should be prescribed in combination with a diuretic. Simultaneous use of digoxin is optional.
Since the removal of the drug from the body occurs in two ways, dose adjustment in patients with impaired renal or liver function is usually not required.
Differences in the effectiveness 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 required. However, a greater susceptibility in some elderly patients to the drug cannot be ruled out, due to possible overdose events due to the delayed elimination of the drug.
During the use of the drug Monopril the following side effects are possible with the systems and organs:
- Sense organs: ear pain, change in taste, tinnitus, visual and hearing impairment;
- Musculoskeletal system: myalgia, muscular weakness in the limbs, arthritis, musculoskeletal pains;
- Lymphatic system: inflammation of 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 mucous membrane, impaired heart rate, abdominal discomfort, constipation, constipation, constipation, dryness ;
- Cardiovascular system: orthostatic hypotension, syncope, palpitations, myocardial infarction, abnormal conduction of the heart, marked reduction in blood pressure, blood flushes to the skin of the face, increased blood pressure, peripheral edema, tachycardia, arrhythmia, angina, cardiac arrest, sudden death;
- Respiratory system: dry cough, shortness of breath, pharyngitis, laryngitis, pneumonia, bronchospasm, pulmonary infiltrates, sinusitis, rhinorrhea, nosebleeds, dysphonia, tracheobronchitis;
- Urinary system: proteinuria, polyuria, renal failure, oliguria, prostate gland disease (adenoma, hyperplasia);
- Central and peripheral nervous system: cerebral ischemia, imbalance, weakness, stroke, headache, memory impairment, dizziness; confusion, anxiety, sleep and memory disturbances, paresthesias, drowsiness, depression;
- Impact on the fetus: reduction in blood pressure of the fetus and newborns, hyperkalemia, oligohydramnios, lung hypoplasia, impaired development of the fetal kidneys, hypoplasia of the skull bones, contracture of the limbs, impaired renal function;
- Laboratory indicators: increased concentration of urea, hyperbilirubinemia, hyponatremia, hypercreatininemia, increased activity of liver enzymes, hyperkalemia; increased erythrocyte sedimentation rate, neutropenia, leukopenia, decrease in hematocrit and hemoglobin concentration, eosinophilia;
- Other: hyperhidrosis, fever, impaired sexual function.
Signs: strong decrease in pressure, bradycardia, shock, disruption of water and mineral balance, acute course of renal failure, stupor.
Therapy: stop taking Monopril, gastric lavage, use of sorbents, vasopressor means, the introduction of intravenous saline, then symptomatic and supportive therapy. Hemodialysis is ineffective.
Before starting treatment, it is necessary to analyze the previously conducted antihypertensive therapy, the degree of increase in blood pressure, salt and / or fluid restriction of the diet and other clinical circumstances. If possible, the previous antihypertensive therapy should be stopped a few days before the start of treatment with Monopril.
To reduce the likelihood of arterial hypotension, diuretics should be canceled 2-3 days before the start of treatment with Monopril.
Before and during treatment, it is necessary to monitor blood pressure, kidney function, the content of potassium ions, creatinine, urea, electrolyte concentrations and liver enzyme activity in the blood.
- Cough. When using ACE inhibitors, including fosinopril, there was an unproductive, persistent cough that passes after discontinuation of therapy. When coughing occurs in patients taking ACE inhibitors, this therapy should be considered as a possible cause as part of the differential diagnosis.
- Swelling of the intestinal mucosa. Swelling of the intestinal mucosa was rarely observed while taking ACE inhibitors. Patients complained of abdominal pain (with nausea and vomiting could not be), in some cases, swelling of the intestinal mucosa occurred without swelling of the face, the activity of C1-esterase was normal. Symptoms disappeared after stopping the use of ACE inhibitors. Swelling of the intestinal mucosa should be included in the differential diagnosis of patients taking ACE inhibitors, complaining of abdominal pain.
- Angioedema. The development of angioedema of the extremities, face, lips, mucous membranes, tongue, pharynx, or larynx was reported in patients using Monopril. With swelling of the tongue, pharynx, or larynx, an airway obstruction may develop with possible death. In such cases, it is necessary to stop taking the drug and carry out urgent measures, including subcutaneous administration of the solution of epinephrine (adrenaline) (1: 1000), as well as taking other measures of emergency treatment. In most cases, swelling of the face, oral mucosa, lips and extremities, discontinuation of the drug resulted in normalization of the condition; however, sometimes prescribing appropriate therapy was required.
- Anaphylactic reactions during desensitization. Two patients during desensitization with hymenoptera venom while receiving an ACE inhibitor enalapril received life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided by the timely suspension of the ACE inhibitor; however, they reappeared after unintentionally resuming the use of an ACE inhibitor. Special care should be taken when desensitizing patients taking ACE inhibitors.
- Anaphylactic reactions during dialysis using high-permeable membranes. Anaphylactic reactions may develop in patients taking ACE inhibitors during hemodialysis using highly permeable membranes, as well as during the apheresis of low-density lipoprotein adsorbing to dextran sulfate. In these cases, the use of another type of dialysis membrane or the use of antihypertensive drugs of another class should be considered.
- Hypotension. In patients with uncomplicated hypertension, hypotension may develop 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 more common in patients with impaired renal function, especially in the presence of systemic connective tissue diseases (SLE or scleroderma). Before initiating therapy with ACE inhibitors and in the course of treatment, the determination of leukocytes and leukocyte formula is carried out (1 time per month in the first 3-6 months of treatment and in the first year of use of the drug in patients with increased risk of neutropenia).
- Symptomatic arterial hypotension with the use of ACE inhibitors often develops in patients with intensive treatment with diuretics, a diet associated with the restriction of table salt, or during dialysis. Transient arterial hypotension is not a contraindication for the use of the drug after carrying out measures to restore the BCC.
- You may need to reduce the dose of diuretic in patients with normal or low blood pressure, previously treated with diuretic drugs or having hyponatremia. Hypotension as such is not a contraindication for the further use of the drug Monopril in chronic heart failure.
- In patients with chronic heart failure, treatment with ACE inhibitors can cause an excessive antihypertensive effect, which can lead to oliguria or azotemia and, in rare cases, to acute renal failure with a fatal outcome. Therefore, in the treatment of chronic heart failure with Monopril, it is necessary to carefully monitor 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 blood pressure is a common and desirable effect at the beginning of the use of the drug in chronic heart failure. The extent of this decline is maximum in the early stages of treatment and stabilizes within one or two weeks from the start of treatment. BP usually returns to baseline without reducing therapeutic efficacy.
- In patients with impaired liver function, elevated plasma concentrations of fosinopril may be observed. With cirrhosis of the liver (includingalcoholic) the apparent total clearance of fosinoprilat is reduced, and the AUC is about 2 times higher than in patients without liver dysfunction.
- Liver dysfunction. In rare cases, the use of ACE inhibitors marked syndrome, the first manifestation of which is cholestatic jaundice. This is followed by fulminant liver necrosis, sometimes fatal. The mechanism of development of this syndrome has not been studied. With the appearance of marked yellowness and a pronounced increase in the activity of liver enzymes, treatment with Monopril should be stopped and appropriate treatment should be prescribed.
- In patients with severe chronic heart failure, renal 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, to acute renal failure and death.
- Hyperkalemia. There have been cases of an increase in the content of potassium ions in the blood serum of patients taking ACE inhibitors, including fosinopril. The risk group in this regard is made up of patients with renal insufficiency, type 1 diabetes, as well as receiving potassium-saving diuretics, potassium-containing dietary supplements or other drugs that increase the content of potassium ions in the blood serum (for example, heparin).
- Impaired renal function. In patients with arterial hypertension with single or bilateral renal artery stenosis or single kidney artery stenosis during treatment with ACE inhibitors, the concentration of blood urea nitrogen and serum creatinine may increase. These effects are usually reversible and disappear after stopping treatment. It is necessary to control renal function in such patients in the first weeks of treatment. In some patients, an increase in the concentration of nitrogen in the blood urea and serum creatinine (usually small and transient) can be observed even without obvious impairment of renal function with simultaneous use of the drug Monopril and diuretics. You may need a dose reduction of Monopril.
- Surgical interventions / general anesthesia. ACE inhibitors can enhance the antihypertensive effect of agents used for general anesthesia. Before surgery (including dentistry), it is necessary to warn the physician / anesthesiologist 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 the BCC.
Influence on ability to drive motor transport and mechanisms
Care must be taken when driving or doing other work that requires increased attention, since dizziness may occur.
- Estrogens weaken the antihypertensive effect of the drug Monopril because of its ability to retain water.
- With the simultaneous use of ACE inhibitors with lithium salts, the lithium content in the blood serum and the risk of lithium intoxication may increase, therefore, monopril and lithium preparations should be used with caution at the same time. It is recommended that careful monitoring of the lithium content in the serum.
- The simultaneous use of antacids (including aluminum or magnesium hydroxide), as well as simethicone can reduce the absorption of fosinopril, therefore, these drugs should be taken at least 2 hours apart.
- Potassium preparations, potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the risk of hyperkalemia. In patients with heart failure, diabetes, at the same time taking potassium-sparing diuretics, potassium, potassium-containing salt substitutes, or other agents that cause hyperkalemia (for example, heparin), ACE inhibitors increase the risk of an increase in serum potassium ions.
- With simultaneous use of the drug Monopril with diuretics, especially at the beginning of diuretic therapy, as well as in combination with a strict diet restricting salt intake, or with dialysis, a pronounced decrease in blood pressure may develop, especially in the first hour after taking the initial dose of Monopril.
- Antihypertensive drugs, opioid analgesics, drugs for general anesthesia enhance the antihypertensive effect of the drug Monopril.
- Fozinopril enhances the hypoglycemic effect of sulfonylurea derivatives, insulin, the risk of developing leukopenia with simultaneous use with allopurinol, cytostatic agents, immunosuppressants, procainamide.
- It is known that NSAIDs indomethacin can reduce the antihypertensive effect of ACE inhibitors, especially in patients with arterial hypertension and low renin activity in blood plasma. Other NSAIDs, for example, acetylsalicylic acid, and selective COX-2 inhibitors may have a similar effect. In patients over 65 years of age, with hypovolemia (including with diuretic treatment), with impaired renal function, the simultaneous administration of NSAIDs (including selective COX-2 inhibitors) and ACE inhibitors (including fosinopril) can lead to worsening renal function, up to acute renal failure. Usually this condition is reversible. Renal function should be carefully monitored in patients taking fosinopril and NSAIDs.
- The bioavailability of the drug with simultaneous use with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propanthelin bromide, digoxin and warfarin does not change.
We picked up some reviews of people taking Monopril:
- Galina. I have been drinking monopril for many years now, when the pressure rises, I immediately feel it, my head starts to ache, my heart palpitations. This is where my dear monoprilchik goes to save me. I used to be a Italy manufacturer. At present, I bought the production of Poland. I don’t know the smell is the same, but I’m afraid to be treated.
- Michael. Monopril was prescribed to me by a cardiologist for the diagnosis of hypertension for daily use. I accept 8 years. Hypertensive crises are not. I take 1 tablet of 20 mg at night. None of the side effects indicated in the abstract are observed. The pressure is kept in the range of 130 80.
The drug Monopril has direct analogues, having in its composition the substance fosinopril: Fozikard (295 rubles), Fozinopril (240 rubles), Fozinopril-Teva (145 rubles).
Other members of the ACE inhibitor group:
- Perinev - domestic drug perindopril, is prescribed for chronic ischemia of the heart muscle, cerebrovascular disease. Provides cardioprotective properties. The average cost is 360 rubles.
- Amprilan is a drug manufactured 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 Croatian drug, the active ingredient is lisinopril. Gives a good effect in the treatment of congestive heart failure and hypertension caused by renal pathology. The cost is 110-200 rubles.
- Berlipril is a German medicine, enalapril is used as the main component. The drug is well suited for relieving hypertension for the first time, and has no pronounced side effects. The average price is 190 rubles.
Before using analogues consult your doctor.
Storage conditions and shelf life
Store in a dry place out of reach of children, at a temperature of 15-25 ° C.
Shelf life - 3 years.