Monopril - Instructions For Use, Price, Reviews, Analogs Of Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Monopril

Monopril: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Monopril

ATX code: C09AA09

Active ingredient: fosinopril (fosinopril)

Manufacturer: Bristol-Myers Squibb S. R. L. (Bristol-Myers Squibb SrL) (Italy), IC En Polfa Rzeszow S. A. (ICN Polfa Rzeszow SA) (Poland)

Description and photo update: 2019-20-08

Prices in pharmacies: from 333 rubles.

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Monopril is an angiotensin-converting enzyme (ACE) inhibitor.

Release form and composition

Dosage form Monopril - tablets: round biconvex shape with a dividing line on one side and engraving "609" - on the other, can have an almost white or white color, without a specific smell (14 pcs. In blisters, in a cardboard box 2 blisters).

The active substance of Monopril is sodium fosinopril, in 1 tablet - 20 mg.

Auxiliary components: crospovidone, microcrystalline cellulose, anhydrous lactose, sodium stearyl fumarate, povidone.

Pharmacological properties

Pharmacodynamics

The active ingredient in Monopril is fosinopril, an ACE inhibitor.

From a chemical point of view, fosinopril sodium is the sodium salt of an ester of the pharmacologically active compound fosinoprilat. Once in the human body, this substance undergoes enzymatic hydrolysis, as a result of which it turns into fosinoprilat, which, due to the presence of a phosphinate group, is a specific competitive ACE inhibitor. By inhibiting the action of ACE, the drug inhibits the conversion of angiotensin I into angiotensin II, which has a vasoconstrictor efficiency. Due to the inhibition of ACE, the concentration of angiotensin II in the blood plasma decreases, which contributes to a decrease in its vasopressor activity and a decrease in the secretion of aldosterone. Due to a decrease in the secretion of aldosterone, a slight increase in the level of potassium ions in the serum (on average 0.1 meq / l), a decrease in the volume of fluid and the content of sodium ions are possible.

Fozinoprilat has the ability to slow down the metabolism of bradykinin, which has a powerful vasodilating property, thereby increasing the antihypertensive effect of Monopril.

A decrease in blood pressure (BP) is not accompanied by changes in renal and cerebral blood flow, circulating blood volume, reflex activity of the myocardium, blood supply to internal organs, skeletal muscles and skin.

The hypotensive effect is equally manifested in the patient's lying and standing positions. It develops within 1 hour after taking Monopril inside, reaches a maximum after 2-6 hours, lasts for 24 hours. It may take several weeks to achieve a pronounced therapeutic effect.

Tachycardia and orthostatic hypotension sometimes occur in patients with hypovolemia and those on a salt-free diet.

The antihypertensive effects of fosinopril and thiazide diuretics, when combined, complement each other.

The gender, age and body weight of the patient do not affect the severity of the action of Monopril.

The drug does not cause the development of a withdrawal syndrome even in the case of an abrupt cessation of therapy.

In chronic heart failure, the beneficial effect of the drug is explained mainly by inhibition of the renin-angiotensin-aldosterone system. Due to the suppression of ACE, both preload and afterload on the myocardium are reduced. Monopril increases exercise tolerance, reduces the severity of chronic heart failure.

Pharmacokinetics

Once in the gastrointestinal tract, fosinopril is absorbed by about 30-40%. Food intake does not affect the rate of absorption, but its rate may be slowed down if Monopril is taken with food. The maximum concentration of the drug in plasma does not depend on the dose, it is reached within 3 hours.

Fosinopril is characterized by a high binding to plasma proteins, amounting to at least 95%. It has a relatively small volume of distribution and is slightly associated with the cellular components of the blood.

It is metabolized by enzymatic hydrolysis with the formation of fosinoprilat mainly in the mucous membrane of the gastrointestinal tract and liver.

It is excreted through the intestines with bile and kidneys in approximately equal amounts.

In patients with normal renal and hepatic function, the half-life is about 11.5 hours, in chronic heart failure - 14 hours.

In case of impaired renal function (creatinine clearance <80 ml / min / 1.73 m ²), the total clearance of fosinoprilat is approximately half that in patients with normal renal function. Absorption, bioavailability and protein binding do not differ significantly. Part of the drug that is normally excreted by the kidneys is excreted through the intestines with bile in patients with renal insufficiency. In patients with renal insufficiency varying degrees, including terminal stage (creatinine clearance <10 mL / min / 1.73 m ²), there is a moderate increase in the value AUC (area under the curve "concentration - time") in plasma - less than 2 times compared to the norm.

The clearance of fosinoprilat during hemodialysis and peritoneal dialysis is on average 2% and 7%, respectively (in relation to the values of urea clearance).

With impaired liver function (alcoholic and biliary cirrhosis), the rate of hydrolysis of fosinopril may be reduced, but its degree does not change noticeably. The total clearance of the drug from the body is approximately half that of patients with normal hepatic function.

Indications for use

• arterial hypertension - as a means of monotherapy or in combination with other antihypertensive drugs, for example, thiazide diuretics;
• CHF (chronic heart failure) - as part of complex treatment.

Contraindications

• Age under 18;
• Lactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
• History of hereditary and idiopathic angioedema, including with the use of other ACE inhibitors;
• The period of pregnancy and breastfeeding;
• History of hypersensitivity to drug components and ACE inhibitors.

According to the instructions, Monopril should be prescribed with caution to patients with renal failure, stenosis of an artery of a single kidney or bilateral stenosis of the renal arteries, hyponatremia (threat of dehydration, chronic renal failure, arterial hypotension), ischemic heart disease, cerebrovascular diseases (including insufficiency) of cerebral circulation, chronic circulation heart failure III and IV functional class (NYHA classification), aortic stenosis; with inhibition of bone marrow hematopoiesis, desensitization, condition after kidney transplantation, systemic pathologies of connective tissue (including systemic lupus erythematosus, scleroderma), hemodialysis, diabetes mellitus, gout, hyperkalemia, diet with limited salt, in conditionsaccompanied by a decrease in circulating blood volume (including vomiting, diarrhea), previous treatment with diuretics; in old age.

Instructions for the use of Monopril: method and dosage

The tablets are taken orally once a day.

The dose is determined by the doctor based on clinical indications.

Recommended daily dosage of Monopril:

• Arterial hypertension: initial dose - 10 mg. The dose is selected individually, taking into account the dynamics of lowering blood pressure (BP), its size can be 10-40 mg. If the hypotensive effect is insufficient, the simultaneous administration of diuretics is indicated. If the use is started against the background of diuretic treatment, then the initial dose should not exceed 10 mg and the use should be accompanied by regular medical supervision. The maximum dose of Monopril is 40 mg per day;
• Chronic heart failure (as part of combination therapy with a diuretic): the initial dose is 10 mg. During the first week of use, it is necessary to regularly monitor the patient's condition, his reaction to Monopril. If it is well tolerated, it is recommended to gradually increase the dose (once a week) to the maximum allowable - 40 mg. Simultaneous administration of digoxin is optional.

Patients with functional disorders of the kidneys or liver and elderly patients (65 years and older) do not usually need dose adjustment.

Side effects

• Cardiovascular system: a feeling of palpitations, a strong decrease in blood pressure, flushing to the skin of the face, tachycardia, orthostatic hypotension, syncope, angina pectoris, arrhythmia, cardiac conduction disturbances, peripheral edema, myocardial infarction, increased blood pressure, cardiac arrest, sudden death;
• Digestive system: impaired appetite, nausea, vomiting, flatulence, diarrhea or constipation, abdominal pain, intestinal obstruction, bleeding, hepatitis, pancreatitis, cholestatic jaundice, stomatitis, dysphagia, glossitis, change in body weight, anorexia, dry mouth;
• Respiratory system: shortness of breath, dry cough, bronchospasm, pneumonia, pulmonary infiltrates, rhinorrhea, dysphonia, laryngitis, sinusitis, pharyngitis, tracheobronchitis, nosebleeds;
• Urinary system: renal failure, hyperplasia and / or adenoma of the prostate gland, proteinuria, oliguria, polyuria;
• Sensory organs: tinnitus, ear pain, hearing and vision impairments, taste changes;
• Nervous system: dizziness, headache, cerebral ischemia, stroke, imbalance, memory impairment, weakness, sleep disorders, depression, anxiety, confusion, paresthesia, drowsiness;
• Lymphatic system: inflammation of the lymph nodes;
• Metabolism: exacerbation of gout;
• Musculoskeletal system: muscle weakness in the limbs, myalgia, arthritis, musculoskeletal pain;
• Allergic reactions: itching, skin rash, dermatitis, angioedema;
• Laboratory indicators: increased urea concentration, hypercreatininemia, increased activity of liver enzymes, hyperbilirubinemia, hyponatremia, hyperkalemia, decreased hematocrit and hemoglobin concentration, increased erythrocyte sedimentation rate (ESR), neutropenia, leukopenia, eosinophilia;
• Effect on the fetus: contractures of the extremities, hypoplasia of the bones of the skull, hypoplasia of the lungs, impaired development of the fetal kidneys, impaired renal function, decreased blood pressure of the fetus and newborns, oligohydramnios, hyperkalemia;
• Others: hyperhidrosis, fever, impaired sexual function.

Overdose

In case of an overdose of Monopril, violations of the water-electrolyte balance, a pronounced decrease in blood pressure, bradycardia, stupor, acute renal failure, shock are possible.

Monopril is canceled, the stomach is washed, sorbents are prescribed (for example, activated carbon), vasopressor agents and infusion of 0.9% sodium chloride solution. Hemodialysis is ineffective. Then symptomatic and supportive therapy is carried out.

special instructions

Treatment is required to begin after a careful analysis of the degree of increase in blood pressure, previous antihypertensive therapy, a decrease in fluid and / or salt content in the diet and other clinical factors. Previously conducted antihypertensive treatment, it is advisable to stop a few days before starting the use of Monopril.

To reduce the risk of arterial hypotension, diuretics are discontinued 2-3 days before starting therapy.

The use of Monopril should be accompanied by regular monitoring of blood pressure, renal function, levels of creatinine, potassium ions, urea, electrolytes and the activity of liver enzymes in the blood serum.

With the development of angioneurotic edema of the lips, face, tongue, larynx or pharynx, mucous membranes, limbs while taking the drug, Monopril should be canceled. Often, discontinuation of treatment ensures the normalization of the patient's condition, if the edema persists, it is necessary to prescribe appropriate therapy, including subcutaneous administration of a solution of epinephrine (adrenaline) (1: 1000). Untimely care can lead to airway obstruction with risk of death.

In rare cases, taking ACE inhibitors can cause swelling of the intestinal mucosa, accompanied by abdominal pain. Since it can proceed without signs of facial edema, with normal C1-esterase activity and no nausea or vomiting in the patient, it must be included in the differential diagnosis of patients with complaints of abdominal pain. The symptoms of edema disappear after discontinuation of Monopril.

Patients with anaphylactic reactions during dialysis using high-permeability membranes or apheresis of low-density lipoproteins with adsorption to dextran sulfate should be prescribed antihypertensive drugs of a different class or the use of dialysis membranes of a different type.

Due to the risk of developing anaphylactic reactions, special care must be taken when desensitizing patients.

In order to prevent the development of suppression of bone marrow function and agranulocytosis, before starting the use of ACE inhibitors and during the course of therapy, it is necessary to regularly (once a month during the first 3-6 months) determine leukocytes and leukocyte formula. In patients with an increased risk (impaired renal function, systemic connective tissue diseases), studies continue during the first year of therapy.

Against the background of dialysis, intensive diuretic therapy, a diet that restricts the consumption of table salt, the development of symptomatic arterial hypotension occurs more often. With transient arterial hypotension, the use of Monopril is continued after the volume of circulating blood is restored.

The use of ACE inhibitors is indicated in patients with chronic heart failure, but it can cause an excessive antihypertensive effect, potentiating the development of azotemia and oliguria, in rare cases - acute renal failure with a fatal outcome. Therefore, each increase in the dose of Monopril or a diuretic in patients of this category requires careful monitoring of their condition, especially during the first two weeks of therapy. Patients with hyponatremia, normal or low blood pressure who have previously taken diuretics may need to reduce the dose of the diuretic.

A slight decrease in systemic blood pressure at the beginning of treatment in patients with chronic heart failure is a typical and desirable effect. The maximum decrease in blood pressure is observed in the early stages of therapy and stabilizes within 1-2 weeks without reducing the therapeutic effect.

In rare cases, taking ACE inhibitors can cause a syndrome that begins with cholestatic jaundice, followed by the onset of fulminant liver necrosis (with a risk of death). Since the nature of this syndrome has not been established, with a significant increase in the activity of liver enzymes and the appearance of a noticeable yellowness in the patient, Monopril should be canceled and appropriate therapy should be prescribed.

In case of impaired liver function, an increased content of fosinopril may be observed in the blood plasma. In cirrhosis of the liver, the total clearance of fosinoprilat, which seems to be normal, is reduced, and about 2 times higher AUC, compared with patients with normal liver function.

With arterial hypertension in patients with stenosis of the artery of a single kidney or with unilateral or bilateral stenosis of the renal arteries, the use of ACE inhibitors can cause reversible processes of an increase in the concentration of serum creatinine and blood urea nitrogen (in this case, the withdrawal of Monopril is required). This category of patients requires regular monitoring of renal function in the first weeks of therapy. An increase in serum creatinine and blood urea nitrogen (usually insignificant and transient) in patients with normal renal function may be caused by the simultaneous administration of Monopril and diuretics (in this case, a decrease in the dose of the drug is required).

With severe chronic heart failure, the use of ACE inhibitors may be accompanied by progressive azotemia and / or oliguria, in rare cases, the risk of developing acute renal failure with a fatal outcome.

Patients with type 1 diabetes mellitus, renal insufficiency, as well as those taking potassium-containing dietary supplements, potassium-sparing diuretics and other drugs that increase the level of potassium ions in the blood serum are at high risk of developing hyperkalemia while taking Monopril.

In the event of a cough, it is necessary to consider taking Monopril as a possible reason for the differential diagnosis.

When preparing for a surgical operation, it is necessary to warn the anesthesiologist about taking Monopril.

Patients are advised to exercise caution, including in hot weather.

Influence on the ability to drive vehicles and complex mechanisms

Due to the possible occurrence of dizziness, care should be taken when driving vehicles and mechanisms.

Application during pregnancy and lactation

Monopril is prohibited for pregnant women. If used in the II and III trimesters, the drug causes damage or intrauterine death of the fetus.

When pregnancy occurs during treatment with fosinopril, the drug should be discontinued as soon as possible. If there is no alternative for the treatment of a woman (which is extremely rare), she should be informed about the potential negative effect on the fetus and a thorough examination should be carried out to identify possible pathologies. In case of detection of oligohydramnios (oligohydramnios), Monopril is not canceled only if its use is vital. However, it should be borne in mind that oligohydramnios sometimes occurs only as a result of irreversible damage to the fetus.

In newborns whose mothers took ACE inhibitors during pregnancy, hyperkalemia, oliguria, arterial hypotension are possible. In this connection, they must be carefully examined. If oliguria is detected, blood pressure monitoring and renal perfusion support are necessary. Replacement blood pressure and dialysis may be required to restore blood pressure and replace impaired renal function. During hemodialysis and peritoneal dialysis in adults, fosinopril is slowly excreted from the circulating blood. There is no experience of elimination of the drug in newborns.

Fozinopril passes into breast milk, therefore, Monopril is contraindicated during lactation. If treatment is necessary, breastfeeding should be discontinued.

Pediatric use

Monopril is not used for the treatment of children and adolescents under the age of 18 years due to the lack of data on its safety and efficacy in patients of this age group.

With impaired renal function

Monopril should be used with caution in renal failure, patients on hemodialysis, after kidney transplantation, as well as in bilateral renal artery stenosis or stenosis of an artery of a single kidney.

The drug is excreted from the body in two ways (by the kidneys and through the intestines), therefore, dose adjustment in patients with impaired renal function is usually not required.

For violations of liver function

Given that the drug is excreted from the body in two ways, dose adjustment is usually not required in case of impaired liver function.

With a pronounced increase in the activity of liver enzymes and the appearance of noticeable jaundice, Monopril should be discontinued and appropriate therapy should be carried out

Use in the elderly

The safety profile of fosinopril in young people and patients aged 65 years and over is approximately the same, so there is usually no need to adjust the dose for the elderly. However, it should be borne in mind that in some elderly patients, a more pronounced susceptibility to Monopril is possible due to its overdose due to its slower excretion.

Drug interactions

During the period of treatment with Monopril, the simultaneous use of other drugs can be started only after consultation with the attending physician, who can evaluate the interaction of drugs, which will avoid the development of undesirable effects.

The following drugs do not affect the bioavailability of Monopril: hydrochlorothiazide, metoclopramide, propranolol, chlorthalidone, digoxin, nifedipine, cimetidine, propantheline bromide, warfarin.

The antihypertensive effect of fosinopril is enhanced by other antihypertensive drugs, opioid analgesics and drugs for general anesthesia.

Simethicone and antacids (including magnesium and aluminum hydroxide) can reduce the absorption of fosinopril, so they should be taken with a minimum interval of 2 hours.

ACE inhibitors can increase blood lithium levels and the risk of toxicity. If necessary, the simultaneous use of Monopril with lithium preparations, care must be taken and the level of lithium in the blood serum should be monitored.

Estrogens retain water in the body, as a result of which they reduce the hypotensive effect of fosinopril.

Monopril enhances the hypoglycemic effect of insulin and sulfonylurea derivatives.

With the simultaneous use of immunosuppressants, cytostatic agents, allopurinol, procainamide, the risk of developing leukopenia increases.

With the simultaneous appointment of diuretics (especially at the beginning of their intake), as well as in combination with dialysis or a strict diet that restricts the consumption of table salt, a pronounced decrease in blood pressure is possible, especially in the first hour after taking the first dose of Monopril.

Potassium-sparing diuretics (spironolactone, amiloride, triamterene) and potassium supplements increase the risk of hyperkalemia. In people with diabetes and heart failure who are receiving potassium / potassium salt substitutes, potassium-sparing diuretics, or other drugs that can cause hyperkalemia (such as heparin), ACE inhibitors may increase serum potassium ions

It has been established that indomethacin can reduce the hypotensive effect of ACE inhibitors, especially in patients with arterial hypertension and low renin activity in blood plasma. A similar effect is expected from other non-steroidal anti-inflammatory drugs (eg, acetylsalicylic acid) and selective inhibitors of cyclooxygenase (COX) -2.

In elderly people over 65 years of age, patients with impaired renal function and hypovolemia (including due to taking diuretics) with the combined use of ACE inhibitors (including fosinopril) or non-steroidal anti-inflammatory drugs, it is possible that kidney function and flesh deteriorate before the development of acute renal failure. This condition is usually reversible. When using these drugs simultaneously with Monopril, renal function should be carefully monitored.

Analogs

Monopril analogs are: Fozikard, Fosinap, Fosinopril, Fosinopril-Teva, Fozinotek.

Terms and conditions of storage

Store in a dry place out of reach of children at a temperature of 15-25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Monopril

According to reviews, Monopril is an effective antihypertensive agent, however, the treatment regimen should be selected by the doctor individually, depending on the characteristics of the patient and the nature of the disease. There are statements that the drug is less likely to cause cough compared to other representatives of this class, although the incidence of this side effect is already low.

Many patients indicate that with monotherapy with the drug, blood pressure does not decrease enough and that complex therapy is required to obtain a stable effect.

Price for Monopril in pharmacies

Depending on the pharmacy chain, the price for Monopril can vary from 400 to 515 rubles. per pack of 28 tablets of 20 mg.

Monopril: prices in online pharmacies

Drug name Price Pharmacy

Monopril 20 mg tablets 28 pcs. 333 r Buy

Monopril tablets 20mg 28 pcs. 429 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!