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Monopril - an ACE inhibitor. Fosinopril is an ester from which the active compound fosinoprilat 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 simultaneous loss of sodium ions and fluid from the body.
Fosinopril 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 symptoms 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.
- arterial hypertension (for monotherapy or as part of combination therapy);
- heart failure (in combination with diuretics).
1 tablet contains fosinopril sodium 20 mg.
Fosinopril is marketed under different brands and generic names, and comes in different dosage forms:
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Dosage and Administration
Before starting treatment hypertension It is required to analyze the previously conducted antihypertensive drug therapy, the degree of increase in blood pressure, restrictions on the amount of salt and / or liquid and other clinical circumstances. If possible, antihypertensive treatment should be discontinued according to the previously used regimen a few days before the start of treatment with Monopril.
The recommended initial dose is 10 mg 1 time / day. The dose must be selected depending on the dynamics of lowering blood pressure. The average dose is 10-40 mg 1 time / day. In the absence of a sufficient hypotensive effect, the additional purpose of diuretics is possible.
If treatment with Monopril is initiated against the background of diuretic therapy, its initial dose should be no more than 10 mg with careful medical monitoring of the patient's condition. In order to reduce the risk of arterial hypotension, diuretics should be canceled 2-3 days before the start of Monopril.
In chronic heart failure The recommended initial dose is 10 mg 1 time / day. Depending on the therapeutic efficacy, the dose can be increased with a weekly interval, increasing it to a maximum of 40 mg 1 time / day. At the beginning and during treatment, careful medical observation is required. The development of arterial hypotension after the initial dose should not interfere with the careful selection of the dose of Monopril after effective relief of arterial hypotension. In case of heart failure, Monopril is recommended to be used in combination with a diuretic.
Since the cardiovascular system: dizziness, feeling of heartbeat, chest pains.
On the part of the respiratory system: cough.
Allergic reactions: skin rash, itching.
From the side of the central nervous system and peripheral nervous system: feeling of fatigue, violation of sensitivity (including paresthesias).
From the musculoskeletal system: myalgia
From the digestive system: nausea, vomiting, dyspepsia, a violation of taste sensitivity.
As a rule, adverse reactions when taking the drug Monopril are easy and temporary in patients both young and older.
- angioedema for the use of ACE inhibitors in history;
- lactation (breastfeeding);
- Hypersensitivity to fosinopril and other components of the drug.
The simultaneous use of antacids (including aluminum hydroxide, magnesium hydroxide, simethicone) can reduce the absorption of fosinopril (Monopril and these drugs should be taken at least 2 hours apart).
In patients receiving monopril simultaneously with lithium salts, it is possible to increase the concentration of lithium in the blood plasma and the risk of developing intoxication with lithium (at the same time, use with caution).
When prescribing Monopril, one should take into account that indomethacin and other NSAIDs (including acetylsalicylic acid) can reduce the antihypertensive effect of ACE inhibitors, especially in patients with low rootin hypertension.
With the joint use of Monopril with diuretics or in combination with a strict diet, limiting salt intake, or with dialysis, the development of severe arterial hypotension may develop, especially in the first hour after taking the initial dose of fosinopril.
When combined with Monopril with potassium-sparing diuretics (including spironolactone, amiloride, triamterene), with potassium supplements, the risk of hyperkalemia increases (at the same time with caution; frequent monitoring of serum potassium is required).
Bioavailability of Monopril does not change with the joint use of the drug with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propanthelin, digoxin, acetylsalicylic acid and warfarin.
ACE inhibitors can enhance the antihypertensive effect of drugs used for general anesthesia.
Pregnancy and Lactation
Monopril is contraindicated in pregnancy. The use of the drug in the II and III trimesters of pregnancy causes damage or death of the developing fetus.
Since fosinoprilat is excreted in breast milk, if you need to use Monopril during lactation, breastfeeding should be stopped.
With the development of angioedema on the background of taking Monopril, the drug should be immediately canceled. Patients should be warned that if there is swelling in the face, eyes, lips and tongue, laryngeal muscle spasm or shortness of breath, you should immediately stop taking the drug and consult a doctor. In such cases, it is necessary to promptly administer adrenaline solution (1: 1000) and take other emergency treatment measures.
Care must be taken when prescribing the drug to patients receiving desensitization therapy, because There is a risk of anaphylactoid reactions.
Anaphylactoid reactions have also been reported during the administration of Monopril during hemodialysis through highly permeable membranes, as well as during the apheresis of LDL with adsorption on dextran sulfate. In such cases, the use of another type of dialysis membrane or other medical treatment should be considered.
In rare cases, patients with uncomplicated arterial hypertension developed Monopril with hypotension. Symptomatic arterial hypotension with the use of ACE inhibitors is most likely in patients after intensive diuretic treatment and / or diet with limited salt content, as well as during kidney dialysis. Temporary hypotensive reaction is not a contraindication for the use of the drug after taking measures to hydrate the body.
In chronic heart failure with or without concomitant renal 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 and death. Therefore, in the treatment with monopril of chronic heart failure, it is necessary to carefully monitor the condition of the patients, especially during the first 2 weeks of treatment, as well as with any increase in the dose of fosinopril or diuretic.
Patients with normal or lowered blood pressure who have previously received intensive diuretic therapy, and those with low sodium levels in the blood, may need to lower the diuretic dose. Hypotension is not a contraindication for the further use of the drug Monopril. Some reduction in systemic blood pressure is a common and desirable effect at the beginning of the use of the drug in heart failure. The extent of this decrease is maximum in the early stages of treatment and stabilizes within 1-2 weeks of therapy. BP usually returns to the values characteristic of the period before treatment begins, without reducing therapeutic efficacy.
If during the treatment with Monopril there is a noticeable yellowness and a pronounced increase in the activity of liver enzymes, the drug should be canceled and appropriate treatment should be prescribed.
With arterial hypertension in patients with renal artery stenosis of one or both kidneys, as well as the simultaneous use of diuretics without signs of renal vascular disease during treatment with ACE inhibitors, blood urea nitrogen and serum creatinine may be elevated. These effects are usually reversible and disappear after stopping treatment. May require a reduction in the dose of diuretic and / or drug Monopril.
In patients with severe chronic heart failure, in whom renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors may lead to oliguria or to progressive azotemia and in rare cases to acute renal failure and / or death.
In patients with heart failure, diabetes, at the same time taking potassium-saving diuretics, potassium dietary supplements and / or salt substitutes containing potassium salts, or other drugs that increase the content of potassium in the blood (eg, heparin), the use of ACE inhibitors increases the risk of development hyperkalemia.
Since fosinopril is eliminated from the body in two ways, a dose reduction of Monopril is usually not required when treating hypertension and heart failure in patients with impaired renal or hepatic function.
There is no difference in the efficacy and safety of treatment with Monopril in patients aged 65 years and older and younger. However, in older patients, greater susceptibility to the drug cannot be ruled out.
Control of laboratory parameters
While taking Monopril, the number of leukocytes in the peripheral blood should be periodically determined, paying attention to patients with impaired renal function, especially against the background of collagenosis (systemic lupus erythematosus or scleroderma), since it has been reported that in rare cases, ACE inhibitors cause agranulocytosis and suppression of bone marrow function with a greater likelihood in this category of patients.
Use in Pediatrics
Safety and efficacy of the drug Monopril in children have not been established.
Symptoms: marked reduction in blood pressure, bradycardia, shock, impaired water and electrolyte status, acute renal failure, stupor.
Treatment: the drug should be stopped, gastric lavage, taking of sorbents (for example, activated carbon), vasopressor agents, infusion of 0.9% sodium chloride solution and further symptomatic and supportive treatment are indicated. The use of hemodialysis is ineffective.
- Brand name: Monopril
- Active ingredient: Fosinopril
- Dosage form: Pills.
- Manufacturer: Bristol-Myers Squibb
- Country of Origin: USA
Studies and clinical trials of Fosinopril (Click to expand)
- A lamellar liquid crystal with fosinopril sodium
- Conformational study of fosinopril sodium in solution using NMR and molecular modeling
- Fosinopril: Pharmacokinetics and pharmacodynamics in congestive heart failure*
- Tolerability and antihypertensive efficacy of fosinopril on 24-hr ambulatory blood pressure in hypertensive elderly subjects
- Solid-state NMR and IR for the analysis of pharmaceutical solids: Polymorphs of fosinopril sodium
- Quantitative analysis of fosinopril sodium by capillary zone electrophoresis and liquid chromatography
- The determination of palladium in fosinopril sodium (monopril) by ICP-MS
- Monitoring of fosinopril sodium impurities by liquid chromatography–mass spectrometry including the neural networks in method evaluation
- Development and validation of liquid chromatography–tandem mass spectrometric method for simultaneous determination of fosinopril and its active metabolite fosinoprilat in human plasma
- Novel flow injection spectrophotometric determination of fosinopril using UV-assisted digestion and an orthophosphates calibration graph
- High-performance liquid chromatography of the drug fosinopril
- Liquid chromatographic–electrospray tandem mass spectrometric method for the simultaneous quantitation of the prodrug fosinopril and the active drug fosinoprilat in human serum
- Simultaneous determination of fosinopril and hydrochlorothiazide in pharmaceutical formulations by spectrophotometric methods
- Fosinopril/hydrochlorothiazide: single dose and steady-state pharmacokinetics and pharmacodynamics
- Fosinopril reduces left ventricular mass in untreated hypertensive patients: a controlled trial
- Comparison of dipyridamole and fosinopril on renal progression in nephrectomized rats
- FOSIDIAL: a randomised placebo controlled trial of the effects of fosinopril on cardiovascular morbidity and mortality in haemodialysis patients. Study design and patients' baseline characteristics
- The Efficiency and Safety of an Ace-Inhibitor–Fosinopril in ESRD Patients During Dialysis
- Metabolic effects of long-term angiotensin-converting enzyme inhibition with fosinopril in patients with essential hypertension: relationship to angiotensin-converting enzyme inhibition
- Fosinopril pharmacokinetics and pharmacodynamics in chronic ambulatory peritoneal dialysis patients
- Insulin sensitivity in normotensive subjects during angiotensin converting enzyme inhibition with fosinopril
- The pharmacokinetics and pharmacodynamics of fosinopril in haemodialysis patients
- Comparative effects of fosinopril and nifedipine on regression of left ventricular hypertrophy in hypertensive patients: A double-blind study
- A liquid chromatographic lon-pairing method for simultaneous determination of benazepril hydrochloride, fosinopril sodium, ramipril and hydrochlorothiazide in pharmaceutical formulations