Moviprep por. 111.896g+10.600g N2+2 sachet A+sachet B

Composition of the drug Moviprep

The action of the drug is based on the interaction of two types of components packaged in sachets. The package contains sachet A and sachet B, which have different compositions and complement each other:

• Sachet A contains the following active ingredients: Macrogol, anhydrous sodium sulfate, sodium chloride, potassium chloride. The following auxiliary elements are used: lemon flavor, aspartame, acesulfame potassium.
• In sachet B, the active ingredients are: ascorbic acid and sodium ascorbate.

The contents of sachet A is a white powder, with a yellowish tint allowed, with a characteristic lemon aroma. And sachet B contains powder, the color of which may be close to brown.

The main purpose of the drug is to provide a moderate laxative effect on the intestines, in order to free it from feces along its entire length, especially the large intestine.

Some components of the drug have a laxative effect, while others increase the volume of feces, due to which the intestinal walls more actively push lumps towards the exit, and natural peristalsis is enhanced. Additionally, the composition includes electrolytes that do not disrupt the water-salt balance in the body - the main side effect of any diarrhea.

Macrogol, as the main laxative, is not absorbed into the bloodstream from the intestine, cannot be metabolized and is excreted unchanged in the feces. A small part of macrogol absorbed into the blood is excreted by the kidneys.

Ascorbic acid, unlike Macrogol, can be absorbed in large quantities. Its removal from the body is ensured by the kidneys and urine.

Moviprep lyophilisate for solution sachet sachet A 2 pcs + sachet B 2 pcs

Elderly patients, weakened or exhausted patients with various concomitant diseases, patients prone to aspiration or regurgitation, with impaired consciousness, especially if the drug is administered through a nasogastric tube, the drug should be used under medical supervision.

The prepared solution of MOVIPREP® does not replace regular fluid intake, therefore it is necessary to maintain a sufficient level of fluid in the body.

In debilitated, debilitated patients, patients with various comorbidities, clinically significant renal impairment, arrhythmia and the risk of electrolyte imbalance, the need to determine electrolyte levels at baseline and after treatment, assess renal function and perform an ECG study should be considered.

In rare cases, serious arrhythmia, including atrial fibrillation, has been observed in association with the use of ionic osmotic laxatives for bowel preparation. These phenomena occur predominantly in patients with existing cardiac risk factors and electrolyte imbalance.

If patients develop any symptoms suggestive of arrhythmias or fluid/electrolyte imbalances (eg, edema, shortness of breath, fatigue, heart failure), plasma electrolyte levels should be determined, an ECG performed, and any abnormalities identified should be treated appropriately.

If the patient experiences symptoms such as severe flatulence, bloating, abdominal pain, or any other reaction that makes it difficult to continue taking the drug, it is necessary to slow down or temporarily stop taking the drug and consult a doctor.

This medicinal product contains 363.2 mmol (8.4 g) sodium per bowel preparation course (bowel preparation course is two liters of MOVIPREP® solution), which is equivalent to 420% of the WHO recommended maximum daily sodium intake of 2 g for an adult . This should be taken into account in patients on a sodium-controlled diet. In this case, only part of the sodium (up to 112.4 mmol (2.6 g) per bowel preparation course) is absorbed.

This medicinal product contains 28.4 mmol/l (1.1 g) potassium per bowel preparation course (bowel preparation course is two liters of MOVIPREP® solution), which should be taken into account in patients with impaired renal function, as well as in patients on a diet with controlled potassium intake.

How does Moviprep work?

The product is used immediately before endoscopic examinations of the intestines, as well as before x-rays. In addition, the drug is prescribed before intestinal surgery so that remaining stool fragments do not interfere with surgeons’ ability to detect and remove tumors, polyps and tumors.

Taking Moviprep does not imply the treatment of diseases of the colon. The product does not relieve inflammation, does not relieve pain, and is not aimed at combating pathogens. It acts as a laxative, gently removing food debris from the body. Unlike conventional laxatives, Moviprep acts within clearly defined time intervals and does not cause intestinal spasms, which is very important for patients with severe painful symptoms that accompany the course of the disease.

Gentle cleansing is provided by Macrogol, which, thanks to long polymer bonds, can capture and retain water molecules, thereby increasing the volume of feces. They, in turn, increase pressure on the intestinal walls, triggering reflex cleansing mechanisms through the activation of peristalsis.

Instructions for use before colonoscopy

Colonoscopy is a study that allows, using a thin hose with a video camera at the end, to penetrate the intestines through the anus and examine the condition of the organ from the inside. The procedure will be faster and will give more information to the doctor if the intestines are empty and their walls will not be covered with food fragments. Oncological diseases are more treatable in the early stages, so it is important to allow the doctor to examine the intestinal walls in as much detail as possible in order to pay attention to the most minor changes in the structure of the tissue.

In addition to taking the drug directly, it is important to follow the recommended diet before the study. Depending on what time the procedure will be performed, you should choose one of three dosage regimens:

1. One-stage, evening.
2. Two-stage.
3. One-stage morning.

If the doctor deems it necessary, he can add his recommendations to the drug regimen. This is most often done when the patient needs a long period of time to get to the test site.

All three schemes involve the preparation of two types of solutions for oral administration. The volume of each is 1 liter. The only difference is the time interval between taking the first and second liter.

To prepare the first liter, you need to take half a glass of water at room temperature and dissolve 1 sachet A and one sachet B in it. After the powder has completely dissolved, the volume of liquid must be brought to 1 liter. The temperature of the liquid should be close to body temperature. The prepared mixture must be consumed within two hours. For comfortable use, it is suggested to drink 1 glass every quarter of an hour or half an hour.

The second liter is prepared in the same way as the first. However, the time of its administration is determined by the time of the prescribed procedure. If a study or surgical intervention is scheduled for the morning, before 10:00, Moviprep should be taken the day before, in the evening. As a rule, the first liter is drunk between 19:00 and 20:00. And the second liter is prepared and consumed between 21:00 and 22:00.

If the procedure is scheduled for the first half of the day, but after 10:00, then the dosage regimen is as follows: the first liter is drunk the day before from 20:00 to 21:00, and the second in the morning of the next day from 06:00 to 07:00.

Provided that the colonoscopy is scheduled for the second half of the day, after 14:00, Moviprep is taken on the day of the study, in the morning. The first liter is from 8:00 to 9:00, and the second is from 10:00 to 11:00.

It is important to drink at least half a liter of another liquid (non-alcoholic and dairy-free) between doses of the drug in order to maintain the water-salt balance in the body.

New schemes for bowel preparation for colonoscopy

The effectiveness of colonoscopy and the detection of intestinal pathology during its implementation largely depend on the quality of intestinal cleansing. Inadequate preparation of the intestine for examination may cause the endoscopist to miss any pathological focus. This, in turn, can cause untimely diagnosis of many serious diseases, including colon cancer, and, as a result, the cost of additional funds for re-preparing the patient for the study and the actual repeat colonoscopy itself. Despite the understanding of the importance of adequate bowel preparation by all stakeholders - gastroenterologists referring patients for examination, medical staff of departments, patients, in daily clinical practice endoscopists regularly encounter poor visualization during colonoscopy. Currently, on the domestic pharmaceutical market there is a fairly large number of different products, the use of which can qualitatively cleanse the intestines for carrying out a full-fledged endoscopic or any other instrumental examination or surgical intervention. Adequate bowel preparation should be properly motivated by doctors in front of patients, in order for them to comply with the diet and regimen of taking a cleanser, chosen for each patient personally.

The number of diagnostic and therapeutic endoscopic examinations of the colon has increased significantly in recent years. At the same time, the capabilities of colonoscopy itself have increased significantly. The quality of endoscopes is improving, and it has become possible to examine the mucous membrane in high-definition (HD) conditions, using narrow-spectrum lighting and magnifying (ZOOM) endoscopy [1]. Currently, colonoscopy is the leading research method in the diagnosis and differential diagnosis of inflammatory bowel diseases, identifying polyps of the large and small intestine, and diverticulosis. Colonoscopy is an indispensable diagnostic method when conducting national screening programs for the early detection of colorectal cancer. The technical capabilities of endoscopy, and even more so the combination of colonoscopy with confocal microscopy, currently make it possible to determine areas of mucosal dysplasia in developing adenomas literally at the cellular level, accurately localizing the lesion with an error of just a few microns. However, such possibilities of endoscopic examination can only be realized in the presence of a clean intestinal mucosa, freed from various organic deposits and foamy contents [2, 3]. Adequate bowel cleansing is especially important when examining the right parts of the colon, where it is technically more difficult to diagnose early forms of malignant neoplasms and (or) flat, serrated neoplasms [4–7]. In addition, insufficient quality of bowel cleansing often leads to forced interruption of an already started colonoscopy, which in turn leads to additional costs for re-preparing the patient for colonoscopy and the actual endoscopic examination itself [1–3]. Re-referring a patient for a colonoscopy, additional time spent on bowel preparation, and performing a repeat colonoscopy itself may carry an unjustified risk and, as a result, late diagnosis of the pathological process.

Despite the obvious importance of high-quality bowel preparation for colonoscopy, in daily practice, unfortunately, it does not always meet the requirements. Insufficient bowel cleansing can cause tumors to “miss.” Thus, according to P. A. Nikiforov, 28 out of 377 patients a year after colonoscopy were diagnosed with stage II or III cancer, and in 34 - stage I cancer, which indirectly indicates that this pathology was missed during the initial examination due to inadequate preparation [8]. Almost the same results are reported by Lebwohl et al. based on an analysis of the work of the endoscopy department of a large multifunctional clinic, where out of 12,787 colonoscopies, bowel preparation was insufficient in 24% of patients [9]. Of note is the fact that only 17% of patients with initial inadequate bowel preparation underwent repeat endoscopy in the next 3 years. Of the 198 adenomas identified in this study, 42% were detected only at repeat colonoscopy.

The challenge in ensuring good bowel preparation is multifactorial. Only by taking into account all the components of this process can the proper quality of the intestinal condition and effective endoscopic examination be achieved.

One of the main components of solving this problem is, strange as it may sound, the patients themselves who are about to undergo a colonoscopy. In addition, the patient factor consists of two parts - subjective, which directly depends on the patient’s behavior, and objective, independent of the behavioral and psycho-emotional state of patients. Before the study, patients do not always adhere to the recommended diet and use of bowel cleansing agents. Even if the most effective existing means of bowel cleansing is used in patients who have violated their diet to one degree or another during the period of preparation for colonoscopy, the result of bowel cleansing may be negative. It is extremely important to convey to the patient, through the mouth of the doctor, medical personnel, or with the help of visual aids and materials, information about the need for strict adherence to diet and dietary restrictions, which are (usually) not so critical for lifestyle, but are extremely important for the quality of bowel preparation. But even if patients fully understand the need to comply with dietary restrictions, their observance cannot be guaranteed in all cases. In addition, the quality of bowel preparation in patients can be influenced not only by various errors in food, but also by objective factors. The overall result of the quality of bowel preparation can be influenced by multiple, at first glance insignificant, factors, for example, a sedentary lifestyle, sedentary work, difficult access to the toilet or limited fluid intake; even multi-bed rooms in clinics and hospitals can affect the psychological state patients and influence the quality of bowel preparation.

Another important component when cleansing the intestines is the correct choice of a drug that directly affects the contents of the intestine and evacuates it from the body. Each drug used in a given situation must meet certain requirements on the part of both research doctors and patients using it.

For endoscopists, it is important that the drug for bowel cleansing, when used, provides a clean mucous membrane without any residue of solid or liquid contents in the intestinal lumen, is well tolerated by patients and does not require additional monitoring of the health status of the subject.

On the other hand, the ideal drug for colon cleansing should not only meet the requirements of doctors, but also fully comply with the wishes of the patients taking this drug. It should have pleasant organoleptic properties with no adverse drug reactions (pain, nausea, vomiting) when taking it. In this case, preference is given to drugs that require less liquid to take, with minimal dietary restrictions and to a lesser extent change the normal rhythm and quality of life.

Currently, there are several groups of drugs on the pharmaceutical market intended for oral administration to prepare the intestines for instrumental studies. Each of these groups differs in the mechanism of action and, therefore, the effectiveness of the preparation. Unfortunately, none of the existing drugs is ideal in all respects, as evidenced by numerous clinical studies [9, 10]. Between different groups of drugs, even those that are similar in composition, there are noticeable differences in the quality of bowel preparation in terms of tolerability by patients [12].

The UK National Patient Safety Agency (NPSA) has issued guidelines for the safe use of oral bowel cleanses [13]. These guidelines make clear the possible clinical risks of using various oral colon cleanses. The recommendations, in particular, note that the decision to use a particular product should be made as responsibly as the decision to conduct an instrumental study itself, and all patients should fill out a written informed consent form to prevent possible risks when using oral cleansers . This guideline, as well as other recent meta-analyses, now focuses specifically on the safety of oral cleanses, provides guidelines for bowel preparation, absolute and relative contraindications for the use of various oral cleanses, and provides recommendations for the selection and use of these drugs in patients with various risk groups [14–17].

With any oral drug, no matter how effective, all bowel preparation efforts can be nullified if the patient does not follow a specific diet before starting preparation. For high-quality preparation, it is necessary to prescribe patients a slag-free diet for 2-3 days before starting bowel cleansing, so that there is as little dense undigested food residues in the intestinal lumen as possible. This provides the basis for subsequent effective lavage. In particular, foods that should be excluded from patients' diets include: vegetables (carrots, beets, cabbage, turnips, radishes, onions, garlic); herbs (sorrel or spinach); porridge, but not all (oatmeal, millet, pearl barley); legumes (peas, beans, lentils, beans); fruits (peach, apple, pear, bananas, tangerines, grapes, dried fruits); nuts of all varieties; any berries; rye bread, any products made from rye flour; dairy products (except fermented milk); fried, smoked meat, smoked sausages. These dietary restrictions are not critical for most patients, since dietary restrictions are recommended only for a short period of time, and besides, there remains a fairly large range of food products allowed for use: broths, eggs, semolina porridge, boiled meat and boiled sausage , cheese, butter, fermented milk products (but not cottage cheese), fish. On the day of the examination, you can only consume liquid food: tea, broth, mineral or boiled water, clear juices. In addition to the dietary restrictions that each patient must adhere to, depending on the type of cleansing drug used, there are absolute and relative contraindications for performing oral bowel preparation for colonoscopy. Thus, absolute contraindications include: suspicion of intestinal obstruction or perforation, obstruction of the gastrointestinal tract at any level, severe acute inflammatory bowel disease or toxic megacolon, impaired consciousness, hypersensitivity or allergic reaction to the components of the drug, difficulty swallowing and the inability to swallow without aspiration (in some cases, bowel cleansing can be done through a nasogastric (nasoduodenal) tube or other tube placed at the level of the duodenum). In this case, the preparation should be carried out in a hospital setting under the supervision of a doctor.

Relative contraindications for oral administration of bowel cleansing drugs are in patients undergoing hemodialysis or peritoneal dialysis, after a kidney transplant, suffering from chronic heart failure, cirrhosis of the liver and (or) having ascites. In these cases, you need to be very careful when choosing a cleanser and give preference to products based on polyethylene glycols.

Thus, drugs containing sodium sulfate and sodium phosphates, magnesium salts should be used with caution in patients with renal failure, liver cirrhosis, chronic heart failure, as there is a risk of developing water and electrolyte disorders.

Research to optimize bowel preparation processes continues to this day [18–21]. In healthy individuals, sodium phosphate-based preparations are currently recommended for use only in cases of individual intolerance to polyethylene glycol (PEG). In other cases, the drugs of choice currently remain those based on polyethylene glycols. But even in this case, there is quite a lot of freedom of choice among representatives of this series. Macrogol cleansers are currently available with molecular weights of 4000 and 3350. The differences in the molecular weight of the product component may seem minor, but these differences can have a significant impact on the quality of bowel preparation and the quality of life of patients.

For a long time, most experts gave preference to drugs based on macrogol 4000. Compared to drugs based on magnesium or sodium salts, these drugs are safe in relation to the state of the body’s water and electrolyte balance. They do not come into contact with the mucous membrane. Once in the lumen of the colon, macrogols form a gel-like substance that accumulates fluid located in the lumen of the intestine. In this case, the mechanoreceptors of the intestinal wall are irritated, peristalsis is activated and active cleansing of the intestine occurs. A significant disadvantage of Macrogol 4000 is the need for strong dilution of the drug and the intake of a significant volume of liquid when preparing for colonoscopy. On average, the volume of the cleansing agent is calculated from the ratio: 1 liter of macrogol 4000 solution per 20 kg of patient’s body weight. So, with an average weight of 70–75 kg, it is necessary to drink 4 liters of solution for adequate bowel preparation. In addition, the composition of the so-called first generation drugs, along with PEG, also includes some salts - in particular, potassium chloride, sodium chloride and sodium bicarbonate, designed to compensate for possible electrolyte losses. The presence of sodium sulfate in the composition of the drug (in various modifications up to 5.0 or 5.7 g) gives the solution a bitter-salty taste, which significantly reduces the organoleptic properties of the solution and can cause mild nausea and discomfort in some patients, especially when taking a large volume liquids.

At the Moscow Scientific Research Center we carried out research work on the use of a PEG solution with a lower molecular weight - macrogol 3350 (Endofalk). The drug is supplied in powder for preparing a solution. The isoosmotic solution of the drug consists of macrogol 3350, a mixture of electrolytes potassium and sodium chloride and sodium bicarbonate, which prevent the absorption of fluid in the lumen of the gastrointestinal tract. Silicon dioxide, also included in the mixture, has an antifoaming effect and prevents the development of flatulence. The use of PEG with a lower molecular weight made it possible to reduce the amount of stabilizing electrolytes, which improved the organoleptic properties of the drug. We observed 68 patients who underwent bowel preparation before colonoscopy. All patients were divided by blind randomization into two groups, the first included 29 people, the second 39 people. Both groups did not differ from each other in terms of gender and age. In order to determine the effectiveness of using PEG with a molecular weight of 3350, the first group of patients received a 3-liter Endofalk solution as preparation for colonoscopy, the second control group of patients received a 4-liter PEG solution with a molecular weight of 4000. Two days before the study, all patients followed a slag-free diet. The drug was taken before the study in two stages. Patients took the first portion of the drug in the evening before the study (starting at 18:00), the second portion - in the morning on the day of the study, 4 hours before the colonoscopy.

When taking the drug, the organoleptic properties and subjective sensations of patients were assessed in the form of a survey. The quality of bowel cleansing was assessed during colonoscopy using the international classification of bowel cleansing quality. Moreover, the study for endoscopists was blind, since they did not know which patient was prepared with which drug, and assessed the quality of bowel preparation only on the basis of objective criteria according to the Chicago Bowel Preparation Scale [22]. According to this classification, the large intestine is divided into three sections - left, middle and right. Each of the segments is assessed using a twelve-point system, to which is added a four-point gradation for assessing the amount of fluid in the intestinal lumen that is already present before the start of the study (Tables 1, 2).

Research results

Based on the results of colonoscopy performed by endoscopists, we did not note a significant significant difference in the quality of bowel preparation using Endofalk or macrogol 4000 solution.

Thus, in 87.4% of patients receiving Endofalk and 85.8% receiving Macrogol 4000, the degree of intestinal cleansing was 36 points; in 9.4% of patients in the first group and 7.6% in the second, the score corresponded to 32–34 points; in 3.2% of the first group of patients and 5.6% of the second group, the degree of intestinal cleansing was assessed within 28–31 points. In both groups, the amount of residual fluid was assessed as 0–1 point.

We noted the difference when taking different bowel preparation regimens during a survey of patients who assessed the taste of the solutions, the quality of night sleep, the number of bowel movements, the appearance of nausea, weakness, vomiting, thirst, dizziness, as well as during an objective and laboratory examination of patients in both groups for changes blood pressure, changes in basic indicators of acid-base balance.

As can be seen from table. 3, patients liked the taste of Endofalk more, which, according to some patients, has a pleasant taste of orange and passion fruit, compared to the bitter-salty taste of macrogol 4000, which is given to it by sodium sulfate in the solution (p < 0.05). The number of bowel movements during preparation with both drugs, as well as the quality of night sleep in both groups, was approximately the same, and we did not note a significant difference.

When assessing subjective feelings, the majority of patients in the first group liked Endofalk and rated it as “good” (96.5%), while less than half of the patients in the second group (43.6%) liked Macrogol 4000 (p < 0. 05). 41% of patients in the same group rated Macrogol 4000 “satisfactory” and 15.4% did not like it at all. Nausea while taking drugs was experienced by 14 people from the second group and 2 from the first; weakness while taking the drugs developed only in one patient when taking Endofalk and in 12 people taking Macrogol 4000. Also, only patients in this group experienced vomiting (1 patient). Thirst after taking the drugs was experienced by 4 patients of the second group and 1 patient while taking Endofalk.

When analyzing data from instrumental and laboratory studies, we noted only a slight increase in blood pressure values ​​in 5 patients taking macrogol 4000, which did not affect the general condition of the patients. There were no changes in the acid-base status in any of the patients under our supervision.

The results of the study showed almost the same efficiency of intestinal cleansing when using traditional drugs based on macrogol 4000 and a new drug for Russia based on macrogol 3350 (Endofalk). However, Endofalk showed better organoleptic properties, and the smaller volume of liquid required when taking this drug allowed us to achieve better subjective sensations for patients compared to taking solutions of macrogol 4000. The results of our studies coincided with similar studies conducted in other countries [23, 24 ].

In addition to a comparative study of traditional bowel preparation, a small pilot study was conducted in a limited group of patients (12 people) on bowel preparation using low volumes of Endofalka (2 liters) in combination with bisacodyl, an irritant laxative that increases intestinal motility and increased mucus production. Three days before the study, patients were prescribed a slag-free diet. On the eve of the colonoscopy, solid food was excluded from the morning until 2 p.m. It was allowed to take only clear liquids (broth, tea, juice without pulp, mineral water), at 14:00 bisacodyl was prescribed - 4 tablets of 5 mg each, and at 18:00 patients were asked to drink 1 liter of Endofalk solution. In the morning, on the day of the study, 3 hours before the colonoscopy, the patients drank another liter of Endofalk solution. At the same time, if desired, when taking Endofalk, it was allowed to additionally take a clear liquid. The results of this training scheme in our study coincided with the work of German colleagues [25]. Good quality of preparation was achieved in more than 90% of patients, which was comparable to the results of preparation according to the traditional regimen using Macrogol 4000 or Endofalk in full. However, when Endofalk was combined with bisacodyl, all patients gave positive subjective assessments.

Conclusion

Preparing the bowel for a colonoscopy is a complex process. During preparation, patients must adhere to a restrictive diet and take special laxatives and additional fluids, which lead to profuse diarrhea. Thus, the intestines are cleared of contents. Often, preparing the intestine for instrumental studies may be accompanied by nausea and bloating. In some cases, the laxative may have an unpleasant taste. Bowel preparation processes, as a rule, disrupt the usual rhythm of life of patients. All these negative factors can influence patients' refusal to undergo colonoscopy.

However, given the recent increase in intestinal diseases, endoscopists and gastroenterologists need to motivate patients to undergo this study and, accordingly, the need for bowel preparation. Motivation should be built on three main pillars: firstly, it is necessary to explain the importance of performing a colonoscopy itself and identifying intestinal pathology at an early stage, secondly, it is necessary to explain to the patient the mechanism of intestinal cleansing when using various schemes, explain the importance of following a diet and rules of administration drugs, and thirdly, an individual approach to each patient is necessary for the optimal choice of drug for him.

Although none of the drugs available in clinical practice show significant superiority in cleansing efficiency, there are significant differences in their tolerability among patients, which, ultimately, should be at the forefront when choosing a particular method of bowel preparation.

When considering the issues of pharmacoeconomics and the cost of various bowel preparation regimens, it should be borne in mind that if the preparation is inadequate, it is necessary to repeat the study and then the cost of a colonoscopy can at least double.

Thus, in the arsenal of modern gastroenterologists and endoscopists there are currently many highly effective oral agents that allow achieving high quality bowel preparation while maintaining a favorable attitude towards the preparation and conduct of colonoscopy itself in patients. In this case, the most important rule must be observed - strictly follow the rules and preparation schemes when using any drug in order to get the best result, otherwise even the best existing drug can be discredited in the eyes of the patient.

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P. L. Shcherbakov1, Doctor of Medical Sciences, Professor A. I. Parfenov, Doctor of Medical Sciences, Professor E. V. Albulova, Candidate of Medical Sciences

GBUZ MKNPTs DZM, Moscow

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