Moviprep

Pharmacological properties

Oral administration of macrogol-based electrolyte solutions causes moderate diarrhea and leads to rapid emptying of the large intestine.

Macrogol 3350, sodium sulfate and ascorbic acid in high doses act on the intestines osmotically, causing a laxative effect.

Macrogol 3350 contributes to an increase in feces, which affects the mobility of the colon through the neuromuscular pathways. As a result of this, an accelerated passage of softened feces through the colon is achieved. The electrolytes contained in the preparation and the additional intake of a clear liquid prevent the violation of the water-electrolyte balance, reducing the risk of dehydration.

Macrogol 3350 remains in the intestine unchanged. It is practically not absorbed in the digestive tract. Macrogol 3350, which is absorbed, is excreted in the urine.

Ascorbic acid is absorbed mainly in the small intestine by the mechanism of active transport, which depends on sodium and is saturated. There is an inverse relationship between the dose taken and the percentage of absorbed dose. With oral doses of 30–180 mg, the amount of absorbed dose is 70–85%. After oral administration, up to 12 g of ascorbic acid is absorbed only 2 g.

After oral administration of high doses of ascorbic acid and when the level of ascorbic acid in blood plasma exceeds 14 mg / l, ascorbic acid is excreted unchanged in the urine.

Indications

For cleansing the intestines before clinical procedures requiring cleaning, for example, before an endoscopic or radiological examination of the intestine.

Application

Adults and the elderly. during the course of treatment, 2 l of the diluted drug Moviprep is used. It is recommended that you additionally drink 1 liter of clear liquid (water, clear soup, fruit juice without pulp, soft drinks, tea and / or coffee without milk) during the course of treatment.

To prepare the first liter of solution - the contents of 1 sachet A and 1 sachet B are dissolved in a small amount of water and adjusted to 1 liter with water. The prepared solution should be boiled for 1-2 hours.

The procedure for diluting the second liter of the drug is similar.

The course of treatment can be carried out with a dose distribution or in one go:

The 1st method, with a dose distribution in 2 parts: the first liter of the diluted drug Moviprep is taken in the evening, the second liter of the diluted drug Moviprep is taken on the morning of the day of the clinical procedure.

2nd method, in one go: drink 2 L of the diluted Moviprep preparation in the evening on the eve of the clinical procedure or 2 L in the morning on the day of the clinical procedure.

Regardless of the preparation method chosen, the interval between the end of fluid intake (Moviprep or clear liquid) in the evening and the start of colonoscopy should be at least 1 hour.

When using the drug in one dose in the morning on the day of the clinical procedure, the interval between the end of taking Moviprep and the start of colonoscopy should be at least 2 hours.

Patients should consider the time to move to the institution where the colonoscopy is performed.

During the course of treatment and until the end of the clinical procedure, it is contraindicated to eat solid food.

Dissolution of the drug Moviprep can last up to 5 minutes. It is recommended to first pour the powder into a container, mix with a small amount of water. The drug Moviprep is taken only after complete dissolution in water. The solution can be taken immediately or cooled before use.

Contraindications

The drug is not used if there is or if you suspect the following conditions:

• hypersensitivity to any component of the drug;
• obstruction or perforation of the digestive tract;
• violation of gastric emptying (for example, paresis of the stomach);
• ileus;
• phenylketonuria (since the drug contains aspartame);
• glucose-6-phosphate dehydrogenase deficiency (since the drug contains ascorbate);
• toxic megacolon complicating inflammatory bowel diseases, including Crohns disease, ulcerative colitis.

It is contraindicated to use the drug in patients in an unconscious state.

Side effects

Diarrhea is a reaction that is expected after taking drugs of this group and causes undesirable effects in most patients. the most common are nausea, vomiting, bloating, pain in the epigastric region, anal irritation, sleep disturbance. diarrhea and / or vomiting can cause dehydration. when using preparations containing macrogol, allergic reactions such as rash, urticaria, pruritus, dyspnea, angioedema, anaphylaxis can occur.

The following are the adverse reactions that have been observed in patients after using Moviprep during clinical trials and in the post-marketing period.

Undesirable effects by frequency of occurrence are classified into the following categories: very often (1/10), often (1/100, 1/10), infrequently (1/1000, 1/100), rarely (1/10 000, 1/1000 ), very rarely (1/10 000), unknown (frequency not determined).

On the part of the immune system: unknown - allergic reactions, including anaphylaxis, dyspnea, skin reactions (see below).

Metabolism and eating disorders: unknown - violation of the level of electrolytes, including a decrease in the level of bicarbonate in the blood, hyper- and hypocalcemia, hypophosphatemia, hypokalemia, hyponatremia and changes in the level of chloride in the blood, dehydration.

Mental disorders: often - sleep disturbances.

From the nervous system: often - dizziness, headache; unknown - convulsions associated with severe hyponatremia.

From the side of the heart: unknown - a temporary increase in blood pressure, arrhythmia, accelerated heartbeat.

From the gastrointestinal tract: very often - abdominal pain, nausea, bloating, anal discomfort; often - nausea, dyspepsia; infrequently - dysphagia; unknown - flatulence, urge to vomit.

On the part of the liver and biliary tract: infrequently - violation of the liver function indicators.

From the skin and subcutaneous tissues: unknown - allergic reactions, including angioedema, itching, urticaria, rash, erythema.

General disorders: very often - malaise, hyperthermia; often - chills, thirst, hunger; infrequently - discomfort.

special instructions

Diarrhea is the expected reaction after taking Moviprep.

Use the drug with caution in debilitated patients and patients with severe clinical impairment, for example:

• violation of the vomiting reflex or a tendency to aspiration or burping;
• impaired consciousness;
• severe renal failure (creatinine clearance 30 ml / min);
• heart failure (III – IV functional class according to NYHA classification);
• dehydration;
• severe acute inflammatory diseases.

Before taking the drug, dehydration of the body should not be allowed. During the use of the drug, it is necessary to monitor the condition of patients who are semi-unconscious or prone to aspiration or burping, especially if the drug is administered through a nasogastric tube.

If a patient develops symptoms indicating a change in fluid / electrolyte levels (e.g. edema, shortness of breath, fatigue, heart failure), it is necessary to check the level of electrolytes in the blood plasma and carry out appropriate treatment.

In debilitated debilitated patients, patients with poor health, severe renal failure, and patients at risk of electrolyte imbalance, the doctor should check the electrolyte level and renal function before and after treatment.

If the patient has symptoms such as severe flatulence, bloating, pain in the abdomen or other reaction that impedes the use of the drug, it is necessary to slow down or temporarily suspend its use and consult a doctor.

Use during pregnancy or lactation. No data available. Macrogol is used after consultation with a doctor in case of urgent need, when the expected benefit to the mother outweighs the potential risk to the fetus and child.

The ability to influence the reaction rate when driving vehicles or working with mechanisms. Not found.

Children. The drug is not recommended for use in children under 18 years of age, since there is no clinical data on the safety of the drug in this age group of patients.

Interactions

Macrogol should not be taken with other drugs for oral use for 1 hour, since they may not be absorbed in the digestive tract. this is especially true for drugs with a narrow therapeutic index or short t½.

Overdose

In the event of an occasional significant overdose leading to profuse diarrhea, conservative treatment is usually sufficient: drinking enough liquid, especially fruit juices. in exceptional cases, in case of an overdose that caused significant metabolic disturbances, intravenous rehydration is possible.

Storage conditions

At a temperature not exceeding 25 ° c in the original packaging. keep the diluted solution at a temperature of 2–8 ° c.

UA / TAK / 1016/0038