Moviprep powder, A No. 2 + B No. 2

Before carrying out a diagnostic study (endoscopic, X-ray and other intestinal examination) and surgery, it is necessary to go through an important bowel preparation process, which includes 3 stages:

1. Compliance with a special diet.

2. The choice of the drug intake regimen depending on the time of the study or surgery.

3. Carrying out the process of bowel cleansing with the help of MOVIPREPЃ.

Powder for preparation of oral solution from white to yellow color with a characteristic lemon odor (sachet A).

1 sachet A

macrogol-3350 100.00 g

sodium sulfate anhydrous 7.500 g

sodium chloride 2.691 g

potassium chloride 1.015 g

Excipients: aspartame - 0.233 g, acesulfame potassium - 0.117 g, lemon flavoring V3938-1 N1 - 0.340 g.

Powder for preparation of oral solution from white to light brown color (sachet B).

1 sachet B

ascorbic acid 4.700 g

sodium ascorbate 5.900 g

111.896 g + 10.600 g - sachet A (1) and sachet B (1) - plastic bags (2) - cardboard packs.

• hypersensitivity to any component of the drug;

• violation of gastric emptying (gastroparesis);

• intestinal obstruction;

• perforation or risk of perforation of the gastrointestinal tract;

• phenylketonuria (due to the aspartame content in the composition);

• deficiency of glucose-6-phosphate dehydrogenase (due to the content of ascorbic acid in the composition);

• toxic megacolon, which is a complication of severe inflammatory bowel disease, including Crohn's disease and ulcerative colitis;

• age under 18;

• unconsciousness.

Carefully

• impaired gag reflex, tendency to aspiration or regurgitation;

• disturbances of consciousness;

• dehydration;

• severe heart failure (III-IV FC according to NYHA classification);

• severe renal failure (CC <30 ml / min);

• severe acute inflammatory bowel disease;

• abdominal pain of unknown etiology;

• the risk of arrhythmias (in patients receiving treatment for cardiovascular disease or with thyroid disease).

If one of the listed diseases is present, the patient should always consult a doctor before taking MOVIPREPЃ.

pharmachologic effect

Pharmacodynamics

Oral administration of a macrogol-based electrolyte solution causes mild diarrhea, which results in rapid emptying of the contents of the colon.

Macrogol-3350, sodium sulfate and ascorbic acid have an osmotic effect that causes a laxative effect.

Macrogol-3350 increases the volume of feces, which leads to increased intestinal motility.

The electrolytes that are part of the drug, as well as additional fluid intake, prevent the violation of the water-electrolyte balance.

Pharmacokinetics

Macrogol-3350 does not change while in the intestine. It is practically not absorbed from the gastrointestinal tract. The absorbed amount of Macrogol-3350 is excreted through the kidneys.

Ascorbic acid is absorbed mainly in the small intestine by active sodium-dependent saturable transport. There is an inverse relationship between the dose received and the percentage absorbed of the dose. With an oral dose of 30 to 180 mg, about 70-85% of the dose taken is absorbed. With the subsequent oral administration of ascorbic acid in a volume of up to 12 g, only 2 g is absorbed.

After oral administration of large doses of ascorbic acid and if its concentration in plasma exceeds 14 mg / l, absorbed ascorbic acid is excreted mainly unchanged through the kidneys.

Side effect

Diarrhea is the expected effect of bowel preparation. Due to the nature of the effect of the drug during the preparation of the intestines for the procedure, undesirable effects are noted in most patients. Although there are some differences in specific cases, the most common adverse effects are: nausea, vomiting, bloating, abdominal pain, irritation in the anus, and sleep disturbances. Dehydration may develop as a result of diarrhea and / or vomiting.

As with other foods that contain macrogol, a variety of allergic reactions are possible, including rash, hives, pruritus, dyspnea, Quincke's edema, and anaphylactic shock.

Adverse effects are classified depending on the frequency of occurrence: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10 000, <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the data obtained).

From the immune system: frequency unknown - allergic reactions, including anaphylactic reactions, dyspnea and skin reactions.

Mental disorders: often - sleep disorders.

From the side of the nervous system: often - dizziness, headache; frequency unknown - seizures associated with acute hyponatremia.

From the side of metabolism and nutrition: the frequency is unknown - dehydration, electrolyte disturbances, including a decrease in the level of bicarbonate in the blood, hypercalcemia and hypocalcemia, hypophosphatemia, hypokalemia and hyponatremia and changes in the levels of chlorides in the blood.

From the side of the cardiovascular system: the frequency is unknown - a short-term increase in blood pressure, arrhythmia, heart palpitations.

From the gastrointestinal tract: very often - abdominal pain, nausea, bloating, irritation in the anus; often - vomiting, dyspepsia; infrequently - difficulty swallowing; frequency unknown - flatulence, retching.

From the liver and biliary tract: infrequently - deviations from the norm of functional liver tests.

On the part of the skin and subcutaneous tissues: the frequency is unknown - allergic skin reactions, including angioedema, urticaria, itching, rash and redness of the skin.

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

If any of the above undesirable effects are aggravated, or the patient has noticed any other undesirable effects not listed above, he should inform the doctor about it.

Application during pregnancy and lactation

The experience of using MOVIPREPЃ during pregnancy and during breastfeeding is limited. MOVIPREPЃ should only be used if the intended benefit to the mother outweighs the potential risk to the fetus or child (medical advice is required).

Application for impaired renal function

The drug should be used with caution in severe renal failure (CC <30 ml / min).

Application in children

The use of the drug under the age of 18 is contraindicated.

Use in elderly patients

Elderly patients should use the drug under medical supervision.

special instructions

Elderly patients, weakened or emaciated 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 MOVIPREPЃ 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 concomitant diseases, with clinically significant impairment of renal function, arrhythmias and a risk of electrolyte imbalance, the need to determine the level of electrolytes at baseline and after treatment, assess renal function and perform an ECG study should be considered.

In rare cases, severe arrhythmias, including atrial fibrillation, have been observed associated with the use of ionic osmotic laxatives for bowel preparation. These phenomena occur mainly in patients with existing cardiac risk factors and electrolyte imbalance.

If patients develop any symptoms that indicate arrhythmias or changes in water / electrolyte balance (eg, edema, shortness of breath, fatigue, heart failure), the level of electrolytes in the blood plasma should be determined, an ECG should be performed, and any abnormalities identified should be adequately treated.

If the patient develops 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.

When treating patients who follow a diet with a controlled sodium content, it should be borne in mind that the drug contains 56.2 mmol of absorbable sodium per 1 liter of solution.

When treating patients with impaired renal function or patients who follow a diet with a controlled potassium content, it should be borne in mind that the drug contains 14.2 mmol of potassium per 1 liter of solution.

Influence on the ability to drive vehicles and mechanisms

During the course of preparation for medical manipulations with MOVIPREPЃ it is recommended to refrain from driving vehicles and other mechanisms.

Overdose

Symptoms: Severe diarrhea, which can lead to imbalance in water and electrolyte balance.

Treatment: Drinking plenty of fluids is usually sufficient, preferably fruit juices. If necessary, intravenous administration of infusion solutions to restore water-electrolyte balance.

Drug interactions

Diarrhea caused by taking MOVIPREPЃ can lead to impaired absorption of other drugs taken at the same time. Medicines taken orally within one hour before the onset of the drug's laxative effect (for example, oral contraceptives) can be cleared from the gastrointestinal tract without being absorbed.