Purification of the colon in the preparation of patients: for endoscopic or radiological examinations; for colonic surgery. The preparation is intended for adults and the elderly.
Composition:
1 sachet (74 g) contains: 64.0 g macrogol 4000 (polyethylene glycol 4000), 5.7 g anhydrous sodium sulphate, 1.68 g sodium bicarbonate, 1.46 g sodium chloride, 0.75 g potassium chloride.
Action:
Osmotic laxative drug. High molecular weight macrogols (4000) are long, linear polymers that bind to water molecules using hydrogen bonds. After oral administration, they increase the volume of intestinal fluids. The volume of unabsorbed intestinal fluid determines the laxative properties of the solution. The content of electrolytes in the prepared solution is such that the exchange of electrolytes between the intestines and plasma practically does not occur. Pharmacokinetic studies confirm the lack of intestinal absorption and metabolism of macrogol 4000 after oral administration.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients. Severe general condition, e.g. dehydration or severe heart failure. Advanced stage of cancer or any other disease of the colon leading to excessive brittleness of the mucous membrane. Patients with risk of or occuring gastrointestinal obstruction. Patients with gastrointestinal perforation or an increased risk of gastrointestinal perforation. Gastric emptying disorders (eg gastroparesis). Bowel obstruction. Colitis or toxic colitis.
Precautions:
In elderly patients in severe general condition, the medicine can only be used under medical supervision. Due to the isotonic composition of the preparation, electrolyte disturbances are not expected to occur, however, water and electrolyte disturbances in the risk of this type of disorder have been reported in particular. In patients with impaired water and electrolyte management, electrolyte disturbances should first be corrected before administering the intestinal cleansing preparation. Caution should be exercised when treating patients with a predilection for water and electrolyte disturbances (including hyponatremia and hypokalaemia) or in patients with disorders that may increase the risk of potential complications, for example in patients with renal insufficiency, heart failure or receiving diuretics. In this case, patients should be properly monitored. Due to the risk of aspiration pneumonia, patients with a tendency to aspirate, bed-ridden patients, patients with neurological disorders or motor dysfunction of the oral cavity should be administered with caution and only under medical supervision. In these patients, the preparation should be administered in a seated position and possibly through a nasogastric tube. Caution should be used when treating patients with heart failure or those at risk for pulmonary edema. The safety and efficacy of the preparation in children under 18 years have not been established. The product contains macrogol (polyethylene glycol or PEG), which can cause allergic type reactions (rash, urticaria, edema) and anaphylactic shock.
Pregnancy and lactation:
The use of the preparation during pregnancy can only be considered in cases where the expected benefits outweigh the possible risks. It is not known whether macrogol 4000 is excreted in human milk. A danger for newborns / children can not be excluded. The preparation should only be used if the expected benefits outweigh the risks.
Side effects:
Very common: nausea, abdominal pain, abdominal distension. Common: vomiting. Not known: hypersensitivity (anaphylactic shock, angioneurotic edema, urticaria, rash, pruritus).
Dosage:
Orally. Adults and elderly patients. The contents of each sachet should be dissolved in 1 liter of water. Mix until the powder is completely dissolved. Dosage is about1 liter of solution for 15-20 kg body weight, which corresponds to an average dosage of 3-4 liters of solution. The solution can be administered either in two divided doses (2 l in the evening on the day before the examination or treatment and 1-2 l in the morning on the day of the examination or surgery, it is generally recommended that the last liquid should be taken 3-4 hours before the examination or treatment ) or in a single dose (3-4 l in the evening on the day before the examination or treatment). There is insufficient data on patients with impaired renal function.
(C)
