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Composition

active ingredients: potassium chloride; sodium chloride; sodium bicarbonate; macrogol 3350;


1 pack contains: potassium chloride 0.185 g, Sodium Chloride 1.4 g, Sodium Bicarbonate 0.715 G, macrogol 3350 52.5 g;


excipients: sodium saccharin; colloidal anhydrous silicon dioxide; banana flavor containing maltodextrin, dextrin, glycerol triacetate (triacetin).


Dosage form

Powder for oral solution.


Basic physical and chemical properties: white powdery mixture of various crystalline substances with banana flavor.


Pharmacotherapeutic group

Osmotic laxatives. Macrogol, combinations.


ATX code A06A D65.


Pharmacological properties

Pharmacodynamics.


The drug is a mixture of various electrolytes and macrogol to produce an isotonic solution for cleansing the intestines.


The pharmacodynamic effect is to induce diarrhea. The intestines are emptied and cleaned. The electrolytes contained in the ready-to-use solution are balanced so as to stop the reverse process of absorption and secretion of water and electrolytes in the digestive tract. The addition of high-molecular macrogol provides an isoosmolar concentration, which is characterized by a particle concentration comparable to that in blood plasma. This prevents any significant fluid change between the intestinal lumen and the vascular cavity. Due to this type of balancing and osmolarity, there is practically no effect on the balance of electrolytes or fluids in the body.


Indications

To clean the intestines before a colonoscopy.


Contraindications

Hypersensitivity to active ingredients, other macrogols, or to one of the ingredients that make up the drug.


Intestinal obstruction or suspected intestinal obstruction, gastrointestinal obstruction, gastrointestinal perforation, risk of gastrointestinal perforation, severe inflammatory bowel diseases (including ulcerative colitis, Crohn's disease), toxic megacolon, gastric emptying disorders.


The drug should not be used in patients who are unconscious or semi-conscious, as well as in patients who are prone to aspiration or belching, with general weakness or violation of the swallowing reflex.


Interactions with other drugs and other types of interactions

Medications that are administered orally for several hours before or during taking the drug may be removed from the gastrointestinal tract, or their absorption may be reduced or completely stopped. This applies, in particular, to delayed-release drugs. If these medications are absolutely necessary for vital reasons, you should avoid taking them orally and use them in a different dosage form or find an alternative.


There may be an interaction between macrogol and certain enzyme tests (for example, ELISA) in the diagnostic examination of intestinal fluid that has been excreted.


The finished solution should not be mixed with other solutions or additives.


Application features

The drug should only be used under medical supervision in elderly patients, patients with reflux esophagitis, or if the patient has a cardiac arrhythmia with suspected or confirmed sinoatrial block or sinus node weakness syndrome.


Patients with chronic inflammatory bowel diseases (except for severe course and toxic megacolon) should use the drug with caution, under the supervision of a doctor.


The drug should not be used in patients with heart failure [Grade III‒IV according to the NYHA classification (New York Heart Association)], renal failure, liver diseases, or patients with severe dehydration, since the safety of use in such patients has not been sufficiently studied. The drug should be used cautiously in patients at risk of water-electrolyte balance disorders (for example, in patients with impaired liver and kidney function, while taking diuretics at the same time). Isolated cases of water-electrolyte balance disorders were recorded in patients at risk. Patients with heart or renal insufficiency may develop acute pulmonary edema due to excessive intake of sodium hydroxide.


Ischemic colitis


Cases of ischemic colitis, including severe colitis, have been reported during post-marketing use in patients treated with macrogol for intestinal preparation. The drug should be used with caution in patients with risk factors for ischemic colitis or in the case of concomitant use of stimulating laxatives (such as bisacodil or Sodium Picosulfate). Patients who experience sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis should be examined immediately.


Do not add any other solutions or additives (in particular, sugar or flavorings that are incompatible with the drug solution) to the ready-to-use solution of the drug, as this may change the osmolarity and electrolyte composition or cause the formation of gas mixtures in the intestines.


It is necessary to monitor the water-electrolyte balance in patients at risk, including elderly patients and debilitated patients.


One package contains 32.7 mmol (752 mg) of sodium. This should be taken into account if the patient follows a controlled sodium diet.


One package contains 2.5 mmol (97 mg) of potassium. This should be taken into account if the patient follows a diet with a controlled potassium content.


Use during pregnancy or lactation.


Pregnancy.


There is no experience of using the drug during pregnancy.


Breast-feeding period.


There are no data on the ingestion of macrogol 3350 in breast milk.


Macrogol 3350 is poorly absorbed. The drug can be used during breast-feeding, if the benefit of using it for a woman exceeds the potential risk to the child.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


It does not affect or has little effect on the ability to drive a car or work with other mechanisms.


Dosage and administration

To completely cleanse the intestines, you need to drink up to 3 (Maximum up to 4) liters of the drug solution. One package corresponds to ½ liter of solution.


The solution is drunk in portions of 200-300 ML every 10 minutes, until the rectal flushing water becomes clear.


Usually, the drug should be completed 4 hours before the start of the study. The total required amount of the solution can also be taken in the evening before the study, or partially in the evening before, and the remainder – the next morning on the day of the study.


Patients should not eat any solid food for 2-3 hours before taking the drug and before completing the study.


Preparation of the solution.


The solution is prepared before use by dissolving the contents of 2 bags in 500 ml of warm or chilled boiled water, and then bring the volume to 1 liter by adding water. The newly prepared ready-to-use solution can be placed in the refrigerator, since it is advisable to use it chilled.


Children.


It should not be used in children, as the safety of using the drug in this age group of patients has not been properly studied.


Overdose

Overdose may cause severe diarrhea. In case of significant overdose, violations of the liquid, electrolyte and acid-base balance may be expected. Adequate fluid replacement and monitoring of serum electrolytes and pH values should be performed.


If a liquid, electrolyte, or acid-base imbalance occurs, it is also necessary to restore the electrolytes and take steps to restore the acid-base balance.


Aspiration may cause toxic pulmonary edema, which requires immediate intensive treatment measures, including ventilation of the lungs under high pressure.


Tags: Diagnostin