Endofalk

Pharmacological properties

endofalk is a mixture of different electrolytes and macrogol to obtain an isotonic solution for cleansing the intestines.

The pharmacodynamic effect is the induction of diarrhea. The intestines are emptied and cleansed. The electrolytes contained in the ready-to-use solution are balanced so as to ensure that the reverse process of absorption and secretion of water and electrolytes in the digestive tract is stopped and there is virtually no clean flow. A high molecular weight macrogol provides an isosmolar concentration, which is characterized by a concentration of particles comparable to that in blood plasma. This prevents any significant fluid changes between the lumen of the intestine and the vascular cavity. With this type of balancing and osmolarity, the effect on the balance of electrolytes or fluids in the body is practically absent.

Pharmacokinetics Macrogol 3350 is an inert compound that undergoes only minimal absorption in the digestive tract and is not metabolized. The minimum amount of macrogol 3350, 1% of the administered dose, is excreted in the urine.

Indications

Bowel cleansing before colonoscopy.

Application

For a complete cleansing of the intestine, it is necessary to drink up to 3 liters, up to a maximum of 4 liters of endofalk. one bag corresponds to 500 ml of solution.

The solution is drunk in portions of 200-300 ml every 10 minutes until the rectal washings are clear.

A solution is usually taken about 4 hours before the start of the study. The total required amount can be drunk in the evening, on the eve of the study, or in part, and the rest - the next morning, on the day of the study.

Patients should not eat solid food for 2-3 hours before taking Endofalk and until the end of the study.

Cooking solution

Solution is prepared immediately before use. The contents of two bags should be dissolved in 500 ml of warm or chilled boiled water and then bring the volume to 1 liter with water. It is advisable to take the solution chilled.

Contraindications

Hypersensitivity to active substances, other macrogols or one of the ingredients that make up the drug, intestinal obstruction, established or suspected, gastrointestinal obstruction, gastrointestinal perforation, risk of gastrointestinal perforation, carcinoma and other severe inflammatory bowel diseases (in including ulcerative colitis, Crohn’s disease), toxic megacolon, violation of gastric emptying.

Endofalk should not be prescribed to patients with impaired consciousness or patients predisposed to aspiration or burping, with general weakness or a violation of the swallowing reflex.

Side effects

From the digestive system: often (≥1 / 100, 1/10) - vomiting, abdominal cramps, abdominal pain and irritation of the anus; very often (≥1 / 10) - nausea, a feeling of fullness and bloating.

These symptoms are more often noted due to the use of a relatively large amount of fluid for a short period of time. If gastrointestinal symptoms occur, the frequency of taking Endofalk should be temporarily reduced or discontinued until the unwanted symptoms disappear.

General disorders: rarely (≥1 / 1000, 1/100) - general malaise and insomnia.

From the cardiovascular system: very rarely (1/10 000) - cardiac arrhythmia, tachycardia and pulmonary edema.

On the part of laboratory indicators: very rarely (1/10 000) in some patients, a decrease in the level of calcium, potassium, sodium in the blood plasma can be noted.

From the side of the central nervous system: very rarely (1/10 000) - neurological disorders as a result of fluctuations in the electrolyte balance can lead to mild disorientation or to generalized seizures.

From the side of the immune system: very rarely (1/10 000) - urticaria, rhinorrhea; itching or dermatitis, probably of an allergic origin; rash, Quincke syndrome, anaphylactic shock.

The literature provides data on two cases of Mallory - Weiss syndrome, noted as a result of vomiting after the use of solutions containing a macrogol.

special instructions

Endofalk is used in elderly patients and in individuals with reflux esophagitis or arrhythmia with suspected or confirmed sinoatrial blockade or sinus node weakness syndrome only under medical supervision.

The drug can be used in patients with chronic inflammatory bowel processes (exception: severe stages of the disease and toxic megacolon), but with caution and, if possible, under medical supervision.

Endofalk cannot be used in patients with heart failure (III and IV degree according to NYHA), renal failure, liver disease, or in people with severe dehydration, since the safety of use in these groups of patients is not well understood. The drug should be taken with caution in patients at risk of impaired water-electrolyte balance (for example, patients with impaired liver and kidney function, while taking diuretics). There have been isolated cases of violations of the water-electrolyte balance in patients at risk. Patients with heart or kidney failure may develop acute pulmonary edema due to excessive intake of sodium hydroxide.

Do not add any other solutions or additives (in particular sugar or flavorings incompatible with the Endofalk solution) to the endofalk solution ready for oral use, as this can change the osmolarity and electrolyte composition or cause increased gas formation in the intestine.

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

During pregnancy and breastfeeding. Pregnancy. There is no experience with the use of the drug during pregnancy.

The period of breastfeeding. There are no data on the intake of macrogol 3350 in breast milk. Macrogol 3350 is poorly absorbed. Endofalk can be used when breastfeeding, if the benefits of the application exceed the potential risk.

Children. Endofalk should not be used in children, since the safety of the drug in this age group of patients has not been adequately studied.

Influence on the ability to drive vehicles and work with other mechanisms. Endofalk does not affect the ability to drive vehicles or work with other mechanisms.

Interactions

Medicines used orally for several hours before or during the administration of endofalk can be removed from the digestive tract or their absorption can be reduced or completely stopped. this applies in particular to modified release formulations. if, for health reasons, this drug is absolutely necessary, replace the use of the oral form of the drug with another dosage form or find an alternative.

The interaction of a macrogol with certain enzymatic tests (e.g. ELISA) may be noted in a diagnostic study of intestinal fluid that has been excreted.

Ready solution cannot be mixed with other solutions or additives.

Overdose

In case of an overdose, severe diarrhea is possible. in case of a significant overdose, the development of violations of the water, electrolyte and acid-base balance is possible. adequate fluid replacement and monitoring of electrolytes in blood plasma and pH values ​​are necessary.

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

With aspiration, toxic pulmonary edema may develop, which requires immediate intensive care, including mechanical ventilation under high pressure.

Storage conditions

It does not require special storage conditions. the ready-made solution is suitable for use for 3 hours when stored at temperatures up to 25 ° C or for 48 hours at a temperature of 2-8 ° s (in the refrigerator).

Exclusive Distributor: Naturfarm, ul. Lesnaya, 30a, Kiev, Pushcha-Voditsa, 04075; phone: (044) 401-81-03.

Supplier: Alpen Pharma AG (Switzerland).