Endofalk powder #6

Instruction for Endofalk

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Endofalk is an osmotic laxative drug.

Release form and composition

Dosage form - powder for preparation of oral solution: crystalline, white, with a pronounced fruit-orange odor (in sachets made of laminated material; 6 or 8 sachets in a cardboard box).
The composition of one sachet:
    active substances: macrogol 3350 (polyethylene glycol) - 52.5 g; sodium chloride - 1.4 g; sodium bicarbonate - 0.715 g; potassium chloride - 0.185 g;
    excipients: sodium saccharinate, colloidal silicon dioxide, fruit flavor, orange flavor.

Pharmacodynamics

The pharmacological action of Endofalk is to initiate watery diarrhea, since a mixture of macrogol 3350 and various electrolytes that make up the preparation has a laxative effect, which leads to an acceleration of intestinal passage.
Due to the addition of high molecular weight polyethylene glycol, an isoosmolar solution is created, in which the concentration of solute particles is comparable to their concentration in blood plasma. The electrolytes in the prepared solution are in a balanced form. This balance and osmolarity prevents absorption of fluid in the stomach and intestines and promotes a normal balance of water and electrolytes between the lumen of the gastrointestinal tract (GI tract) and the vascular bed. Thus, the body's water-salt balance is practically not disturbed.
Polyethylene glycol prevents unwanted gas formation caused by the metabolizing action of bacteria due to the fact that it is not subject to absorption and metabolism.

Pharmacokinetics

Since macrogol 3350 with a high molecular weight is an inert compound, when passing through the gastrointestinal tract, it is absorbed to an insignificant extent and is not metabolized during passage.
A minimum amount of polyethylene glycol is excreted in the urine - less than 1% of the dose taken.

Indications for use

Endofalk is indicated for use for preparatory bowel movements in the following cases:
    X-ray or endoscopic (including colonoscopy, sigmoidoscopy) examination of the lower intestine;
    surgical procedures requiring the absence of chyme (intestinal contents).

Contraindications

Absolute:
    intestinal obstruction (ileus) or suspected ileus;
    obstruction of the lumen of the stomach / intestines;
    toxic megacolon;
    perforation or suspected gastrointestinal perforation;
    severe colitis in the acute stage;
    erosive and ulcerative lesions of the gastrointestinal tract;
    tendency to regurgitation and aspiration of gastric contents;
    violation of the swallowing reflex;
    general weakness, impaired consciousness;
    severe dehydration;
    heart failure syndrome III and IV according to the classification of the New York Heart Association (NYHA);
    impaired renal function;
    liver disease;
    age up to 18 years;
    individual hypersensitivity to polyethylene glycol and / or other components of the drug.
With caution, Endofalk should be prescribed to patients with chronic inflammatory bowel diseases, cardiac arrhythmias with suspected or confirmed sinoatrial blockade / sick sinus syndrome, reflux esophagitis, as well as elderly patients.

Instructions for use of Endofalk: method and dosage

Endofalk is taken orally in the form of a solution, which must be prepared immediately before use. 2–3 hours before taking the drug and until the end of the study or surgery on the intestines, solid food intake is contraindicated.
To prepare Endofalk solution, the contents of 1 sachet are diluted in 0.5 liters of chilled boiled water.
It is recommended to take the solution in portions of 0.2-0.3 liters every 10 minutes. For complete cleansing of the intestines, it is necessary to prepare and drink 3-4 liters of solution. The medicine should be taken within 3–4 hours, usually on the day of the proposed study or surgery. You can also drink Endofalk solution the evening before the study, or take one part in the evening and the other in the morning.

Side effects

The incidence of side effects on the scale of the World Health Organization by systemic organ classes (very often - more than 10%; often - more than 1%, but less than 10%; infrequently - more than 0.1%, but less than 1%; rarely - more than 0 , 01%, but less than 0.1%; extremely rare - less than 0.01%):
    Gastrointestinal tract: very often - flatulence, a feeling of fullness in the stomach, nausea; often - irritation of the anus, stomach cramps, vomiting;
    immune system: very often - rhinorrhea, urticaria, allergic dermatitis, anaphylactic shock;
    heart: very rarely - tachycardia, arrhythmias, pulmonary edema;
    nervous system: very rarely - neurological disorders from mild disorientation to generalized convulsive seizures (due to impaired water and electrolyte metabolism);
    the body as a whole: infrequently - insomnia, general malaise;
    instrumental and laboratory studies: very rarely - a clinically significant decrease in serum calcium, sodium and potassium levels.
On the part of the gastrointestinal tract, adverse reactions are mainly due to the intake of a sufficiently large amount of liquid in a relatively short period of time. If such effects occur, in particular nausea and / or vomiting, you should slow down the intake of Endofalk solution or suspend it for a while until the undesirable symptoms disappear.
In the medical literature, there are two cases of Mallory-Weiss syndrome due to vomiting after taking solutions for bowel cleansing containing macrogol.

Overdose

With an overdose of Endofalk, severe diarrhea is possible. Violations of the water-salt / acid-base balance can only be expected in the case of severe overdose.
Treatment consists of fluid replacement and monitoring of serum electrolytes and pH. In case of violation of the water-electrolyte, acid-base balance, their correction is necessary.
In the event of toxic pulmonary edema (due to aspiration of stomach contents), emergency intensive care, including positive pressure breathing, is necessary.

Special instructions

The patient should inform the attending physician about all medications taken simultaneously with Endofalk, as well as about the occurrence of any adverse reactions.

Influence on the ability to drive vehicles and complex mechanisms

It is recommended to be careful when driving vehicles and engaging in all types of activities that require increased attention and fast motor / mental reactions.

Application during pregnancy and lactation

At this time, clinical studies of the use of Endofalk in women during pregnancy and lactation have not been conducted. In experiments on animals, no teratogenic effects have been revealed.
There is no data on the penetration of macrogol 3350 into breast milk. However, the drug is absorbed in very small quantities.
Due to the lack of experimental data, it is necessary to prescribe Endofalk to pregnant and lactating women with caution, and in the case when the expected benefit to the mother is higher than the potential risk to the fetus and child.

Pediatric use

According to the instructions, Endofalk is contraindicated in children and adolescents under 18 years of age.

With impaired renal function

In case of impaired renal excretory function, renal failure, the use of Endofalk is contraindicated.

For violations of liver function

The drug is prohibited for use in liver diseases.

Use in the elderly

The use of Endofalk in elderly patients with concomitant diseases requires medical supervision.

Drug interactions

The absorption of drugs taken orally within a few hours before or during the use of Endofalk can be significantly reduced or completely stopped. In particular, this applies to modified release formulations.
When used for diagnostic studies of fluid secreted from the intestine, test enzyme assays (for example, ELISA), macrogol 3350 can interact with enzyme tests.
The prepared solution of the drug is not recommended to be mixed with other additives or mixtures (for example, sugar or flavors that are not compatible with Endofalk's solution), as this may change the osmolarity and / or electrolyte composition of the solution, it is also possible to form an explosive gas under the influence of intestinal bacteria during decomposition some additives.

Terms and conditions of storage

Store in a dark place, out of reach of children, at a temperature not exceeding 25 ° C.
Shelf life is 5 years.
The prepared solution can be stored at a temperature of 25 ° C for no more than 3 hours or at a temperature of 5 ° C (in the refrigerator) for 48 hours.

Reviews

According to the few reviews about Endofalk, the drug has a fairly high cost compared to similar domestic drugs. But at the same time it effectively, consistently and gently cleanses the intestines, without pain and spasms. It has a rather pleasant taste, so you can take the solution without much difficulty.
Some patients note that the effect of the drug does not stop 3-4 hours after taking the last dose, as described in the instructions. A complete colon cleanse takes much longer.

Terms of sell

You can buy Endofalk without a prescription.