Endofalk powder for solution for oral use №6

Description

Endofalk Storage
active substances: 1 package (55,318 g of powder) contains: macrogol 3350 – 52,500 g, sodium chloride – 1,400 g, sodium bicarbonate – 0,715 g, potassium chloride – 0,185 g;

Endofalk excipients: saccharin sodium, colloidal anhydrous silica, passion fruit flavor, orange flavor.

Endofalk Dosage form
Powder for oral solution.

Main physical and chemical properties: white powdery mixture of various crystalline substances.

Pharmacotherapeutic group
Osmotic laxatives. Macrogol, combinations.

ATX code A06A D65.

Pharmacological properties

Pharmacodynamics.

Endofalk is a mixture of different electrolytes and macrogol to obtain an isotonic solution for bowel cleansing.

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 the cessation of the reverse process of absorption and secretion of water and electrolytes in the digestive tract. The addition of high molecular weight macrogol provides an isoosmolar concentration, which is characterized by a concentration of particles comparable to that in blood plasma. This prevents any fluid from moving significantly between the intestinal lumen and the vascular cavity. Due to this type of balancing and osmolarity, the effect on the balance of electrolytes or fluid in the body is virtually absent.

Pharmacokinetics.

Macrogol 3350 is an inert compound that is only minimally absorbed in the gastrointestinal tract and is not metabolized. The minimum amount of macrogol 3350, <1% of the administered dose, is excreted in the urine.

Indication
To clean the intestines before colonoscopy.

Contraindication
Hypersensitivity to the active substances, other macrogols or to any of the components of the drug.

Intestinal obstruction or suspected intestinal obstruction, gastrointestinal obstruction, gastrointestinal perforation, risk of gastrointestinal perforation, carcinoma and other severe inflammatory bowel disease (including ulcerative colitis, Crohn’s disease), toxic megacolon.

Endofalk should not be used in patients who are unconscious or semi-conscious, or in patients prone to aspiration or belching, with general weakness or impaired swallowing reflex.

Interaction with other medicinal products and other forms of interaction
Medicines that are taken orally for several hours before or while taking Endofalk may be eliminated from the gastrointestinal tract or their absorption may be reduced or completely stopped. This applies in particular to delayed-release medicines. If vital signs are absolutely necessary, oral administration should be avoided and this medicinal product (s) should be used in another dosage form or an alternative should be found.

Interaction between macrogol and certain enzyme tests (for example ELISA) at diagnostic research of the intestinal liquid which was deduced is possible.

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