Enterosgel^® Instruction

International Non-Proprietary Name (INN): polymethylsiloxane polyhydrate
Dosage form: sachets
Structure
In 100 g:
Active ingredient: polymethylsiloxane polyhydrate 70 g;
Excipients: purified water 30 g.
Description
Homogeneous paste-like mass of white or almost white colour, odourless.
Pharmacological classification: intestinal adsorbent
ATC code: А07B

Pharmacodynamics

Enterosgel^® has a porous structure of hydrophobic organic silicon matrix (molecular sponge) that sorbs mostly medium molecular toxic metabolites (m.m. 70–1,000). The medicinal product has pronounced sorption and detoxification properties. In the intestinal lumen, it binds endogenous and exogenous toxic substances of various nature, including bacteria and bacterial toxins, antigens, food allergens, drugs and poisons, salts of heavy metals, radionuclides, alcohol and removes them from the body. Enterosgel® also sorbs some metabolic waste, including excess bilirubin, urea, cholesterol and lipid complexes, as well as metabolites responsible for endogenous toxicosis. Enterosgel^® does not reduce absorption of vitamins and trace elements, it helps restore the damaged intestinal microflora. Enterosgel^® does not affect gastrointestinal motor function.

Pharmacokinetics

Enterosgel^® is not absorbed in the gastrointestinal tract, it is excreted unchanged in 12 hours.

Intended uses

In adults and children as a detoxification agent:

• Acute and chronic intoxications of various origin;
• Acute intoxication by strong and poisonous substances, including drugs and alcohol, alkaloids, salts of heavy metals;
• Part of complex therapy of acute intestinal infections of any origin (toxic infection, salmonellosis, dysentery, non-infectious diarrhoea, dysbacteriosis);
• Purulent-septic diseases aggravated by severe intoxication, as part of complex therapy;
• Food and drug allergies;
• Hyperbilirubinemia (viral hepatitis) and hyperazotemia (chronic renal failure);
• Prevention of chronic intoxications in workers exposed to health and safety hazards (occupational intoxication by chemical agents of polytropic action, xenobiotics, incorporated radionuclides, lead compounds, mercury, arsenic, petroleum products, organic solvents, nitrogen oxides, carbon, fluorides, salts of heavy metals).

Contraindications

Individual intolerance to the medicinal product, intestinal atony.

Dosage and administration

Enterosgel^® is taken orally 1-2 hours before or after meals or administration of other medicines with water.

Stir the necessary amount of the medicinal product in a glass of water (ratio 1:3) at room temperature and drink the mixture, or take the medicinal product orally and wash it down with water. 

• Dosage for adults and children over 14 years old: 15–22.5 g (1–1.5 tablespoon) 3 times per day.
  Daily dose 45–67.5 g.
• Children aged 5 to 14 years old: 15 g (1 tablespoon) 3 times per day.
  Daily dose 45 g.
• Children under 5 years old: 7.5 g (0.5 tablespoon) 3 times per day.
  Daily dose 22.5 g.
• For children under 1 year old: mix 2.5 g (0.5 teaspoon) of the medicinal product with breast milk or water (ratio 1:3) and give before every feeding (6 times per day).
• To prevent chronic intoxications: 22.5 g 2 times per day for 7–10 days monthly. In cases of severe intoxication, the dose of the medicinal product can be doubled during the first 3 days.

In cases of acute intoxication, the duration of treatment is 3–5 days. In cases of chronic intoxications and allergic conditions, the duration of treatment is 2-3 weeks. For a repeat course, consult a doctor.

Side effects

May cause nausea, constipation. In case of severe renal and/or liver failure, aversion towards the medicinal product may appear.

Overdose

No cases of overdose were reported.

Interaction with other drugs

Simultaneous intake of Enterosgel^® with other medicines may reduce the absorption of the latter.

Enterosgel^® can be used in complex therapy with other drugs, provided a time interval of 1-2 hours is observed before or after the intake of other medicinal products.

Pregnancy and lactation

Enterosgel^® is not contraindicated during pregnancy and lactation.

Influence on the ability to drive vehicles and operate mechanisms

Enterosgel^® showed no effects on the ability to drive and operate machinery.

Storage conditions

Store at temperatures between 4°C and 30°C (39.2°F and 86°F). Keep out of the reach of children. Protect from drying after opening the package. Protect from freezing.

Shelf life

3 years. Do not use it after the expiry date indicated on the package.

Manufacturer

Pharmasil / SILMA, Russia. https://enterosgel.ru/en