Solosorb (Gel) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

A07B (Intestinal adsorbents)

Active Substance

Polymethylsiloxane polyhydrate (Grouping name)

Dosage Form

Solosorb

Gel for oral suspension: tubes 225 g

Dosage Form, Packaging, and Composition

Gel for the preparation of an oral suspension in the form of a moist mass of white or almost white color, consisting of jelly-like lumps of various sizes, odorless.

225 g – tubes – cardboard packs.

Clinical-Pharmacological Group

Enterosorbent

Pharmacotherapeutic Group

Enterosorbent agent

Pharmacological Action

Enterosorbing agent.

Polymethylsiloxane has a porous structure of an organosilicon matrix (molecular sponge) of a hydrophobic nature, which is characterized by a sorption action only towards medium-molecular-weight toxic metabolites (molecular weight from 70 to 1000).

Polymethylsiloxane has pronounced sorption and detoxification properties. In the lumen of the gastrointestinal tract, it binds and removes from the body endogenous and exogenous toxic substances of various natures, including bacteria and bacterial toxins, antigens, food allergens, medicinal products and poisons, salts of heavy metals, radionuclides, alcohol; it also sorbs some products of the body’s metabolism, including excess bilirubin, urea, cholesterol and lipid complexes, as well as metabolites responsible for the development of endogenous toxicosis.

Polymethylsiloxane does not reduce the absorption of vitamins and microelements, contributes to the restoration of disturbed intestinal microflora and does not affect its motor function.

Pharmacokinetics

Not absorbed in the gastrointestinal tract, excreted unchanged within 12 hours.

Indications

In adults and children as a detoxification agent: acute and chronic intoxications of various origins; acute poisonings with potent and poisonous substances, including medicinal products and alcohol, alkaloids, salts of heavy metals; acute intestinal infections of any genesis as part of complex therapy (foodborne toxic infections, salmonellosis, dysentery, diarrheal syndrome of non-infectious origin, dysbiosis); purulent-septic diseases accompanied by severe intoxication, as part of complex therapy; food and drug allergy; hyperbilirubinemia (viral hepatitis) and hyperazotemia (chronic renal failure); for the prevention of chronic intoxications in workers of hazardous industries (occupational intoxications with chemical agents of polytropic action, xenobiotics, incorporated radionuclides, lead, mercury, arsenic compounds, petroleum products, organic solvents, nitrogen oxides, carbon, fluorides, salts of heavy metals).

ICD codes

Dosage Regimen

Administer orally, maintaining an interval of 1-2 hours before or after meals or intake of any other medicinal products.

For adults, the dose is 15 g to 22.5 g (approximately one to one and a half tablespoons), taken three times daily.

For children aged 3 to 5 years, the dose is 7.5 g (approximately half a tablespoon), taken three times daily.

For children aged 1 to 3 years, the dose is 5 g (approximately one teaspoon), taken three times daily.

For infants up to 1 year, administer 2.5 g (approximately half a teaspoon). Mix the gel thoroughly with a triple volume of breast milk, infant formula, or water. Give this mixture before each feeding (typically six times daily).

In cases of severe intoxication, the dosage for adults may be doubled during the first three days of therapy, under medical supervision.

The average duration of treatment is 3 to 5 days for acute conditions. For chronic intoxications and allergic diseases, the course can be extended to 2-3 weeks, as directed by a physician.

For prophylactic use in occupational hazards, take the standard adult dose once or twice daily.

Adverse Reactions

From the digestive system nausea, constipation.

Contraindications

Intestinal atony.

Use in Pregnancy and Lactation

Not contraindicated during pregnancy and breastfeeding.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Special Precautions

Can be used in complex therapy with other medicinal products, provided the rule of separate administration in time is observed: 1-2 hours before or after taking other medicinal products.

Drug Interactions

When taken simultaneously, a decrease in the absorption of other medicinal products is possible.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.