Silicasorb^® (Powder) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

A07BC (Intestinal adsorbents, other)

Active Substance

Colloidal silicon dioxide (USNF The United States "National Formulary")

Dosage Form

Silicasorb®

Powder for oral suspension: jars 12 g, 25 g or 50 g 1 pc.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral suspension white or almost white in color; the prepared suspension is white or almost white in color.

12 g – jars (1) with first opening control – cardboard packs.
25 g – jars (1) with first opening control – cardboard packs.
50 g – jars (1) with first opening control – cardboard packs.

Clinical-Pharmacological Group

Enterosorbent

Pharmacotherapeutic Group

Enterosorbent agent

Pharmacological Action

An inorganic non-selective polyfunctional enterosorbent based on highly dispersed silica with particle sizes up to 0.09 mm and with the chemical formula SiO₂.

It has pronounced sorption and detoxification properties.

In the gastrointestinal tract lumen, it binds and removes from the body endogenous and exogenous toxic substances of various natures, including pathogenic bacteria and bacterial toxins, antigens, food allergens, drugs and poisons, salts of heavy metals, radionuclides, alcohol.

It also sorbs some products of the body’s metabolism, including an excess of bilirubin, urea, cholesterol, and lipid complexes, as well as metabolites responsible for the development of endogenous toxicosis.

Pharmacokinetics

After oral administration, the active substance is not broken down and is not absorbed in the gastrointestinal tract. It is excreted from the body unchanged.

Indications

Acute and chronic intoxications of various etiologies in children and adults; acute intestinal infections of various etiologies, including foodborne toxic infections, as well as diarrheal syndrome of non-infectious origin, dysbiosis (as part of complex therapy); purulent-septic diseases accompanied by severe intoxication; acute poisonings with potent and poisonous substances, including drugs and alcohol, alkaloids, salts of heavy metals; food and drug allergy; hyperbilirubinemia (viral hepatitis and other jaundices) and hyperazotemia (chronic renal failure); for residents of environmentally unfavorable regions and workers in hazardous industries for preventive purposes.

ICD codes

Dosage Regimen

Administer orally as a suspension.

Prepare the suspension immediately before use by mixing the powder with 50-100 mL of cool, boiled water.

Stir thoroughly until a homogeneous, slightly opalescent suspension is formed.

Determine the individual dose based on the patient’s body weight, age, and severity of intoxication.

For acute poisonings, initiate therapy with a gastric lavage using a 1-2% suspension.

For adults, use 1.0-1.5 g (approximately one heaping teaspoon) of powder three times daily.

For children, calculate the daily dose as 0.1-0.2 g per kg of body weight, divided into 3-4 doses.

Adjust the duration of treatment according to the indication: 3-5 days for acute intoxications and up to 10-15 days for chronic conditions or allergies.

For preventive purposes in hazardous occupational or environmental exposures, use 1.0 g twice daily for prolonged courses.

Maintain an interval of at least 1 hour between the intake of Silicasorb and any other medications or food.

In cases of severe intoxication, the single dose may be doubled under medical supervision.

Adverse Reactions

Rarely allergic reactions, dyspepsia, constipation.

Contraindications

Peptic ulcer of the stomach and duodenum in the acute phase; gastrointestinal bleeding; intestinal atony; individual intolerance to the drug containing Colloidal silicon dioxide.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not contraindicated.

Use in Hepatic Impairment

Use in impaired liver function is permitted.

Use in Renal Impairment

Use in impaired renal function is permitted.

Pediatric Use

Use according to indications is possible.

Special Precautions

With long-term use (more than 14 days), impaired absorption of vitamins and calcium is possible, in connection with which the prophylactic use of multivitamin preparations and preparations containing calcium is recommended.

Drug Interactions

With simultaneous use with other drugs, a decrease in the therapeutic effect of the latter is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.