Sorbodez^® (Suspension) Instructions for Use

Marketing Authorization Holder

PharmVILAR NPO, LLC (Russia)

ATC Code

A07B (Intestinal adsorbents)

Active Substance

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

Dosage Form

Sorbodez®

Oral suspension 70 mg/1 ml: 25 ml, 100 ml, 150 ml, 200 ml or 250 ml

Dosage Form, Packaging, and Composition

Oral suspension white in color; sedimentation of suspension particles during storage is allowed.

Excipients: potassium sorbate – 0.15 g, purified water – up to 100 ml.

25 ml – sachets (from 2 to 40 pcs.) – cardboard packs.
100 ml – bottles (1) (with a measuring cup or measuring spoon) – cardboard packs.
150 ml – bottles (1) (with a measuring cup or measuring spoon) – cardboard packs.
200 ml – bottles (1) (with a measuring cup or measuring spoon) – cardboard packs.
100 ml – tubes (1) (with a measuring cup or measuring spoon) – cardboard packs.
150 ml – tubes (1) (with a measuring cup or measuring spoon) – cardboard packs.
200 ml – tubes (1) (with a measuring cup or measuring spoon) – cardboard packs.
250 ml – tubes (1) (with a measuring cup or measuring spoon) – cardboard packs.

Clinical-Pharmacological Group

Enterosorbent

Pharmacotherapeutic Group

Antidiarrheals, intestinal anti-inflammatory/antimicrobial drugs; intestinal antimicrobial drugs; intestinal adsorbents

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, and 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.

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 poisoning 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 prevention purposes.

ICD codes

Dosage Regimen

Administer orally. Shake the bottle vigorously before each use to achieve a uniform suspension.

For acute poisonings and intoxications, perform gastric lavage first, using the suspension as a 1-2% aqueous solution.

For adults, the typical single dose is 1.5-2 grams of colloidal silicon dioxide. Take this dose 3 times daily. The maximum daily dose for adults is 12 grams.

For children aged 1 to 3 years, administer 0.5 grams per dose, 3 times daily. The maximum daily dose for this age group is 2 grams.

For children aged 4 to 7 years, administer 1 gram per dose, 3 times daily. The maximum daily dose for this age group is 4 grams.

For children aged 8 to 14 years, administer 1.5 grams per dose, 3 times daily. The maximum daily dose for this age group is 6 grams.

Calculate the exact volume in milliliters based on the suspension concentration of 70 mg/ml. Use only the provided measuring device for accurate dosing.

For acute conditions, the typical treatment duration is 3-5 days. For chronic intoxications and allergic diseases, extend the course to 10-14 days.

Take the suspension 1-2 hours before meals or other medications. Maintain a minimum 1-2 hour interval between taking Sorbodez^® and the administration of any other drugs or food to prevent adsorption and reduced efficacy.

In cases of severe poisoning, the dose may be doubled during the first 2-3 days of therapy, as determined by a physician.

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 is permitted in case of impaired liver function.

Use in Renal Impairment

Use is permitted in case of impaired renal function.

Pediatric Use

Use is possible according to indications.

Special Precautions

With long-term use (more than 14 days), impaired absorption of vitamins and calcium is possible, therefore prophylactic administration 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.