Prostosorb (Powder) Instructions for Use

Marketing Authorization Holder

Charoit Pharma, LLC (Russia)

Manufactured By

Flora Kavkaza, JSC (Russia)

ATC Code

A07BC (Intestinal adsorbents, other)

Active Substance

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

Dosage Form

Prostosorb

Powder for suspension for oral administration: sachets or jars

Dosage Form, Packaging, and Composition

Powder for the preparation of a suspension for oral administration is light, white or white with a bluish tint, odorless; when shaken with water, it forms a suspension.

Sachets – cardboard packs.
Sachets (2) – cardboard packs.
Sachets (3) – cardboard packs.
Sachets (4) – cardboard packs.
Sachets (5) – cardboard packs.
Sachets (10) – cardboard packs.
Sachets (30) – cardboard packs.
Sachets (50) – cardboard packs.
Sachets (100) – cardboard packs.
Jars – 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 sorptive and detoxifying properties.

In the lumen of the gastrointestinal tract, 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 as a suspension in water.

Prepare the suspension immediately before use by thoroughly mixing the powder in 50-100 mL of water to form a uniform suspension.

Determine the daily dose individually based on the patient’s body weight: administer 0.1-0.2 g per kg of body weight per day, divided into 3-4 doses.

For acute poisonings, initiate therapy with gastric lavage using a 1-2% suspension; subsequently, administer the standard daily dose.

For adults, the average single dose is 3 grams; the average daily dose is 9 grams.

For children aged 1 to 3 years, the average single dose is 0.5-1 gram; the daily dose is 1.5-3 grams.

For children aged 4 to 7 years, the average single dose is 1-1.5 grams; the daily dose is 3-4.5 grams.

For children aged 7 years and older, the average single dose is 1.5-2 grams; the daily dose is 4.5-6 grams.

In cases of severe intoxication, the daily dose may be increased by 50-100% during the first 2-3 days of therapy.

The average duration of treatment is 3-5 days; for chronic intoxications and allergic conditions, extend treatment to 10-15 days.

Repeat the course of treatment as directed by a physician, with a minimum interval of 2 weeks between courses.

Maintain an interval of 1-1.5 hours between the intake of Prostosorb and food or other medications.

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 is possible according to indications.

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 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.