Sorbex (Capsules) Instructions for Use

Marketing Authorization Holder

VALARTIN PHARMA, LLC (Ukraine)

ATC Code

A07BA01 (Activated charcoal)

Active Substance

Activated charcoal (BP British Pharmacopoeia)

Dosage Form

Sorbex

Capsules 250 mg: 20 or 200 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, black body, black cap with white “SORBEX” marking; capsule contents – a free-flowing, coarse, shiny black powder.

Capsule body composition iron oxide black (E172) – 1.33%, brilliant black (E151) – 0.71%, gelatin – up to 100%.
Capsule cap composition iron oxide black (E172) – 1.33%, brilliant black (E151) – 0.71%, gelatin – up to 100%.
Composition of ink for capsule marking shellac (E904), titanium dioxide (E171).

10 pcs. – blisters (1) – cardboard package.
10 pcs. – blisters (2) – cardboard package.
10 pcs. – blisters (3) – cardboard package.

Clinical-Pharmacological Group

Enterosorbent

Pharmacotherapeutic Group

Enterosorbent agent

Pharmacological Action

Adsorbent agent. It has enterosorbing, detoxifying, and antidiarrheal action. It belongs to the group of polyvalent physicochemical antidotes and has high surface activity.

It adsorbs poisons and toxins from the gastrointestinal tract before their absorption, including alkaloids, glycosides, barbiturates and other hypnotic and narcotic agents, heavy metal salts, toxins of bacterial, plant, and animal origin, phenol derivatives, hydrocyanic acid, sulfonamides, and gases.

It also adsorbs excess of certain metabolic products – bilirubin, urea, cholesterol, endogenous metabolites responsible for the development of endogenous toxicosis.

It weakly adsorbs acids and alkalis (including iron salts, cyanides, methanol, ethylene glycol). It does not irritate the gastrointestinal mucosa.

Pharmacokinetics

Not absorbed, not broken down, completely excreted through the gastrointestinal tract within 24 hours.

Indications

Exogenous and endogenous intoxications of various origins (as a detoxifying agent). Foodborne toxic infections, dysentery, salmonellosis (as part of complex treatment).

Poisoning by medicinal products (psychotropic, hypnotic, narcotic agents, etc.), alkaloids, heavy metal salts, and other poisons. Gastrointestinal diseases accompanied by dyspepsia and flatulence.

Food and drug allergy. Hyperbilirubinemia, hyperazotemia. To reduce gas formation in the intestine before ultrasound and X-ray examinations. For the prevention of chronic intoxications in hazardous industries.

ICD codes

Dosage Regimen

Administer orally. Determine the dosage individually based on the indication, clinical presentation, and patient age.

For adults, use a standard dose of 250-750 mg (1-3 capsules) three to four times daily. For acute conditions like foodborne toxic infections or poisoning, initiate therapy with a higher dose of up to 2-4 grams.

For children aged 3 to 7 years, prescribe 250 mg (1 capsule) three times daily. For children aged 7 to 14 years, prescribe 250-500 mg (1-2 capsules) three times daily.

In cases of acute poisoning, perform gastric lavage first using a 10-20% aqueous suspension of activated charcoal. After lavage, administer 20-30 grams (80-120 capsules) of charcoal as an aqueous suspension into the stomach.

For the prevention of chronic intoxications, take 1-2 grams (4-8 capsules) twice daily. To reduce gas before ultrasound or X-ray examinations, take 2-4 grams (8-16 capsules) on the eve of the procedure.

The typical treatment duration is 3 to 5 days. For acute poisoning, extend therapy to 5-7 days or longer if the toxic substance undergoes enterohepatic circulation.

Maintain a 2-hour interval between taking Sorbex and other medicines or food to prevent impaired absorption of nutrients and pharmaceuticals.

Adverse Reactions

Possible dyspepsia, constipation, diarrhea, dark staining of feces; with long-term use – hypovitaminosis, impaired absorption of nutrients from the gastrointestinal tract.

Contraindications

Hypersensitivity to activated charcoal, ulcerative lesions of the gastrointestinal tract (including gastric and duodenal ulcer, ulcerative colitis), gastrointestinal bleeding, simultaneous administration of antitoxic medicinal products whose effect develops after absorption (including methionine), intestinal atony; children under 3 years of age.

With caution

Patients with diabetes mellitus and persons on a low-carbohydrate diet.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible as prescribed by a doctor.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Special Precautions

When treating intoxications, it is necessary to create an excess of activated charcoal in the stomach (before its lavage) and in the intestine (after gastric lavage).

A decrease in the concentration of activated charcoal in the medium promotes desorption of the bound substance and its absorption (to prevent resorption of the released substance, repeated gastric lavage and administration of activated charcoal are recommended).

The presence of food masses in the gastrointestinal tract requires the administration of charcoal in high doses, as the gastrointestinal contents are sorbed by charcoal and its activity decreases.

If poisoning is caused by substances involved in enterohepatic circulation (cardiac glycosides, indomethacin, morphine and other opiates), activated charcoal must be used for several days.

Drug Interactions

Activated charcoal has adsorbing properties and, when taken simultaneously with other medicinal products, can significantly reduce their absorption from the gastrointestinal tract, which leads to a decrease in the effectiveness of other medicinal products.

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.