Ultrakarb

INSTRUCTIONS FOR MEDICAL USE OF ULTRACARB (Ultracarb)

Composition:

Active ingredient: activated charcoal;

1 vial contains 50 g of activated charcoal;

Excipients: citric acid monohydrate; acacia (gum arabic); glycerin; purified water.

Pharmaceutical form. Granules for oral suspension.

Main physicochemical properties: black-colored granules, relatively uniform in size.

Pharmacotherapeutic group.

Intestinal adsorbents. Medicinal charcoal.

ATC code A07BA01.

Pharmacological properties.

Pharmacodynamics.

Activated charcoal is a specifically carbonized material of vegetable origin with a large internal surface area capable of adsorbing harmful, undesirable, and pathogenic substances from the gastrointestinal tract. In cases of intoxication, activated charcoal can be used to adsorb active substances from the gastrointestinal tract.

Adsorption of a partially absorbed active ingredient by activated charcoal leads to a concentration gradient between circulating plasma and intestinal contents. Therefore, passively absorbed substances may diffuse in the reverse direction—back into the intestinal lumen. Thus, repeated administration of activated charcoal may also be effective, even after absorption of the active ingredient.

Pharmacokinetics.

Since activated charcoal is not absorbed in the gastrointestinal tract, there is no distribution phase or metabolism.

Activated charcoal is a locally acting medicinal product which, after oral administration, adsorbs active dissolved substances that have entered the gastrointestinal tract. For this reason, the medicinal product should be administered as soon as possible after ingestion of toxic substances or drug overdose.

To prevent desorption of the adsorbed toxic substance, it is important that the administered activated charcoal passes rapidly through the gastrointestinal tract, for example, by co-administration of an osmotic laxative (sodium sulfate).

Clinical characteristics.

Indications.

Acute oral poisoning and overdose of medicinal products.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Active ulcerative or erosive gastrointestinal lesions, gastrointestinal bleeding, intestinal obstruction.

Ultrakarb should not be administered in poisoning with irritant substances (concentrated acids or bases), as this may complicate esophagogastroduodenoscopy.

Special precautions.

In case of acute oral poisoning or overdose of medicinal products, seek immediate medical advice or contact a toxicological center. Ultrakarb suspension should be administered immediately as per received instructions.

Activated charcoal does not adequately adsorb organic and inorganic salts and solutions, such as iron salts, lithium, thallium, cyanide, methanol, ethanol, ethylene glycol, and petroleum-based solvents. For these substances, other methods of toxin elimination should be used (e.g., gastric lavage).

Main toxic substances and their antidotes:

Specific antidotes:

Cyanide – sodium nitrite / 4-dimethylaminophenol
Iron compounds – deferoxamine
Lithium – calcium polystyrene sulfonate
Methanol – ethanol
Ethylene glycol – ethanol

In many types of intoxication, Ultrakarb should be used in combination with a specific antidote (e.g., in paracetamol poisoning: Ultrakarb and acetylcysteine).

If it is essential for the patient to receive oral therapy or a specific oral antidote, the use of activated charcoal should be avoided.

The use of activated charcoal is not recommended in patients taking antiperistaltic drugs or who have ingested a toxic substance with antiperistaltic effects, due to the risk of developing paralytic ileus, which may lead to perforation.

Ultrakarb may blacken stools.

Ultrakarb contains glycerin (excipient), which may cause headache, gastrointestinal irritation, and diarrhea.

Interaction with other medicinal products and other forms of interaction.

Activated charcoal generally reduces the efficacy of orally administered medicinal products. Therefore, when used concomitantly with other drugs, Ultrakarb should be taken 1–1.5 hours before or after the administration of other medicinal products.

Concomitant administration of furosemide and activated charcoal leads to a significant reduction in furosemide efficacy.

Activated charcoal may also reduce the effectiveness of ovulation inhibitors.

Special instructions for use.

Due to the adsorptive properties of the medicinal product, activated charcoal should be taken 1–1.5 hours before or after other medicinal products or food during concomitant pharmacotherapy.

Prolonged use (more than 15 days) may be associated with impaired absorption and may lead to deficiency of vitamins, hormones, fats, and proteins in the body, requiring appropriate pharmacological or dietary correction.

In cases of hypovitaminosis, which may occur with prolonged use of activated charcoal, polyvitamins should be prescribed.

Use during pregnancy or breastfeeding.

Women of reproductive age / contraception

Activated charcoal may interact with oral contraceptives. Therefore, during treatment, an alternative effective and safe method of contraception should be selected.

Pregnancy

There are no data on the negative impact of activated charcoal, when used according to indications, on the health of pregnant women or on the fetus. Therefore, Ultrakarb may be used during pregnancy as indicated.

Breastfeeding

Activated charcoal is not absorbed from the gastrointestinal tract, is not metabolized, and is excreted unchanged. There are no data indicating that the use of activated charcoal during breastfeeding poses a risk to the infant's health. Therefore, Ultrakarb may be used during breastfeeding as indicated.

Ability to affect reaction speed when driving or operating machinery.

Ultrakarb does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Dosage and duration of treatment are determined by the physician depending on the patient's condition and disease course.

Adults and children from 12 years of age

Administer 50–100 g of activated charcoal (1–2 bottles of Ultrakarb) as soon as possible. In severe poisoning, administer 20 g of the medicinal product every 4–6 hours for several days (20 g of activated charcoal corresponds to approximately 160 ml of suspension).

Children under 12 years of age

Prior to administration of Ultrakarb to children under 4 years of age, a physician’s consultation is mandatory.

Recommended dosage: approximately 1 g of activated charcoal per 1 kg of body weight.

In acute poisoning in children under 12 years of age, half the adult dose should be administered (1/2 bottle of Ultrakarb); for children under 4 years of age, 1/4 of the bottle content should be administered, with the frequency of administration agreed with the physician.

If the patient is unconscious, the physician or nurse under physician supervision should administer the suspension via a gastric tube to prevent aspiration.

Ultrakarb can also be used after vomiting or gastric lavage.

To prevent poisoning due to absorption into the body and to eliminate toxins already absorbed, Ultrakarb should be administered as soon as possible. However, in some cases, slow administration may still be effective.

In cases of severe poisoning, repeated administration of activated charcoal is recommended.

Preparation of the suspension

Shake the granulate. Add water up to the red mark on the bottle. Shake vigorously for 1 minute. This results in approximately 400 ml of suspension. Open the bottle carefully and use the suspension immediately.

If repeated administration is required, the suspension should be shaken before use. From a microbiological standpoint, the ready-to-use oral suspension should be used immediately after preparation.

If symptoms persist and the patient’s condition does not improve, additional medical consultation is required.

The bottle has a special cap that can be used as an adapter for quick and direct attachment of a gastric tube. Before inserting the tube, the cap should be carefully unscrewed to release pressure from the bottle, then screwed back on and the top part of the nozzle cut off.

Children.

Activated charcoal is not absorbed in the gastrointestinal tract, is not metabolized, and is excreted unchanged when administered orally. The specific dosage form of Ultrakarb (suspension) allows its use from birth; however, use in children under 4 years of age is possible only after consultation with a physician, who will determine the dose and duration of treatment based on the patient’s condition and disease characteristics.

Recommended dosage: approximately 1 g of activated charcoal per 1 kg of body weight.

In acute poisoning in children under 12 years of age, half the adult dose should be administered (1/2 bottle of Ultrakarb); for children under 4 years of age, 1/4 of the bottle content should be administered, with the frequency of administration agreed with the physician.

Overdose.

Administration of high doses of medical charcoal may cause small intestinal obstruction. This can be avoided by administering laxatives (e.g., sodium sulfate).

Significant exceeding of maximum single doses may cause adverse reactions: nausea, vomiting, constipation.

Adverse reactions.

Most adverse reactions associated with the use of activated charcoal are related to the gastrointestinal system. Most adverse reactions may also be causally linked to the underlying disease.

Frequency of adverse reactions is unknown (cannot be determined from available data).

Most commonly observed adverse reactions: vomiting, constipation, stomach discomfort, diarrhea, nausea, sudden defecation, anal irritation, and hypersensitivity reactions.

There have been isolated reports (associated with high-dose activated charcoal intake) of: (pseudo)intestinal obstruction requiring surgical intervention; formation of charcoal fecal concretions in the sigmoid colon.

Gastrointestinal disorders (diarrhea, constipation) accompanying prolonged use of activated charcoal are easily resolved by discontinuing the drug and symptomatic therapy. Prolonged use of Ultrakarb (more than 15 days) may be associated with impaired absorption and may lead to deficiency of vitamins, hormones, fats, and proteins in the body, requiring appropriate pharmacological or dietary correction.

Shelf life.

5 years.

Storage conditions.

Store in the original packaging in a dry place, protected from moisture.

Packaging.

Plastic bottle closed with a screw cap. One bottle per cardboard box labeled in Ukrainian.

Category of dispensing.

Over-the-counter.

Manufacturer.

Norit Nederland B.V. / Norit Nederland B.V.

Manufacturer’s address.

Mr. Ovingkanaal OZ 3, Klazienaveen, 7891 EV, Netherlands

Marketing authorization holder.

"Business Center Farmatsiya" Limited Liability Company

Address of the marketing authorization holder.

18 Sholudenka Street, Vyshhorod, Vyshhorod District, Kyiv Oblast, 07300, Ukraine