ATOKSIL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ATOXIL (ATOXIL)

Composition:

Active substance:

1 vial contains 10.0 g of silicon dioxide (highly dispersed);

1 sachet contains 2.0 g of silicon dioxide (highly dispersed).

Pharmaceutical form. Powder.

Main physicochemical properties: light amorphous white powder, tasteless and odorless.

Pharmacotherapeutic group. Enterosorbents. ATC code A07BC.

Pharmacological Properties.

Pharmacodynamics.

Atoksil is an enterosorbent with pronounced sorption properties, exhibiting detoxifying, antimicrobial, and wound-healing effects. It adsorbs and removes from the body endogenous and exogenous toxic substances of various origins, including food and bacterial allergens, microbial endotoxins, and other poisons, as well as toxic by-products formed during protein putrefaction in the intestine.

It promotes the transport of various toxic substances—including medium-sized molecules, oligopeptides, amines, and other compounds—from the internal environment of the body (blood, lymph, interstitium) into the gastrointestinal tract, driven by concentration and osmotic gradients, followed by their subsequent elimination from the body.

Pharmacokinetics.

The drug is practically not absorbed from the intestine.

Clinical characteristics.

Indications.

Acute intestinal diseases accompanied by diarrheal syndrome (salmonellosis, foodborne toxicoinfections); in complex therapy of viral hepatitis A and B.

Externally – treatment of purulent wounds, trophic ulcers, and burns.

Contraindications.

− Hypersensitivity to silicon dioxide;

− peptic ulcer of the stomach and duodenum in the stage of exacerbation;

− intestinal ulcers and erosions;

− intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

When Atoksil was used simultaneously with acetylsalicylic acid, platelet disaggregation processes were enhanced.

In combined therapy with nicotinic acid and simvastatin, Atoksil exhibits a synergistic effect – promotes reduction of atherogenic lipid fractions in blood and increases high-density lipoprotein cholesterol levels.

Use of Atoksil in intracorporeal sorption detoxification in combination with standard antiseptic solutions (furacilin, bifuran, trifuran, chlorhexidine bigluconate) increases the efficacy of treatment of purulent-inflammatory diseases.

Special precautions for use.

Oral intake of the dry powder is prohibited.

Atoksil should be taken 1 hour before other oral medicinal products when used as part of combination therapy, due to the possibility of adsorption of these agents and, consequently, reduction of their efficacy.

Use during pregnancy or breastfeeding.

Due to lack of data on the use of Atoksil during pregnancy or breastfeeding, the use of the drug is not recommended.

Ability to influence reaction rate while driving or operating machinery.

Has no effect.

Method of administration and dosage.

Atoksil should be taken as an oral suspension. The contents of 1–2 sachets (2–4 g) should be thoroughly mixed in 50–100 mL (¼–½ cup) of neutral non-carbonated or cooled boiled water until a homogeneous suspension is formed.

To open the bottle with powder, add neutral non-carbonated or cooled boiled water up to the 250 mL mark and mix until a homogeneous suspension is obtained.

The daily dose for adults and children aged 7 years and older is 12 g; if necessary, the daily dose may be increased up to 24 g. For children aged 1 to 7 years, the daily dose is 150–200 mg per 1 kg of body weight. The daily dose should be divided into 3–4 doses. The maximum single dose should not exceed half of the daily dose.

The prepared aqueous suspension should be taken orally 1 hour before meals or taking other medications.

In acute intestinal diseases, treatment in adults and children aged 7 years and older should begin with the maximum single dose of 7 g, administered 2–3 times daily. If the patient cannot take the enterosorbent independently, the Atoksil suspension should be administered into the stomach through a tube.

In acute intestinal disorders, the treatment course lasts 3–5 days. In severe cases, the treatment duration may be extended up to 10–15 days.

The treatment course for viral hepatitis depends on the severity of the disease and lasts 7–10 days.

External use. After wound cleaning, apply the powder in a layer of 3–5 mm and cover with a dry sterile dressing. Dressings should be changed daily until wound healing.

Children. The drug is contraindicated in children under 1 year of age.

Overdose.

No cases of overdose have been reported.

Adverse reactions.

The medicinal product is generally well tolerated. In isolated cases, constipation may occur.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

The prepared suspension should be stored in a tightly closed vial, at a temperature between 2 °C and 8 °C, for no more than 32 hours.

Packaging.

10.0 g of powder in a vial, 1 vial per cardboard box.

2.0 g of powder in a sachet, 20 sachets per cardboard box.

Availability. Over-the-counter.

Manufacturer.

LLC "Orisil-Farm".

Manufacturer's address and place of business.

Ukraine, 77300, Ivano-Frankivsk region, Kalush, Zavodska St., 1B.