APPROVED
by the Order of the Ministry
of Healthcare of Ukraine
No. 905 dated 01.12.2014
Registration certificate
No. UA/2616/01/01

PRESCRIBING INFORMATION

ATOXIL

Composition:
active ingredient:
– 1 flask contains 10 g silicon dioxide (highly-dispersive);
– 1 sachet contains 2,0 g silicon dioxide (highly-dispersive).

Formulation. Powder
Main physicochemical properties: light amorphous white powder, without taste or odour.
Pharmacotherapeutic group. Intestinal sorbent. ATX code A07BC.
Pharmacological properties.
Pharmacodynamic properties.
Atoxil is an intestinal sorbent with significant sorption properties, shows disintoxication, anti-microbial and wound healing effect. It absorbs in the digestive tract and removes form the body endogenic and exogenic toxic agents of different origin, including food and bacterial allergens, microbial endotoxins and other toxic agents, toxic products resulting from proteins bio degradation in the intestinal tract.
It promotes transportation from the internal environment of an organism (blood, lymph, interstitium) to the digestive tract due to the concentration and osmotic gradients of various toxic products, including medium molecules, oligopeptides, amines and other substances with subsequent excretion from the body.
Pharmacokinetics.
The drug is practically not absorbed in the intestinal tract.

Clinical profile.
Indications. Acute intestinal diseases associated with diarrheal syndromee (salmonellosis, food toxic infections); in a comprehensive therapy of viral hepatitis A and B.
External use – treatment of septic wounds, trophic ulcers and burns.
Counterindications.
– Increased sensitivity to silicon dioxide;
– ulcerous stomach and duodenal ulcer in the stage of exacerbation;
– ulcers and erosion of the intestine;
– bowel obstruction.
Interaction with other drugs and other types of interactions.
When Atoxil is administered simultaneously with acetylsalicylic acid, the processes of thrombocytes disaggregation were increased. In a comprehensive treatment with nicotinic acid and simvastatin, Atoxil shows synergistic effect – it helps to decrease the level of atherogenic fractions of blood lipids and increase the level of cholesterol of the lipoprotein of high density. Administration of Atoxil in case of intracorporal sorption detoxification combined with standard solutions of antiseptics (furaciline, bifuran, trifuran, chlorhexidine begluconate) improve the efficacy of treatment of purulent-inflammatory diseases.
Special warnings and precautions for use.
Oral administration of dry powder is prohibited.
If Atoxil is used as a part of comprehensive therapy, it should be administered 1 hour before administration of other oral medications because of their possible absorption and thus, decrease of efficacy.
Administration during pregnancy or breastfeeding.
Due to the lack of information regarding use of Atoxil during pregnancy or breastfeeding, administration of the drug is not recommended.
Ability to influence the speed of reactions while driving or working with other mechanisms. Does not effect.
Method of administration and doses.
Atoxil is taken as a suspension for oral administration. The content of 1-2 sachets (2-4 g) should be thoroughly stirred in 50-100 ml (1/4 – 1/2 of glass) of neutral non-carbonated or cooled boiled water until getting a homogeneous suspension.
Open the flask with powder, add neutral non-carbonated or cooled boiled water up to the mark of 250 ml and stir over until getting a homogeneous suspension. Daily dose for adults and children over 7 years old is 12g, if necessary, daily dose may be increased to 24 g; for children from 1 to 7 years old the daily dose is 150- 200 mg per 1 kg of body weight. The daily dose is divided into 3- 4 administrations. Maximal single dose should not exceed a half of the daily dose. Prepared water suspension of the drug is taken orally 1 hour before the meal or administration of medications. In the case of acute intestinal diseases, adults and children over 7 years old should start treatment with a maximal single dose of 7 g, the drug should be administered 2-3 times a day. If the patient can not intake the intestinal sorbent without assistance, Atoxil should be administered into the stomach through the probe.
In the case of acute intestinal diseases, the course of treatment is 3-5 days. In severe cases, the treatment duration can be extended to 10-15 days.
The course of treatment of viral hepatitis depends on the severity of illness and is 7-10 days.
External use. To apply the powder in 3-5 mm layers after cleaning of the wound and cover it with a dry aseptic bandage. The bandage should be changed within 24 hours before wound cleaning.
Children.
The drug should not be prescribed to the children under the age of 1.
Overdosing.
The cases of overdosing were not reported.
Adverse reactions.
The drug is usually well tolerated. In rare cases, constipation may occur.
Shelf life: 3 years

Storage conditions.
Store in the original package out of reach of children at a temperature not exceeding 25 ° C. Keep ready-made suspension in a tightly closed flask at a temperature from 2 to 8 °C not more than 32 hours.

Package.
10,0 g of powder in a flask, 1 flask in a cardboard package.
2,0 g of powder in sachets, 20 sachets in a cardboard package.

Category of availability. Availible without prescription.

Manufacturer.
Orisil-Pharm, LLC

Location of the manufacturer and the address of its facilities.
1B Zavodska street, Kalush, Ivano-Frankivsk region, Ukraine, 77300
Last viewed date 01.12.2014