Polisorb is a non-organic, non-selective polyfunctional enterosorbent based on superfine silicon dioxide with particles sizes up to 0.09 mm and an absorptive capacity in case of oral administration of 300 m2/g.
Polisorb containing colloidal silicon dioxide has a high adsorptive capacity and therefore detoxification properties. In the gastrointestinal tract lumen, the product binds and excretes endogenic and exogenic substances of various origin causing diarrhoea and other gastrointestinal disorders, including pathogenic bacteria and bacterial toxins (Markelov et al. 20081). Accordingly, the performance of Polisorb has been demonstrated for the treatment of diarrhoea.
Diarrhea is a common symptom that can range in severity from an acute, self- limited annoyance to a severe, life-threatening illness. Diarrhoea is defined as increased volume, fluidity, or frequency of faecal discharges compared with the patient’s normal stools. Clinical features vary greatly depending on the cause, duration, and severity of the diarrhoea, on the area of bowel affected, and on the patient’s general health.
Polisorb powder can be used for the treatment of diarrhoea in adults as well as in children. Dosages for children should be calculated on the basis of the child’s age (Table 1). No safety concerns arise and no dose adjustment is necessary in elderly patients, renal impaired patients and hepatic impaired patients, respectively. The product can be used by pregnant women as well as breastfeeding mothers.
The daily dose should be divided into 3 portions. Maximum daily dose for adults: 330 mg/kg of body weight. One heaped teaspoonful contains 1 g of the product; one heaped tablespoonful contains 2.5-3 g of the product.
Table1 Polisorb dosage calculation
Children from 1 to 2 years old
1 gram per intake (which roughly corresponds to 1 teaspoon)
30-50 ml of water
Children from 2 to 7 years old
1,5 grams per intake (which roughly corresponds to 1 and a half teaspoon)
50-70 ml of water
Children from 7 to 14 years old
2 grams per intake (which roughly corresponds to 2 teaspoon)
70-100 ml of water
Adults and childre over 14 years old
3 – 6 grams per intake (which roughly corresponds to 1-2 tablespoon)
100-150 ml of water
Duration of use depends on aetiology and severity of a disease. For the treatment of acute diarrhoea it is recommended to begin the therapy with Polisorb within the first 24 hours after the beginning of diarrhoea. Regularly, Polysorb MP treatment is used in combination with other methods of treatment, in particular together with oral rehydration solutions (ORS). Treatment duration of 3 to 5 days is expected. Depending on the persistence of diarrhoea, treatment duration can be extended.
Due to the adsorbent capacity of colloidal silicon dioxide, concurrent administration of other medications together with Polisorb may result in a reduced absorption resulting in a reduced therapeutic efficacy. In case of longer administration of Polisorb , e.g. longer than 14 days, vitamin and calcium malabsorption may occur and it is recommended to ensure adequate multivitamin and calcium intake, e.g. in form of multivitamin preparations and calcium products. To prevent these situations with a reduced absorption, the Polisorb suspension should be administered orally 1 hour before or after meal or administration of other medicines.
The range of applications
Polisorb has high adsorptive activity and therefore detoxification properties (Markelov et al. 20081). In the gastrointestinal tract lumen, the product binds and excretes endogenic and exogenic substances of various origin, including pathogenic bacteria and bacterial toxins, antigens, food-borne allergens, pharmaceuticals and poisons, salts of heavy metals, radionuclides and alcohol. Polisorb also adsorbs some metabolic products, including excessive bilirubin, cholesterol and lipid complexes, as well as metabolites causing endogenic toxicosis. Clinically, decrease in duration of diarrhoea, stool frequency, abdominal pain, distension, nausea, and vomiting after oral administration of silicon dioxide has been described (Bauer and Hirschbrunn 199216; Uehleke et al. 201214).
It has to be pointed out that Polisorb does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. The performance of Polisorb for the treatment of diarrhoea is achieved only by the well-known physico-chemical properties of colloidal silicon dioxide, it is not absorbed and therefore Polisorb clearly fulfils the standard for Medical Devices.
Altogether, favourable safety and tolerability of Polisorb powder for the treatment of diarrhoea in infants, children as well as in adults in the investigated and recommended doses have been confirmed by the results of the clinical studies. No concern on safety arose from all of the available clinical data of Polisorb.
Polisorb powder is manufactured by Polisorb, Chelyabinsk/Russia. The device was developed to provide a product with strong intestinal adsorbent activity and a favourable safety profile. In the gastrointestinal tract lumen, the product binds and excretes endogenic and exogenic substances of various origin causing diarrhoea and other gastrointestinal disorders, including pathogenic bacteria and bacterial toxins. Accordingly, the performance of Polisorb MP has been demonstrated for the treatment of diarrhoea.
The performance of Polisorb for the treatment of diarrhoea is achieved only by the well-known physico-chemical properties of colloidal silicon dioxide, it is not absorbed and therefore Polisorb MP clearly fulfills the standard for Medical Devices.
Polisorb powder containing silicon dioxide is claimed for the treatment of diarrhoea of different aetiology Polisorb powder can be used for the treatment of diarrhoea in adults as well in children. Dosages for children should be calculated on the basis of the child’s age. Treatment duration of 3 to 5 days is expected. Depending on the persistence of diarrhoea, treatment duration can be extended.
As it is not absorbed form the gastrointestinal tract, it does not cause any systemic side effects. Except rare reports on allergic reactions and patients with obstipation, no further vigilance cases have been documented for this device.
The risks identified in the risk management documentation have been addressed by the clinical data presented in this Clinical Evaluation Report. The clinical evidence demonstrates conformity with relevant Essential Requirements. In conclusion, the use of the Polysorb MP powder in the proposed indication and in the targeted population is considered to be safe when used according to the correct recommendations of use.
In addition, based on the available clinical and post- marketing data, the risk/benefit ratio is considered as favourable.