Lactofiltrum® (Tablets, Powder) Instructions for Use
ATC Code
A07BC30 (Intestinal adsorbents in combination with other drugs)
Clinical-Pharmacological Group
Enterosorbent regulating the balance of intestinal microflora
Pharmacotherapeutic Group
Antidiarrheals, intestinal anti-inflammatory/antimicrobial agents; intestinal adsorbents; other intestinal adsorbents
Pharmacological Action
The pharmacological action is due to the properties of the active components included in the composition – lignin and lactulose.
Hydrolyzed lignin is a natural origin enterosorbent consisting of wood component hydrolysis products, possesses high sorptive activity and a nonspecific detoxifying action. It binds in the intestine and removes from the body pathogenic bacteria and bacterial toxins, medicinal products, salts of heavy metals, ethanol, allergens, as well as an excess of certain metabolic products, including bilirubin, cholesterol, histamine, serotonin, urea, other metabolites responsible for the development of endogenous toxemia.
Lactulose is a synthetic disaccharide, the molecule of which consists of galactose and fructose residues. In the large intestine, lactulose is fermented by the normal intestinal microflora as a substrate, stimulating the growth of bifido- and lactobacilli. As a result of lactulose hydrolysis in the large intestine, organic acids are formed – lactic, acetic, and formic, which suppress the growth of pathogenic microorganisms and thereby reduce the production of nitrogen-containing toxic substances. This process leads to an increase in osmotic pressure in the lumen of the large intestine and stimulation of peristalsis.
The complex action of the drug is aimed at normalizing the microbiocenosis of the large intestine and reducing the intensity of endogenous toxic conditions.
Pharmacokinetics
Hydrolyzed lignin is not absorbed and is completely excreted from the intestine within 24 hours.
Lactulose is not absorbed and is not hydrolyzed in the stomach and upper intestine. Hydrolysis of lactulose occurs in the large intestine.
Indications
Disorders of the intestinal microflora, including those resulting from antibiotic therapy; as part of the complex therapy of irritable bowel syndrome, hepatitis, liver cirrhosis, allergic diseases (atopic dermatitis, urticaria).
ICD codes
| ICD-10 code | Indication |
| K58 | Irritable bowel syndrome |
| K63.8 | Other specified diseases of intestine |
| K73 | Chronic hepatitis, not elsewhere classified |
| K74 | Fibrosis and cirrhosis of liver |
| L20.8 | Other atopic dermatitis (neurodermatitis, eczema) |
| L50 | Urticaria |
| Y40 | Systemically acting antibiotics |
| ICD-11 code | Indication |
| 9A06.70 | Atopic eczema of the eyelids |
| DA92.1 | Pneumatosis intestinalis of the small intestine |
| DA98.Z | Polyps of small intestine, unspecified |
| DB31.1 | Pneumatosis of the colon |
| DB36.Z | Certain infections of the colon, unspecified |
| DB93 | Fibrosis or cirrhosis of liver |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| DD91.0Z | Irritable bowel syndrome, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| EA80.0 | Infantile atopic eczema |
| EA80.1 | Childhood atopic eczema |
| EA80.2 | Adult atopic eczema |
| EA80.Z | Atopic eczema, unspecified |
| EA85.20 | Atopic hand eczema |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally, with water, one hour before meals and other medications to prevent adsorption and ensure efficacy.
For adults and children over 12 years, the dose is two to three tablets or the contents of two to three powder sachets, taken three to four times daily.
For children 8 to 12 years, the dose is one to two tablets or the contents of one to two powder sachets, taken three to four times daily.
For children 3 to 7 years, the dose is one tablet or the contents of one powder sachet, taken three to four times daily.
For children 1 to 3 years, the dose is half a tablet or the contents of half a powder sachet, taken three to four times daily; crush the tablet or mix powder with a small amount of water.
The average treatment duration is 2 to 3 weeks; the course may be repeated on physician’s recommendation after a two-week interval.
Adjust the duration and frequency based on the underlying condition and clinical response.
Adverse Reactions
From the digestive system rarely – flatulence, diarrhea.
Other allergic reactions.
Contraindications
Hypersensitivity to the components of the drug, intestinal obstruction; gastrointestinal bleeding; galactosemia.
With caution exacerbation of gastric and duodenal ulcers, intestinal atony.
Use in Pregnancy and Lactation
Data on the safety of use during pregnancy and lactation are not available.
Special Precautions
Can be used in complex therapy together with other medicinal products, subject to the rule of separate administration.
Drug Interactions
A decrease in the therapeutic effect of some concomitantly administered oral drugs is possible.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder for oral suspension 60 mg+177.5 mg: pouch 325 mg 10, 20, 30 or 50 pcs.
Powder for oral suspension with cocoa flavor 60 mg+177.5 mg: pouch 325 mg 10, 20, 30 or 50 pcs.
Powder for oral suspension 120 mg+355 mg: pouch 650 mg 10, 20, 30 or 50 pcs.
Powder for oral suspension with cocoa flavor 120 mg+355 mg: sachet 650 mg 10, 20, 30, or 50 pcs.
Powder for oral suspension 240 mg+710 mg: sachet 1300 mg 10, 20, 30, or 50 pcs.
Powder for oral suspension with cocoa flavor 240 mg+710 mg: sachet 1300 mg 10, 20, 30, or 50 pcs.
Powder for oral suspension 360 mg+1065 mg: sachet 1950 mg 10, 20, 30, or 50 pcs.
Powder for oral suspension with cocoa flavor 360 mg+1065 mg: sachet 1950 mg 10, 20, 30, or 50 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Forms
 |
Lactofiltrum® | Powder for oral suspension 60 mg+177.5 mg: pouch 325 mg 10, 20, 30 or 50 pcs. |
| Powder for oral suspension with cocoa flavor 60 mg+177.5 mg: pouch 325 mg 10, 20, 30 or 50 pcs. | ||
| Powder for oral suspension 120 mg+355 mg: pouch 650 mg 10, 20, 30 or 50 pcs. | ||
| Powder for oral suspension with cocoa flavor 120 mg+355 mg: sachet 650 mg 10, 20, 30, or 50 pcs. | ||
| Powder for oral suspension 240 mg+710 mg: sachet 1300 mg 10, 20, 30, or 50 pcs. | ||
| Powder for oral suspension with cocoa flavor 240 mg+710 mg: sachet 1300 mg 10, 20, 30, or 50 pcs. | ||
| Powder for oral suspension 360 mg+1065 mg: sachet 1950 mg 10, 20, 30, or 50 pcs. | ||
| Powder for oral suspension with cocoa flavor 360 mg+1065 mg: sachet 1950 mg 10, 20, 30, or 50 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral suspension from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 60 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 177.5 mg |
Excipients: potato starch – 35.75 mg, polysorbate 80 – 6.555 mg, talc – 5.44 mg, colloidal silicon dioxide – 3.275 mg, sucralose – 0.05 mg, mannitol up to a mass of 325 mg.
325 mg – single-use sachets (10) – cardboard packs (1).
325 mg – single-use sachets (20) – cardboard packs (1).
325 mg – single-use sachets (30) – cardboard packs (1).
325 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension with cocoa flavor, from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 60 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 177.5 mg |
Excipients: potato starch – 35.75 mg, cocoa flavor – 9.75 mg, polysorbate 80 – 6.555 mg, talc – 5.44 mg, colloidal silicon dioxide – 3.275 mg, sucralose – 0.05 mg, mannitol up to a mass of 325 mg.
325 mg – single-use sachets (10) – cardboard packs (1).
325 mg – single-use sachets (20) – cardboard packs (1).
325 mg – single-use sachets (30) – cardboard packs (1).
325 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 120 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 355 mg |
Excipients: potato starch – 71.5 mg, polysorbate 80 – 13.11 mg, talc – 10.88 mg, colloidal silicon dioxide – 6.55 mg, sucralose – 0.1 mg, mannitol up to a mass of 650 mg.
650 mg – single-use sachets (10) – cardboard packs (1).
650 mg – single-use sachets (20) – cardboard packs (1).
650 mg – single-use sachets (30) – cardboard packs (1).
650 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension with cocoa flavor, from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 120 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 355 mg |
Excipients: potato starch – 71.5 mg, cocoa flavor – 19.5 mg, polysorbate 80 – 13.11 mg, talc – 10.88 mg, colloidal silicon dioxide – 6.55 mg, sucralose – 0.1 mg, mannitol up to a mass of 650 mg.
650 mg – single-use sachets (10) – cardboard packs (1).
650 mg – single-use sachets (20) – cardboard packs (1).
650 mg – single-use sachets (30) – cardboard packs (1).
650 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 240 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 710 mg |
Excipients: potato starch – 143 mg, polysorbate 80 – 26.22 mg, talc – 21.76 mg, colloidal silicon dioxide – 13.1 mg, sucralose 0.2 mg, mannitol up to a mass of 1300 mg.
1300 mg – single-use sachets (10) – cardboard packs (1).
1300 mg – single-use sachets (20) – cardboard packs (1).
1300 mg – single-use sachets (30) – cardboard packs (1).
1300 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension with cocoa flavor, from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 240 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 710 mg |
Excipients: potato starch – 143 mg, cocoa flavor – 39 mg, polysorbate 80 – 26.22 mg, talc – 21.76 mg, colloidal silicon dioxide – 13.1 mg, sucralose 0.2 mg, mannitol up to a mass of 1300 mg.
1300 mg – single-use sachets (10) – cardboard packs (1).
1300 mg – single-use sachets (20) – cardboard packs (1).
1300 mg – single-use sachets (30) – cardboard packs (1).
1300 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 360 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 1065 mg |
Excipients: potato starch – 214.5 mg, polysorbate 80 – 39.33 mg, talc – 32.64 mg, colloidal silicon dioxide – 19.65 mg, sucralose – 0.3 mg, mannitol up to a mass of 1950 mg.
1950 mg – single-use sachets (10) – cardboard packs (1).
1950 mg – single-use sachets (20) – cardboard packs (1).
1950 mg – single-use sachets (30) – cardboard packs (1).
1950 mg – single-use sachets (50) – cardboard packs (1).
Powder for the preparation of oral suspension with cocoa flavor, from light brown to dark brown in color with inclusions from white to brown. The prepared suspension is from light brown to dark brown in color.
| 1 sachet | |
| Lactulose (calculated as 100% substance) | 360 mg |
| Hydrolyzed lignin (calculated as 100% substance) | 1065 mg |
Excipients: potato starch – 214.5 mg, cocoa flavor – 58.5 mg, polysorbate 80 – 39.33 mg, talc – 32.64 mg, colloidal silicon dioxide – 19.65 mg, sucralose – 0.3 mg, mannitol up to a mass of 1950 mg.
1950 mg – single-use sachets (10) – cardboard packs (1).
1950 mg – single-use sachets (20) – cardboard packs (1).
1950 mg – single-use sachets (30) – cardboard packs (1).
1950 mg – single-use sachets (50) – cardboard packs (1).
Tablets: 10, 20, 30, or 60 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Form
|
Lactofiltrum® | Tablets: 10, 20, 30, or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets dark brown in color with white-gray inclusions, capsule-shaped, biconvex, with a score line.
| 1 tab. | |
| Hydrolyzed lignin | 355 mg |
| Lactulose | 120 mg |
Excipients: croscarmellose sodium – 20 mg, magnesium stearate – 5 mg, microcrystalline cellulose – to obtain a tablet weighing 550 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
60 pcs. – polymer bottles (1) – cardboard packs.
![Lactofiltrum® [Tablets, Powder] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Lactofiltrum® [Tablets, Powder] 2")