Lactobacillus acidophilus, Bifidobacterium BB12
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Clinical Pharmacology
PHARMACOTHERAPY GROUP
Eubiotic. ATX Code: A07FA51
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Linex® Forte normalizes intestinal microflora. One capsule of Linex® Forte contains lactic acid bacteria (Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. Lactis (BB-12)), each capsule contains 109 colony forming units of live lyophilized lactic acid bacteria. Live lactic acid bacteria are a normal component of the natural intestinal microflora. The main functions of lactic acid bacteria:
- protective: synthesis of substances with antibacterial activity;
- enzyme-producing: hydrolysis of fiber, proteins, fats, starch, bile acid deconjugation
- synthetic: synthesis of vitamins of group B, C, K, amino acids, organic acids, etc. The lactic acid bacteria LA-5 and BB-12 inhibit the growth of pathogenic bacteria by:
- lowering the pH in the intestine (the result of the ability of LA-5 to synthesize lactic acid and BB-12 to synthesize acetic and succinic acids in addition to lactic acid);
- production of metabolites that have a toxic effect on pathogenic bacteria (formation of H2O2);
- the formation of antimicrobial substances, bacteriocins (LA-5 secretes acidocyan, broad-spectrum bacteriocin, which prevents the growth of bacteria and fungi);
- competition with pathogenic bacteria for nutrients;
- interactions with adhesion receptors, thus preventing the colonization of other potentially pathogenic microorganisms.
Pharmacokinetics
Lactic acid bacteria, such as LA-5 and BB-12, act directly in the gastrointestinal tract; when taken orally, the drug is not subjected to systemic absorption. Standard pharmacokinetic studies are therefore not applicable. The resistance of LA-5 and BB- 12 to the effects of gastric juice and bile allows the strains to survive in large numbers when passing through the stomach and duodenum. Both strains are attached to the intestinal mucosa. Like other microorganisms, they are gradually excreted from the gastrointestinal tract by peristalsis and defecation.
Indications
Treatment and prevention of intestinal dysbiosis. The intestinal dysbiosis is manifested by the following symptoms: diarrhea (diarrhea), dyspepsia (indigestion), constipation, flatulence (bloating), nausea, belching, vomiting, abdominal pain, allergic skin reactions are possible.
Composition
1 capsule contains: Active ingredient: Powder Probiotech AB Blend 64 (Probio-tec® AB Blend 64) - 60,000 mg (powder contains active ingredients: Lactobacillus acidophilus (LA-5) - 13.8 mg and Bifidobacterium animalis subsp. Lactis (BB-12) - 4.2 mg; auxiliary components: anhydrous dextrose - 29.1 mg, microcrystalline cellulose - 6 mg, potato starch 6 - mg, magnesium stearate - 0.9 mg). Excipients: Beneo Synergy 1 (Beneo® Synergy 1) - 171,500 mg (powder contains 90-94% inulin and 6-10% oligofructose (dextrose + fructose + sucrose)); magnesium stearate - 3,500 mg. The composition of the capsule body: hypromellose - 33.149 mg, titanium dioxide (E 171) - 0.691 mg. The composition of the capsule cap: hypromellose - 22.080 mg, titanium dioxide dye (E 171) - 0.240 mg, iron yellow dye (E 172) - 0.240 mg.
Lactobacillus acidophilus, Bifidobacterium BB12 is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Linex | Sandoz | Switzerland | capsules |
Normobact L | Medana Pharma | Poland | powder |
Normobact Junior | Medana Pharma | Poland | pills |
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Dosage and Administration
Linex® Forte capsules are preferably taken during or after meals with a small amount of liquid. Adults and teenagers over 12 years old: 1 capsule 1-3 times a day. Children from 2 to 12 years: 1 capsule 1-2 times a day. Newborns and children up to 2 years: 1 capsule 1 time per day. Diarrhea in children under 6 years old must be treated under the supervision of a physician. When prescribing Linex® Forte for children and patients who cannot swallow the whole capsule, it is necessary to open it, pour the contents into a spoon and mix it with a small amount of liquid. The duration of treatment depends on the cause of the development of dysbiosis and the individual characteristics of the organism. The drug Lineks® Forte can be taken until the symptoms of dysbacteriosis disappear. Do not exceed the recommended daily dosage.
Adverse reactions
The drug is well tolerated. No adverse effects have been reported, but hypersensitivity reactions may occur.
- hypersensitivity to the drug;
- hereditary intolerance to fructose, deficiency of sucrase, isomaltase, or glucose-galactose malabsorption.
Contraindications
With caution in diabetes mellitus (composed of simple sugars), a lack of immune system (for example, HIV infection). Diarrhea in children under 6 years old must be treated under the supervision of a physician.
Drug interactions
Undesirable interactions with other drugs are not marked. With the simultaneous use of antibiotics, the recommended interval between taking the drug (antibiotic) and Linex® Forte capsules is 3 hours.
Pregnancy and Lactation
Due to the lack of data on the use in pregnant women, it is not recommended to use Linex® Forte capsules during pregnancy and breastfeeding without first consulting a doctor. In appointing the drug for the treatment of acute diarrhea during pregnancy and breastfeeding, it is necessary to monitor the doctor.
Special instructions
Do not drink Linex® Forte with hot drinks and take it along with alcohol. You must consult with your doctor before taking the drug if you have:
- body temperature above 38 ° C;
- traces of blood or mucus in the stool;
- diarrhea lasts more than two days and is accompanied by acute abdominal pain, dehydration and weight loss;
- chronic diseases - diabetes, HIV infection.
When treating diarrhea, it is necessary to replace lost fluid and electrolytes.
INFLUENCE ON THE ABILITY TO DRIVE MOTOR TRANSPORT AND MANAGEMENT OF MECHANISMS
The drug does not affect the driving of vehicles and control mechanisms.
Overdosage
There is no evidence of overdose symptoms.
- Brand name: Linex
- Active ingredient: Lactobacillus acidophilus, Bifidobacterium BB12
- Dosage form: Capsules
- Manufacturer: Sandoz
- Country of Origin: Switzerland
Studies and clinical trials of Lactobacillus acidophilus, Bifidobacterium BB12 (Click to expand)
- Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001 modulate gene expression of subset specific transcription factors and cytokines in peripheral blood mononuclear cells of obese and overweight people
- Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 Induce Different Age-Related Metabolic Profiles Revealed by 1H-NMR Spectroscopy in Urine and Feces of Mice
- Salivary mutans streptococci and lactobacilli modulations in young children on consumption of probiotic ice-cream containing Bifidobacterium lactis Bb12 and Lactobacillus acidophilus La5
- Prato cheese as suitable carrier for Lactobacillus acidophilus La5 and Bifidobacterium Bb12
- Exopolysaccharides production by Lactobacillus acidophilus LA5 and Bifidobacterium animalis subsp. lactis BB12: Optimization of fermentation variables and characterization of structure and bioactivities