Lactobacterin (Lyophilisate, Suppositories) Instructions for Use

ATC Code

A07FA01 (Lactic acid-producing microorganisms)

Active Substance

Lactobacillus (Grouping name)

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

Antidiarrheal, intestinal anti-inflammatory/antimicrobial agents; antidiarrheal microorganisms

Pharmacological Action

The therapeutic effect of the drug is due to the antagonistic action of lactobacilli against pathogenic and conditionally pathogenic microorganisms, including staphylococci, enteropathogenic Escherichia coli, Proteus, Shigella, which determines the corrective effect of the drug in cases of bacteriocenosis disorders.

The drug improves metabolic processes, prevents the formation of protracted forms of intestinal diseases, and increases the body’s nonspecific resistance.

Indications

For gastrointestinal diseases

• Convalescents who have had acute intestinal infections, in the presence of intestinal dysfunction or isolation of pathogenic and conditionally pathogenic bacteria;
• Somatic diseases complicated by dysbiosis resulting from the use of antibiotics, chemotherapy, and other causes;
• Complex treatment of weakened children with diseases of infectious and non-infectious etiology, accompanied by dysbiosis and atopic dermatitis;
• Chronic colitis of various etiologies, including nonspecific ulcerative colitis.

For diseases of the female genital area

• For sanitation of the genital tract in nonspecific inflammatory diseases of the genitals and for prenatal preparation of pregnant women in the “risk” group with violations of the purity of vaginal secretion up to III-IV degree.

ICD codes

Dosage Regimen

Lyophilisate

Lactobacterin for intestinal diseases is used orally, and in obstetric-gynecological practice – intravaginally.

Dissolve the contents of the vial with boiled water at room temperature at the rate of 5 ml (a teaspoon) of water per 1 dose of the drug.

Dissolve as follows: pour the required amount of water into a glass (according to the number of doses indicated on the vial); open the vial by removing the cap and stopper; transfer a small amount of water from the glass into the vial; after dissolution (the drug dissolves in no more than 5 minutes, forming a homogeneous whitish-gray or yellowish-beige suspension), transfer the contents of the vial into the same glass and mix. One teaspoon of the drug dissolved in this way constitutes 1 dose.

For intestinal diseases, the drug should be taken 40-60 minutes before meals and preferably washed down with milk. Treatment is recommended to be accompanied by the use of vitamins.

For intestinal diseases, Lactobacterin is used in the following daily doses

The course of treatment with Lactobacterin for various diseases is

A) for protracted and chronic course of dysentery, post-dysenteric colitis, convalescent treatment after acute intestinal infections, as well as for prolonged intestinal dysfunction of unknown etiology – at least 4-6 weeks;

B) for nonspecific ulcerative colitis, as well as chronic colitis and enterocolitis – up to 2 months;

C) for dysbiosis of various etiologies – 3-4 weeks.

If there is no effect from the use of the drug for 2 weeks, it is necessary to re-examine the microflora of the gastrointestinal tract and correct it with other drugs depending on the result obtained.

To consolidate the obtained clinical effect or in the absence of complete normalization of microflora after the end of the course of treatment, for diseases occurring with relapses, repeated courses of treatment are advisable. In these cases, before prescribing the drug, a repeated examination of the microflora is necessary. Maintenance doses of the drug (half the daily dose) are prescribed after 2-3 weeks for 1-1.5 months.

For inflammatory diseases of the genitals, Lactobacterin is prescribed at 5 doses 2 times a day intravaginally for 10-12 days, starting from the 10-12th day of the menstrual cycle. For prenatal preparation of pregnant women in the “risk” group, Lactobacterin is prescribed at 5 doses once a day for 5-8 days.

For intravaginal use, dissolve the contents of the vial in 5-10 ml of boiled water at room temperature, soak a sterile tampon with the dissolved drug, insert the tampon into the vagina and leave for 2-3 hours.

Treatment should be carried out under the control of the restoration of the purity of vaginal secretion to I-II degree, the appearance of lactoflora and the disappearance of clinical symptoms of the disease.

Suppositories

Administered orally, administered intravaginally.

The dose is set individually, depending on the indication, method of application, patient’s age, treatment regimen.

In children and adolescents under 18 years of age, this agent should be used in dosage forms intended for the corresponding age group.

Adverse Reactions

Reaction to the administration of the drug has not been identified.

Contraindications

• Vulvovaginal candidiasis.

Use in Pregnancy and Lactation

Permitted.

Special Precautions

Precautions for use.

The dissolved drug must not be stored. The drug is unsuitable for use if the integrity of the packaging is compromised (cracked vials), the drug without labeling, the drug with changed physical properties (change in color, shrinkage of biomass), in the presence of foreign inclusions.

Influence on the ability to drive vehicles and mechanisms

None.

Overdose

Not registered.

Drug Interactions

Due to the high antibiotic resistance of lactobacilli, the use of Lactobacterin during antibiotic therapy is allowed.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature not exceeding 10°C (50°F). Keep out of reach of children.

Shelf Life

The shelf life of the drug is 1 year (with a content of at least 2×10⁹ live lactobacilli per dose); 2 years (with a content of at least 4×10⁹ live lactobacilli per dose).

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.