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Lactobacterin lyof d/susp. for oral and topical administration, approx. 5dz N10

Registration Certificate Holder

NPO MICROGEN (Russia)

Dosage form

Medicinal product - Lactobacterin dry (Lactobacterin dry)

Description

Tablets
1 tab.
Lactobacillus acidophilus 4000000000 CFU

3 doses - bottles (10) - cardboard packs. 5 doses - bottles (10) - cardboard packs.

Indications

For diseases of the gastrointestinal tract:

convalescents who have suffered acute intestinal infections, in the presence of intestinal dysfunction or the release of pathogenic and opportunistic bacteria;
somatic diseases complicated by dysbiosis resulting from the use of antibiotics, chemotherapy and other reasons;
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 sanitization of the genital tract in case of nonspecific inflammatory diseases of the genitals and prenatal preparation of pregnant women at risk with violations of the purity of vaginal secretions up to the III-IV degree.

Contraindications for use

vulvovaginal candidiasis.

pharmachologic effect

The therapeutic effect of the drug is due to the antagonistic effect of lactobacilli in relation to pathogenic and opportunistic 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.

Drug interactions

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

Dosage regimen

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

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

Dissolution is carried out as follows: pour the required amount of water into a glass (in accordance with the number of doses indicated on the bottle); open the bottle by removing the cap and stopper; transfer a small amount of water from the glass into the bottle; after dissolution (the drug dissolves in no more than 5 minutes to form a homogeneous suspension of whitish-gray or yellowish-beige color), transfer the contents of the bottle into the same glass and mix. One teaspoon of the drug dissolved in this way is 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:

Age Dose

Up to 6 months 3 doses 2 times a day From 6 months to 1 year 3 doses 3 times a day From 1 to 3 years 5 doses 2 times a day Over 3 years and adults 5 doses 2-3 times a day

The course of treatment with Lactobacterin for various diseases is:

a) for protracted and chronic dysentery, post-dysenteric colitis, after-treatment of convalescents after acute intestinal infections, as well as for long-term intestinal dysfunction of unknown etiology, treatment - at least 4-6 weeks;

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

c) for dysbacteriosis of various etiologies - 3-4 weeks.

If there is no effect from using 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 the microflora after the end of the course of treatment, for diseases that occur with relapses, repeated courses of treatment are advisable. In these cases, before prescribing the drug, a repeated study of the microflora is necessary. Maintenance doses of the drug (half the daily dose) are prescribed every 2-3 weeks for 1-1.5 months.

For inflammatory diseases of the genitals, Lactobacterin is prescribed 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 at risk, Lactobacterin is prescribed 5 doses once a day for 5-8 days.

How the drug works

Lactobacterin has a detrimental effect on pathogenic and conditionally pathogenic microbes, including staphylococcus, E. coli, Proteus, and Shigella. Thanks to this, the medicine restores the imbalance in the microbiocenosis of the digestive system and vagina.

Also this drug:

help improve metabolic processes;
serve to prevent the transition of intestinal diseases to a chronic form;
increases the body's innate resistance to the invasion of infectious agents.

After entering the body, lactobacilli:

promote the formation of lactic acid and hydrogen peroxide;
trigger the production of lysozyme and other substances that resemble antibiotics in their activity;
help the absorption of vitamins;
normalize and help maintain the balance of the bacterial flora of the vagina.

In what cases is Lactobacterin prescribed?

The instructions for Lactobacterin contain an extensive list of indications. First of all, these are pathologies of the digestive system associated with an imbalance in the intestinal microflora in patients without age restrictions. The drug is also successfully used in the treatment of diseases of the female reproductive system caused by an imbalance in the vaginal microflora.

For gastrointestinal diseases Lactobacterin is used for:

normalizing the intestinal microflora after an acute intestinal infection or food poisoning in cases where there are symptoms of intestinal malfunction or pathogenic or conditionally pathogenic flora is released in the biomaterial;
therapy for intestinal dysbiosis resulting from long-term use of antibiotics, hormones, or undergoing a course of treatment for cancer;
treatment of chronic colitis;
treatment of infectious and non-infectious diseases, which are accompanied by intestinal dysbiosis and skin manifestations, in children whose body is weakened.

In gynecology, Lactobacterin is prescribed to restore the microflora of the external genitalia after a course of antibiotics for bacterial vaginosis, in the treatment of inflammation of a non-infectious nature. Suppositories are also indicated for:

preparation for surgical interventions or special diagnostics of gynecological pathologies;
carrying out infection prevention after childbirth or after gynecological operations;
prenatal preparation of women at risk and having 3 or 4 degrees of smear purity.

How to use Lactobacterin suppositories

The regimen for using suppositories depends on the indications for use:

to normalize vaginal microflora after taking antibiotics, treat non-infectious inflammations - five doses twice a day for 10-12 days;
to prevent the development of infections after childbirth or gynecological operations, during prenatal preparation - 5 doses once a day for a course of 7-8 days.

At the end of the course of treatment, a smear on the flora to determine the effectiveness of treatment.

The use of probiotics for liver diseases

Hepatic encephalopathy

Hepatic encephalopathy is a common complication of chronic liver diseases, which is brain dysfunction due to liver failure and/or portosystemic shunting and manifests itself in a wide range of neurological and mental disorders (from subclinical manifestations to coma). The main drugs for the treatment of hepatic encephalopathy are non-absorbable disaccharides (lactulose) and antibiotics (rifaximin).

Interest in the use of probiotics for hepatic encephalopathy is associated with the scientific data accumulated to date on the significant role of intestinal microbiota in the pathogenesis of liver diseases. It is known that long-term intestinal dysbiosis, especially bacterial overgrowth syndrome, leads to the development of non-alcoholic steatosis and steatohepatitis, intrahepatic intralobular cholestasis, as well as functional disorders of the extrahepatic biliary tract [47].

The possibilities of influencing the intestinal microflora are being actively studied today, but are still quite limited. Most studies are devoted to dietary correction, the effects of pre- and probiotics. The most complete evidence base regarding the use of probiotics in hepatic encephalopathy is presented in the recently published Cochrane review (2017) [48].

The review authors summarized RCTs published up to and including June 2016 that examined any probiotic at any dose compared with placebo, no intervention, or any other treatment in patients with any degree of acute or chronic hepatic encephalopathy.

A total of 21 RCTs were included in the review ( n

=1420). Of these, 14 compared probiotics with placebo or no treatment, and 7 with lactulose. The duration of treatment ranged from 10 to 180 days. The most commonly used probiotic was VSL#3.

Compared with placebo or no intervention, probiotics had no effect on mortality (7 RCTs; n

=404; RR 0.58; 95% CI 0.23–1.44).

Incomplete resolution of hepatic encephalopathy symptoms was less common among patients treated with probiotics (10 RCTs; n

=574;
RR 0.67; 95% CI 0.56–0.79). Compared with no treatment, patients with minimal hepatic encephalopathy who received a probiotic were less likely to develop clinically overt encephalopathy (10 RCTs; n
=585; RR 0.29; 95% CI 0.16–0.51), but there was an effect on the incidence hospitalizations and treatment refusals/changes were uncertain. Compared with no treatment, probiotics improved quality of life, but this finding is based on three trials with low quality evidence.

Patients treated with probiotics had lower plasma ammonia levels than those without treatment (10 RCTs; n

=705; mean difference 8.29 mmol/L; 95% CI 13.17–3.31).

All RCTs comparing probiotics with lactulose were of very low quality, and the comparison results were not statistically significant for all endpoints studied: all-cause mortality (2 RCTs; n

=200;
OR 5.0; 95% CI 0.25—102.00); incomplete resolution of symptoms (7 RCTs; n
= 430; RR 1.01; 95% CI 0.85–1.21);
complications associated with the development of clinically obvious hepatic encephalopathy (6 RCTs; n
= 420; RR 1.17; 95% CI 0.63-2.77);
number of hospitalizations (1 RCT; n
= 80; RR 0.33; 95% CI 0.04–3.07);
drug intolerance leading to treatment discontinuation (3 RCTs; n
= 220; RR 0.35; 95% CI 0.08–1.43);
treatment change/discontinuation (7 RCTs; n
=490; RR 1.27; 95% CI 0.88–1.82);
quality of life (1 RCT; n
=69);
plasma ammonia concentration (6 RCTs; n
= 325; mean difference –2.93 mmol/L; 95% CI 9.36–3.50).

Based on the results of the review, the authors concluded that, compared with placebo or no intervention, the use of probiotics in patients with hepatic encephalopathy improves recovery, prevents the development of clinically overt hepatic encephalopathy, improves quality of life and leads to a decrease in plasma ammonia concentrations, but little or nothing. does not affect mortality. The benefit of probiotics over lactulose in hepatic encephalopathy cannot be assessed due to the very low quality of the available evidence. To clarify the true effectiveness of probiotics in hepatic encephalopathy, high-quality RCTs that meet the standards of their implementation and reporting of results are needed.

Non-alcoholic fatty liver disease

Non-alcoholic fatty liver disease (NAFLD) is a disease or spectrum of diseases resulting from excess accumulation of fats (mainly triglycerides) in the liver with the development of steatosis affecting more than 5% of hepatocytes, in the absence of alcohol consumption in toxic doses, the use of steatogenic drugs or congenital violations [49]. NAFLD is a multisystem disease that increases the risk of type 2 diabetes mellitus (T2DM), cardiovascular disease, chronic kidney disease, osteoporosis and hypogonadism [50]. Currently, the incidence of NAFLD is increasing worldwide, making it the most common form of liver damage among the population of industrialized countries. NAFLD can occur in various forms from hepatic steatosis to steatohepatitis and cirrhosis, and is also one of the causes of the development of hepatocellular cancer [51].

As with hepatic encephalopathy, interest in the use of probiotics in NAFLD is associated with scientific evidence of the significant role of the intestinal microbiota in the pathogenesis of liver diseases. Recent publications also indicate a potential role of microbiota in the development of NAFLD. Because the liver and intestine are anatomically connected through the hepatic portal system, the intestinal microflora and its metabolic byproducts can influence liver pathology [52]. In this regard, probiotics have been proposed as a treatment option for NAFLD due to their modulating effects on the microbiota. The intestinal microbiota exerts its effect through the formation of insulin resistance, influence on the metabolism of lipids, proteins and carbohydrates and the induction of obesity, as well as hepatotoxic bacterial products such as ethanol [53].

In 2007, the results of a Cochrane systematic review on the effects of probiotics and synbiotics on obesity, insulin resistance, T2DM and NAFLD were published [54]. The authors systematically searched for RCTs examining the use of probiotics in NAFLD among publications available in five databases up to May 2006, without restrictions on age or language. Selection criteria included RCTs evaluating treatment of NAFLD with probiotics at any dose, duration, regardless of route of administration, compared with no intervention, placebo or other methods.

As a result, no RCTs that met the inclusion criteria were found. Preliminary data from two non-randomized pilot studies suggested that probiotics may be well tolerated, improve liver function tests, and reduce levels of lipid peroxidation markers. The authors concluded that due to the lack of RCTs, it is not possible to either support or refute the benefit of probiotics in patients with NAFLD.

Since the publication of this systematic review, at least 5 RCTs have been conducted to date. In a placebo-controlled RCT, R. Aller et al. [55] studied the effect of probiotics L. bulgaris

and
S. thermophilus
on various parameters of liver function and risk factors for cardiovascular diseases. The results of the RCT showed that the study probiotics, compared with placebo, led to a decrease in the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (γ-GTP), and therefore the authors concluded that probiotics have a positive effect on liver function.

L. acidophilus over 8 weeks.

La5 and
B. lactis
Bb12 (
n
=36), with regular yogurt (
n
=36) in patients with NAFLD. Bb12 consumption resulted in decreased serum levels of ALT, AST, triglycerides, and low-density lipoprotein cholesterol [56].

Later A. Alisi et al. [57] published the results of an RCT that compared the effects of VSL#3 ( n

=22) and placebo (
n
=22) on the severity of fatty liver disease (according to ultrasound) in children with NAFLD. Treatment was carried out for 4 months. Children taking VSL#3 showed a significant reduction in the severity of fatty liver disease and body mass index. These data, according to the authors of the RCT, indicate that the use of VSL#3 may improve the severity of fatty liver disease and, therefore, prevent the progression of NAFLD.

In an RCT, P. Vajro et al. [58] showed that in obese children with NAFLD, taking the probiotic L. rhctmnosus

GG is associated with a significant reduction in serum peptidoglycan polysaccharide antibody titers, which are an indirect indicator of the severity of small intestinal bacterial overgrowth syndrome. In addition, in the group receiving the probiotic, there was an improvement in liver function in the form of a decrease in ALT.

Also, a placebo-controlled RCT by A. Sepideh [59] showed a positive effect of probiotics on glycemic (glucose, insulin, insulin resistance) and inflammatory (TNF-α and IL-6) parameters in patients with NAFLD.

The results of these 5 RCTs add little to the conclusions of the authors of the 2007 Cochrane review, since all of these studies examined indirect (surrogate) endpoints (measures of liver function, etc.), rather than clinically significant outcomes such as mortality, development of coronary heart disease, T2DM, chronic renal failure, etc.

Thus, given the current evidence base, it is impossible to draw a conclusion either for or against the use of probiotics in NAFLD.